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THE JPO SIX-MONTH STUDY-CUM-RESEARCH FELLOWSHIP PROGRAM FOR FY 2015
FINAL REPORT
Toward the Improvement of IP Policy and Examination Guidelines
for Biotechnological and Plant Related Inventions in the
Philippines: Lessons from Japan
By Ramil R. Llantos IPRS II
Intellectual Property Office of the Philippines (IPPHL)
Supervised by
Dr. Yorimasa Suwa, Senior Researcher, APIC, JIPII
Advisers
Associate Professor Koichi Sumikura
National Graduate Institute for Policy Studies (GRIPS)
Professor Setsuko Asami
Tokyo University of Science
In Coordination with
Asia-Pacific Industrial Property Center (APIC)
Japan Institute for Promoting Invention and Innovation (JIPII)
November 4, 2015 - March 31, 2016
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Acknowledgement
First and above all, I would like to thank GOD ALMIGHTY for, without His graces and blessings, I will not make it
through with this research study.
I would like to express my deepest gratitude to the following institutions for without their support this
fellowship program will not be possible:
The Japan Patent Office (JPO)
The Intellectual Property Office of the Philippines (IPOPHL)
The Asia Pacific Industrial Property Center (APIC)
The Japan Institute for Promoting Invention and Innovation (JIPII)
I wish to present my sincerest appreciation to Dr. Yorimasa Suwa , Senior Researcher of APIC/JIPII, who
serves as my supervisor and patiently guiding me during my research.
I sincerely thank Associate Professor Koichi Sumikura of GRIPS and Professor Setsuko Asami of Tokyo
University of Science whose valuable suggestion and constructive criticism have contributed to my ideas on the
project.
I am very much thankful to the following interviewees for sharing their expertise:
Ms. Yumiko Matsunami and Mr. Hajime Kamijo, JPO
Mr. Tomohiro Kamogawa, Mr. Eijiro Nakata, Mr. Kiyoshi Watanabe and Mr. Keisuke Kondo, SAKATA SEED
Co.
Mr. Kazuaki Nakashima and Mr. Shinichi Inoue, Japan Patent Attorneys Association (JPAA)
Mr. Takashi Fujita and Mr. Koji Kanazawa, Hiraki & Associates
Mr. Hiromitsu Watanabe, Mitsubishi UFJ Research and Consulting
Ms. Akiko Nagano, Ministry of Agriculture, Forestry and Fishery (MAFF)
Mr. Hajimu Morioka, National Institute of Genetics (NIG)
I would like to express my special gratitude and thanks to all the staff members of APIC-JIPII particularly Ms.
Asako Watanabe, Ms. Satoko Miyazaki, Ms. Michiko Hiyama and Mr. Takao Ogiya who serves as my family in
Japan.
I would also like to extend my gratitude to the IPPHL Officials:
Dir. Epifanio M. Evasco, Director Bureau of Patents
Atty. Lolibeth R. Medrano, Asst. Director Bureau of Patents
Ms. Gloria T. Salvado, Division Chief, MSBED
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Immeasurable appreciation to Ms. Indra Rathakrisnan of MyIPO for encouragement, support and sharing her
culture and knowledge and for being my “little sister” in Japan.
Finally, to my caring, loving, and supportive wife, Eileen, my children, Raphael and Eira, my mother Remedios,
my extended family: my deepest gratitude. Your encouragement when the times got rough are much
appreciated and duly noted. I love you guys!
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Abstract
Problems of patent examiners in IPPHL were dealing on proper approach to patent applications concerning
different subject matters in biotechnology and its examination. Rules and regulations governing biotechnology
in the Philippine patent practice has to be amended and give further details about.
IP Philippines have uttered Biotechnology has rising patent application filings, hence, making it as one of the
top priorities for examination. Mounting the bureau's workload, identifying training needs through patent
examination reviews and guidelines should center on practices to new specific trainings particularly in
biotechnology. In some general notions of the national laws, e.g. hinged on international patent and
conventions, have bent doubts concerning the protection of biotechnological and certain microbiological
inventions, while synchronization is necessary to clarify the said doubts.
The methodology used in this research involves gathering relevant data from the specified documents,
observations and interpretation of information from different publicly available materials. To be able to confirm
and verify the reliability and accuracy of information available from the collected data and published documents,
the researcher conducted selected interviews employing a guided questions methodology. The interviews are
divided into 2 main target groups: Plant Patent Experts and Plant Variety Protection Experts.
Results of the analysis from the relevant data collected from specified documents and results of the
interview sessions were used in implementing and making proposals to the Philippines. The study on the
differences or similarities in the implementation and application of appropriate and relevant legislative patent
provisions in patent examination practices between the Philippines and Japan encourages support for current
and future revisions of the implementing Rules and Regulations in the field of biotechnology. By introducing
conceptual aspects of the Japanese patent system as a model will provide a perspective on how to handle
applications in biotechnology specifically plant related inventions.
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Table of Contents
Acknowledgement......................................................................................................................................................i
Abstract....................................................................................................................................................................iii
List of Figures............................................................................................................................................................iv
List of tables..............................................................................................................................................................iv
List of Acronyms........................................................................................................................................................v
Chapter 1. Introduction............................................................................................................................................1
Chapter 2. Basic Information and Previous Studies.................................................................................................4
2.1. Summary of Legislative Provisions - The Philippines..........................................................................................4
2.1.1. Intellectual Property Protection in the Philippines.........................................................................................4
2.1.2. Provisions in the Intellectual Property Code of the Philippines (R.A. 8293)...................................................9
2.1.3. Provisions in the Plant Variety Protection Act of 2002 (PVP) (R.A. 9168).....................................................10
2.2. Summary of Legislative Provisions - Japan.......................................................................................................12
2.2.1. Intellectual Property Protection in Japan......................................................................................................13
2.2.2. Provisions in the Japan Patent Law...............................................................................................................13
2.2.3. Provisions in the Seeds and Seedlings Act of Japan......................................................................................15
2.3. Previous Studies...............................................................................................................................................16
Chapter 3. Methodology of this Study...................................................................................................................25
3.1. Comparative Analysis of the Legislative Provisions: The Philippines & Japan..................................................25
3.1.1. Collecting Information...................................................................................................................................25
3.1.2. Comparative Analysis....................................................................................................................................25
3.2. Case Studies (Examination Practices): The Philippines and Japan....................................................................25
3. Interviews of Relevant Persons in Japan.............................................................................................................26
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Chapter 4. Results and Analysis.............................................................................................................................31
4.1. Observations from the Relevant Documents...................................................................................................31
4.2. Summary of the Interviews..............................................................................................................................32
4.2.1. Interview to Biotechnology Division, Third Examination department, Japan Patent Office
(JPO)........................................................................................................................................................................32
4.2.2. Interview to the IP Committee on Agriculture and Fisheries in Japan Patent Attorneys Association
(JPAA)......................................................................................................................................................................35
4.2.3. Interview to SAKATA SEED Co.......................................................................................................................37
Chapter 5. Implications and Recommendations to the Philippines......................................................................40
5.1. Policy Making...................................................................................................................................................40
5.2. The Examination Guidline................................................................................................................................40
5.3. Committee for Making the Policy....................................................................................................................41
5.4. Human Resource Development.......................................................................................................................41
5.5. Issues in the Future..........................................................................................................................................42
References..............................................................................................................................................................44
Appendix: Minutes of the interviews....................................................................................................................47
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List of Figures
Figure 1: Number of Filed Biotechnology Applications in IPOPHL ............................................................................6
Figure 2: Number of Granted Biotechnology Applications in IPOPHL ......................................................................7
Figure 3: Number of PVP Applications Filed in the Philippines ..............................................................................10
Figure 4: Number of PVP Applications Granted in the Philippines .........................................................................10
Figure 5: Critical Differences between Plant Variety Protection and Patent Protection .......................................10
List of Tables
Table 1: Top Patent Applicants of 2015 in IPOPHL .................................................................................................8
Table 2: Top Countries of Origin for Patents in 2015 ..............................................................................................9
Table 3: Comparison between protection of an invention by patent and protection of a variety by plant variety
protection ..........................................................................................................................................................29
Table 4: Comparison of the scope of protection in the UPOV Convention and the Agreement on Trade-Related
Aspects of Intellectual Property Rights .............................................................................................................31
Table 5: Patent eligible subject matter for GM plants internationally ...................................................................35
Table 6: Availability of patent protection for non-GM plants and methods for their production, and for plant
varieties .............................................................................................................................................................39
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List of Acronyms APIC Asia-Pacific Industrial Property Center
CBD Convention on Biological Diversity
CGRFA Commission on Genetic Resources for Food and Agriculture
COP Conference of the Parties
DUS Testing Distinctness Uniformity and Stability Testing
EC European Commission
EU European Union
FAO Food and Agriculture Organisation of the United Nations
GATT General Agreement on Tariffs and Trade
IT-PGRFA International Treaty on Plant Genetic Resources for Food and Agriculture
IPOPHL Intellectual Property Office Philippines
IPR Intellectual Property Right
JIPII Japan Institute for Promoting Invention and Innovation
JPAA Japan Patent Attorneys Association
JPO Japan Patent Office
LMOs Living Modified Organisms
MAFF Ministry of Agriculture, Forestry and Fisheries of Japan
MAT Mutually Agreed Terms
MS Multilateral System
MTA Material Transfer Agreement
NCSS National Center for Seeds and Seedlings
NGO Non-Governmental Organization
PGRFA Plant genetic resources for food and agriculture
PVP Plant Variety Protection
TRIPS Agreement on Trade-Related Aspects of Intellectual Property Rights
WIPO World Intellectual Property Organisation
WTO World Trade Organisation
UNCED United Nations Conference on Environment and Development
UPOV International Union for the Protection of New Varieties of Plants
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CHAPTER 1. Introduction
Biotechnology can be considered as one of the key industries in the future. After information technology,
biotechnology is increasingly recognized as the next wave in the knowledge-based economy. Advancement in
the field of molecular biology, biotechnology and molecular medicine has emphasized the potential of
biotechnology for the plant and pharmaceutical industry (Burrone, 2006).
The advancement in Biotechnology field is rapidly changing the industry but returns on investments may be
slow. For this reason, it is vital for public research organizations and enterprises to protect the innovation that
they generate with. Granting monopoly to the owners for a certain period of time in the form of Intellectual
Property Rights (IPR), can provide a basis for return on investment in research and development. (European IPR
Helpdesk, 2014).
Latest advances in agricultural biotechnology have enabled the field of plant biology to move forward in
great strides. In particular, latest breakthroughs in plant genomics, crop science and molecular biology, have
brought about a paradigm shift of thought regarding the manner by which plants can be used both in agriculture
and in medicine (Hefferon, K., 2010).
The world where the population is continuing to increase, there has been a need to develop crop plants for
increased productivity, improved quality and to satisfy changing human preferences. Plant biotechnology can
bolster plant-breeding efforts to meet these new challenges in a sustainable way (Pua, E.C. & Davey, M.R., 2007).
IP Philippines have uttered Biotechnology has rising patent application filings, hence, making it as one of the
top priorities for examination. Mounting the bureau's workload, identifying training needs through patent
examination reviews and guidelines should center on practices to new specific trainings particularly in
biotechnology. In some general notions of the national laws, e.g. hinged on international patent and
conventions, have bent doubts concerning the protection of biotechnological and certain microbiological
inventions, while synchronization is necessary to clarify the said doubts.
A plant biotechnology patent allows the patent holder to exclude others from making, using, selling, or
importing the patented invention for a limited period of time. The scope and reach of biological patents vary
among jurisdictions, and may include biological technology and products, genetically modified
organisms and genetic material.
Patent applications filed in the Philippines may be eligible for a patent as provided in R.A. 8293, however the
application must adhere to a set of requirements for patentability, i.e. the invention must contain a patentable
subject matter; the invention must be fully disclosed; new or novel, involve an inventive step and be industrially
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applicable. Philippine-filed patent applications are evaluated in accordance with the Intellectual Property Code
of the Philippines (R.A. 8293) and with the Philippines’ Implementing Rules and Regulations for Patents, Utility
Models and Industrial Designs; likewise, the IPOPHL’s Manual of Substantive Examination Procedure (MSEP),
which is a ‘general reference guide’ for patent examination, is referred to in the assessment of patent
applications.
Certain concepts in the national laws based upon international patent and conventions have created
uncertainty regarding the protection of plant biotechnological and certain microbiological inventions, whereas
harmonization is necessary to clarify the said uncertainties.
Problems of patent examiners in our country were dealing on proper approach to patent applications
concerning different subject matters in biotechnology and its examination. Rules and regulations governing
biotechnology in the Philippine patent practice has to be amended and give further details about.
Despite significant variation in the field of biotechnology, patent examiners share similar concerns, including:
low diversity of the examining body, growing demands of an expanding applications, constant challenges of
institutional change, continuing education burnout, challenges of teaching and learning, and maintenance of
institutional identity within a rapidly changing world.
One of the most critical issues facing the patent system today, in our country and globally, is the need for
harmonization of patent laws and procedures, and the need for work-sharing among patent offices to deal with
overwhelming workloads. There may not be enough information in my present setting to make inquiries to an
ongoing effort towards work-sharing with patent offices abroad and ultimate harmonization on patent laws and
procedures.
Without a concrete, clear cut policy on how to handle applications concerning biotechnology, there will be
no uniformity on how to tackle this kind of claims. The patent applications will be examined on a different
approach and vary from one Patent Examiner to the other. With the possibility of having different opinions on
the case.
Patent practice was developed and designed from researched agenda with practitioners who examine patent
applications. Trainers/examiners with extreme experience and insightful thoughts to give clear advice on patent
examination were inadequate. Focused training workshops were limited from practical examples and exercises.
Group discussions for sharing understanding of the strategies, methods, techniques and principles were less
involved.
Hence, this study will focus on the patentability requirements in search and substantive examination in the
field of plant biotechnology, such as the basics in genetic engineering, DNA technology, sequencing,
biotechnology in industry, application of technology, biological process of microbes plants cells in use for
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humans, how life sciences involving living organisms or biological techniques provide chemicals, e.g. drugs, food
and services meet the needs of humans. Likewise, the study would be able to identify the best practices that will
be most helpful in formulating concrete guidelines for patent examination in the field of Plant Biotechnology.
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CHAPTER 2. Basic Information and Previous Studies
1. Summary of Legislative Provisions - The Philippines
It is a State policy of the Philippines to protect and promote intellectual property rights. This policy was
preserved both in the 1973 Constitution which provides that “the exclusive right to inventions, writings and
artistic creations shall be secured to inventors, authors, and artists for a limited period” and in the 1987
Constitution which clearly mandates that the State shall protect intellectual property. (Chan Robles Virtual Law
Library, (n.d.)).
An effective intellectual and industrial property system is important to the development of domestic and
creative activity, facilities transfer of technology, attracts foreign investments, and ensures market access for
our products. It shall protect and secure the exclusive rights of scientists, inventors, artists and other gifted
citizens to their intellectual property and creations, particularly when beneficial to the people, for such periods.
The Intellectual Property Code of the Philippines was created by virtue of Republic Act No. 8293, which took
effect on January 1, 1998 under the presidency of Fidel V. Ramos.
As early as 1930’s the Philippines have implemented some form of intellectual property protection early on
in the history through its Penal Code and Japan in 1885 through a patent ordinance. There have been a lot of
amendments and ‘modernization’ for the protection of intellectual property through patents and among other
intellectual property rights during the course of both laws.
The Philippines and Japan continues to provide and implement the standards of protection for inventions
through patents as set in each country’s respective national laws, i.e. the Intellectual Property Code of the
Philippines (R.A. 8293 of 1997 Part II: The Law on Patents, as amended by R.A. 9502 of 2008) and the Japan
Patent Law Japan (of 1959, as amended by Law No. 36 of 2014).
In the Philippines, laws for the protection of intellectual property are stated in the Intellectual Property Code
of the Philippines (R.A. 8293 of 1997). Some of the provisions of the IP Code of the Philippines includes (1) laws
on patents, (2) laws on trademarks, service marks and trade names, and (3) laws on copyright.
1.1. Intellectual Property Protection in the Philippines
There are no plant patents in the Philippines. If the technical feasibility of an invention concerning a plant or
animal is not confined to a particular plant or animal variety, such an invention shall be patentable. Therefore, a
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claim wherein specific plant varieties are not individually claimed is not excluded from patentability even though
it may embrace plant varieties. The country achieved compliance with its obligations under the WTO-TRIPS
agreement on June 2007 with the passage of Republic Act 9168, otherwise known as the Plant Variety
Protection Act of 2002 (PVPA).
Because the process, products, and genetic materials used in biotechnology R&D have proprietary
considerations, issues of intellectual property protection by patents and plant variety protection (PVP) arises.
The present Intellectual Property Code of the Philippines allows the patenting of microorganisms, but not plants
and animals. Plant varieties will be protected by sui generis mechanism of the PVP. The challenge is for the
country to strengthen its IPR laws to provide protection to researchers, discoverers, and investors.
Figure 1. Number of Filed Biotechnology Applications in IPOPHL (Source: Bureau of Patents, IPOPHL)
Figure 2. Number of Granted Biotechnology Applications in IPOPHL (Source: Bureau of Patents, IPOPHL)
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Table 1. Top Patent Applicants of 2015 in IPOPHL (Source IPOPHL Website)
COUNTRY
APPLICANT/OWNER
COUNT OF INVENTION
APPLICATIONS
CH - Switzerland NESTEC S.A. 63
US - United States of Amer. COLGATE-PALMOLIVE 56
US - United States of Amer. QUALCOMM 54
CH - Switzerland NOVARTIS AG 50
KR - Rep. of Korea SAMSUNG ELECTRONICS 50
US - United States of Amer. DOW AGROSCIENCES LLC 46
CH - Switzerland F. HOFFMANN LA ROCHE 38
US - United States of Amer. ABBOTT LABORATORIES 36
CH - Switzerland PHILIP MORRIS PRODUCTS 36
DE - Germany Fed. Rep. Bayer Pharma 29
SE - Sweden TELEFONAKTIEBOLAGET L 29
The Philippines is a regional biotechnology leader and a model for science-based Genetic Engineering
regulatory policy. The country was poised to be the first Southeast Asian country to commercialize locally
developed GE crops had it not been for a 2012 court decision postponing approval of the already completed Bt
eggplant field trials. The case has been elevated to the Philippine Supreme Court which has yet to issue a
decision. According to experts, further delays in commercializing
Philippine GE research are expected to erode the country’s GE regional leadership status, and in general
terms, may dapen the long term competitiveness of Philippine agriculture (Corpuz, P., 2015).
The Philippines was the first to cultivate GE crops commercially in the region (2003). GE corn has been on
sale in the country since 2003 and in 2014 comprised 26 percent of total corn area. Bt eggplant has completed
most pre-commercialization requirements and Golden rice is in the testing stage (Corpuz, P., 2015).
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Table 2. Top Countries of Origin for Patents in 2015 (Source IPOPHL Website)
COUNTRY FILINGS % OF TOTAL FILINGS
US – United States of America 1,107 29.79%
JP – Japan 660 17.76%
PH – Philippines 364 9.80%
CH-Switzerland 309 8.32%
DE – Germany Federal Republic 178 4.79%
KR – Republic of Korea 172 4.63%
GB – Great Britain 83 2.23%
FR – France 76 2.05%
NL – Netherlands 72 1.94%
CN – Peoples China 66 1.78%
SE – Sweden 52 1.40%
Patent applications filed in the Philippines may be eligible for a patent, however the application must comply
to a set of requirements for patentability, i.e. the invention must contain a patentable subject matter; the
invention must be fully disclosed; new or novel, involve an inventive step and be industrially applicable.
Philippine-filed patent applications are evaluated in accordance with the Intellectual Property Code of the
Philippines (R.A. 8293) and with the Philippines’ Implementing Rules and Regulations for Patents, Utility Models
and Industrial Designs; likewise, the IPOPHL’s Manual of Substantive Examination Procedure (MSEP), which is a
‘general reference guide’ for patent examination, is referred to in the assessment of patent applications
(Lamasan, J.O., 2013).
In Philippine patent laws, apart from voluntary licenses, both laws (R.A. 165 and R.A. 8293) afford the grant
of compulsory licenses based on specific conditions, i.e. when the patent “relates to food or medicine or is
necessary for public health or public safety”(R.A. 165, 1947) and “where the public interest, in particular,
national security, nutrition, health or the development of other vital sectors of the national economy as
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determined by the appropriate agency of the Government, so requires”(R.A. 8293, 1997); in addition, provision
on the “Use of Invention by Government” was provided in R.A. 8293 for similar conditions.
On the other hand, RA 9168 or the Plant Variety Protection Act of 2002 is aimed at protecting and securing
the exclusive rights of plant breeders with respect to their new plant variety, particularly when advantageous to
people, through an effective intellectual property system. Under the PVP system, a plant breeder could apply for
a PVP certificate over a new plant variety from the National Plant Variety Protection Board.
Figure 3. Number of PVP Applications Filed in the Philippines (Source Phil. Plant Variety Protection Office)
Data as of September 18, 2015.
Figure 4. Number of PVP Applications Granted in the Philippines (Source Phil. Plant Variety Protection Office)
Data as of September 18, 2015.
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A certificate and ownership rights would be given to the plant breeder if the plant variety has passed the test
of distinctness, uniformity, stability, and newness. Holders of a certificate of plant variety would have the right
to authorize the production or reproduction, conditioning for the purpose of propagation, offering to sale,
selling or other marketing strategies, exporting, importing and stocking of the plant variety. The traditional
rights of the farmer to save, use, replant and sell his produce from a protected variety, provided that
propagation is not being done for commercial purposes has been acknowledged in the PVP.
1.2. Provisions in the Intellectual Property Code of the Philippines (R.A. 8293)
PATENTABLE SUBJECT MATTER
Patentable subject matter relates to an invention which is a product, process or improvement in all fields of
technology which is new, involves an inventive step and is industrially applicable. It does not explicitly indicate in
the law that useful effect or technical progress are required, however valuable end result created from
experimentation are essential to reinforce the patentability of the invention.
Section 21 (Patentable Inventions) Intellectual Property Code of the Philippines (R.A. 8293, as amended by R.A.
9502): “Any technical solution of a problem in any field of human activity which is new, involves an inventive step
and is industrially applicable shall be patentable. It may be, or may relate to, a product, or process, or an
improvement of any of the foregoing” (R.A. 8293, 1997).
BIOLOGICAL INVENTIONS
Biological materials (e.g. microorganisms or ‘treated’ seeds) that are capable of self-reproduction or are capable
of being reproduced in a biological system are deemed as patentable subject matter; likewise for non-biological
or microbiological processes (e.g. genetic engineering) and products thereof.
NON-PATENTABLE SUBJECT MATTER
Non-Patentable subject matter relates to an invention that are excluded in patent laws that enumerates
creations or ideas that do not possess the “technical character” as required in a patentable invention. Inventions
that are not deemed as “technical solutions to problems”.
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Section 22 (Non-Patentable Inventions), Intellectual Property Code of the Philippines (R.A. 8293, as amended
by R.A. 9502): “The following shall be excluded from patent protection:
22.1. Discoveries, scientific theories and mathematical methods, and in the case of drugs and medicines, the
mere discovery of a new form or new property of a known substance which does not result in the enhancement
of the known efficacy of that substance, or the mere discovery of any new property or new use for a known
substance, or the mere use of a known process unless such known processes results in a new product that
employs at least one new reactant. For the purpose of this clause, salts, esters, ethers, polymorphs, metabolites,
pure form, particle size, isomers, mixtures of isomers, complexes, combinations, and other derivatives of a
known substance shall be considered to be the same substance, unless they differ significantly in properties
with regard to efficacy;
22.2. Schemes, rules and methods of performing mental acts, playing games or doing business, and programs
for computers;
22.3. Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods
practiced on the human or animal body. This provision shall not apply to products and composition for use in
any of these methods;
22.4. Plant varieties or animal breeds or essentially biological process for the production of plants or animals.
This provision shall not apply to micro-organisms and non-biological and microbiological processes. Provisions
under this subsection shall not preclude Congress to consider the enactment of a law providing sui generis
protection of plant varieties and animal breeds and a system of community intellectual rights protection;
22.5. Aesthetic creations; and
22.6. Anything which is contrary to public order or morality.” (R.A. 9502, 2008).
1.3. Provisions in the Plant Variety Protection Act of 2002 (PVP) (R.A. 9168)
The present Intellectual Property Code of the Philippines permits the patenting of microorganisms, but not
plants and animals, the country achieved compliance with its commitments under the WTO-TRIPS agreement on
June 2007 with the passage of Republic Act 9168, otherwise known as the Plant Variety Protection Act of 2002
(PVPA). Plant varieties will be protected by sui generis mechanism of the PVP.
R.A. No. 9168 “The Philippine Plant Variety Protection Act of 2002” An act to provide protection to new plant
varieties and establishing a National Plant Variety Protection Board.
11
PVP Act grants exclusive rights to the breeder of a new plant variety so that he/she can exploit or
commercialize the variety.
Article 38. Requirement for the Grant of Plant Variety Protection
Plant Variety Protection shall be granted for varieties that are:
(a) New- variety not been sold, offered for sale or otherwise disposed of to others;
(b) Distinct - clearly distinguishable characteristics from a particular genotype or combination of
genotypes;
(c) Uniform - relevant characteristics are similarly expressed;
(d) Stable - characteristics remain unchanged after repeated propagation;
Article 58. Rights of Holders of Plant Variety Protection
In respect of the Propagating materials, holders of the Certificate of Plant Variety Protection shall have the right
to authorize any of the following acts:
(a) Production or reproduction;
(b) Conditioning for the purpose of propagation;
(c) Offering for sale;
(d) Selling or other marketing;
(e) Exporting;
(f) Importing; and
(g) Stocking for any purpose mentioned above
The holder may make his authorization subject to conditions and limitations.
Article 61. Terms of Protection
For trees and vines, the period of protection shall be twenty five (25) years from the date of the grant of the
Certificate of Plant Variety Protection and twenty (20) years from the said date for all other types of plants,
unless declared void ab initio or cancelled otherwise, as provided under Articles 92 and 93, respectively.
Article 67. Exemptions to Plant Variety Protection
The Certificate of Plant Variety Protection shall not extend to:
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a) Acts done for non-commercial purposes;
b) Acts done for experimental purposes;
c) Acts done for the purpose of breeding other varieties, except when Sections 39 and 40 of the Act
apply; and
d) The traditional right of small farmers to save, use, exchange, share or sell their farm produce of a
variety protected under the Act, except when a sale is for the purpose of reproduction under a
commercial marketing agreement. The Board shall determine the conditions and issue the guidelines
under which this exception shall apply, taking into consideration the nature of the plant cultivated,
grown and sown. This exception shall also extend to the exchange and sale of seeds among and
between said small farmers: Provided, that the small farmers may exchange or sell seeds for
reproduction and
e) Replanting in their own land. The right granted to small farmers under this provision does not include
the right to sell the protected variety under the trademark or tradename of the holder which is
associated with the registered denomination. [Sec. 43] (R.A.9168, 2002).
2. Summary of Legislative Provisions-Japan
In Japan, it became clearly apparent that a patent system must be established in order to speed up
modernization efforts which began after the start of the Meiji Reform, and the "Patent Monopoly Act" was
publically proclaimed in Japan on April 18 of year 18 of the Meiji Era (1885). In addition, the New Utility Model
Law was enacted in the year 38 of the Meiji Era (1905) in order to complement the patent system. (A History of
System of Industrial Property Rights (n.d.)).
In the course of the Edo period, there was a trend to dislike new things, a "Law for New Items" was declared
in the year 6 of the Kyoho Era (1721). The purpose of this law was described as "to ensure that absolutely no
new types of products would be manufactured" (A History of System of Industrial Property Rights (n.d.)).
After the introduction of Japan to Western things, the patent system was introduced from Europe and
United States. In year 4 of the Meiji Era (1871), Japan publicly proclaimed its own law, called Provisional
Regulations for Monopoly, which was the first patent law in Japan. However, the implementation of this law was
postponed the next year because the people of the country did not understand it well enough at the time to be
able to use it, and the government office had problems with the management of this law (A History of System of
Industrial Property Rights (n.d.)).
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2.1. Intellectual Property Protection in Japan
The history of Japanese patent started in the Meiji era, with the introduction of the idea of the patent to Japan
by Mr. Fukuzawa Yukichi in 1867. In 1871, an experimental patent system was put into operation but it was
ended the following year. The "Patent Monopoly Act", which was designed from the French Patent Law and is
the first patent law, was enacted in 1885, and the first 7 patents were granted on August 14, 1885 under this
new law. Hotta Zuisho obtained Japanese Patent No. 1 for an anticorrosive paint (History of Japanese Patent
Law (n.d.)).
The Patent Monopoly Act was substituted by the Patent Act in 1888, and then it was substituted by the
Patent Law in 1899, which was revised in 1909. In 1905 the utility model law was introduced, and in 1921 the
Patent Law was revised. The ‘first-to-file’ rule was introduced in the 1921 revision. It was in 1959 when the
current Japan Patent Law had a major amendment and making the European patent laws as the reference. The
revisions included the term of patent, opposition proceedings and conformity with the Patent Cooperation
Treaty (PCT) in relation to criteria of novelty.
In 1975 Japan joined the World Intellectual Property Right Organization, and in 1978 international
applications based on the Patent Cooperation Treaty start. There was another major amendment in 1995. In the
following years various amendments were successively made, including the acceptance of English patent
applications and elimination of the pre-grant opposition system. In this year, applications in English can be filed
at JPO, the number of Patent issued reached 2 million (History of Japanese Patent Law (n.d.)).
2.2. Provisions in the Japan Patent Law (of 1959, as amended by Law No. 36 of 2014)
PATENTABLE SUBJECT MATTER
Article 2 (Inventions), Japan Patent Law (of 1959, as amended by Law No. 36 of 2014):
Patentable subject matter must be an “invention” as required in Article 2(1) of the Japan Patent Law and it
must also be “industrially applicable” Article 29(1).
The first articles of the patent law state that their objective is to promote industrial development by urging
the protection and taking advantage of inventions and utilization of devices. They do not mention inventor’s
rights or exclusive rights; rather, inventions are treated more as public goods in that contents of patent
14
applications are made available to the public before the patent is granted. Thus, Japanese patent policy has
advocated the utilization of inventions towards industrial development (Maskus, K.E. & McDaniel C., 1998).
NON-PATENTABLE SUBJECT MATTER
Article 32 (Unpatentable Inventions), Japan Patent Law (of April 13, 1959, as amended by Law No. 36 of
2014):
Article 32 of the Japan Patent Law describe that “Notwithstanding Article 29, any invention that is liable to
injure public order, morality or public health shall not be patented”(Patent Act (Act No. 121 of April 13, 1959, as
amended up to Act No. 36 of May 14, 2014).
In addition with article 32, unpatentable inventions, if we interpret the meaning of the Patentable subject
matter under Japan Patent Law, we can also figure out that everything that is not an “invention” (Art. 2(1)) and
not “industrially applicable” (Art. 29(1)) can also be considered not patentable.
Examples of subject matter that do not meet the requirements for an "invention"
(1) Simple discoveries of laws of nature, and natural phenomena;
(2) Ideas that violate laws of nature (perpetual motion machines, etc.);
(3) Ideas that do not use laws of nature (pure algorithms, methods of conducting business, methods of playing
games, etc.),
(4) Techniques that can be attained by personal skill (how to throw a knuckleball, etc.); and
(5) Artistic works (Japan Patent Attorneys Association (n.d.)).
Examples of subject matter that do not meet the requirements for "industrial applicability"
(1) Methods of medical treatment, or operating on or diagnosing a human being;
(2) Inventions for pure personal use such as methods of smoking, method of tying knots, new cooking recipes,
etc.; and
(3) Inventions that are highly unrealistic such as a protective net covering the entire earth with a plastic film, a
device capable of changing the orbit of the earth, etc.
Most cases in this category do not require any consideration as they would be readily rejected by common
sense. However, there may be some cases which require careful consideration and may have practical
significance (Japan Patent Attorneys Association (n.d.)).
15
2.3. PROVISIONS IN THE SEEDS AND SEEDLINGS ACT OF JAPAN (ACT NO. 83 OF MAY 29, 1998) Last
Amendment by ACT No. 49 of May 18, 2007.
THE SEEDS AND SEEDLINGS ACT (ACT NO. 105 OF 1947) IS ENTIRELY REVISED.
The Seeds and Seedlings Act of Japan conforms to the UPOV Convention Act of 1991 which offers international
rules for the protection of new varieties of plants.
Article 1 : Purpose
The purpose of this Act is to promote the breeding of plant varieties the rational distribution of propagating
material by providing for a system relating to the registration of plant varieties for the protection of new plant
varieties and regulations relating to the indication of designated seeds, so as to contribute to the development
of agriculture, forestry and fisheries (Plant Variety Protection and Seed Act of Japan, (n.d.)).
Article 3: Condition for Variety Registration
The condition for variety registration according to Article 3 of PVP Law of Japan describes that “Any person who
has bred a variety fully meeting the requirements set forth below or his/her successor in title may obtain a
registration for the variety” (Plant Variety Protection and Seed Act of Japan, (n.d.)).
The following are the conditions for variety registration:
Distinctness
Uniformity
Stability
These conditions are used in the examination of characteristics (DUS testing) if the applied plant variety satisfies
these three conditions, the applied variety is entitled for plant variety registration.
Article 19: Grant and Duration of the Breeder's Right
A breeder's right shall become effective upon a variety registration. Duration of a breeder's right shall be
twenty-five years (thirty years, in the case of varieties provided in Article 4 paragraph (2)) from the date of
variety registration (Plant Variety Protection and Seed Act of Japan, (n.d.)).
16
Article 20: Effects of the Breeder’s Right
The holder of the breeder’s rights has a sole right to use in the course of business, propagating material,
harvested material and processed products of the registered variety and varieties which, by the expressions of
characteristics are not clearly distinguishable from the registered variety.
The holder also has the sole right to use varieties which are bred by changing parts of the expressions of the
characteristics of the registered variety while keeping the expressions of its essential and varieties whose
production requires repeated use of the registered variety.
Article 21: Limitation of the effects of the Breeder's Right
The effects of a breeder's right shall not extend to the following acts:
Exploitation of the variety for the purpose of breeding new varieties and for other experimental and
research purposes;
Use of farm-saved seeds, as prescribed in the act;
Exhaustion of the breeder’s rights. (Plant Variety Protection and Seed Act of Japan, (n.d.)).
3. Previous Studies
Protecting plant-based intellectual property internationally presents unique challenges. Member countries of
the World Trade Organization are obligated to pass some type of plant breeder’s rights and provide protection
for biotechnology inventions. The intellectual property rights (IPRs) component of the World Trade
Organization (WTO) agreement which compelled signatories to put in place some type of sui generis system of
plant variety protection and patent protection for biotechnology inventions by 2000 (some developing countries
have until 2005 to implement these IPRs). A number of countries still disallow novel plants and animals from
patent coverage, although many of them do allow patenting of novel microbes as is required by WTO (Pray, C.E.;
Govindasamy, R.; & Courtmanche, A.,2003).
International Organizations
Policy concerns related to plant genetic resources are socially, technically and scientifically complex. They are
also commonly very much controversial, typically in light of recent developments in genetic research, which
17
have led to an increase in the alleged commercial value of plant genetic resources. A number of international
instruments have been developed over the years in different fora to address these complex issues.
Convention on Biological Diversity (CBD) came into force in 1993, the objectives of the CBD are the
conservation of biological diversity, the sustainable use of its components, and the fair and equitable sharing of
the benefits arising from the use of genetic resources (Eaton, D.; Kalaugher, E.; & Bijman, J., 2004).
Global System for Plant Genetic Resources refers to a pool of programs and plans supervised by the
Commission on Genetic Resources for Food and Agriculture (CGRFA) of the United Nations Food and Agriculture
Organization (FAO) (Eaton, D.; Kalaugher, E.; & Bijman, J., 2004).
International Treaty on Plant Genetic Resources for Food and Agriculture (IT-PGRFA) popularly known as the
International Seed Treaty. The new treaty is intended to resolve specific issues relating to agricultural
biodiversity in the CBD. The IT-PGRFA establishes a multilateral system (MS) for access and benefit sharing. The
IT-PGRFA also incorporates the important germplasm collections of the international agricultural research
centers (IARCs) of the Consultative Group on International Agricultural Research (CGIAR) (Eaton, D.; Kalaugher,
E.; & Bijman, J., 2004).
Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) the TRIPS Agreement applies to all
WTO members. A minimum standards for all forms of IPR protection was established by TRIPS. Member
countries are obliged to offer patent protection for all inventions but allows an exclusion to be made for plants
and animals (other than micro-organisms). Protection is however required for plant varieties, if not by patents,
then at least by an effective sui generis system. (Eaton, D.; Kalaugher, E.; & Bijman, J., 2004).
World Intellectual Property Organization (WIPO) is a UN dedicated agency that administers international
treaties dealing with different aspects of intellectual property protection and promoting international
harmonization of IPR systems. WIPO is also collaborating with UPOV on the relationship between plant variety
protection and patent protection for biotechnological inventions (Eaton, D.; Kalaugher, E.; & Bijman, J., 2004).
International Union for the Protection of New Varieties of Plants (UPOV) is an international convention
establishing agreement between its members on specific provisions of national plant variety protection
legislation. Two major restrictions to this protection were initially the breeders' exemption and the farmers'
18
privilege. The farmers' privilege was restricted to an optional exception in the 1991 UPOV Act, for this reason,
many developing countries have chosen the 1978 Act (Eaton, D.; Kalaugher, E.; & Bijman, J., 2004).
Patents and Plant Variety Protection
TRIPs requirement to implement patents for biotechnological inventions and plant variety protection can lead to
intersecting or overlapping forms of protection. In particular, a new plant variety may also represent an
invention, most likely in the form of a genetically engineered component that is protected by patent protection.
In general, the scope of either the patent or the plant breeder's right has to be limited if this issue is to be
clarified.
WIPO and UPOV look for clarification on the interaction between patents and plant variety protection. A joint
symposium was organized in October 2002 by WIPO and UPOV on the said issue. UPOV has acknowledged the
secured preservation of the breeder's exemption as one of the defining characteristics of plant variety
protection, as distinct from patents (Eaton, D.; Kalaugher, E.; & Bijman, J., 2004).
In some situations, the coverage of patents and plant breeders’ rights might be the same, for example a plant
variety. The 1991 Act of the UPOV Convention, in comparison to the 1978 Act, no longer forbids protection of
new plant varieties by the grant of a special title or a patent for the same botanical genus or species and thereby
acknowledges that both systems may even be applied to the same variety (Jördens, R., 2002).
Table 3 gives an outline comparison between protection of an invention by patent and protection of a variety
by PVP.
Rights Conferred by the Protection
The benefits provided by the patent system and the UPOV system are alike, as can be seen from the following
table 4 which evaluates the scope of protection in the UPOV Convention and the TRIPS Agreement. In the
agreement, World Trade Organization (WTO) sets international minimum standards on intellectual property
protection and binds all Members of WTO.
Even though the rights resulting from the two intellectual property right systems do not differ much, it is
generally accepted that patents offer a stronger protection than plant variety rights. The reason is that the plant
breeders’ right does not extend to acts done for experimental purposes and acts done for the purpose of
breeding other varieties, the so called breeders’ exemption. Furthermore the UPOV Convention includes an
optional exception as regards the use of farm saved seed. (Jördens, R., 2002).
19
Table 3 (Jördens, R., 2002).
Patent Protection Breeder’s right based on the UPOV Convention
I. Object of protection invention plant variety
II. Requirements for protection
1. documentary examination required required
2. field examination not required required
3. plant material for testing deposit of material may be required only in certain cases
required
4. conditions for protection (a) novelty
(b) industrial applicability
(c) unobviousness (inventive step)
(d) an enabling disclosure
(a) commercial novelty
(b) distinctness
(c) uniformity
(d) stability
(e) an appropriate denomination
III. Scope of Protection
1. determination of scope of protection
determined by the claims of the patent fixed by the national legislation in accordance with the UPOV Convention
2. use of a protected variety for breeding further varieties
may require the authorization of the patentee
does not require authorization of the right holder (breeder’s exemption)
3. use of propagating material of the protected variety grown by a farmer for subsequent planting on the same farm
may require the authority of the patentee
often does not require authorization of the right holder
IV. Variety Denomination not required required
V. Term of Protection 20 years from date of application 18 years for trees and vines, 15 years for other species, from date of grant (increased respectively to 25 years and 20 years in the 1991 Act).
20
Table 4 (Jördens, R., 2002).
TRIPS Agreement (Article 28)
UPOV
(1991 Act – Article 14)
“1. A patent shall confer on its owner the following
exclusive rights: (a) where the subject matter of a patent is a product, to prevent third parties not having the owner’s consent from the acts of:
“(1) [Acts in respect of the propagating material]
(a) Subject to Articles 15 and 16, the following acts
in respect of the propagating material of the protected variety shall require the authorization of
the breeder
Making,
Using,
(i)production or reproduction
(multiplication)
(ii) conditioning for the purpose of propagation
Offering for sale (iii) offering for sale
Selling , or (iv) selling or other marketing
Importing (v) exporting
(vi) importing
For these purposes that product;” (vii) stocking for any of the purposes mentioned in (i) to (vi), above.”
Significant differences between Plant Variety Protection and Patent Protection
Subject Matter
Plant variety protection system’s objective is to grant breeders control over the propagating material of
protected varieties or vegetative and reproductive materials of a plant, it does not cover technical processes for
the production of those varieties. On the contrary, patent protection is offered for both the plant itself and the
process used to make that plant.
Moreover, in patent system, key genetic material or information expressed by plants can be removed from the
public domain and held exclusively by one individual or corporation. Under PVP systems, plant genetic material
stay unprotected and available to the public for further research and development. (The Differences between
Plant Variety Protection and Patent Protection on Plants (n.d.)).
21
Scope
Due to the exceptions and limitations present in most PVP systems the range of the exclusive rights granted to a
breeder under a TRIPS-compliant patent system is much better. Most PVP systems grant important exceptions
and limitations to these exclusive rights, such as the farmers’ privilege and the breeders’ exemption. TRIPS-
compliant patent systems do not agree to such similar exceptions and limitations (The Differences between
Plant Variety Protection and Patent Protection on Plants (n.d.))
Eligibility Requirements
Condition for protection is easier under PVP systems than under patent systems. Industrial applicability and
inventive step is not required, which provides PVP system more flexibility. Thus, no definite amount of human
intervention is necessary in order to qualify for protection. “Therefore, the criteria of distinctness, uniformity
and stability are normally adapted to the mode of reproduction of the variety and can provide more flexibilities
than requirements for patentability.” (The Differences between Plant Variety Protection and Patent Protection
on Plants (n.d.))
Patent eligible subject matter
The concern of patent eligible subject matter has lately come to importance with the decision, in June 2013, of
the US Supreme Court in Association for Molecular Pathology v. Myriad Genetics, Inc. (the "Myriad" case). The
Court ruled that naturally occurring DNA, even in its isolated form, is no longer patentable subject matter in the
US, but that cDNA with some exceptions is. Table 5 below provides general guidelines to what is patent eligible
subject GM plant subject matter in the listed countries. This information should be considered as a guide only
(Foote, H., 2013).
Protecting non-GM plants with patents
Patent protection for non-GM plants is not available in all jurisdictions. In some countries plant varieties are
excluded from patent protection. In other countries plant varieties can be protected by either patent of plant
variety type protection. Table 6 below summarizes this information for the same 16 jurisdictions in Table 3
(Foote, H., 2013).
22
Table 5 - Patent eligible subject matter for GM plants internationally (Foote, H., 2013).
Country
Isolated
DNA
sequences
from plants
Modified
sequences /
expression
cassettes with
heterologous
sequence
elements
Transgenic
plant cells
Transgenic
plants
Transgenic
plant parts
(e.g. seeds)
Methods for
producing
transgenic
plants
Australia yes yes yes yes yes yes
Argentina no yes no no no yes
Brazil no yes no no no yes
Canada yes yes yes no no yes
Chile yes yes no no no yes
China yes yes yes no no yes
Europe yes yes yes yes yes yes
India no yes no no no no
Indonesia yes yes yes yes yes yes
Japan yes yes yes yes yes yes
New Zealand yes yes yes yes yes yes
Philippines yes yes yes no no yes
Thailand no yes no no no yes
United States no yes yes yes yes yes
Vietnam yes yes yes yes yes yes
South Africa yes yes yes yes yes yes
All countries in the table with the exception of India allow claims to methods for producing transgenic plants. Therefore good method claims are important. However in some countries examiners may still object if they consider such claims encompass the transgenic plants themselves if these are not patent eligible.
23
Table 6 – Availability of patent protection for non-GM plants and methods for their production, and for plant varieties (Foote, H., 2013).
Country Non-transgenic plants Refined methods* for the
breeding of non-transgenic plants Plant varieties
Australia Yes Yes No
Argentina No Yes No
Brazil No Yes No
Canada No** Yes No
Chile No Yes No
China No Yes No
Europe Yes No No
India No No No
Indonesia No No No
Japan Yes Yes Yes
New Zealand Yes Yes Yes
Philippines No No No
Thailand No Yes No
United States Yes Yes Yes
Vietnam Yes Yes No
South Africa No No No
*For methods for production of non-GM plants to be protectable by patents, additional technical steps beyond standard breeding practices, such as steps that cannot occur in nature, may be required. **In Canada, a claim to a non-transgenic cell is eligible, and should be enforceable against a plant comprising the cell
Protection of Plants or Plant Varieties by an Intellectual Property Right.
The European situation
Most of the European countries protect plant inventions and plant varieties under patent law and plant variety
rights law respectively. According to article 53 (b) of the European Patent Convention, to which a large majority
24
of European countries are a contracting party, plant varieties are excluded from patent protection. It has been
confirmed in a directive of the European Community (the “Biotech Directive”). (Directive 98/44/EC of the
European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological invention, OJ L
213, 30.7.1998, p. 13).
One reason to close the door on patentability for plant varieties appears to be the fact that in most European
countries, tailor made protections systems were available for plant varieties based on the UPOV Convention,
which contained at that time a ban on double protection. Another reason to exclude plant and animal varieties
from patentability was that no agreement on this subject seemed possible. The whole Convention might have
been in trouble if this controversial issue had not been excluded.
In Europe only the results of modern biotechnology are subject of European patent applications. Especially
gene sequences, and the techniques to introduce the sequence in plant material, are protected by patents. Such
inventions could be used in respect of an indefinite number of plant varieties and are for that reason not
excluded from patentability under article 53, b, of the EPC.
On the other hand, the subject of plant variety protection which is the new varieties of plants is mostly the
result of the application of traditional breeding techniques. There are only few cases that the CPVO received
applications for plant variety protection in respect of genetically modified varieties (Kiewiet B., 2003).
The situation in the USA
IPR protection of plants and plant varieties in the United States is different from the European situation. have
the choice between There are three kinds of intellectual property rights for breeders or inventors of new plant
varieties to protect their creations. Breeders or inventors can choose from utility patent system for plant
inventions not expressed in the form of a plant variety only. The Plant Patent Act (PPA) of 1930 provides
protection for asexually reproduced, novel plant varieties, not consisting of tuber propagated plants or plants
found in an uncultivated state. Last but not the least the Plant Variety Protection Act (PVPA) of 1970 as
amended in 1994 which is based on the UPOV 1991 Convention that provides protection to the breeder of any
sexually or tuber propagated plant variety (Kiewiet B., 2003).
25
CHAPTER 3: Methodology of this Study
3.1. Comparative Analysis of the Legislative Provisions: The Philippines and Japan
3.1.1. Collecting Information
Gathering relevant information from all kinds of materials or references that are publicly available such as
patent laws and examination guidelines from Japan and the Philippines, plant variety protection law of Japan
and the Philippines, relevant secondary literature, case studies, news articles, court decisions, documents
retrieved from the internet, technical and opinion papers from patent experts, plant variety protection experts,
and the academe shall form part as basis for this paper.
3.1.2. Comparative analysis
The collected data and information plays a big part in comparing the legislative provisions of the Philippines and
Japan. A large number of documents and data relating to the provisions of patent law and plant variety
protection law of both countries were studied. The researcher compared the patent laws and the plant variety
protection laws of both country. The comparison of the provisions, concept, systems and operations have
identified the differences and similarities in their respective laws.
3.2. Case Studies (Examination Practices): The Philippines and Japan
Case studies from different countries not just from the Philippines and Japan were collected, to have a variety of
perspective in order to identify the best possible practices of examining plant related inventions. Different
scenarios have been identified and will definitely help the researcher to decide on which practices will be
suitable for the Philippines.
JPO’s guidelines for substantive examination of biotechnological inventions were also obtained and studied.
Although there is no separate guidelines for plant related inventions, the said guidelines will be sufficient
because the guidelines includes examination of plant patent.
The main focus of the research is how to create a guideline for substantive examination of plant related
invention for the patent examiners of IPOPHL. With JPO’s biological inventions guidelines as a model the IPOPHL
can curved out the relevant and suitable policy for plant related inventions in the Philippines.
26
3.3. Interviews of relevant persons in Japan
To be able to confirm and verify the reliability and accuracy of information available from the collected data and
published documents, the researcher conducted selected interviews employing a guided questions
methodology.
The interviews are divided into 2 main target groups: Plant Patent Experts and Plant Variety Protection
Experts.
For plant patent experts, interviews are designed for Patent Examiners, Patent Attorneys and Academic
Researchers of IP Law Study.
For plant variety protection experts, interviews are designed for PVP Examiners, PVP Attorneys and Major
Plants and Seeds Company Representative.
In correspondence with each group, there is a specific questions list. For plant patent experts there are 12
questions while for plant variety protection experts there are 16 questions.
The interview revealed some facts which could not have been obtained through other means. The interview
also revealed the personal insights and opinions of the experts which is very valuable in formulating policy for
plant related inventions. During interviews some discussions between the researcher’s adviser, coordinator and
experts are taken place that can add in the enrichment of the discussions of personal views and information.
Personal interviews can give the researcher a practical view of what’s going on in the real scenario where the
data or information are actually supplied by the persons involved in the system.
The questionnaires were discussed and approved by the supervisor – Dr. Yorimasa Suwa of Asia-Pacific
Industrial Property Center (APIC) and by the two advisers – Associate Professor Koichi Sumikura of National
Graduate Institute for Policy Studies (GRIPS) and Professor Setsuko Asami of Tokyo University of Science.
Questionnaires for the Interview
For JPO Patent Examiner Department
About the situation of the plant related inventions:
1. In the Philippines, the plant related invention filings are increasing annually, specifically plant related
biotechnological inventions. Most of the plant related inventions are filed by foreign applicants. What is the
situation of plant related inventions in Japan?
27
2. In the Philippines, the most typical plant related inventions are categorized asplant breeding method, plant
genetic engineering and plant variety although unpatentable there are still some applications filed. What are the
most typical plant related inventions that are being filed in JPO?
About the policy for the plant related inventions:
3. Are there any policy specialized for the plant related inventions in JPO?
4. Does JPO have a manual specialized for substantive examination for plant related invention besides the
Examination Guidelines to patent applications relating to biological inventions?
About the skills of the examiner for the plant related inventions:
5. Do the patent examiners undergo any training regarding examinations of the plant related Inventions or
biological inventions?
6. Are there any separate group that takes care of the plant related inventions or the biological inventions in
JPO? What is your opinion on the creation of a separate group or division for the plant related inventions or
biological inventions?
About the problems specific to the plant related invention:
7. What are the major causes of the examination problems on the plant related inventions?
8. In what kind of a situation, the examiners of JPO encounter the problems in examining the plant related
inventions?
9. Regarding the problems the examiners have encountered, what measures dothey apply to address the said
problems?
About the relation between the plant patent and Plant Variety Protection:
10. What are the advantages of having a separate protection for Plant Patent and Plant Variety Protection? Is it
advantageous for the applicant to have both protections?
11. Do JPO collaborate or work with the Ministries of Agriculture, Forestry and Fisheries regarding some of the
Plant related Inventions? Is this necessary or important? Are there any complications if JPO will not consult
MAFF or vice versa about a certain plant related invention?
For the PVP Expert
28
About the Situation of Plant Variety Protection
1. In the Philippines, there is a lack of public awareness about Plant Variety Protection and as a consequence the
breeders turn to seek Patent Protection instead of plant variety protection. What is the situation of plant variety
protection in Japan? Is there any policy regarding promotion of plant variety protection in Japan?
2. I understand that Japan is a member of UPOV, before joining UPOV; does Japan have some sort of Plant
Protection?
About the Examination of PVP Application
3. Who is in charge of examining the application for PVP? Is there any qualification for the job?
4. Can you describe the examination process of PVP application in Japan? Do you have a substantive
examination of application for PVP?
5. Do they have a manual for substantive examination for Plant Variety Protection? (ask only if answer in item 3
is affirmative).
6. Does your PVP or other national law or regulation require any disclosure of source, consent from local owners
from which the plant variety has been improved, and the sharing of benefit derived there from?
7. If the response to item # 6 is negative, do you have any plan to protect the interest of local owners from
which the improved plant varieties has been derived?
8. Does your PVP require the applicant to deposit samples of the new plant variety which is registered?
9. Does your PVP provide national treatment for nationals of another country which by treaty, convention or law
affords similar privileges to Japanese Citizens? If that was the case, does your law permits the use of relevant
test reports produced by other UPOV members?
About the Relationship between PVP and Plant Patent
10. Can a new plant variety be allowed double protection under more than one IP (e.g., patent and sui generis
PVP)?
11. What are the advantages of having a separate protection for Plant Patent and Plant Variety Protection? Is it
advantageous for the applicant to have both protections?
12. Do the Ministries of Agriculture, Forestry and Fisheries collaborate or work with JPO regarding some of the
Plant related Inventions? Is this necessary or important?
About problems specific to Plant Variety Protection
29
13. Is there any decision or case law in Japan which clarifies any issue(s) in relation to protection of new plant
variety? If so, can you please provide some details?
14. Do you have any problem in implementing your protection regime for new plant varieties and existing
varieties (if any)? Please describe.
15. If you do not have problems in the implementation, could you suggest any mechanism which ensures
successful implementation?
16. What other relevant measures Japan implemented or will implement in your PVP legislation in order to
improve and promote an effective system for plant varieties protection?
For the Company
About the Company’s Methods of Breeding
1. What kind of breeding method do you usually practice in your seed company?
2. Do you still practice the traditional method of breeding?
3.Can you please share your knowledgeabout biological and non-biological processesof production of plants?
Can you please give some example of biological and non-biological processes?
About the situation of plant related invention
4. The Philippines is an agricultural country and most of the seeds and plants company focus on vegetables and
fruits, as a leading seeds and plant company what is your main focus of research?
5. On the average, how long does it take to develop a potential plant variety?
About the relation between the plant patent and PVP
6. Do your company filed for separate patent protection and plant variety protection for a single plant?
7. What are the advantages of having a separate protection for Plant Patent and Plant Variety Protection?
8. How many patent applications and plant variety protection applications does your company filed in a year?
How many patent and PVP your company have?
9. I believe that obtaining patent takes time,and specially PVP with all the field testing to be done. Do your
company wait for the patent or PVP to be approved before your product released in the market?
About the problems specific to GMO related invention
10. In the Philippines genetically modified plants have a negative impressions to some groups like Greenpeace
Philippinesand to the extent of even filing legal cases,do you have any experience or situation like these here in
Japan?
30
11. What is your opinion regarding how safe GMO products are in the environment and human health?
12. What kind of safety assessment your company is employing before your products are released to the
market?
13.Do you have any legal cases or infringement cases regarding your plant patent or PVP?
About the importance of IP
14. Can you please explain how important to your Company the IP protection?
15. What kind of IP protection your Company utilizes?
16. Do you have any request regarding the plant related inventions to JPO, or, if you have developped your
business in the Philippines, to IPPHIL?
31
CHAPTER 4: Results and Analysis
4.1. Observations from the Relevant Documents
In this new age of technology the Intellectual Property Office of the Philippines must cope up with the emerging
challenges in the field of Intellectual Property. In the field of biotechnology specifically plant related inventions
the following problems of Patent Examiners are identified:
Dealing on Proper Approach to patent applications concerning different subject matters in
biotechnology especially in plant related inventions.
Uncertainty about the concepts in the national laws based upon international patent and conventions.
Knowledge of the subject matter.
Lack or absence of standardized office actions.
Lack of policies about the subject matter (manual or guidelines for substantive examination).
An effective patent system essentially involves procedures by which patentable subject matter is defined and
patents are issued reflecting both the interests of the patent holder and the interest of others. In modernizing
the system, aspects must be built into it, which include clearly defined, easy to follow and readily accessible
administrative and legal procedures.
To strengthen and improve the quality of patent examination there is a need to have a concrete and clear cut
policy on how to handle applications concerning biotechnology. Concepts in the National laws based upon
international patent and conventions have created uncertainty. Law on Intellectual Property in the Philippines
was amended many times to cope up with the changing world particularly with that of economy and technology
without sacrificing the country’s national interest. With each amendment, changes in patent requirements and
guidelines are inevitable from patent term to patent subject.
The present Intellectual Property Code of the Philippines allows the patenting of microorganisms, but not
plants and animals. Plant varieties will be protected by sui generis mechanism of the PVP. Countries that have
joined the World Trade Organization are obligated to pass some type of plant breeder’s rights and provide
protection for biotechnology inventions. Many developing countries, however, have resisted actually passing
such laws. The Philippines achieved compliance with its obligations under the WTO-TRIPS agreement on June
2007 with the passage of Republic Act 9168, otherwise known as the Plant Variety Protection Act of 2002 (PVPA).
The two systems to protect intellectual property rights in relation to plant material are the Patent System
and Plant Variety Protection. Patent system focused on examining genetic structure and phenotypic
32
characteristics whereas PVP system focused solely on the phenotypic characteristics of plants. It is not easy for
new plant varieties to fulfill the conditions necessary to obtain patent rights, especially the novelty and
inventive step conditions.
Figure 5. Critical Differences between Plant Variety Protection and Patent Protection
4.2. Summaries of the Interviews
Six personal interviews were conducted and divided into two target groups: Plant Patent Experts and Plant
Variety Protection Experts. For Plant Patent group, experts from JPO and Patent Attorneys were interviewed,
and for the PVP group, experts from MAFF, JPAA, Patent Attorneys and Representatives from Sakata Seed
Corporation.
4.2.1. Interview to Biotechnology Division, Third Examination department, Japan Patent Office (JPO)
The interview takes place at the JPO Building in Kasumigaseki, Chiyoda-ku Tokyo at around 10: 00 am to 11:00
am on February 25, 2016. The respondents were Ms. Yumiko Matsunami, Director Biotechnology Division Third
Examination Department, JPO and Mr. Hajime Kamijo, Director Foods and Microorganisms Sub-Division,
Biotechnology Division, Patent Examination Department.
Patent System
Protection for both
product s & processes
Protection for plants &
key genetic material
Protection is more
absolute
Difficult to obtain
PVP System
Protection for
propagating material &
not technical process
Protection for vegetative
and reproductive
materials
Provide exceptions
Easier to obtain
33
Main Contents:
About the situation of the plant related inventions:
The situation in Japan in terms of number of patent applications filed under biotechnology is steadily increasing.
IPC International Classification Class A01H 5/00 which relates to plant related inventions filings begins to decline
since 2001. Unlike biotechnology field the filing of applications is increasing and continuously increasing. In
terms of applicants by nationality the proportion of local and foreign filings are almost the same.
About the policy for the plant related inventions:
In JPO all the technical fields are handled based on the same examination guidelines. They don’t have any
specific policy for plant related inventions. Every patent examiner follow the same general examination
guidelines which are suitable to all the examination divisions of JPO. In the 1990’s JPO added the biology
chapter in the examination guidelines, the biotechnology field and plant related inventions which are
incorporated in the biology chapter of the guidelines has a more detailed procedures. JPO has no specific
guideline for plant related invention.
About the skills of the Examiner for the plant related inventions:
In terms of academic background of the JPO Patent Examiners, there are a few substantive examiners who have
academic backgrounds exclusively for plant related areas. The overall trends of the background of the JPO
Patent Examiners are general academic backgrounds in genetic engineering. Patent Examiners in JPO have a
general knowledge or expertise in the area, after joining JPO various trainings and learnings are acquired in the
plant related aspects, the overall knowledge will be enhanced as the examiner accumulates experience.
Typically the academic backgrounds of the examiners are genetic engineering or general pharmaceutical
background and most of the Patent Examiner has a Master’s Degree and Doctorate Degree. They form a study
work group with examiners of plant related backgrounds and have some lectures to share their knowledge in
the study group. They don’t have any special internal official training program focusing on just the plant related
invention in terms of the details of the technical aspects as part of the official training. Generally they enhanced
their technical skills and obtain additional information and knowledge by way of doing day to day office works.
There are several working groups which handle animal related and plant related inventions. There are 20
examiners who work on plant and animal related invention. There is only 1 examiner in that group that has a
plant related background. The majority of the group in terms of technical field handled mice for experiment or
operation for animal stem cells or microorganisms. One advantage of JPO is having the group system because
34
when it comes to decision and judgement even though the examiner works independently if she or he belongs
to this group they can consult one another when it comes to decision making.
About the problems specific to the plant related invention:
There are some issues several years ago about plant related inventions, the difference between monocot and
dicot plants. The JPO received more applications involving genetic engineering like recombination of genetic
aspects a few years ago was not possible to conduct recombination of monocot for the industrial aspect. There
are various controversial issues and debates as to whether the examiner will tell the applicant that for the
monocot plant it is not possible to do recombination. At the moment the JPO don’t have a backlog of old
applications concerning these kind of application. The most difficult issue confronted by the examiner of plant
related invention is when a plant created as a result of recombining instead of using deposited plants. They
cannot identify the genetic marks on this specific type of new plant. Determination of these cases is the most
difficult aspect when it comes to recombining plants as long as you can identify the genes it is very easy and
clearly you can identify the plant. However, when it comes to recombining plants the inventor does not know
exactly how it has been changed neither the examiner therefore it becomes very difficult to examine. Normally
the inventor will claim that this particular gene transformed in that particular manner by this new particular
marker that the inventor identified but when it comes to the actual question, if it is sufficient or insufficient to
identify the new plant itself neither the inventor nor the examiner has the answer.
About creation of Examination Guidelines
JPO has released the updated version of the “Examination Guidelines for Patent and Utility Model” and
“Examination Handbook for Patent and Utility Model” last September 16, 2015 in Japanese and English versions.
The objective of the updates is to make the Examination Guidelines clearer and concise by providing enough
case examples and court precedents, in order to make the Examination Guidelines easier to understand and
internationally acceptable.
The Examination Guidelines explain basic ideas of examination practices and procedures. They are applied to
inventions pertaining to any technical fields in general. It summarizes the basic ideas of applying applicable laws
such as Patent Act. On the other hand Examination Handbook summarizes practices and procedures that the
examiner needs to consider when conducting their examination work, and contains case examples, court
decisions, and examples of the application to specific technical fields which are useful to understand the ideas
35
shown in the Examination Guidelines. The special criteria for specific technical fields and case examples, which
are included in the Guidelines before the update, were moved to the Handbook.
4.2.2. Interview to the IP Committee on Agriculture and Fisheries in Japan Patent Attorneys Association
(JPAA)
The interview takes place at the JPAA office in Kasumigaseki, Chiyoda-ku Tokyo from 1:30 pm to 3:30 pm on
February 9, 2016. The respondents were Mr. Kazuaki Nakashima, Chairperson of IP Committee on Agriculture
and Fisheries, JPAA, Nakashima International Patents & Trademarks, and Mr. Shinichi Inoue, Patent Attorney
Chemical Department, Asamura Patent Office.
Main Contents:
About the situation of Plant Variety Protection:
Most of the Japanese plant breeders are Prefectures (80%), for example “Koshihikari”, famous and popular rice
was developed by Agricultural Research Institute of Niigata Prefecture. Plant variety protection is under Ministry
of Agriculture, Forestry and Fisheries not JPO. PVP is independent of plant chemistry, only characters, length,
weight, shape of the leaf, etc. Budapest treaty deposit system usually accept microorganism, but in Japan seeds
are also deposited, hydridoma producing antibody can also be deposited. In PVP anyone can file an application
even without attorney or legal representative.
Before joining the UPOV, Japan has its own plant protection law. But the protection is for the name of the
plant variety not the plant itself. It is prescribed to protect honor of breeders and not the substantive benefit.
The protection is only a recommendation and not an award. This protection was established after the World
War 2 when Japan was under the United States. The old PVP law and the current law is very different.
Previous Law (Agricultural Seeds and Seeding’s Law)
Article 7 Any person who raised the seed and sapling of an excellent new species can apply to the Minister of
Agriculture, Forestry and Fisheries and can receive the registration of the name of the seed and sapling.
Current Law (Seeds and Seeding’s Law)
Article 1 The purpose of this Act is to promote the breeding of plant varieties and the rational distribution of
propagating material by providing for a system relating to the registration of plant varieties for the protection of
36
new plant varieties and regulations relating to the indication of designated seeds, so as to contribute to the
development of agriculture, forestry and fisheries.
About the examination of PVP application:
PVP is examined by the Ministry of Agriculture, Forestry and Fisheries (MAFF). Substantive examination
(comparative cultivation) is performed by National Center for Seeds and Seedling (NCSS). There are 2 types of
examination, documentary examination and substantive examination. The documentary examination was done
by MAFF and the substantive examination was done by National Center for Seeds and Seedlings (NCSS). The
breeding and comparison testing was done by persons working in NCSS in Ibaraki Prefecture which have a
background of science and technology like biology.
After publication of application, following examinations are conducted regarding whether the applied variety
satisfies the conditions for variety registration.
a. Examination of characteristics (DUS Testing). Under DUS testing the following activity takes place like growing
test, on-site inspection and documentary examination.
b. Examination of Variety Denomination
c. Examination of Novelty, whether or not propagating material or harvested material of the variety have been
transferred in the course of business, in Japan earlier than one year before the date of application or in any
foreign state earlier than four years before the date of publication.
d. Rejection of application if the variety does not meet the conditions for registration.
Other details of the examination procedure for PVP can be found on their manual for substantive examination
which can be accessed in MAFF website.
About the relationship between PVP and Patent
In Japan plant variety can be protected by patent and PVP it means to say that you can have both protections at
the same time. The scopes of the rights can be different from each other. Please note that unlike US, specific
provision of patent for plant does not exist in Japan. However, you can obtain a normal patent right on plant
itself by using deposit system based on Budapest treaty. The scope of patent right is based on the description
of the claim even the genotype is different or in the case the genotype is the same it is within the scope of the
patent right while on the case of PVP it is based on phenotype even though genotype is different in comparison
with the species it is within the scope of the breeder’s right this maybe another advantage of double protection.
37
The Ministry of Agriculture, Forestry and Fisheries usually don’t collaborate with JPO regarding some plant
related inventions because their function is independent of each other. Maybe MAFF collaborates with the
Trademarks Division if there are some problems with the examination of denomination.
About problems specific to Plant Variety Protection
Regarding implementation of protection regime for new plant varieties and existing varieties, under the current
practice, the identity of genomics DNA cannot legally influence the protection. The infringement on PVP is
confirmed legally by comparative cultivation Therefore, it may take a long time to confirm the infringement.
Degenerative improvement is not included in PVP infringement it is difficult to prove if it is infringement or not.
Other relevant measures in PVP legislation has been implemented in order to improve and promote an effective
system for plant variety protection in Japan. Patent application based on deposit of seeds or cells under
Budapest treaty are already implemented in Japan.
4.2.3. Interview to SAKATA SEED Co
The interview takes place at the Sakata Seed Corporation in Yokohama, Japan at around 10: 00 am to 12:00 pm
on February 5, 2016. The respondents were Mr. Tomohiro Kamogawa, Genetic Resources Department,
Research and Development Division; Mr. Eijiro Nakata, Manager, Research and Development Division; Mr.
Kiyoshi Watanabe, General Manager, Legal Department and Mr. Keisuke Kondo, Japanese Patent Attorney,
Legal Department.
Main Contents:
About the Company’s methods of breeding:
The main method of breeding of Sakata Seed Corporation is the conventional breeding which is very traditional.
They use some biotechnology technique like trait marker to accelerate the breeding but they don’t conduct
genetically modified plants.
About the situation of plant related invention:
The main focus of their research or production depends on the demand, people sometimes need virus resistant
plant, beautiful flowers, fruits, vegetables, easy to harvest plants, etc. It also depends on the area where the
plant will be used, for example very dry condition of the area, the plant should be a drought plant. They gather
38
information on each area of interest and they will prioritize some area because they cannot make varieties for
each area.
The time of developing a new plant variety depends on crops plant life cycle, for example melon, if you
planted a melon you can get the next seed in 100 or 120 days that means you can make generations 2 or 3 times
a year. In onion the next seed can be produced in 2 years or only 1 generation in 2 years. Plant life cycle is very
important for the period of breeding. Basically it takes more than 8 to 10 years to develop a new variety of good
quality but for ornamental plants it takes about 5 years because it’s easier to breed ornamental flowers using
local resources.
About the relation between the plant patent and PVP:
Sakata don’t usually file patent protection for their plant varieties because of its difficulty to acquire. They
usually file for PVP, but they can still apply for patent protection if they want to because you can have plant
patent and PVP at the same time in Japan.
Plant patent system and PVP is very important, utility patent can protect the usage of that variety so the
others cannot use the plant variety for next breeding and PVP can protect only that variety so if another breeder
used your variety for breeding their own variety you cannot stop them from using your variety. Patent has the
stronger protection but it is very difficult to obtain. In the current situation plant breeding protection is very
much harmonized, the breeders exchanged their resources and made some agreement to keep and maintain a
system to share resources with everybody.
There are about 100 PVP applications per year and 200 species of ornamental plants per year. They also have
100 to 200 hybrid plants but they do not file for PVP protection they only sell them to other breeders.
Application for patents are very few including worldwide application at least 10 application per year. They have
1000 PVP registration and 100 to 200 every year. Sakata also have 10 domestic patent and 20 international
patent mainly in the United States.
Sakata immediately releases their products in the market after filing their PVP they don’t usually wait for the
application to be granted and basically they can sell their products even before obtaining the patent or PVP
registration.
About the problems specific to GMO related inventions:
Sakata uses conventional method of breeding and they don’t have GMO products. Just like in the Philippines
many people in Japan doesn’t like GMO products. Many people don’t know GMO exactly so there is a miss
conception so GMO products are not accepted by many people of Japan not only Greenpeace. GMO is
39
important in the process of making soy sauce but many people really don’t know a lot of GMO products. Some
of the products mostly expensive products contain information in the label that the product is GMO free.
According to the interviewee GMO products were checked and approved by the agency of the government
before it is released in the market so he believes that GMO products are safe. Sakata don’t have a safety
assessment for GMO because they don’t use GMO technology.
Sakata does not have any legal cases or infringement cases regarding plant patent and PVP. Japanese people
don’t like lawsuit, Sakata don’t like lawsuit.
About the importance of IP:
IP protection is very important for Sakata because they are so called Maker Company, they produce new
product or new variety so they don’t want other company to steal their technique or invention. They use
different IP protection like trade secret, trademark, PVP or patent.
They hope that PVP system will be globalized or have standardized system so that they can sell their products
to other countries. They are hoping that Japan Government can establish a unification system with Asian
countries like CPPO of Australia. If you have a CPPO your product can be protected in many countries. They are
hoping to have the same situation in Asia especially in plant breeding, they can easily develop plants by
combination by using different resources from different countries.
40
CHAPTER 5: Implications and Recommendations to the Philippines
It is a recognized fact that the Philippines desire for economic development, growth and technological
development is dependent on the promotion of scientific research and invention. An effective patent system
essentially involves procedures by which patentable subject matter is defined and patents are issued reflecting
both the interests of the patent holder and the interest of others. In modernizing the system, aspects must be
built into it, which include clearly defined, easy to follow and readily accessible administrative and legal
procedures.
The manual for substantive examination in the field of biotechnology must be designed to satisfy the
aforementioned objectives by providing the user comprehensive guidelines on matters of patent Law and
substantive examination practice. The processing of patent application must be consistent with the doctrines
embodied in R.A. 8293 (IP Code of the Philippines) and provides information regarding existing jurisprudences,
decisions and interpretations on matters regarding the patentability of patent applications.
5.1. Policy Making
After extensive research about the Patent system in Japan, it has shown that sustained efforts and attention
have been geared towards the attainment of desired Patent system to be internationally acceptable. In order to
enhance intellectual property protection worldwide, the JPO grants robust patents that will not be invalidated
afterward; broad patents that have coverage matching the extent of the technical levels of inventions and their
disclosure; and valuable patents that are recognized around the world. (Excerpt from JPO’s “Quality Policy on
Patent Examination).
In the case of the Philippines, delivering quality and timely patents is on top priority. Different
programs/projects are being conducted by the management of IPOPHL in order to be globally competitive. One
of these programs/projects is the standardization of examination procedures. In 2012 the revised Implementing
Rules & Regulations (IRR) on Patents, Utility Models & Industrial Designs has been introduced. In 2013, the
Examination Guidelines for Pharmaceutical Patent Applications Involving Known Substances (QUAMA) has been
introduced. In 2014, the Manual of Patent Examination Practice was also introduced. In this manual, discussions
about the examination procedures in biotechnology were insufficient and needs to be revised because of the
rapidly changing technology. In JPO, they have included special criteria for specific technical fields like Computer
Software-related Inventions, Biological Inventions and Medicinal Inventions. In the 1960’s JPO Examination
41
Guidelines contain chapter for examining microorganisms, biotechnological inventions were not yet included
during that time. Only in the 1990’s version, they started to add some chapters of plant and animals in the
Examination Guidelines but it was not that sufficient.
5.2. The Examination Guidelines
The primary principles of Examination Guidelines are efficiency, quality and user friendliness. It is important for
the IPOPHL to have this in mind in creating the guidelines. It is not practical to have a separate guideline for the
different fields of biological inventions like biological materials, microorganisms, plants, animals and genetic
engineering; these fields can be incorporated into one guideline under the biological inventions.
During the interview, some valuable advice from the interviewees were solicited. In order to have an efficient,
quality and user-friendly Examination Guidelines for Biology, it is important that all items such as novelty,
progressiveness, definiteness requirements, operability requirements, support requirements, way to proceed
the examination are described. In addition, it is important that useful examples, precedent judgments, examples
of the applications are shown in understanding the way of thinking of Examination Standard.
They believe that these topics can help the Examiners to easily understand the requirements of patenting the
applications of the specific technical fields. But it should be noted that the examiner does NOT need to use the
special criteria when they can determine the patent-eligibility of the claimed subject matter by applying
“General Criteria”.
5.3. Committee for making the policy
As a result of the interviews with the Experts from JPO who are once a member of the working group who
created The Examination Guidelines, the ideal number of members of the group should be 6 to 7 members. The
members are Examiners from the concerned division. It is also ideal to have at least one member coming from
the Academe or Expert in the field. The members will make the draft of the outline and will be distributed to
other Examiners and ask for their opinions and outputs about the case. Inviting Scholars outside the examining
division was proved to be helpful. The process takes time and it is advised that the consultations with fellow
Examiners and Scholars be done at least three times after each revision of the draft to ensure the accuracy of
the information.
5.4. Human Resource Development
42
There is a training program offered by the Intellectual Property Office (IPOPHL) for the Patent Examiners in
order to develop their skills in substantive examination. Training on Advanced and Emerging Fields for Patent
Examiners by Balik Scientists/University Professors and Foreign Experts are keeping the Examiners up to date
with technical developments. There is a Structured Training Program for the newly hired Patent Examiners that
lasts for six months. IPOPHL is working for a project called Graduate Scholarship Program for Patent Examiners
in which they encourage the examiners to enroll in a graduate school and have their Master’s Degree in Science
or Engineering.
Most of JPO’s Patent Examiner has Master’s Degree and Doctorate Degree which makes them experts in
their field which is an advantage. JPO Patent Examiners usually don’t have special training or official training on
a particular subject matter like plant-related inventions. The only training they have is when they become
Patent Examiners in JPO and lasts for two years.
Another advantage of JPO is having a study working group system in their respective division, in which they
exchange knowledge by consulting team members and conducting lectures. One advantage of this group
system is when it comes to decision and judgment making even though the examiner works independently if she
or he belongs to this group they can consult one another so when it comes to decision-making it gives a huge
advantage.
Recommendation for IPOPHL is to continue their projects for the development of Patent Examiners.
Encourage the Examiners to create Study working groups within respective Examination Division. This system
will minimize the problems of examination in special technology like biotechnology by consulting fellow
Examiner about the case and most of all will have the same stand and position about the case. Engage in
International Partnership and Cooperation with other Patent Offices that will benefit both countries.
5.5. Issues in the Future
Patent System
In order for the Philippines to be relevant in the field of Biotechnology and to encourage local inventors to file
more inventions, the Government should take the initiative to talk and land an agreement with the top
biotechnology companies and convince them to share their technology to local inventors. The concept is to
create a Patent Pool for Biotechnology Inventions where the local inventors can freely access the technology
anytime without infringing the rights of the patent owners. This agreement will be both beneficial for the
private companies, the local inventors and small time companies. With this concept, developing countries can
cope up with the flourishing biotechnology industry and will contribute to the economy.
43
To protect the small farmers in the Philippines, revision of the patent law is also necessary. The concept of
including the Farmer’s rights in the patent system will ensure the welfare of the small farmers. Farmers of the
developing country usually have a hard time obtaining a good variety of plant crops to have a nice and abundant
harvest and the main reason was a lack of financial capacity to purchase these good varieties of plant crops. The
situation is, the farmers cannot store the seeds of their harvest for future use, so every time they want to plant
their crops they need to buy the said good variety of plants which is very costly. If this concept will be included
in the patent law farmers from the Philippines will be greatly benefitted.
PVP System
Philippines natural resources are very abundant and needs to be protected so that it will not be exploited by
others. The current PVP Law only protects the new plant varieties but the local/old varieties used in traditional
knowledge and the wild variety of plants that can be found only in the Philippines are not protected. These said
plants are prone from exploitation by others and the Philippines cannot get anything from it. If this concept will
be considered in the future, the Philippines can benefit from the earnings or royalty it will generate.
44
References
A History of System of Industrial Property Rights (n.d.). Retrieved February 4, 2016 from JPO:
https://www.jpo.go.jp/cgi/linke.cgi?url=/seido_e/rekishi_e/rekisie.htm
Blakeney, M. (2011). Patents and Plant Breeding: Implications for Food Security. Retrieved February 22, 2016
from Social Science Research Network: http://papers.ssrn.com/sol3/papers.cfm?abstract_id=1927220
Burrone, E. (2006). Patents at the Core: the Biotech Business. Retrieved January 28, 2016, from WIPO:
http://www.wipo.int/sme/en/documents/patents_biotech_fulltext.html
Chan Robles Virtual Law Library (n.d.). Intellectual Property Code of the Philippines - An Overview. Retrieved
January 28, 2016 from Chan Robles Virtual Law Library:
http://www.chanrobles.com/legal7code.htm#.VqmL3Jp9600
Corpuz, P. (2015). Philippine Agricultural Biotechnology Situation and Outlook. USDA Foreign Agricultural Service
GAIN Report. Retrieved February 3, 2016 from Global Agricultural Information Network:
http://gain.fas.usda.gov/Recent%20GAIN%20Publications/Agricultural%20Biotechnology%20Annual_Manila_Ph
ilippines_7-10-2015.pdf
Eaton, D.; Kalaugher, E.; & Bijman, J. (2004 April). International Agreements Relating to Plant Genetic Resources
for Food and Agriculture and Implications for Dutch Policy. Retrieved February 15, 2016 from AgEcon Search:
http://ageconsearch.umn.edu/handle/29132
European IPR Helpdesk (2014). Fact Sheet, Intellectual Property in Biotechnology. Retrieved January 28, 2016,
from European IPR Helpdesk:
https://www.iprhelpdesk.eu/sites/default/files/newsdocuments/IP_in_Biotechnology.pdf
Foote, H. (2013). International IP Protection for Plants. Retrieved February 17, 2016 from AIPLA:
http://www.aipla.org/SearchCenter/pages/results.aspx?k=Humphrey%20Foote
Hefferon, K. (2010 June). Plant biotechnology patents: applications in agriculture and medicine. Retrieved
January 28, 2016 from PubMed.gov: http://www.ncbi.nlm.nih.gov/pubmed/20180763
History of Japanese Patent Law (n.d.). Retrieved February 4, 2016 from Prior Art Search & Translation:
http://www.searchpriorart.com/databases/JP-patent-history.htm
IPOPHL (n.d.). About Intellectual Property Office. Retrieved January 28, 2016 from IPPHL:
http://www.ipophil.gov.ph/index.php/ip-knowledge2/about-intellectual-property-office
Japan Patent Attorneys Association (n.d.). Unpatentable Subject Matter. Retrieved February 12, 2016 from
JPAA: https://www.jpaa.or.jp/english/patent/unique_jpo_practices.html#subcontents1
45
Jördens, R. (2002). Compilation of the 2002 & 2003 Joint Symposia Documents of WIPO and UPOV. Retrieved
February 12, 2016 from UPOV:
http://www.upov.int/meetings/en/doc_details.jsp?meeting_id=4687&doc_id=255747
Kiewiet B., (2003). Relation Between PVP and Patents on Biotechnology. Retrieved February 22, 2016 from
Community Plant Variety Office:
http://www.cpvo.europa.eu/documents/articles/BK%20Bangkok%20November%202003.pdf
Lamasan, J.O. (2013 September). WIPO/JPO Long-Term Research Fellowship Program: Patent Examination
Practices Involving Known Pharmaceutical Substances: The Philippines and Japan. Retrieved from JPO:
http://www.training-
jpo.go.jp/en/images_x/uploads/japanese/FY2013/Final%20Research%20Paper%20(2013LTF%20Joseph%20R
hei%20O%20Lamasan).pdf
Maskus, K.E. & McDaniel C. (1998 December). Impacts of the Japanese Patent System on Productivity Growth.
Retrieved February 12, 2016 from University of Colorado at Boulder:
http://www.colorado.edu/economics/papers/papers99/wp99-1.pdf.
Namikawa, R. (2011). Overlapping of intellectual property systems for plant variety as a result of advances in
biotechnology. Retrieved February 12, 2016 from Chukyo University:
http://nc.chukyo-
u.ac.jp/search/index.html?cx=005622576581114648311%3A2xflxga3fpm&cof=FORID%3A10&oe=euc-
jp&q=+Overlapping+of+intellectual+property+systems+for+plant+variety+as+a+result+of+advances+in+biote
chnology&sa=Search&siteurl=nc.chukyo-u.ac.jp%2Findex.html&ref=nc.chukyo-
u.ac.jp%2Fseikyu%2Findex.html&ss=
Patent Act of Japan (Act No. 121 of April 13, 1959, as amended up to Act No. 36 of May 14, 2014)(n.d.).
Retrieved February 12, 2016 from WIPO: http://www.wipo.int/wipolex/en/text.jsp?file_id=370746
Philippines Adopts PVP Law (2002 June). Retrieved February 3, 2016 from GRAIN:
https://www.grain.org/article/entries/2019-philippines-adopts-pvp-law
Plant Variety Protection and Seed Act of Japan (Act No. 83 of May 29, 1998, as last amended by Act No. 49 of
May 18, 2007)(n.d.). Retrived February 12, 2016 from WIPO:
http://www.wipo.int/wipolex/en/text.jsp?file_id=187739#LinkTarget_602
Republic Act 9168 (2002). An Act to Provide Protection to New Varieties, Establishing a National Plant Variety
Protection Board and for Other Purposes. Retrieved February 3, 2016 from PVPO:
http://pvpo.bpinsicpvpo.com.ph/
46
Pray, C.E.; Govindasamy, R.; & Courtmanche, A. (2003). The Importance of Intellectual Property Rights in the
International Spread of Private Sector Agricultural Biotechnology. Retrieved February 15, 2016 from:
http://citeseerx.ist.psu.edu/viewdoc/download?doi=10.1.1.512.5986&rep=rep1&type=pdf
Pua, E.C. & Davey, M.R. (2007). Biotechnology in Agriculture and Forestry 59: Transgenic Crops IV. Retrieved
January 28, 2016, from Google Books:
https://books.google.co.jp/books?id=NsoIT3QX0DwC&pg=PA3&lpg=PA3&dq=Helmke+and+Minerick+2006&
source=bl&ots=IOyV2Fi7cF&sig=2vhvU4TKFymNgq3gl29d0HxuwfI&hl=en&sa=X&ved=0ahUKEwiCm6bww8vK
AhWhxqYKHZu6BjcQ6AEINjAF#v=onepage&q=Helmke%20and%20Minerick%202006&f=false
Republic Act No. 165 (1947). An Act Creating a Patent Office, Prescribing its Powers and Duties, Regulating the
Issuance of Patents, and Appropriating Funds Therefor. Retrieved February 3, 2016 from The LawPhil Project:
http://www.lawphil.net/statutes/repacts/ra1947/ra_165_1947.html
Republic Act No. 5921 or the Pharmacy Law, and for Other Purposes. Retrieved February 3, 2016 from IPPHL:
http://www.ipophil.gov.ph/images/Patents/IRRs/RepublicAct9502.pdf
Republic Act No. 8293 (1997). Intellectual Property Code of the Philippines. Retrieved February 3, 2016 from
IPPHL: http://www.ipophil.gov.ph/images/Patents/IRRs/RepublicAct8293.pdf
Republic Act No. 9502 (2008). An Act Providing for Cheaper and Quality Medicines, Amending for the Purpose
Republic Act No. 8293 or the Intellectual Property Code, Republic Act No. 6675 or the Generics Act of 1988
Standing Committee on the Law of Patents. (2009). Retrieved February 22, 2016 from WIPO:
http://www.wipo.int/edocs/mdocs/scp/en/scp_13/scp_13_3.pdf
Straus, J. (2002). Measures Necessary for the Balanced Co-Existence of Patents and Plant Breeders Rights, A
Predominantly European View. Retrieved February 12, 2016 from UPOV:
http://www.upov.int/meetings/en/details.jsp?meeting_id=4687
The Differences between Plant Variety Protection and Patent Protection on Plants (n.d.). Retrieved February 17,
2016 from Public Citizen: http://www.citizen.org/Page.aspx?pid=3306&q=PVP%20versus%20Patent
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MINUTES OF THE INTERVIEW With JPO Patent Examiner Department
Time of interview:
10:00 to 11:00 am on 25th February 2016
Place:
JPO Building
3-4-3 Kasumigaseki, Chiyoda-ku Tokyo, 100-8915, Japan
Participants:
Ms. Yumiko Matsunami, Director Biotechnology Division Third Examination Department, JPO
Mr. Hajime Kamijo, Director Foods and Microorganisms Sub-Division, Biotechnology Division, Patent
Examination Department
Main contents:
About the situation of the plant related inventions:
1. In the Philippines, the plant related invention filings are increasing annually, specifically plant related
biotechnological inventions. Most of the plant related inventions are filed by foreign applicants. What is the
situation of plant related inventions in Japan?
In Japan the filing of biotechnology applications in general are on the increase while applications for plant
related invention under biotechnology is steadily decreasing. The particular chart shows IPC International
Classification Class A01H 5/00 which relates to filing regarding the said plant related invention. Starting 2001 the
number of filing begins to decline, but if you look at the biotechnology field the filing of applications are
increasing and still continue to increase. In terms of applicants by nationality as you can see at the bottom chart
the proportions are almost the same, local and foreign filing.
2. In the Philippines, the most typical plant related inventions are categorized to xx, xx and xx. What are the most
typical plant related inventions that are being filed in JPO?
In Japan the typical plant related inventions in terms of IPC International Classification, this relates to
horticulture and vegetables nurturing, these areas are not really the section that I am involved with and handled
by different section. So the division that I belong to, handles as I mentioned earlier, plants that involves new
novel aspects, a process or method of obtaining those new type of plants such as genetic engineering which I
am directly involved. As I mentioned earlier plant related inventions are in the decline.
About the policy for the plant related inventions:
3. Are there any policy specialized for the plant related inventions in JPO?
4. Does JPO have a manual specialized for substantive examination for plant related invention besides the
Examination Guidelines to patent applications relating to biological inventions?
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Regarding questions 3 and 4, I think I can answer them both at the same time because they are inter-related
questions. In JPO all of the technical fields are handled based on the same examination guidelines. We don’t
have any specific policy just applied to plant related inventions. However, let me show you a copy of the
examination guidelines which cover this particular field. Basically we follow the general examination guidelines
who are applied to all of the divisions within JPO. But when it comes to biotechnology field we have a more
detailed guidelines and you can access this in the JPO website. It’s been seven or eight months since I become
head of this division but Mr. Kamijo entered JPO earlier so he has tremendous knowledge and expertise
particularly with this field. For two and a half years Mr. Kamijo was the leader of the examining team handling
plant related inventions.
About the skills of the examiner for the plant related inventions:
5. Do the patent examiners undergo any training regarding examinations of the plant related Inventions or
biological inventions?
In terms of technical background of the JPO Examiners, actually there are few substantive examiners who have
academic backgrounds exclusively for plant related areas because of you look at the overall trend of the
background of the JPO examiners they have more over all general academic backgrounds in genetic engineering
for example, so there are very little or narrow down background in plant related backgrounds. But ofcourse if
you have the general knowledge or expertise in the area, after you join JPO, various trainings and learnings will
be acquired in the plant related aspects so the overall knowledge will be enhanced as the examiner accumulates
experience. So in my particular division I find more examiner who has genetic engineering background or
general pharmaceutical areas and there are many examiners with Master’s Degree and Doctorate Degree and
they have this general overview. We have study work groups with examiners with plant related backgrounds will
give talks and lectures so that they can share their knowledge in the study group. However, we don’t have any
special internal official training program focusing just the plant related invention in terms of the details of the
technical aspect as part of the official training. So generally they enhance their technical skills and obtain
additional information and knowledge by way of doing their day to day office works.
6. Are there any separate group that takes care of the plant related inventions or the biological inventions in
JPO? How do you think on the creation of a separate group or division for the plant related inventions or
biological inventions?
There are several working groups which handle animal related inventions and plant related inventions
And we have also different divisions that handle cell related inventions. There are 20 examiners who work on
plant and animal related invention, and me myself belongs there. As far as I know there is only one in that group
that has a plant related background. The majority of the group in terms of technical field and their university
background, most of them handled mice for experimental or operations for animal stem cells or microorganisms
and things like that. Of course including myself the day to day operations of reading the applications and prior
arts expands my knowledge in the said area. As for the technical areas for groups who handles the day to day
basis they are involved in advanced technology, we have a system which the examiner consult each other
among the team member so that system is established. One advantage of JPO is having this group system when
it comes to decision and judgment even though the examiner works independently if she or he belongs to this
group they can consult one another when it comes to decision making it gives us a huge advantage.
About the problems specific to the plant related invention:
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7. What are the major causes of the examination problems on the plant related inventions?
Several years ago there are some issues about plant related inventions , the difference between monocot and
dicot plants. Because of the advanced genetic engineering we started receiving more application involving
genetic engineering, involving recombination of genetic aspects and even if you employ agrobacterium to a few
years ago it is not possible to conduct recombination on monocot for the industrial aspect. We have various
controversial issues and debates as to whether we should tell the applicant that for the monocot plant is not
possible to do recombination and then the applicant writes the claims they will have to debate us if they should
do so. Right now we don’t have the backlog of the old filing when it was filed when the days it is difficult to do
the recombination of monocot we are now a phase with that particular issue. Instead one of the most difficult
that we have confronted in substantive examination of plant related invention is when it comes when a plant
who was created as a result of recombining instead of using deposited plant, how should we identify the
genetics mark on this specific type of this new plant, that was the most difficult problem that we faced. So in the
claim if it is identified by marker or genetic types when it comes to the question if it is sufficient or insufficient to
directly identify the new plant that poses another difficulty on the substantive examiner handling the case.
Determination of these cases is the most difficult aspect when it comes to recombining plants as long as you can
identify the genes it is very easy and clearly you can identify the plants. However when it comes to recombining
plants the inventor does not know exactly how it has been changed neither the examiner therefore it becomes
very difficult to patent. Normally the inventor will claim that this particular gene transformed in that particular
manner by this new particular marker that the inventor identified but when it comes to the actual question that
if it is sufficient or insufficient to identify the new plant itself neither the inventor or the examiner has the
answer.
8. In what kind of a situation, the examiners of JPO encounter the problems in examining the plant related
inventions?
Mr. Commissioner just answered question number 8 and we will go on question number 9.
9. Regarding the problems the examiners have encountered, what measures do they apply to address the said
problems?
Regarding question number 9, as we have mentioned before, the examiners consult each other.
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MINUTES OF THE INTERVIEW With JPAA PVP Expert
Time of interview:
1:30 to 3:30 pm on 9thFebruary, 2016
Place:
Hatsumei Suishin Kyokai (JIPII)
4-2, Kasumigaseki 3-chome, Chiyoda-ku Tokyo 100-0013, Japan
Participants:
Mr. Kazuaki Nakashima, IP Committee on Agriculture and Fisheries Chairperson Mr. Shinichi Inoue, Patent Attorney Chemical Department, Asamura Patent Office
Main contents:
About the Situation of Plant Variety Protection
1. In the Philippines, there is a lack of public awareness about Plant Variety Protection and as a consequence the
breeders turn to seek Patent Protection instead of plant variety protection. What is the situation of plant variety
protection in Japan? Is there any policy regarding promotion of plant variety protection in Japan?
Actually most (80%) of Japanese breeders are Prefectures (80%). For example “Koshihikari”, a famous and
popular rice was developed by Agricultural Research Institute of Niigata prefecture. Plant variety protection is
under Ministry of Agriculture, Forestry and Fisheries not JPO. Most of the breeder other than prefecture is
company such as “Sakata No Tane” (SAKATA SEED CORPORATION). they create in good faith but Chinese
someone stole seed from Japanese seed lines and Japanese cannot protect such infringement. Korean seed
company create new plant variety using Japanese seed, Japanese breeder in good faith cannot protect their
variety so in this situation Japanese protect their product by using Trademark. I don’t know any proven patent
protection flaw that affect protection. PVP is independent of plant chemistry, only characters, length, weight,
shape of the leaf, but .... I understand that Philippines cannot protect plant itself by patent but Japanese is Ok.
Budapest treaty, deposit system usually accept microorganism, but Japanese seeds can be deposit, hybridoma,
hydridoma producing antibody can be deposit and acceptable. Honda Company applies for double protection of
their plant variety. In PVP if the variety has been published it will not be rejected unlike with patents it will be
rejected. During the transfer of the seeds or sold to anyone and If the breeder sold his product in the market 1
year before filing then it’s not good, but the same thing under patent they don’t have the same system under
PVP. Can anyone file for PVP even without attorney or legal representative? Yes it’s possible under the law.
2. I understand that Japan is a member of UPOV, before joining UPOV, does Japan have some sort of Plant
Protection?
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Partially Yes. However, previous law (before joining UPOV) was for protection of NAME of PLANT variety, NOT
plant itself. In other word, it is prescribed to protect HONOR of breeders, not substantive benefit. There is a
plant protection but it only protects the owner of the plant not the plant itself. The protection is only a
recommendation and not an award. This protection was established after the World War 2 and Japan was under
United States and all the food situation was so bad and the plants and seeds deteriorated very much so the
Japanese Government must do something and they need this. The protection was used for not to misuse or bad
face usage. The old PVP law and the current law is very different.
Previous Law (Agricultural Seeds and Seeding’s Law)
Article 7 Any person who raised the seed and sapling of an excellent new species can apply to the Minister of
Agriculture, Forestry and Fisheries and can receive the registration of the name of the seed and sapling.
Current Law (Seeds and Seeding’s Law)
Article 1 The purpose of this Act is to promote the breeding of plant varieties and the rational distribution of
propagating material by providing for a system relating to the registration of plant varieties for the protection of
new plant varieties and regulations relating to the indication of designated seeds, so as to contribute to the
development of agriculture, forestry and fisheries.
About the Examination of PVP Application
3. Who is in charge of examining the application for PVP? Is there any qualification for the job?
PVP is examined by the Ministry of Agriculture, Forestry and Fisheries (AFF). Substantive examination
(comparative cultivation) is performed by National center for Seeds and Seedling. There are 2 types of
examination, documentary examination and substantive examination. The documentary examination was done
by MAFF and the substantive examination was done by National Center for Seeds and Seedlings (NCSS). The
breeding and comparison testing was done by persons working in NCSS in Ibaraki Prefecture which have a
background of science and technology like biology.
4. Can you describe the examination process of PVP application in Japan? Do you have a substantive examination
of application for PVP?
Please visit and see the following English web page
http://www.hinsyu.maff.go.jp/en/en_top.html
After publication of application, following examinations are conducted regarding whether the applied variety
satisfies the conditions for variety registration.
a. Examination of characteristics (DUS Testing). Under DUS testing the following activity takes place like growing
test, on-site inspection and documentary examination.
b. Examination of Variety Denomination
c. Examination of Novelty, whether or not propagating material or harvested material of the variety have been
transferred in the course of business, in Japan earlier than one year before the date of application or in any
foreign state earlier than four years before the date of publication.
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d. Rejection of application if the variety does not meet the conditions for registration.
5. Do they have a manual for substantive examination for Plant Variety Protection? (ask only if answer in item 3
is affirmative).
Yes, see the web page. Very detailed in the webpage.
6. Does your PVP or other national law or regulation require any disclosure of source, consent from local owners
from which the plant variety has been improved, and the sharing of benefit derived therefrom?
YES, in general, the specification must describe parental species (father and mother).
<Effects of the Breeder's Right>
Article 20 The holder of a breeder's right shall have an exclusive right to exploit, in the course of business, the
variety which is registered (hereinafter referred to as "registered variety") and varieties which, by the
expressions of the characteristics, are not clearly distinguishable from the registered variety. However, this shall
not apply where an exclusive exploitation right is granted in relation to the breeder's right, to the extent where
the holder of the exclusive exploitation right is granted an exclusive right to exploit those varieties.
(2) The holder of the breeder's right for a registered variety shall also have an exclusive right to exploit
varieties described in following items, the scope of which shall be the same as the right which the breeders of
the said varieties would, if obtained a variety registration, be granted. In this case, the proviso of paragraph (1)
of this Article shall apply mutatis mutandis.
(i) varieties which are bred by changing parts of the expressions of the characteristics of the registered
variety while retaining the expressions of its essential characteristics using such methods as selection of a
mutant, backcrossing, transformation by genetic engineering or other methods specified by the Ordinance of
the Ministry of Agriculture, Forestry and Fisheries and which are clearly distinguishable from the initial
registered variety by the expressions of the characteristics; or
(ii) varieties whose production requires the repeated use of the registered variety.
(3) Where a registered variety is bred by changing parts of the expressions of the characteristics of a variety
other than the registered variety while retaining the expressions of its essential characteristics using methods
specified by the Ordinance of the Ministry of Agriculture, Forestry and Fisheries prescribed in item 1 of
paragraph (2) of this Article, for the purpose of the application of paragraph (2) of this Article and paragraph (2)
of Article 21, the words "following items" in paragraph (2) of this Article and "each item of paragraph (2) of
Article 20" in paragraph (2) of Article 21 shall be deemed to be replaced with the words "item 2" and "item 2 of
paragraph (2) of Article 20," respectively.
You have to submit the strain of the father and the mother or parent of the plant for the child or the product to
be protected. Breeder’s right also transfers the right to the dependent or child of the plant. If the breeder or
farmer transfers the rights to obtain the breeders right to company then they will have to share but not to share
because they have some kind of contract. Very similar with the patent invention but designation in the patent
area has been revised recently so I don’t really say that it’s the same but if somebody came up with new
varieties then the treatment will be quiet similar with that of the PVP.
7. If the response to item # 6 is negative, do you have any plan to protect the interest of local owners from which
the improved plant varieties has been derived?
53
Question not relevant
8. Does your PVP require the applicant to deposit samples of the new plant variety which is registered?
YES, seeds or seedlings must be deposited. Deposited seeds and seedling are subjected to judgement of
Distinctness, Uniformity and Stability (DUS testing). Please see the website
http://www.hinsyu.maff.go.jp/en/about/contents/5.pdf
9. Does your PVP provide national treatment for nationals of another country which by treaty, convention or law
affords similar privileges to Japanese Citizens? If that was the case, does your law permits the use of relevant
test reports produced by other UPOV members?
YES, Documentary Examination at page 6. Please see the website
http://www.hinsyu.maff.go.jp/en/about/leaflet.pdf
Yes, especially members of UPOV, even foreigners leaving in different country but their country is a member of
UPOV they can have the same treatment as Japanese national have. Japan is also member of some bilateral
treaties or treaties those countries can receive the same treatment such as Taiwan. Documentary Examination-
growing test and on-site inspection may not be conducted, where examination of characteristics is possible
through documents such as examination reports produced in a member of UPOV based on examination
cooperation, or detailed investigation reports made by the applicant.
About the Relationship between PVP and Plant Patent
10. Can a new plant variety be allowed double protection under more than one IP (e.g., patent and sui generis
PVP)?
Yes, In Japan, Patent and PVP can protect plant species simultaneously.
11. What are the advantages of having a separate protection for Plant Patent and Plant Variety Protection? Is it
advantageous for the applicant to have both protection?
The scopes of the rights can be different from each other. Please note that unlike US, specific provision of
patent for plant does not exist in Japan. However, we can obtain a normal patent right on plant itself by using
deposit system based on Budapest treaty. In the Philippines you said that plants cannot be protected by patent,
in genetically modified plants they can create many species of plants and each of this species can be protected
one by one. The scope of patent right is based on the description of the claim even the genotype is different or
in the case the genotype is the same it is within the scope of the patent right while on the case of PVP it is based
on phenotype even though genotype is different in comparison with the species it is within the scope of the
breeder’s right this maybe another advantage of double protection.
12. Do the Ministries of Agriculture, Forestry and Fisheries collaborate or work with JPO regarding some of the
Plant related Inventions? Is this necessary or important?
Maybe with Trademarks because of Examination of Denomination. With patents basically no cooperation within
the two.
About problems specific to Plant Variety Protection
54
13. Is there any decision or case law in Japan which clarifies any issue(s) in relation to protection of new plant
variety? If so, can you please provide some details?
"The first place not to the description of the characteristics of the varieties that are listed in the variety
registration Application is define the scope of rights, and ultimately be one that is defined by the plant itself,
which is confirmed by the field survey, etc. of the examiner, variety registration gun described is not intended to
directly affect the range of rights at the time of the (2004 (Gyou) No. 278), "" variety registration, the
characteristics of the varieties that are listed in the registry of Plant varieties (Seeds and seedlings Law Article 18
2 No. 4) section, on the registered variety breed registry, are intended to identify identification, technical scope
(patent law 70 paragraph 1 of the patented invention, which is defined on the basis of the description of the
scope of the claims in the patent law ) Unlike thereby do not delimit the scope of rights (i.e., be provided with a
properties and the same properties according to breed registries differ in other characteristics not found in the
variety register, If it is determined to be a different breed it is not intended to infringe on the breeder's rights of
registered varieties (2005 (Gyoko) No. 10001) "
Unlike the specification (i.e. descriptions) of patent application, the descriptions for PVP should not influence
the scope of the PVP right. In PVP the actual product or actual species that will be protected by PVP. In living
things we cannot describe by words or by text that’s why in the patent we have a deposit system.
14. Do you have any problem in implementing your protection regime for new plant varieties and existing
varieties (if any)? Please describe.
Under the current practice, the identity of genomic DNAs cannot legally influence the protection. The
infringement on PVP is confirmed legally by comparative cultivation. Therefore, it may take long time to confirm
the infringement. Degenerative improvement is not included in PVP infringement it is difficult to prove if it is
infringement or not.
15. If you do not have problems in the implementation, could you suggest any mechanism which ensures
successful implementation?
The people can entrust NCSS to keep the species, they can deposit their registered species as long as they want.
16. What other relevant measures Japan implemented or will implement in your PVP legislation in order to
improve and promote an effective system for plant varieties protection?
Patent application based on deposit of seeds or cells under Budapest treaty. In the Philippines I’m not sure if
the seeds can be deposited. The deposition of seeds is already implemented in Japan.
Supplemental Questions
1. Do PVP applications have an annual fee?
Yes
2. How about if the application was rejected, can the applicant revive the application?
If there is a written opinion and explain and justify the variation with other plants that can reverse the rejection
or notice of refusal.
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3. Can a 3rd party submit a written opinion or opposition about the application before or after registration?
The seeds and seedlings act did not provide such clause in opposition. Because opposition is done in
administrative body so it will cancel the administrative decision. In patent the 3rd party can provide an
opposition or 3rd party observation.
4. You have said that the application will be published after filing so it is open to public for criticism?
In patents that is the case if the application was published but, in PVP there is a growing test and it will take
some time to determine the result so it must be published earlier so that the provisional protection will take
effect.
5. What is your opinion about genetically modified plants?
There are some resistance from the people, they don’t like GMO products.
56
MINUTES OF THE INTERVIEW With the Sakata Seed Corporation Expert
Time of interview10:00 am- 12:00 pm on 5thFebruary, 2016
Place:
Sakata Seed Corporation
2-7-1, Nakamachidai, Tsuzuki-ku, Yokohama, Kanagawa 224-0041, Japan
Participants:
Mr. Tomohiro Kamogawa, Genetic Resources Department, Research & Development Division
Mr. Eijiro Nakata, Manager, Research & Development Division
Mr. Kiyoshi Watanabe, General Manager, Legal Department
Mr. Keisuke Kondo, Japanese Patent Attorney, Legal Department
Main contents:
About the Company’s Methods of Breeding
1. What kind of breeding method do you usually practice in your seed company?
Our main method for breeding is a conventional breeding which is very traditional, sown and grown and then make selection from that field and then collect the seed from the good plant. Good plant means we have a opposite of breed faster is the opposite of breeding and then we pick up the plant which is not the opposite, and then we have a succeeded next season, that is a kind of routine map, looks like a routine map but it is a method of our company. Biotechnology is a kind of how to say help for this breeding so you ask another kind of breeding that is the main offer or method to help the breeding just like trait marker breeding it can accelerate breeding. Other method is Discardia or sometimes Astacardia or Pointcardia it can shorten the period of breeding. Other method is a Woptitchscardia especially for vestibule plants we can make a virus free plant from the main stem so we use such kind of method or help in breeding. Basically this is the kind of breeding usually outside the traditional method.
2. Do you still practice the traditional method of breeding?
Yes (already answered in question no. 1.)
3. Can you please share your knowledge about biological and non-biological processes of production of plants? Can you please give some example of biological and non-biological processes?
I don’t know the meaning of biological and non-biological processes is because usually everything biological processes so non-biological means discardia or something? Process of production of plants means a, we can re grow plants from single cell but it is still discardia i think that is a
57
biological process. So what are non-biological processe? So DNA marker selection is a kind of non-biological process.
About the situation of plant related invention
4. The Philippines is an agricultural country and most of the seeds and plants company focus on vegetables and fruits, as a leading seeds and plant company what is your main focus of research?
One focus is a, from demand, so every farmer every market have some demand some people want a virus resistant plant, beautiful flower, fruits, vegetables, easy harvest for the farmers, so everybody have a different needs specially for farmers they want they have to make money from the plant so if you want a such kind of product it means a even what condition can grow a they can sell or harvest, the first priority I think is stability, in this stability we have a lot of components because in some area we have a lot of question of disease in such area we have a drug plant in some area very dry condition in such case we need a drought plant, it depend on the demands for each area, so first we correct the information from the area what kind of demand do you need then we comeback then we put the breeding then we put the subject in the breeding but we have to have a another good point because only correct seed then we can release variety which can cover all needs still it cannot be the leading variety so we have to put another good point which people doesn’t know you know that is our point based on the basis of their needs so some people expect we need such aid sometime several tons or hectare that is a need but we have to overcome this so anyway the breeding objective mainly their needs in everywhere. We cannot make varieties for each area we collect data and we have to prioritize each areas and we have to make varieties for the priority areas. But anyway the information is very important we can put the same variety in different area if the need is there.
5. On the average, how long does it take to develop a potential plant variety?
Actually it depends on crops, for example we breed melon or tomato. These it depends on plant life cycle. About melon, if we sow the seed you can get next seed in 100 or 120 days it means we can make generations three times a year or two times a year. About onion you sow the seed you can get the next seed in two years so only one generation in two years. Plant varieties means two parent line on this parent line is very fixed parent line I mean genetically fixed. All genes are almost same so we have to make some generation fixed line so plant life cycle is very important for the period of breeding but basically from zero start it takes more than ten years at least 8 years to 10 years because if you start today you can correct mortality and then grow that plant then cross then sow the next seed then it takes 1 year for 1 generation 5 years means 5 serving or 5 seals with 5 or 6 season you can have a pretty fixed line but we have to check the seed productivity they make trial for a lot of areas so to make a new variety a good variety it takes about 10 years but for ornamental plants its about 5 years it is more easy to breed ornamental flowers using local resources. Our company starts at 1913 we have almost 100 years of history so breeding is not the only start so we start and start again to continuously breed product and study and study.
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About the relation between the plant patent and PVP
6. Do your company filed for separate patent protection and plant variety protection for a single plant?
I think in Japan recently we cannot patent a new variety because of obviousness or inventive step. So basically we use PVP for a single plant and a concept for new technique for patent. If that plant have special trait for example high content of lycopene that maybe patentable if not PVP that’s different from EPO. If there is a high level of invention we can get patent and also plant variety protection. There is no bar for double protection in Japan. Plant variety protection is not so strong as patent system, so sometime if we found a very important material we try to get patent but it is not easy and depends on country in EP it is hard to get patent than the US but maybe we will try to get IPR by plant variety protection if it is subject to taken by other companies.
7. What are the advantages of having a separate protection for plant patent and plant variety protection?
Utility patent can protect the usage of that variety so another people cannot use that plant variety for next breeding so for us it’s a good point but plant variety protection can protect only that variety copying that variety so we cannot stop the breeding by using the variety if you only have plant variety protection so in this business plant patent is more stronger we want to have plant patent but it is difficult. About the plant variety protection we usually get this on the OP variety such as lettuce, in OP variety we can sell the seed and let the seed in the plant and you can reproduced the same variety in such case plant variety can want but the farmers can get the variety in the plant but it is not the same variety from the original variety so we don’t need plant variety patent in such case. Plant patent system is very important and also plant variety protection is very important for us because any variety which exists in the world and developed according to another varieties which is a nature of plant breeding so we consider plant variety which is not so strong as patent very much harmonize with current situation to keep and maintain a system to share resources with everybody. But sometime we made a very special agreement with Argentina who obligate us to share the benefits among our products. We have few patent case so we consider plant variety protection more suitable for our plant breeding I think. Some competitors use our varieties and we use their varieties this is the basic of agriculture for hundred million years and every time we exchange resources that’s the history of plant breeding that’s why plant breeding protection is very much harmonize with current situation. If everybody protect variety by patent nobody can breed anymore. My company’s object, if that variety is very suitable and different from previous plant, we like to apply patent.
8. How many patent applications and plant variety protection applications does your company filed in a year? How many patent and PVP your company have?
100 PVP applications a year with hybrids around 100 to 200 of PVP. But hybrid we do not apply protection we just sell hybrids, for ornamental plants we get plant variety protection to commercialize so maybe almost 200 species per year. Patent very few, including worldwide application at least 10 not so much. We don’t concern other company on how many they filed PVP, in patent other competitor apply huge number every year like Monsanto and Syngenta they apply huge number of patent application in Japan. 1000 PVP registration and 100 to 200 every year.
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Domestic patent is 10 or so and international patent is 20 mainly in United States, we can get line patent for example broccoli line. Plant patent in US is like PVP but patent is stronger than PVP. Plant patent is different only in United States, just for vegetative plant, ornamental, fruits and some vine I think. In the US there are PVP, plant patent and utility patent. Patent for parts of plant and PVP for seeds.
9. I believe that obtaining patent takes time, and specially PVP with all the field testing to be done. Do your company wait for the patent or PVP to be approved before your product released in the market?
Basically after we apply PVP we will release it to the market because the application date is most important or even 1 year we can get the patent even we sell the plant they binding by a year. Basically before we can get patent or PVP we can sell it.
About the problems specific to GMO related invention
10. In the Philippines genetically modified plants have a negative impressions to some groups like Greenpeace Philippines and to the extent of even filing legal cases, do you have any experience or situation like these here in Japan?
As I told you before we use conventional method of breeding we don’t have GMO product. In Japan it is also the same not just like groups like Greenpeace but many people don’t like GMO, because they don’t know GMO exactly so there is ambitiousness in mind or against GMO so GMO is not accepted by many people in Japan not only Greenpeace. But honestly GMO is important in process of soy sauce but many people don’t know a lot of GMO products. Some expensive products contain no GMO in the labels.
11. What is your opinion regarding how safe GMO products are in the environment and human health?
In my personal opinion, GMO is checked by the company before releasing and if the product was approved by the government it is safe. But there is difference between safe or just ambitious that’s the difference or maybe that’s the reason we don’t accept GMO in Japan. But personally GMO products are basically safe but still I avoid GMO products in my stomach, so different mind and heart. We are worried about new technology we don’t know if it is GMO or Non-GMO and we have some proposal from some institute and we are waiting for this new technology if GMO or not probably EU study every technology and get some final statements if the new technology is concern GMO we will dispose it. But it is important is for formal statement will be done if the product is GMO or not. We also have a new technology the New Found Breeding Technology (NFBT).
12. What kind of safety assessment your company is employing before your products are released to the market?
Not safety assessment but we sell sweetcorn produced in United States so it should be no
problem. In United States there are a lot of GMO corn, so before we sell the product we check our
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sweetcorn if it is not GMO or no GMO contamination. We do such a test but as I told you we don’t
use GMO technology so we don’t do the safety assessment for GMO.
13. Do you have any legal cases or infringement cases regarding your plant patent or PVP?
Japanese don’t like lawsuit Sakata don’t like lawsuit. I heard some mushroom case in Fushima
Prefecture, Nameko case I heard PVP case that is an original breeder files PVP in Japan but that is
not stable and change, in deposition it change so the PVP holder was sued but the lawsuit was
denied because it was not an infringement. There is no much case.
About the importance of IP
14. Can you please explain how important to your company the IP Protection?
Of course it is very important for us because we are so called maker company we make a new
variety I mean a new product, progress product so every time we struggle to make new products
in such case we don’t want to steal the technique or such invention by other companies. The way
of protection is very different some we can help by trade secrets, some by PVP, patent we use
according to product for example plant variety we don’t need PVP we protect by trade secret but
a very advanced and important invention we want to protect by patents. So of course IP
protection is very important for us because we are Maker Company. So in the near future we use
our IP for our sales not for business it is not now but in the near future we will use it in our
business. If our product was protected by trade secret and somebody bought that product and use
the reverse engineering technique in our product maybe we will change our mind and use
different protection for our product either by variety or patent. It is very difficult to keep our IP in
a trade secret but it depends on the plant variety but some of our product are protected by trade
secrets.
15. What kind of IP protection your company utilizes?
As we mentioned before there are 3 ways plant variety protection, plant patent and utility patent,
hybrid is also not easy to copy and key to our IP. Well IP has a different protection like trademarks,
design and utility model.
16. Do you have any request regarding the plant related inventions to JPO, or if you have developed
your business in the Philippines, to IPPHL?
We hope that PVP system will be globalized standard for other countries if you have a specific
system we couldn’t sell our products in your country. There are 2 conventions 1978 and 1991 of
UPOV convention, Japan is the only member in Asia who adopts the 1991 convention. Thailand
has their own plant variety system different from others and I heard that it is not working very
well so they are thinking to improve something in some areas similar to their situation so that it is
much easier to collaborate and hope to work with us. We prepare for patent in the US and EP and
which one is okay is the question. I think there is more chance to get a patent in the US if you have
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many money for fee you can get a US patent system if you don’t you can choose the EP system. US
system is a little bit not perfect but we can choose their licensing per se if we get some patent but
if there is a reasonable condition we are open for license that per se is good progress in the United
States way of protection that is very reasonable happy in US, happy in EPO and happy for users. I
hope Japan government can stablish a unification system with Asian countries like CPPO that’s
vulnerable rights of AU. If you get CPPO there are many protection in each country. In Japan we
aim for same situation in Asia, especially in plant breeding, plant breeding is the way to develop
plants by combination because not only single resources we can develop a product but we can
combine many resources from other counties to make hybrid products. This nature is the same
with other countries not only single country but much better progression is suitable for plant
breeder.
[The end of document]
