Extending Patentability to Include Plant and Animal Inventions Under the TRIPS Agreement and the Patents Act 1990 (Cth)

Krysiu Smith (07176228)

LWN075 International Commercial Transactions – Research Paper

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EXTENDING PATENTABILITY TO INCLUDE PLANT AND ANIMAL

INVENTIONS UNDER THE TRIPS AGREEMENT AND THE PATENTS ACT 1990

(CTH)

Australia is a party to numerous international treaties and agreements in relation to

intellectual property and more specifically patents. As a party to these treaties and

agreements, Australia is required to implement the international regime’s substantive

provisions into domestic legislation. Intellectual property law is an ever changing and

expanding field, especially in relation to the law of patents which deals with all fields of

technology. Recently, the most controversial area of patent law is the patentability of plant

and animal inventions, especially in relation to farmers’ rights and ethical considerations.

This paper investigates how intellectual property rights, specifically the exclusion of plant

and animal inventions from patentability, are governed under the current international and

domestic patent regimes. This paper will argue that the current exclusion of the patentability

of plant and animal inventions under the World Trade Organisation’s (“WTO”) Trade-

Related Intellectual Property Rights Agreement 19941 (“TRIPS Agreement”) is justified and

despite numerous, persuasive arguments, should not be amended at this time; although

amendment may become relevant in the future.

1. OVERVIEW OF THE CURRENT INTERNATIONAL INTELLECTUAL

PROPERTY REGIME

Intellectual property includes copyrighted materials, patents, trade marks, industrial designs,

trade names and know-how. All forms of intellectual property can be divided into two broad

categories: copyright and related rights; and industrial property.2 Industrial property mainly

refers to patents, trade marks, geographical indications, know-how and trade secrets.

Intellectual property that is related to international trade in goods and services is regulated by

1 Trade-Related Intellectual Property Rights Agreement, opened for signature on 15 April 1994 (entered into

force 1 January 1995). 2 Mo, International Commercial Law (LexisNexis Butterworths, Australia, 5

th ed, 2013), 7.75.



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the WTO. Australia became a member of the WTO on 1 January 19953 and is bound by its

agreements, including the TRIPS Agreement.

The current TRIPS Agreement is Annex 1C to the Agreement Establishing the World Trade

Organisation and contains 73 articles and a Preface. It forms one of the four pillars of the

WTO trade system: the General Agreement on Tariffs and Trade 1994 (and associated

agreements), the General Agreement on Trade in Services 1994, the dispute settlement

mechanism and the TRIPS Agreement.

The current international regime in respect of intellectual property is vast. The agreements

most relevant to Australian patent law include:

TRIPS Agreement;

Paris Convention for the Protection of Industrial Property 18834 (“Paris

Convention”);

Patent Cooperation Treaty 19705 (“PCT”);

Patent Law Treaty 20006 (“PLT”);

Budapest Treaty on the International Recognition of the Deposit of Microorganisms

for the Purposes of Patent Procedure 19777 (“Budapest Treaty”); and

Australia-US Free Trade Agreement8 (“AUSFTA”).

9

The agreement most relevant to the patentability of plant and animal inventions is the TRIPS

Agreement. However, a brief overview of each other international patent treaty is useful to

understand how the general patent process works internationally.

3 World Trade Organisation, Member Information: Australia and the WTO (2014) World Trade Organisation

<http://www.wto.org/english/thewto_e/countries_e/australia_e.htm>. 4 Paris Convention for the Protection of Industrial Property, opened for signature on 20 March 1883 (entered

into force 10 October 1925). 5 Patent Cooperation Treaty, opened for signature on 19 June 1970 (entered into force 31 March 1980).

6 Patent Law Treaty, opened for signature on 2 June 2000 (entered into force 16 March 2009).

7 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of the

Patent Procedure, opened for signature on 19 June 1970 (entered into force 7 July 1987). 8 Australia-US Free Trade Agreement, opened for signature on 18 May 2004, ATS 1 (entered into force 1

January 2005). 9 Davidson, Monotti and Wiseman, Australian Intellectual Property Law (Cambridge University Press,

Australia, 2nd

ed, 2012), 12.14.



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1.1. TRIPS Agreement

Australia became a signatory to the TRIPS Agreement when it became a member of the WTO

on 1 January 1995.10

The TRIPS Agreement regulates all forms of intellectual property rights,

and is the most influential intellectual property treaty with respect to Australian domestic

intellectual property law. The Patents (World Trade Organisation Amendments) Act 1994

(Cth) was enacted to amend the Patents Act 1990 (Cth) in order to bring Australian law into

line with the standards and principles prescribed for patents in the TRIPS Agreement.11

The main features of the TRIPS Agreement include the general requirement to comply with

the substantive provisions in the Paris Convention. With respect to patents, the TRIPS

Agreement includes the following provisions: the National Treatment Principle under Article

3(1); the Most-Favoured-Nation Principle under Article 4; the general provisions on

patentability of subject matter and the relevant exceptions to patentability under Article 27;

the exclusive rights of inventors under Articles 28, 30 and 31; the general patent application

process under Articles 29 and 34; and the twenty year minimum term of protection under

Article 33.

a. National Treatment Principle

Article 3(1) TRIPS Agreement grants national treatment to all WTO Members. Under this

principle a WTO member is obliged to treat foreign nationals and its own nationals equally

when complying with the TRIPS Agreement. However, the operation of the National

Treatment Principle is, in respect of patents, subject to the exceptions provided in the Paris

Convention.12

b. Most Favoured Nation Principle

Article 4 TRIPS Agreement applies the Most Favoured Nation Principle:

any advantage, favour, privilege or immunity granted by a Member to the nationals of

any other country shall be accorded immediately and unconditionally to the nationals of

all other Members.

10

World Intellectual Property Organisation, Agreement on Trade-Related Aspects of Intellectual Property

Rights (TRIPS Agreement), WIPO

<http://www.wipo.int/wipolex/en/other_treaties/parties.jsp?treaty_id=231&group_id=22>. 11

Davidson, above n 4, 12.14.2. 12

Trade-Related Intellectual Property Rights Agreement, opened for signature on 15 April 1994 (entered into

force 1 January 1995), Article 3(1).



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The general purpose of the Most Favoured Nation Principle is to ensure that all nationals of

WTO Members are treated equally by an individual WTO member.13

However, the

application of the Most Favoured Nation Principle, with respect to patents, is subject to the

following exceptions:

if a privilege is derived from international agreement on judicial assistance of law

enforcement of a general nature; and

if a privilege is derived from an international agreement made prior to the entry into

force of the TRIPS Agreement provided that the agreement is consistent with the

WTO Agreement.14

These exceptions ensure the effective operation of the Most Favoured Nation Principle and

are necessary to regulate international trade and commerce.15

1.2. Paris Convention

Australia acceded to the Paris Convention on 30 July 1925, and it entry came into force on 10

October 1925.16

The Paris Convention was the first major international treaty designed to

assist inventors obtaining protection for intellectual property rights in more than one country.

The Convention contains three categories of substantive provisions: the National Treatment

Principle, the right of priority and some other general rules. The National Treatment

Principle is the same as the National Treatment Principle in the TRIPS Agreement. The right

of priority, in the case of patents, enables a means of access into national patent systems for

foreign patentees without loss of the priority date given to their first filing. The priority date

of a patent is the date that the inventor files its complete specification of the invention (the

complete patent application).

13

Mo, above n 1, 7.81. 14

Mo, above n 1, 7.82. 15

Ibid. 16

World Intellectual Property Organisation, Paris Convention, WIPO

<http://www.wipo.int/treaties/en/ShowResults.jsp?treaty_id=2>.



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1.3. PCT

Australia’s entry into force of the PCT came into effect on 31 March 1980.17

The PCT

established an International Patent Cooperation Union ‘for cooperation in the filing,

searching, and examination, of specifications for the protection of inventions, and for

rendering special technical services’. The PCT regulates how inventors may seek patent

protection in a number of selected PCT contracting states with a single specification. Chapter

I PCT regards this single specification as equivalent to a regular national filing as prescribed

under the Paris Convention. Chapter II PCT allows the inventor the opportunity to delay the

entry into the national phase by asking for a preliminary examination on the basis of an

international search report. The objective of this examination is to provide a preliminary and

non-binding opinion on whether the claimed invention appears to be novel, to involve an

inventive step and to be industrially applicable.18

1.4. PLT

Australia acceded to the PLT on 16 December 2008, and its entry into force occurred on 16

March 2009.19

The PLT harmonises formal patent procedures such as the requirements to

obtain a filing date for a patent specification, the form and content of a patent specification,

and representation.

1.5. Budapest Treaty

Australia acceded to the Budapest Treaty on 7 July 1987.20

The Budapest Treaty establishes

the International Depository Institution system. The International Depository Institution

system requires inventors, of inventions that are micro-organisms, which cannot be described

adequately in the words of the complete specification to deposit a sample of their invention

with the International Depository Institution. The provisions also apply where an invention

involves the use, modification or cultivation of a micro-organism which is not reasonably

available to a person skilled in the relevant art.21

17


Patent Cooperation Treaty, opened for signature on 19 June 1970 (entered into force 31 March 1980), Article

33. 19

World Intellectual Property Organisation, Patent Law Treaty, WIPO

<http://www.wipo.int/treaties/en/ShowResults.jsp?lang=en&treaty_id=4>. 20


Ibid.



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1.6. AUSFTA

The AUSFTA entered into force on 1 January 2005. Chapter 17 of the AUSFTA deals with

intellectual property rights, including patents. The Australian parliament enacted the US Free

Trade Agreement Implementation Act 2004 (Cth) to comply with the AUSFTA, as the

AUSFTA includes limitations on the substantive provisions of patent law compared to the

TRIPS Agreement. In particular, amendments were made to the grounds for opposition and

revocation of a patent as well as for amendments to patent requests or complete patent

specifications.22

The Paris Convention, the PCT, the PLT, the Budapest Treaty and the AUSFTA do not

regulate the scope of patentability, the term of the patent or what subject matter may be

excluded from patentability. Substantive provisions of this nature are found in the TRIPS

Agreement.

2. OVERVIEW OF THE CURRENT AUSTRALIAN DOMESTIC REGIME

Patent law and plant breeder’s rights in Australia is generally governed by the Patents Act

1990 (Cth) and the Plant Breeder’s Rights Act 1994 (Cth). Both pieces of legislation reflect

the patent law requirements under the above international treaties.

2.1. Patents Act 1990 (Cth)

Under the Patents Act 1990 (Cth), a patent is a right granted by the Crown, which confers

private property rights in the form of a limited monopoly over the invention of products,

methods and processes. There are two types of patent that may be granted: a standard patent23

and an innovation patent.24

An invention is defined to mean ‘any manner of new manufacture

the subject of letters patent and grant of privilege within section 6 of the Statute of

Monopolies’25

, and includes alleged invention.26

If a patent is granted, the patentee is given

exclusive rights, during the term of the patent (twenty years for a standard patent27

and eight

22

Ibid 12.14.6. 23

Patents Act 1990 (Cth), s 18(1). 24

Patents Act 1990 (Cth), s 18(1A). 25

Statute of Monopolies 1624 (Imp). 26

Patents Act 1990 (Cth), Schedule 11. 27

Patents Act 1990 (Cth), s 67.



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years for an innovation patent28

), to exploit the invention.29

In order to be patentable, an

invention needs to be:

1. a manner of manufacture within the meaning of section 6 of the Statute of

Monopolies;30

2. novel and involve either an inventive step (standard patent) 31

or an innovative step

(innovation patent),32

when compared to the prior art base as it existed before the

priority date (date of the patent specification) of the invention;

3. useful;33

and

4. not used in secret.34

It has long be accepted that methods of calculation, discoveries, abstract ideas, laws of nature,

scientific theories, intellectual information and theoretical business schemes are not

patentable unless that are applied for a new and useful purpose.35

The threshold requirement for patentability is that the invention must be a manner of

manufacture36

, within the meaning of the Statute of Monopolies.37

The term “manner of

manufacture” is not defined in the Patents Act 1990 (Cth), and the explanatory memorandum

simply states that ‘an invention must belong to the useful arts rather than the fine arts’.38

The

term “manner of manufacture” has been considered in a number of Australian and

international cases and represents a contentious area of patent law.

28

Patents Act 1990 (Cth), s 68. 29


Patents Act 1990 (Cth), ss 18(1)(a), 18(1A)(a). 31

Patents Act 1990 (Cth), s 18(1)(b). 32

Patents Act 1990 (Cth), s 18(1A)(b). 33

Patents Act 1990 (Cth), ss 18(1)(c 18(1A)(c). 34

Patents Act 1990 (Cth), ss 18(1)(d), 18(A)(d). 35

J Lahore, ‘Computers and the Law: The Protection of Intellectual Property’ (1978) 9 Federal Law Review 15,

22. Approved in CCOM v Jiejing (1994) 122 ALR 417, 447. 36

NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655, 663. 37

Patents Act 1990 (Cth), ss 18(1), 18(1A). 38

Patents Bill 1990 (Cth), cl 31.



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2.2. Plant Breeder’s Rights Act 1994 (Cth)

The Plant Breeder’s Rights Act 1994 (Cth) adopts the minimum standards prescribed under

the Convention for the Protection of New Varieties of Plants 1961 (“UPOV”) and complies

with Article 27.3(b) TRIPS Agreement.39

There is no protection under the Plant Breeder’s Rights Act 1994 (Cth) for merely breeding a

variety.40

Rather, the Plant Breeder’s Rights Act 1994 (Cth) provides plant breeders with

certain exclusive rights (“Plant Breeder’s Rights”) in relation to other plant breeders being

unable to propagate material of a protected plant variety.41

Propagating material means any

part or product from which (whether alone or in combination with other parts of product of

that plant) another plant with the same essential characteristics can be produced. Propagating

material includes seeds, seedlings, tubers and bulbs, cuttings and cell lines.42

“Essential

characteristics” means heritable traits or determinants that contribute to the principle features,

performance or value of the variety of plant.43

To be registrable under section 44 Plant Breeder’s Rights Act 1994 (Cth), the plant variety

must: have a plant breeder; be distinctive; be uniform; be stable (DUS criteria); not have been

exploited by or with the permission of the plant breeder (unless that exploitation occurred

only recently);44

and be given a name. To satisfy the DUS criteria (stability of the plant

variety), a comparative growing trial of the plant variety must be undertaken in Australia by

an accredited qualified person for the species of plant, or the plant variety’s stability could be

based upon a certified test report obtained from a UPOV contracting state.45

Plant breeders who are able to register a plant variety receive a monopoly protection in

Australia for twenty-five years for trees and vines, and twenty years for other plant

varieties.46

39

Davidson, above n 3, 16.1. 40

The Grain Pool of Western Australia v The Commonwealth of Australia (2000) 202 CLR 479, 510. 41

Plant Breeder’s Rights Act 1994 (Cth), s 11. 42

Plant Breeder’s Rights Act 1994 (Cth), s 3(1). 43


Plant Breeder’s Rights Act 1994 (Cth), s 43. 45


Plant Breeder’s Rights Act 1994 (Cth), s 22.2.



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3. PATENTABILITY OF PLANT AND ANIMAL INVENTIONS UNDER THE

TRIPS AGREEMENT, THE PATENTS ACT 1990 (CTH) AND THE PLANT

BREEDER’S RIGHTS ACT 1994 (CTH)

Article 27 TRIPS Agreement provides the requirements for ‘patentable subject matter’.

Article 27.1 TRIPS Agreement states that, subject to Articles 27.2 and 27.3 TRIPS Agreement,

‘patents shall be available for any inventions, whether products or processes, in all fields of

technology, provided that they are new, involve an inventive step and are capable of

industrial application’.

Article 27.2 TRIPS Agreement provides a general exception to patentability by allowing

Member states to exclude from patentability inventions where:

the prevention within their territory of the commercial exploitation of which is necessary

to protect ordre public or morality, including to protect human, animal or plant life or

health or to avoid serious prejudice to the environment, provided that such an exclusion is

not made merely because the exploitation is prohibited by law.

Article 27.3(b) TRIPS Agreement is the most relevant to the patentability of plant and animal

inventions. Article 27.3(b) provides:

Members may also exclude from patentability:

…

(b) plants and animals other than micro-organisms, and essentially biological processes

for the production of plants or animals other than non-biological and microbiological

processes. However, Members shall provide for the protection of plant varieties

either by patents or by an effective sui generis system, or any combination thereof.

Article 27 TRIPS Agreement clearly provides, despite an overarching requirement of

patentability of all inventions in all fields of technology, a discretionary prohibition on the

patentability of plant or animal inventions, unless the plant invention is in the form of a plant

variety.



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Australia chose to adopt the discretionary exclusion of the patentability of plant and animal

inventions in section 18(3) Patents Act 1990 (Cth), which provides:

For the purposes of an innovation patent, plants and animals, and the biological processes

for the generation of plants and animals, are not patentable inventions.

There is currently no express prohibition for obtaining a standard patent for a plant or animal

invention. However, it is highly unlikely that a plant or animal invention could satisfy the

high threshold tests of novelty and inventive step required for a standard patent under section

18(1) Patents Act 1990 (Cth).

Australia complies with the requirement that plant varieties must be protected with the

enactment of the Plant Breeder’s Rights Act 1994 (Cth).

4. SHOULD THE CURRENT DISCRETIONARY PROHIBITION ON THE

PATENTABILITY OF PLANT AND ANIMAL INVENTIONS UNDER THE

TRIPS AGREEMENT, AS ENACTED IN THE PATENTS ACT 1990 (CTH) BE

AMENDED?

A number of papers have been commissioned and released in relation to the patentability of

plant and animal inventions under the TRIPS Agreement and the Patents Act 1990 (Cth),

including the 2004 Australian Advisory Council on Intellectual Property’s paper, “Should

plant and animal subject matter be excluded from protection by the innovation patent”, and

the 2006 Council for Trade-Related Aspects of Intellectual Property Rights paper, “Review of

the provisions of Article 27.3(b)”. These papers demonstrate the controversial and complex

nature of any amendment to the Patents Act 1990 (Cth) or Article 27 TRIPS Agreement.

4.1. The Exclusion under Article 27.3(b) TRIPS Agreement and Section 18(3)

Patents Act 1990 (Cth)

Generally, the main arguments for and against expanding the current patent protection in

Australia to include plant and animal inventions is public policy based. This includes

arguments relating to private rights, public good, domestic and international trade, economic



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interests, ethics and environmental safety. There is lively debate for both sides of the

argument.

Briefly, the main objections to extending patentability to include plant and animal inventions

are:

Living matter forms part of our common heritage, and should not be regarded as a

commodity over which exclusive rights are awarded;

The patenting of plants and animals encourages interference with nature, and will lead

to a decline in genetic diversity; and

Devaluation of animal life and the suffering of laboratory animals.47

Another objection to extending patent protection is that the grant of exclusive rights over

plant and animal inventions will lead to an increase in costs of, and a restriction in access to,

re-use and exchange of seeds by farmers.48

Also, an unavoidable consequence of granting

inventors exclusive rights is the creation of barriers to entry into the market and a stifling of

competition. 49

There is also a fear that removing the exclusion would interfere with

longstanding industry practice and would therefore have a serious negative impact on access

to, particularly, plant material and varieties for farmers and researchers. 50

However, proponents of the extension of patent law to include the patentability of plant and

animal inventions argue that the main objective of patent law is to promote private sector

investment in incentive activities that contribute to new technologies to solve problems. As

patent protection facilitates the transfer of technology between sectors (including public and

private) and the dissemination of research, allowing plant and animal inventions to be

patentable would contribute to solving problems in developed and developing countries in

47

Commonwealth, Advisory Council on Intellectual Property, Should plant and animal subject matter be

excluded from protection by the innovation patent (Professor Paul Greenfield, Chairman), 2004, 9 citing

Australian GeneEthics Network, Submission no. 71 to House of Representatives Standing Committee on

Primary Industries and Regional Services Report on Primary Producer Access to Gene technology, titled “Work

in Progress, Proceed with Caution” (2000) 11; Animal Patents: The Legal, Economical and Social Issues, Ed.

W. H. Lesser, Macmillan Publishers Ltd, 1989 New York; E.S. Van de Graff, “Patent Law and Modern

Biotechnology”, 1997, 68. 48

World Trade Organisation, Council for t=Trade-Related Aspects of Intellectual Property Rights, Review of the

provisions of Article 27.3(b): Summary of issues raised and points made (Secretariat), 2006, 3 citing Minutes of

the Council for TRIPS Meeting, [106], [15]. 49

Commonwealth, above n 41, 16. 50

Ibid.



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areas such as agriculture, nutrition, health and the environment. 51

In fact, the exclusion may

be considered to be actively detrimental to research in Australia, 52

as the patent system

provides an important incentive to the private sector to conclude licensing agreements, and to

discourage confidentiality and trade secret arrangements. 53

Extending patentability to include plant and animal inventions may encourage the

development and use of new technologies that may otherwise never occur. Inventors are

encouraged to continue to research and develop new plant and animal inventions as, under

the patent law system’s exclusive rights, they will obtain a return on their investment in the

research. Further, the patent law system’s requirement for full, open and honest disclosure of

all parts of the invention enables other inventors and innovators to both build on and around

the existing inventions. 54

In addition, the patentability of plant and animal inventions exclusion was introduced into

section 18(3) Patents Act 1990 (Cth) without any evidence to prove that material harm would

occur if innovation patents for plant or animal inventions were made available. Particularly in

respect of animal inventions, there is not even any potential for conflict with a sui generis

system of protection, as none exists in Australia.55

Numerous stakeholders have argued that plant and animal inventions should be accorded

adequate patent protection in the same manner that other inventions in other fields of

technology have been protected. 56

There is a general view, that the current Australian and

international patent protection systems have a ‘gap’ in relation to plant and animal inventions,

due to the broad prohibition and, in relation to animal inventions, the absence of a sui generis

system (similar to the sui generis system for plants created by the Plant Breeder’s Rights Act

1994 (Cth)). ‘If it can be demonstrated that there are social benefits in closing any gap in

protection, then all [intellectual property] mechanisms must be considered, including a sui

generis system for animals.’57

51

World Trade Organisation, above n 42, 2-3. 52




Ibid, 16-17. 56


Commonwealth, above n 41, 16.



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4.2. Ethical Exceptions to Patentability and Article 27.2 TRIPS Agreement

Due to the ethical considerations that need to be contemplated whenever animals are included

in scientific research, the ordre public and morality exception in Article 27.2 TRIPS

Agreement creates a direct link to the exclusion of plant and animal inventions in Article

27.3(b) TRIPS Agreement. In particular, the following specific concerns should be

considered: those relating to public health, restrictions on research materials, limitation on

competition as in the case of gene use restriction technologies, human rights, agricultural

security, bio-piracy, traditional knowledge and farmers rights and the concern that the current

provisions of Article 27.3 TRIPS Agreement does not prevent the abuse of patent systems.58

Opponents of the patentability of plant and animal inventions believe that the ‘patenting of

life forms is in itself unethical and harmful and therefore should be unconditionally

prohibited’.59

They argue that the ordre public and morality exception embodied in Article

27.2 TRIPS Agreement is insufficient to prohibit the patentability of plant and animal

inventions as the exception is ‘unnecessary and cumbersome’.60

The basis of this argument is

that the exception does not prevent the commercial exploitation of the invention. The

exception in Article 27.2 TRIPS Agreement amounts to redefining morality for Members. The

patentability of plant and animal inventions make the exceptions in Article 27.2 TRIPS

Agreement meaningless for those Members that consider patents on ‘life forms to be

immoral, contrary to the fabric of their society and culture’. 61

Opponents argue that the

minimum amendment to the TRIPS Agreement that is acceptable in this regard is to clarify

Article 27.3 TRIPS Agreement so that it does not in any manner restrict the rights of

Members to resort to the exceptions in Article 27.2 TRIPS Agreement. 62

However, proponents argue that Article 27.2 TRIPS Agreement adequately reflects ethical

concerns as far as patent law is concerned and any other ethical concerns should be addressed

in other laws, such as the protection of the environment, public health or animal welfare.

Patents do not guarantee inventors unfettered exploitation of the invention. Rather such

exploitation is subject to the domestic laws, including matters relating to ethics, welfare and

58

World Trade Organisation, above n 42, 10, citing Minutes of the Council for TRIPS Meeting, [87], [112],

[127],[152], [184]. 59

Ibid citing Minutes of the Council for TRIPS Meeting, [105], [143]. 60

Ibid. 61

Ibid citing IP/C/W “Taking Forward the Review of Article 27.3(b) of the TRIPS Agreement”, 2. 62

Ibid citing IP/C/W “Taking Forward the Review of Article 27.3(b) of the TRIPS Agreement”, 4.



Page 14 of 24

bio-piracy. Therefore, there is no need to specifically exclude inventions in order to prevent

their exploitation:

Explicitly excluding particular subject matter from patentability will not of itself prevent

either research or exploitation of such technology. Instead, it could make it more difficult

to control, for example by encouraging secrecy.63

Further, the current disclosure requirements of the patent law system and the control over

exploitation of patents facilitate the operation of laws designed to protect public morality,

health and the environment. 64

4.3. Conditions of Patentability in Article 27.1 TRIPS Agreement and Plant and

Animal Inventions

Another concern raised by opponents of extending the patent system relates to the grant of

excessively broad patents which do not necessarily fully meet the tests of patentability. This

concern also includes the consideration of the costs and burdens of the revocation of such

patents. 65

The absence of clear definitions in Article 27.1 TRIPS Agreement for the elements

of patentability has left vague areas in the patent law system; particularly with respect to the

definition of “invention”, and the scope of patentable micro-organisms and microbiological

and non-biological processes. There are concerns that allowing Members to have complete

discretion could result in a number of concerns, including unduly low thresholds for novelty,

inventive step and industrial applicability due to the processes in place in certain Member

states regarding patent specifications. 66

Another view is that the specific definitions and scope of patentability need to be left to the

discretion of individual Member states in order to allow Members to exert their own morals

and culture on patents within their jurisdiction. This freedom constitutes part of the

flexibilities inherent in the TRIPS Agreement. 67

63

Ibid citing IP/C/W “Communication from Switzerland: Review of Article 27.3(b): The View of Switzerland”. 64



Ibid 11. 67

Ibid 11.



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The Patents Act 1990 (Cth) already provides definitions of each of the terms of patentability

including: “invention”, “exploit” and” prior art base”. These definitions, and others (such as

“novel”, “inventive”, “innovative” and “useful”), have been considered and interpreted in

numerous Australian cases. This practice of creating precedent for patents appears to allow

Australian patent law to remain flexible so that it may capture and protect new types of

inventions and technologies now and into the future. This is the flexibility and freedom the

TRIPS Agreement attempts to protect by including the discretionary exclusions in Articles

27.2 and 27.3 TRIPS Agreement.

5. HOW COULD THE CURRENT INTERNATIONAL AND DOMESTIC

REGIMES BE AMENDED?

A number of suggestions have been made to the Council for Trade-Related Aspects of

Intellection Property Rights for the amendment of the TRIPS Agreement. These include:

amending the TRIPS Agreement to remove the exceptions, as the exceptions to

patentability authorised by Article 27.3(b) TRIPS Agreement are unnecessary and

patent protection should be extended to all patentable inventions of plants and

animals;

maintaining Article 27.3(b) TRIPS Agreement as the provision provides Members

with flexibility to decide whether or not to exclude plants and animals from

patentability in light of their specific domestic interests and needs;

retaining the exception contained in Article 27.3(b) TRIPS Agreement but including

definitions of certain terms to clarify the distinction between plant, animals and

micro-organisms; and

amending or clarifying Article 27.3(b) TRIPS Agreement to prohibit the patenting of

all life forms, including plants and animals, micro-organisms and all other living

organisms and their parts, including genes, as well as natural processes that produce

plants, animals and other living organisms.68

68

Ibid 3-4.



Page 16 of 24

To ensure that the objectives of patent law are met, if extending patent protection to plant and

animal inventions, it is necessary to have international agreement on the rules for the

protection of plant and animal inventions, rather than simply relying only on domestic

legislation.69

International agreement is also important when considering whether to amend

the Patents Act 1990 (Cth), due to Australia’s current obligations under the numerous

international patent and intellectual property treaties and agreement.

5.1. Extending Patentability to Include Plant and Animal Inventions vs

Maintaining Article 27.3(b) TRIPS Agreement and the Section 18(3) Patents Act

1990 (Cth) Exclusion

Article 27.3(b) TRIPS Agreement provides considerable flexibility to Members to choose

whether or not to include or exclude the patentability of plant and animal inventions in their

domestic legislative regimes.70

In Australia, it is possible to obtain an innovation patent under

section 18(1A) Patents Act 1990 (Cth) for a plant or animal invention if the inventor can

demonstrate that the invention is a manner of manufacture, is novel and involves an

innovative step, is useful, was not used in secret,71

and was not a biological process for the

generation of plants and animals.72

Many stakeholders believe that innovation patents are

becoming a more appropriate form of protection of plant inventions due to the incredibly

complex technology in the field. The Department of Primary Industries Queensland and the

Australia Research Council have both argued that the generation of genetically modified

plants using molecular biology and plant transformation techniques is increasing, and there

appears to be a corresponding increase in the use of the patent system to protect inventions in

this area.73

However, opponents believe that the innovation patent is ill suited for plant and animal

inventions because it limits the commercialisation of ‘incremental spin-off innovations and

improvements, reduces the efficiency and competitiveness of the industry and significantly

reduces levels of innovation’.74

One particular argument against extending the patentability of

plant inventions was raised by the Grains Research and Development Corporation during

69

Ibid 3. 70

Ibid 6. 71

Patents Act 1990 (Cth), s 18(1A). 72



Ibid 22.



Page 17 of 24

submissions to the Australian Advisory Council on Intellectual Property. The Grains

Research Development Corporation claimed that farm saved seed is crucially important to

Australian growers for technical and economic reasons. Farm saved seed allows farmers to

minimise costs and remain internationally competitive as farmers do not receive subsidies,

face high risks of crop failure due to a variable climate and produce yields that are typically

one third of other countries. The Grain Research Development Corporation was of the view

that farmers would ‘revolt’ if they no longer had access to farm saved feed, as would occur

should the exception to patentability of plant and animal inventions be removed.75

Nevertheless, there is a gap in the protection of animal inventions as there is no requirement

for a sui generis system like that of plant breeder’s rights. Innovators should be able to

choose between different forms of protection according to their circumstances and the nature

of the innovation.76

However, it appears from submissions made to the Advisory Council on

Intellectual Property that, at least in Australia, there is little research being conducted, or

inventions based on, animals.

5.2. Define Terms in Article 27.3(b) TRIPS Agreement

The absence of clear definitions may lead to legal uncertainty regarding the scope of

patentability. Zimbabwe has argued that the difficulty in WTO Members agreeing on

definitions should not deter the Council for Trade-Related Aspects of Intellectual Property

Rights from developing definitions of certain terms. However, the absence of definitions at

an international level affords Members flexibility in the use and interpretation of these

terms.77

5.3. Conclusions

The Australian Advisory Council on Intellectual Property considered the above arguments

and concluded that the current exclusion from the innovation patent of plants and animals and

biological processes for their generation should be maintained at this time. However, this

recommendation does not take into account the absence of a sui generis system for animal

inventions similar to the Plant Breeder’s Rights Act 1994 (Cth), despite the possible social

benefits in encouraging research and innovation in this area and closing the gap between

75

Ibid 22. 76

Ibid 17. 77

World Trade Organisation, above n 42, 7.



Page 18 of 24

plant and animal rights. A possible argument against establishing a sui generis system for

animals is the higher level of ethics that need to be considered before an inventor is approved

a research grant. The response to this argument, from a legal perspective, is that the ethics

relating to animal research is governed by other areas of law and pieces of legislation.

6. WHO SHOULD BE RESPONSIBLE FOR AMENDING THE CURRENT

INTERNATIONAL AND DOMESTIC REGIMES

6.1. International Regime

Article 27.3(b) TRIPS Agreement ‘is a result of a carefully negotiated balance.’78

Article

27.3(b) TRIPS Agreement already allows Members considerable freedom with regard to the

patentability of biotechnological inventions, therefore, it is the responsibility of each Member

to strike the correct balance when accounting for economic, ethical and other concerns,

without losing sight of the fact that granting intellectual property rights to biotechnology

inventions is one of the factors for developing domestic skill in this sector. Further, ethical

and moral matters are not factors to be considered in commercial calculations, and ‘their

force should not be affected by reasoned commercial concerns’: 79

Cultural and social values of many societies cannot countenance the appropriation or

marketing of life in any form or at any stage.80

In addition, biological materials are research ingredients and patents for these materials

should be granted as long as the patentability requirements are met and the commercial

exploitation of such living organisms does not go against public order.81

Therefore, the superiority of such intrinsic values in particular countries is a matter for

domestic legislative process to determine, and not for the WTO, whose ‘trade mandate is

narrow and insufficient to decide on these matters’. 82

78

Ibid 11. 79

Ibid 11. 80

Ibid 11. 81

Ibid 11. 82

Ibid 11.



Page 19 of 24

6.2. Domestic Regime

The Intellectual Property Research Institute of Australia have also argued that it is the

responsibility of the legislature to amend the current Patents Act 1990 (Cth) if necessary:

in such a controversial area … the legislature should bear the burden to prove that the

benefits of stimulation of innovation in this area outweigh the possible risks involved …

it is not enough to argue that there are no reasons to justify the exclusion of plant and

animal subject matter … empirical evidence is required on whether the current patent

regime is operating effectively in this sector or whether increased [intellectual property]

rights in the form of innovation patents are needed to stimulate greater investment in

research, development and commercialisation … in the absence of evidence showing

further [intellectual property] rights are required, the extension of the innovation patent to

plant and animal subject matter should not occur.83

7. CONCLUSION

Australia’s current patent regime, in the form of the Patents Act 1990 (Cth) and the Plant

Breeder’s Rights Act 1994 (Cth), adequately reflects and implements the international patent

regime in respect of the patentability of plant and animal inventions. Article 27(3)(b) TRIPS

Agreement provides WTO Members with a discretion to exclude from patentability plant and

animal inventions, as long as the Members make a sui generis system available to protect

plant varieties. Australia has used the discretion in Article 27.3(b) TRIPS Agreement in the

Patents Act 1990 (Cth) to exclude the patentability of plant and animal inventions, and also

enacted the Plant Breeder’s Rights Act 1994 (Cth) as the Australian sui generis system

protecting plant breeder’s rights.

However, there have been numerous arguments for and against the exclusion of the

patentability of plant and animal inventions under section 18(3) Patents Act 1990 (Cth) and

Article 27.3(b) TRIPS Agreement. The majority of these arguments have been submitted to

the Australian Advisory Council on Intellectual Property Rights and the WTO Council for

Trade-Related Aspects of Intellectual Property. Both Councils have considered these

arguments and have released papers in 2004 and 2006, respectively.

83

Commonwealth, above n 41, 16 citing the Intellectual Property Research Institute of Australia.



Page 20 of 24

Opponents of the extension of the patents system to include the patentability of plant and

animal inventions assert that extending the patent protection will lead to an increase in cost

of, and a restriction in access to, re-use and exchange of seeds by farmers, as well as a

general barrier to entry into the market and a stifling of competition. The opponents argue

that extending the patent protection is also unethical as the ‘patenting of life forms is in itself

unethical and harmful and therefore should be unconditionally prohibited’.84

They argue that

the ordre public and morality exception embodied in Article 27.2 TRIPS Agreement is

insufficient in its current form, as it allows for the interpretation that it will be superseded by

Article 27.3 TRIPS Agreement, should the patent protection be extended. Finally, opponents

to the extension state that the current form of Article 27 TRIPS Agreement is vague and open

to liberal interpretation as it does not define certain important terms, such as “invention”.

However, proponents of the extension of the patent system contend that the main objective of

patent law is to encourage the private sector to continue to innovate in new technologies in

order to solve new problems, transfer technologies and disseminate new knowledge. They

argue that the patent system aids problem solving in developed and developing countries by

creating an incentive for inventors, by granting those inventors exclusive proprietary rights.

In fact, the exclusion of the patentability of plant and animal research may be considered to

be actively detrimental to research in Australia as the patent system provides an important

incentive to the private sector to conclude licensing agreements, and to discourage

confidentiality and trade secret arrangements. Proponents also argue that plant and animal

inventions should be accorded the same patent protection as other fields of technologies,

especially in relation to animal inventions where there is not even a requirement for a sui

generis system similar to that for plant varieties.

Proponents point out that the ordre public and morality exception in Article 27.2 TRIPS

Agreement is flexible in order to allow Member states to reflect their own social and cultural

values in their domestic legislation. This is the same argument proponents use to address the

issue of the absence of definitions in Article 27 TRIPS Agreement.

Ultimately, despite the numerous and persuasive arguments put forward by the proponents of

extending the patent system to include the patentability of plant and animal inventions, the

84

World Trade Organisation, above n 42, 10 citing Minutes of the Council for TRIPS Meeting, [105], [143].



Page 21 of 24

Australian Advisory Council on Intellectual Property’s recommendation that the current

patent system remain unchanged is a sensible one. Although there is undoubtedly a ‘gap’ in

the protection of plant and animal inventions, especially animal inventions of any kind (as

there is no equivalent sui generis system), there is no empirical research proving Australia’s

current need for plant or animal invention protection, at least under the patent system. Issues

of ethics and morals are dealt with under other areas of law, as is the exploitation of any life

form invention. In addition, it is already possible to obtain an innovation patent under section

18(1A) Patents Act 1990 (Cth) for a plant or animal related invention if the inventor can

demonstrate novelty, an innovative step and usefulness.

However, this is a controversial area of law, and an ever changing field of technology. Due to

the current discretion to exclude from patentability plant or animal inventions under Article

27.3 TRIPS Agreement, there is no reason why, in the future, Australia may not amend the

Patents Act 1990 (Cth) or introduce a sui generis system for animal inventions similar to the

Plant Breeder’s Rights Act 1994 (Cth). If this change were to occur, it would be a matter for

the legislature to approve and implement.



Page 22 of 24

BIBLIOGRAPHY

1. Books

Davidson, Monotti and Wiseman, Australian Intellectual Property Law (Cambridge

University Press, Australia, 2nd

ed, 2012)

Mo, International Commercial Law (LexisNexis Butterworths, Australia, 5th

ed, 2013)

2. Journals

J Lahore, ‘Computers and the Law: The Protection of Intellectual Property’ (1978) 9 Federal

Law Review 15

3. Cases

CCOM v Jiejing (1994) 122 ALR 417

NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655

The Grain Pool of Western Australia v The Commonwealth of Australia (2000) 202 CLR 479

4. Legislation

Patents Act 1990 (Cth)

Patents Bill 1990 (Cth)

Plant Breeder’s Rights Act 1994 (Cth)

Statute of Monopolies 1624 (Imp)



Page 23 of 24

5. Treaties

Australia-US Free Trade Agreement, opened for signature on 18 May 2004, ATS 1 (entered

into force 1 January 2005)

Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the

Purposes of the Patent Procedure, opened for signature on 19 June 1970 (entered into force 7

July 1987)

Paris Convention for the Protection of Industrial Property, opened for signature on 20 March

1883 (entered into force 10 October 1925)

Patent Cooperation Treaty, opened for signature on 19 June 1970 (entered into force 31

March 1980)

Patent Law Treaty, opened for signature on 2 June 2000 (entered into force 16 March 2009)

Trade-Related Intellectual Property Rights Agreement, opened for signature on 15 April 1994

(entered into force 1 January 1995)

6. Other

Commonwealth, Advisory Council on Intellectual Property, Should plant and animal subject

matter be excluded from protection by the innovation patent (Professor Paul Greenfield,

Chairman), 2004

World Intellectual Property Organisation, Agreement on Trade-Related Aspects of

Intellectual Property Rights (TRIPS Agreement), WIPO

<http://www.wipo.int/wipolex/en/other_treaties/parties.jsp?treaty_id=231&group_id=22>

World Intellectual Property Organisation, Paris Convention, WIPO

<http://www.wipo.int/treaties/en/ShowResults.jsp?treaty_id=2>



Page 24 of 24

World Intellectual Property Organisation, Patent Law Treaty, WIPO

<http://www.wipo.int/treaties/en/ShowResults.jsp?lang=en&treaty_id=4>

World Trade Organisation, Council for t=Trade-Related Aspects of Intellectual Property

Rights, Review of the provisions of Article 27.3(b): Summary of issues raised and points

made (Secretariat), 2006

World Trade Organisation, Member Information: Australia and the WTO (2014) World

Trade <Organisation http://www.wto.org/english/thewto_e/countries_e/australia_e.htm>

Documents

Extending Patentability to Include Plant and Animal Inventions Under the TRIPS Agreement and the Patents Act 1990 (Cth)