IPOS Examination (Patentability) Guidelines 2010

Guide on Patentability Issues arising during Search & Examination

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Version of the Guide: 20 Sep 2010

Guide on Patentability Issues arising during Search &

Examination


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What is in this Guide? This Guide explains IPOS’ Search and Examination (SE) practice on patentability issues in Singapore. Purpose of this Guide This Guide serves as a source of reference for our Examiners appointed pursuant to rule 2(3) of the Patent Rules and this will assist them in the course of performing SE on Singapore patent applications as well as patents in re-examination or post grant SE. The Registry of Patents, IPOS will continue to update this Guide from time to time, so as to keep it relevant as far as possible.

Statements made in this Guide are not in themselves an authority and should not be used as a set of legal requirements. Reference to legal requirements includes reference to the Singapore Patents Act (Cap. 221), the Singapore Patents Rules and the Singapore legal decisions.

Feedback if any This Guide is prepared by the Patent Quality Management Unit (Search & Examination). If you have any suggestions or feedback in relation to this Guide, please drop us an e-mail ([email protected]) and attention it to this Unit. Patent Quality Management Unit (Search & Examination) Registry of Patents Intellectual Property Office of Singapore 51 Bras Basah Road #04-01 Plaza By The Park Singapore 189554 Tel: (65) 63398616 Fax (General): (65) 63390252 Fax (Patents): (65) 63399230 http://www.ipos.gov.sg; [email protected] (attention: Patent Quality Management Unit (Search & Examination))


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CONTENTS

Chapter Paragraphs Description 1 Introduction 1.1 to 1.5 A. Background 1.6 B. Singapore patents case law 2 Patentable Inventions 2.1 A. Statutory Requirements 2.2 to 2.4 B. Legislative History 2.5 to 2.6 C. Effect of the 1996 amendments – Open floodgates? 2.7 to 2.13 D. Patentable subject matter

i. Approach taken in Europe ii. Approach taken in UK iii. Approach taken in US iv. Approach taken in Singapore

2.14 to 2.16 E. Invention 2.17 to 2.18 F. Patentable Invention 2.19 G. Patentability Assessment: In a Nutshell 3 Novelty 3.1 A. Statutory Requirements 3.2 to 3.6 B. State of the art 3.7 to 3.9 C. Grace Period 3.10 to 3.15 D. Priority Date 3.16 to 3.20 E. Novelty Test

i. Signpost is not enough ii. Publicly made available iii. Combining prior art iv. Enabling Disclosure

3.21 to 3.23 F. Minimum Documentation 3.24 to 3.25 G. Internet Disclosures 3.26 to 3.27 H. Prior Art Consideration: Standard of proof


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CONTENTS Chapter Paragraphs Description

3.28 to 3.31 I. Medical Use Claims 3.32 J. Novelty assessment: In a nutshell 4 Inventive Step 4.1 to 4.2 A. Statutory Requirements 4.3 to 4.6 B. Inventive Step Test 4.7 to 4.9 C. The Inventive Concept 4.10 to 4.14 D. The skilled addressee 4.15 to 4.17 E. Common General Knowledge 4.18 to 4.22 F. Third and fourth steps mentioned in the Windsurfing case 4.23 G. Combining prior art 4.24 H. No rule of thumb 4.25 I. Inventive Step assessment: In a nutshell 5 Industrial Application 5.1 to 5.2 A. Statutory Requirements 5.3 to 5.4 B. Industry 5.5 to 5.6 C. Capable of industrial application: Insufficient if vague and

speculative 5.7 to 5.8 D. “Methods of treatment & diagnosis” Exception 5.9 E. Industrial Applicability assessment: In a nutshell 6 Offensive, immoral or anti-social behaviour 6.1 A. Statutory Requirements 6. 2 to 6.7 B. Legislative History 6.8 to 6.12 C. What is offensive, immoral or anti-social behaviour

i. Examiner’s personal beliefs should not colour their judgment ii. Abhorrent iii. Offensive and non-offensive use


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CONTENTS Chapter Paragraphs Description

6.13 to 6.18 D. Section 13(3) 6.19 to 6.22 E. Patentability (Sections 13(2)) of inventions relating to genes 6.23 to 6.24 F. Patentability (Sections 13(2)) of inventions relating to

Chimeric animals 6.25 to 6.27 G. Patentability (Sections 13(2)) of inventions relating to

transgenic animals 6.28 to 6.30 H. Patentability (Sections 13(2)) of inventions relating to the

use of human embryonic stem cells 6.31 I. Section 13(2) assessment: In a nutshell

Annex List of Patent Decisions in Singapore

Table 1: 2.10 Comparison of patentability provisions Table 2: 2.19 Overall Steps Involved in section 13 assessment Table 3: 3.30 Comparison of Medical Use provisions (Novelty) Table 4: 3.32 Steps Involved in assessing novelty under section 14 Table 5: 4.25 Steps Involved in assessing inventive step under section 15 Table 6: 5.2 Comparison of Industrial Application & Method of Treatment &

Diagnosis provisions Table 7: 5.9 Steps Involved in assessing industrial application under section 16

Table 8: 6.3 Comparison of Morality provisions Table 9: 6.31 Steps Involved in assessing the subject matter under section 13(2)


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1 INTRODUCTION A Background

1.1 The patent system in Singapore has features which are similar to other patent regimes

around the world. In a nutshell, it allows for patent applications for inventions to be filed with the Registry of Patents (Registry) at the Intellectual Property of Singapore (IPOS), searched and examined on formal and substantive (includes patentability) requirements, published soon after 18 months and granted patents if the grant requirements are met. Further, as Singapore is a member of the Patent Co-operation Treaty (PCT), in addition to allowing PCT applications to be filed with the Registry as a PCT receiving Office, PCT applications designating Singapore can enter national phase with the Registry.

S29 r36-50

1.2 What is special in the Singapore patent system is the availability of several search and substantive examination (SE) options for applicants to choose from. They are namely:

• the LOCAL SE route where applicants file search and/or examination requests with the Registry,

• the FOREIGN SE route where applicants rely on the SE results of

corresponding or international/PCT patent applications and

• the MIXED SE route where applicants rely on the search results of corresponding or international/PCT patent applications and file examination requests with the Registry.

S 2(1)

1.3 This Guide focuses on the LOCAL & MIXED SE route where Search, Examination

or combined Search and Examination requests are filed with the Registry and then subsequently sent to the Examiner. Section 2(1) of the Patents Act defines an Examiner to mean “such person, organisation or foreign or international patent office or organisation as may be prescribed to whom the Registrar may refer questions relating to patents, including search and examination of applications for patents”.

r2(3)

1.4 Rule 2(3) of the Patent Rules explains that the Examiners prescribed for the purposes of section 2 shall be the Australian Patent Office, the Austrian Patent Office, the Danish Patent and Trademark Office and the Hungarian Patent Office.

1.5

The law that the Examiners apply when conducting Search, Examination or combined Search and Examination on Singapore patent applications is Singapore


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patents law and this includes the Patents Act, the Patents Rules and local case law in Singapore. Foreign case law and practice may be referred to, especially when it is grounded on similarly worded legislative text. However, where there is a conflict between local and foreign case law and practice, the local case law and practice prevail and take precedence. We would add that the jurisprudence in Singapore is relatively young in this area and there are provisions in the Patents Act which have yet to be judicially decided on. Hence, in the absence of local case law on these provisions, we would refer to relevant foreign law and practice for guidance. In any event, we are not bound by these foreign law and practice but there could be relevant principles to which we can draw from enabling us to provide an interface during this period until local jurisprudence is available. This Guide is that interface.

B Singapore patents case law

1.6 Even though the patent system in Singapore started as early as in 1937, local case law only started to grow in the last two decades. And grow we did, as to date, there are patent decisions made by the Registry of Patents, IPOS, the High Court as well as the Court of Appeal (which is the highest court of appeal in Singapore). These decisions are important in the patent history of Singapore as they lay down the foundation on how our patent legislation should be applied and we have annexed to this Guide (Annex) a list of these patent decisions for one’s ease of reference. Copies of these patent decisions are also provided to the Examiners and in addition, they can also ask for them from our Patent Quality Management Unit (Search & Examination).


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2 PATENTABLE INVENTION A Statutory requirements

S 13

2.1 Patentable inventions

Section 13.—(1) Subject to subsection (2), a patentable invention is one that satisfies the following conditions:

(a) the invention is new; (b) it involves an inventive step; and (c) it is capable of industrial application

(2) An invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention. (3) For the purposes of subsection (2), behaviour shall not be regarded as offensive, immoral or antisocial only because it is prohibited by any law in force in Singapore.

B Legislative History

2.2 Section 13 of the Patents Act shares its roots with section 1 of the United Kingdom Patents Act 1977.

2.3 This section was amended by The Patents (Amendment) Act 1995 and the amendments came into force on 1 Jan 96 via The Patents Act (Commencement) Notification 1995. Section 13 as it was then (see extract below) was amended by deleting subsections (2) and (5).

2.4 Section 13 as it was then (prior to the amendment in 1996).

Patentable inventions 13. —(1) Subject to subsections (2) and (3), a patentable invention is one that satisfies the following conditions:

(a) the invention is new; (b) it involves an inventive step; and (c) it is capable of industrial application.

(2) It is hereby declared that the following (among other things) are not


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inventions for the purposes of this Act, that is to say, anything which consists of —

(a) a discovery, scientific theory or mathematical method; (b) a literary, dramatic, musical or artistic work or any other aesthetic creation whatsoever; (c) a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer; or (d) the presentation of information,

but the foregoing provisions shall prevent anything from being treated as an invention for the purposes of this Act only to the extent that a patent or an application for a patent relates to that thing as such. (3) An invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention. (4) For the purposes of subsection (3), behaviour shall not be regarded as offensive, immoral or anti-social only because it is prohibited by any law in force in Singapore. (5) The Minister may, by order published in the Gazette, vary the provisions of subsection (2) for the purposes of maintaining them in conformity with developments in science and technology.

NB. The sub-sections in italics were deleted in the 1996 amendments.

C Effect of the 1996 amendments – Open floodgates?

2.5 Arising from the 1996 amendments where Section 13 as it was then was amended by deleting subsections (2) and (5), some questioned whether they resulted in the opening of floodgates and that anything now can be an invention. Guidance in Singapore can be derived from the Parliamentary Speech of Assoc. Prof. Ho Peng Kee (then Parliamentary Secretary to the Minister for Law) when he introduced the amendments to the Patents Act in 1995 and explained during the Second Reading in Parliament:

Sir, other amendments in the Bill include the deletion of section 13(2) of the Act. Section 13(2) is a short and non- exhaustive listing of subjects which are


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considered non-patentable, eg, a discovery or mathematical model.

He went further to explain:

Sir, this deletion will not limit our flexibility in rejecting any subject matter which is non-patentable under section 13(1). The existing provisions are sufficient to enable Singapore to keep up with advances and changes in science and technology.

2.6 Section 13(2) as it was then, provides a non exhaustive list of subject matter which

were not inventions under Section 13 and with the removal of this subsection, the impact as to what inventions fall under Section 13 remains unchanged. The repeal of this non exhaustive list should not be read to mean that subject matter which was formerly excluded as “invention” is now considered as “patentable invention”. The subject matter still has to meet the requirements of it being an invention and that it meets the test in section 13.

D Patentable subject matter i. Approach taken in Europe

2.7 Articles 52(2) and 52(3) of the European Patent Convention (EPC) contains a non exclusive list of subject matter as such that are not to be regarded as inventions and article 53 identifies the types of inventions that are excluded from patentability. In UK, similar provisions are found in sections 1, 4A and Schedule A2 of the UK Patents Act. Even though the UK and EPC requirements are similar, the steps leading up to an assessment of whether an invention meets these requirements is not the same.

2.8 In brief, the European Patent Office (EPO) determines whether the claimed subject matter in the patent application as a whole is excluded from being considered an invention and assesses whether the claimed subject matter has a technical character. In the process, features of the claimed subject matter having technical character are identified and assessed for inventive step. An invention is non patentable if it has no technical character. Therefore if the claimed subject matter does not have technical character the claims will not be examined. More information on the patent practice before the EPO can be found in http://www.epo.org/.

ii. Approach taken in UK

2.9 The UK patent office’s practice on the other hand applies the “four step approach” referred to by Jacob LJ in Aerotel Ltd v Telco Holdings Ltd & Ors Rev 1 [2007] RPC 7 (Aerotel/Macrossan). This test is reproduced as follows:


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40. The approach is in 4 steps:

“(1) properly construe the claim

(2) identify the actual contribution;

(3) ask whether it falls solely within the excluded subject matter;

(4) check whether the actual or alleged contribution is actually technical in nature”.

2.10 A quick comparison of articles 52(2), 52(3) and 53 of the European Patent Convention (EPC) with sections 1, 4A and Schedule A2 of the UK Patents Act and sections 13, 14, 16 of the Singapore Patents Act can be found in the table below. For the most part, one can say that our laws are similar. However, what is noticeably absent in the Singapore provisions is an elaboration of what is not considered to be an invention. Neither is there any mention about excluding plant or animal varieties or essentially biological processes for the production of plants or animals from patentability.

Table 1: Comparison of patentability provisions

SG Current UK Current EPC

Not inventions No Equivalent statutory provision

“(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, …- … a discovery, scientific theory or mathematical method… as such.” Re: UK Section 1(2)

“(2) The following in particular shall not be regarded as inventions…: …discoveries, scientific theories and mathematical methods… as such.” Re: EPC Art 52(2)


“(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, …- … a literary, dramatic, musical or artistic work

“(2) The following in particular shall not be regarded as inventions…: … aesthetic creations… as such.” Re: EPC Art 52(2)


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SG Current UK Current EPC or any other aesthetic creation whatsoever… as such.” Re: UK Section 1(2)


“(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, …- … a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer… as such.” Re: UK Section 1(2)

“(2) The following in particular shall not be regarded as inventions…: … schemes, rules and methods for performing mental acts, playing games or doing business, and programs for computers… as such.” Re: EPC Art 52(2)


“(2) It is hereby declared that the following (among other things) are not inventions for the purposes of this Act, …- … the presentation of information;… as such.” Re: UK Section 1(2)

“… presentations of information… as such.” Re: EPC Art 52(2)

Not patentable / patent not to be granted

“An invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention.” Re: SG Section 13(2)

“A patent shall not be granted for an invention the commercial exploitation of which would be contrary to public policy or morality” Re: UK Section 1(3)

European patents shall not be granted in respect of: “(a) inventions the commercial exploitation of which would be contrary to "ordre public" or morality…” Re: EPC Article 53a

Unpatentable / patent not to be granted

No Equivalent statutory provision

“An invention shall not be considered unpatentable solely on the ground that it

European patents shall not be granted in respect of: “(b) plant or animal varieties or essentially


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SG Current UK Current EPC concerns - (a) a product consisting of or containing biological material; or (b) a process by which biological material is produced, processed or used.” Re: UK Paragraph 1 Schedule A2

biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof” Re: EPC Article 53b

Not capable of industrial application / patent not to be granted

“An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application.” Re: SG Section 16(2)

“A patent shall not be granted for the invention of- (a) a method of treatment of the human or animal body by surgery or therapy, or (b) a method of diagnosis practised on the human or animal body.” Re: UK Section 4A(1)

European patents shall not be granted in respect of “(c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Re: EPC Article 53c

Not patentable / patent not to be granted

No Equivalent statutory provision

“The following are not patentable inventions – (a) the human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene; (b) processes for cloning human beings; (c) processes for modifying the germ

(1) The human body, at the various stages of its formation and development, and the simple discovery of one of its elements, including the sequence or partial sequence of a gene, cannot constitute patentable inventions. Re: EPC Rule 28 Under Article 53(a), European patents shall not be granted in


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SG Current UK Current EPC line genetic identity of human beings; (d) uses of human embryos for industrial or commercial purposes; (e) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes; (f) any variety of animal or plant or any essentially biological process for the production of animals or plants, not being a micro-biological or other technical process or the product of such a process.” Re: UK Paragraph 3 Schedule A2

respect of biotechnological inventions which, in particular, concern the following: (a) processes for cloning human beings; (b) processes for modifying the germ line genetic identity of human beings; (c) uses of human embryos for industrial or commercial purposes; (d) processes for modifying the genetic identity of animals which are likely to cause them suffering without any substantial medical benefit to man or animal, and also animals resulting from such processes. Re: EPC Rule 28 See also European Directive 98/44/EC on the legal protection of biotechnological inventions


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iii. Approach taken in US

2.11 In the US 35 Patents Code, section 100 defines the term “invention” to mean an invention or discovery and section 101 states that whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. Its Supreme Court in Diamond v. Chakrabarty, 447 U.S. 303, 206 USPQ 193 (1980), held that microorganisms produced by genetic engineering are not excluded from patent protection by 35 U.S.C. 101. It also read the term 'manufacture' in section 101 in accordance with its dictionary definition to mean 'the production of articles for use from raw materials prepared by giving to these materials new forms, qualities, properties, or combinations whether by hand labor or by machinery.'". More information on the patent practice before the USPTO can be found in http://www.uspto.gov/ Recently, the case of In re Bilski, 545 F.3d 943, 88 U.S.P.Q.2d 1385 (Fed. Cir. 2008), revived discussions on this subject when the US Court of Appeals for the Federal Circuit did not apply the "useful, concrete, and tangible" test for patent-eligibility previously set out in State Street Bank & Trust Co. v. Signature Financial Group, Inc., 149 F.3d 1368 (Fed. Cir. 1998). In place, the court applied the machine-or transformation test as the applicable test for patent-eligible subject matter. This is now pending before the US Supreme Court. This prompted the USPTO to issue interim examination instructions (See extracts below) for evaluating subject matter eligibility under 35 USC § 101 pending the Supreme Court’s decision on the appeal.

“There are two criteria for determining subject matter eligibility and both must be satisfied. The claimed invention (1) must be directed to one of the four statutory categories, and (2) must not be wholly directed to subject matter encompassing a judicially recognized exception, as defined below.

Step 1: Is the claim directed to one of the four patent-eligible subject matter categories: process, machine, manufacture, or composition of matter? …

Step 2: Does the claim wholly embrace a judicially recognized exception, which includes abstract ideas, mental processes or substantially all practical uses (pre-emption) of a law of nature or a natural phenomenon, or is it a particular practical application of a judicial exception?”.

More information on the interim examination instructions can be found in http://www.uspto.gov/web/offices/pac/dapp/opla/2009-08-


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25_interim_101_instructions.pdf

iv. Approach taken in Singapore

2.12 The approaches taken in Europe, UK and even in the US, however different their patent laws may be, reveal a similar constant challenge faced when assessing whether a particular subject matter is deserving of patent protection. Judicial bodies continue to struggle to identify workable tests that could successfully sieve out cases not eligible for patent protection. Tests such as “technical character”, “technical contribution”, “technical effect”, "useful, concrete, and tangible" and “machine or transformation” have sprung out through the years and we need to approach the use of such tests with the relevant background (e.g. different statutory provisions) in mind.

2.13 In Singapore, our Examiners should approach section 13 as it is and begin to assess whether a claimed subject matter in a patent application is an invention. Unlike in some other jurisdictions, our Examiners need not be embroiled in the debate on whether a particular claimed subject matter falls within a statutory list of exclusions and whether the subject matter has “technical character”, “technical contribution” or “technical effect”. Instead, our Examiners should focus on the quest in ascertaining whether a claimed subject matter is an invention to begin with.

E. Invention 2.14 What then is an invention? In the Singapore Court of Appeal’s decision of Merck &

Co Inc v Pharmaforte Singapore Pte Ltd [2000] SGCA 39, Chao Hick Tin JA said said:

“In this regard, we must also point out that the fact that a discovery is made does not mean there is an invention. The latter does not necessarily follow from the former“.

His Honour cited Lindley LJ’s statement in the United Kingdom’s case of Lane Fox v Kensington and Knightsbridge Electric Lighting Co [1892] 3 Ch 424 at p 429 where he said:

“An invention is not the same thing as a discovery. When Volta discovered the effect of an electric current from his battery on a frog’s leg he made a great discovery, but no patentable invention. Again, a man who discovers that a known machine can produce effects which no one before him knew could be produced by it, may make a great and useful discovery; but, if he does no more, his discovery is not a patentable invention: … He has added nothing but knowledge to what previously existed. A patentee must do something


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more; he must make some addition, not only to knowledge, but to previously known inventions, and must so use his knowledge and ingenuity as to produce either a new and useful thing or result, or a new and useful method of producing an old thing or result.”

2.15 Our Examiners should thus look out for that “something more” for the subject matter in question to rise above the status of a “discovery” to the status of an “invention”. Subject matter e.g. a scheme, rule or method for performing a mental act, playing a game or doing business, or a program for a computer will thus have to pass the first hurdle of it being an invention.

2.16 However, even if the Examiner were to form a preliminary view that the subject matter in question is not an invention, he should proceed to consider if the other limbs in section 13(1) are met. This subsequent step could assist the Examiner in re-assessing his earlier preliminary view that the subject matter in question is not an invention.

F Patentable invention 2.17 In Singapore, section 13(1) states that a patentable invention is one that satisfies the

following conditions: (a) the invention is new; (b) it involves an inventive step; and (c) it is capable of industrial application.

Section 13(2) also goes on to say that “An invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention.”

2.18 Hence, even after determining that the subject matter in question is an invention, is new, involves an inventive step and is capable of industrial application, the invention can still fail to qualify as a patentable invention if the publication or exploitation of the invention would be generally expected to encourage offensive, immoral or anti-social behaviour.


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G Patentability assessment: In a nutshell

2.19 In sum, the Examiner will assess the subject matter in question as follows and he should include his assessment on all steps in the Written Opinion or Examination Report, as the case may be. The following table summarises the steps to be taken by the Examiner.

Table 2: Overall Steps Involved in section 13 assessment Step 1 Is the subject matter in question is an invention? If yes or no, proceed to

Step 2.

Step 2 Is the subject matter in question, new? If yes or no, proceed to Step 3.

Step 3 Does the subject matter in question, involve an inventive step? If yes or no, proceed to Step 4.

Step 4 Is the subject matter in question, capable of industrial application? If yes or no, proceed to Step 5

Step 5 Is the subject matter in question, the publication or exploitation of the invention would be generally expected to encourage offensive, immoral or anti-social behaviour?


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3 NOVELTY A Statutory requirements

S 14

3.1 Novelty

Section 14.—(1) An invention shall be taken to be new if it does not form part of the state of the art. (2) The state of the art in the case of an invention shall be taken to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in Singapore or elsewhere) by written or oral description, by use or in any other way. (3) The state of the art in the case of an invention to which an application for a patent or a patent relates shall be taken also to comprise matter contained in an application for another patent which was published on or after the priority date of that invention, if the following conditions are satisfied:

(a) that matter was contained in the application for that other patent both as filed and as published; and (b) the priority date of that matter is earlier than that of the invention.

(4) For the purposes of this section, the disclosure of matter constituting an invention shall be disregarded in the case of a patent or an application for a patent if occurring later than the beginning of the period of 12 months immediately preceding the date of filing the application for the patent and either —

(a) the disclosure was due to, or made in consequence of, the matter having been obtained unlawfully or in breach of confidence by any person —

(i) from the inventor or from any other person to whom the matter was made available in confidence by the inventor or who obtained it from the inventor because he or the inventor believed that he was entitled to obtain it; or (ii) from any other person to whom the matter was made available in confidence by any person mentioned in sub-paragraph (i) or in this sub-paragraph or who obtained it from any person so mentioned because he or the person from whom he obtained it believed that he


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was entitled to obtain it;

(b) the disclosure was made in breach of confidence by any person who obtained the matter in confidence from the inventor or from any other person to whom it was made available, or who obtained it, from the inventor;

(c) the disclosure was due to, or made in consequence of, the inventor displaying the invention at an international exhibition and the applicant states, on filing the application, that the invention has been so displayed and also, within the prescribed period, files written evidence in support of the statement complying with any prescribed condition; or

(d) the disclosure was due to, or made in consequence of, the inventor describing the invention in a paper read by him or another person with his consent or on his behalf before any learned society or published with his consent in the transactions of any learned society.

(5) In subsection (4) (d), “learned society” includes any club or association constituted in Singapore or elsewhere whose main object is the promotion of any branch of learning or science. (6) In this section, references to the inventor include references to any proprietor of the invention for the time being. (7) In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.

B State of the Art

S 14(1) S 14(2) S17

3.2 Section 14(1) sets out the requirements on novelty. It says that an invention shall be taken to be new if it does not form part of the state of the art. Section 14(2) explains that the state of the art in the case of an invention shall be taken to comprise:

• all matter (whether a product, a process, information about either, or anything else)

• which has at any time before the priority date of that invention been made available to the public (whether in Singapore or elsewhere)

• by written or oral description, by use or in any other way.


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R42(3) 3.3 Where a Request for Examination Report relies on Foreign Search Results and the Examiner requires any non-English documents cited in these results to be translated into English, such translations may be sought from the IPOS Officer in the Patents Search and Examination Unit who had previously forwarded the Request for Examination Report to the Examiner. The applicants will then be informed of this need and they will be required to respond within a specified time frame e.g. 2 months. In the light of high translation costs to be borne by the applicants, translations of the whole or part of the Non-English cited document should be sought only after the Examiner exhausts the following alternatives:

(a) Rely on his or her knowledge of the e.g. French and German language where applicable (b) Refer to any English family members (c) Refer to any available English Abstracts (d) Apply Machine Translation Tools (freely available from the web) or request the applicants to furnish a Machine Translation over the Non-English cited document.

If, from the above, the Examiner is still of the opinion that a translation of part or the whole Non-English cited document is necessary, he/she may proceed to request for it.

S2(1) S 14(2) S 14(3) S17

3.4 Section 14(2) defines a cut off date when making a state of the art consideration to include all matter made publicly available at any time before the priority date. However, Section 14(3) carves out an exception as it explains that the state of the art in the case of an invention to which an application for a patent or a patent relates includes matter

• contained in an application for another patent* which was published on or after the priority date of that invention, if

o that matter was contained in the application for that other patent both as filed and as published; and

o the priority date of that matter is earlier than that of the invention. * Section 2(1) defines "patent" to mean a patent under the Patents Act and includes a patent in force by virtue of Section 117 (3).

S 14(3)

3.5 In sum, Section 14(3) allows under limited circumstances, matter published after the priority date of the invention to be considered as part of the state of the art. Only applications for a patent, that is, either an application which is made under the Act or one which is treated as such, are considered. See Figure below which illustrates a patent application filed in Singapore and was accorded a number 123. This application 123 claims priority of an earlier filed patent application in US. Hence, the assessment of novelty will cover all relevant disclosures made before the US filing date, this being the priority date of Singapore patent application 123. Meanwhile,


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there is a Singapore patent application 234 that was filed before the US filing but was published after Singapore patent application 123. Singapore patent application 234 can fall under the ambit of Section 14(3).

S 15 3.6 It must also be noted that the Section 14(3) consideration is also limited to the assessment of novelty and is not used for assessing inventive step.

C Grace Period

S 14(4) S 14(5) 3.7 On the issue of matter that had been made available to the public, Section 14(4)

provides for certain matter to be disregarded under Section 14(1) notwithstanding that the matter falls under Section 14(2), if the disclosure was made under certain circumstances, and within what is seen as a 12 month “grace period”. These circumstances briefly include disclosures made as a result of a breach of confidence or where the inventor revealed the invention at an International Exhibition or before a learned society and Section 14(5) explains that a “learned society” includes any club or association constituted in Singapore or elsewhere whose main object is the promotion of any branch of learning or science.

r8 3.8 In the case of a disclosure at an International Exhibition, rule 8 of the Patent Rules details the requirements that applicants are required to comply with.


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International exhibitions 8.—(1) An applicant for a patent who wishes the disclosure of matter constituting an invention to be disregarded in accordance with section 14 (4) (c) shall, within the same day of filing the application for the patent, inform the Registrar in writing that the invention has been displayed at an international exhibition. (2) The applicant shall, within 4 months from the day of filing the application, file a certificate, issued by the authority responsible for the exhibition, stating that the invention was in fact exhibited there. (3) The certificate shall also state the opening date of the exhibition and, where the first disclosure of the invention did not take place on the opening date, the date of the first disclosure. (4) The certificate shall be accompanied by an identification of the invention, duly authenticated by the authority. (5) For the purposes of section 2 (2), a statement may be published in the journal that an exhibition described in the statement falls within the definition of international exhibition in section 2 (1). (6) In the case of an international application for a patent (Singapore), the application of this rule shall be subject to rule 86 (4).

3.9 Examiners will be informed of whether such a disclosure has been made in the

Patents Form 1 filed by the applicant. The patent request form (See extract of Patents Form 1 below) of the patent application contains a section which facilitates the applicant in making such a disclosure. Patents Form 1 is also enclosed together with the Request for Search and/or Examination, when the Request is forwarded to the Examiner.

For PCT national-phase (SG) entry applications, where applicants file a request for Examination with IPOS, the Examiner will note that such a disclosure is made at the International phase and this fact is revealed in the International Search Report (Rule 33.1 of the PCT Regulations).


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D Priority Date S 14(2)

3.10 It is recalled that Section 14(1) says that an invention shall be taken to be new if it

does not form part of the state of the art while Section 14(2) explains that the state of the art in the case of an invention shall be taken to comprise all matter which has at any time before the priority date of that invention been made available to the public.

S17 3.11 Subsections (1) & (2) of Section 17 of the Patents Act are reproduced below and they explain what the priority date refers to. In a nutshell, the priority date of an invention by default is the date of filing of a patent application unless there is an earlier relevant application filed in a convention country.

Priority date 17.—(1) For the purposes of this Act, the priority date of an invention to which an application for a patent relates and also of any matter (whether or not the same as the invention) contained in the application is, except as provided by the provisions of this Act, the date of filing the application.

(2) Where in or in connection with an application for a patent (referred to in this section as the application in suit) a declaration is made, whether by the applicant or any predecessor in title of his, complying with the relevant requirements of the rules and specifying one or more earlier relevant applications for the purposes of this section made by the applicant or a predecessor in title of his, and the application in suit has a date of filing, within the period referred to in subsection (2A) (a) or (b), then —

(a) if an invention to which the application in suit relates is supported by matter disclosed in the earlier relevant application or applications, the priority date of that invention shall, instead of being the date of filing the application in suit, be the date of filing the relevant application in which that matter was disclosed or, if it was disclosed in more than one relevant application, the earliest of them; and

(b) the priority date of any matter contained in the application in suit which was also disclosed in the earlier relevant application or applications shall be the date of filing the relevant application in which that matter was disclosed or, if it was disclosed in more than one relevant application, the earliest of them.

S17 r9 r9A r9B

3.12 The other subsections of section 17 and the corresponding provisions in the rules specify requirements that include when the subsequent patent application has to be filed in order to claim priority over the earlier relevant application, when the


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r9C

declaration of priority has to be made and when documents supporting the priority claim are required to be furnished.

r9B(4) r33 3.13 During the search process, the Examiners shall identify as far as possible, all relevant

prior art immediately before the date of filing of a patent application, regardless of whether there is a priority declaration made in the patent application.

r9B(4) 3.14 During the examination process, the Examiner shall generally not investigate the validity of the priority claim. However, the Examiner shall do so when there is a potential prior art that is published on or after the priority date but before the date of filing of the patent application that is being examined. Hence, in Singapore, priority documents are not furnished by the applicants as a matter of course in all cases. They are to be furnished by the applicants when the Examiner informs the Registrar of the need.

r9C

3.15 Likewise, in the case of non English priority documents, rule 9C states that translations need to be furnished only when required (the Examiner informs the IPOS Officer in the Patents Search and Examination Unit who had previously forwarded the Request for Search and/or Examination Report to the Examiner, of the need) and where the validity of the claim to priority is relevant to determining whether the invention concerned is patentable.

E Novelty Test 3.16 Tay Yong Kwang J in the decision of Mühlbauer AG v Manufacturing Integration

Technology Ltd [2009] SGHC 45 where he applied the guiding principles set out by Lai Kew Chai J in Trek Technology (Singapore) Pte Ltd v FE Global Electronics Pte Ltd (No. 2) [2005] 3 SLR 389 at [16] and they are reproduced as follows:

(a) the issue is determined by asking whether an invention forms part of the state of the art; (b) the prior art must, in order to invalidate the patent, be such that a person of ordinary skill and knowledge of the subject would at once perceive and understand and be able to practically apply the discovery without the necessity of making further experiments; (c) the prior art documents must be construed as at the date of publication and it is not permissible to perform an ex post facto analysis; (d) each prior art document has to be considered separately and not combined into a mosaic to arrive at the invention; (e) the person skilled in the art is an unimaginative person of competent but


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average technical skill; (f) the prior art document must contain clear directions to do what the patent claims to have invented.

i. Signpost is not enough

3.17 Further guidance can be found in Merck & Co Inc v Pharmaforte Singapore Pte Ltd, [1999] SGHC 323, where the plaintiffs argued that any prior art that is relied on to destroy novelty must unequivocally point to the invention and must not merely be a signpost on the path to discovering the invention. Lai Kew Chai J in delivering the judgment of the High Court agreed and he said that “they correctly stated that anticipation only arises if it discloses to a notional instructed reader essential integers to the invention as claimed: General Tire and Rubber Co v Firestone Tyre and Rubber Co [1972] RPC 457 at 485.”.

ii. Publicly made available

3.18 Tay Yong Kwang J in Insitutut Pasteur v Genelabs Diagnostics Pte Ltd [2000] SGHC 53 at paragraph 188 also explained:

188 The law concerning anticipation is strict to the patentee and to the challenger of the patent. A claim is invalid if it covers any item of the prior art which has been disclosed to anyone (except in confidence), by any means (written or oral or by use), anywhere in the world, at any time in history (before the priority date). Even availability to a single member of the public will suffice. Similarly, availability to the public is satisfied if the document can be found on the shelves of a public library. It is irrelevant whether anyone knew it was available or had inspected it. [Vitoria, Encyclopedia of United Kingdom and European Patent Law] Anticipation can therefore encompass a disclosure which the inventor was totally ignorant of.

iii. Combining prior art

3.19 As for the combination of prior art in the assessment of novelty, Tay Yong Kwang J in Insitutut Pasteur v Genelabs Diagnostics Pte Ltd [2000] SGHC 53 at paragraph 190 said:

Anticipation must be found within the document alleged to have anticipated the invention. It is not permissible to combine the teachings of two or more documents except where one of these directs the reader to study the other. One cannot create a "mosaic of extracts" from documents spread over a number of years [Von Heydon v Neustadt (1880) 50 LJ Ch. 126]. Similarly, "it is not open to you to take a packet of prior documents and by putting a puzzle together produce


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what you say is a disclosure in the nature of a combination of the various elements which have been contained in the prior documents. … it is necessary to point to a clear and specific disclosure of something which is said to be like the patentee’s invention" [Lowndes’ Patent (1928) 45 RPC 48].

iv. Enabling Disclosure

3.20 Another novelty requirement is that the disclosure must be ‘enabling’, i.e. sufficient so as to enable the skilled addressee to put the invention into practice. The Court of Appeal in Genelabs Diagnostics Pte Ltd v Institut Pasteur [2000] SGCA 60 observed that Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] SGCA 39 had concluded that for a prior publication to anticipate the patent it must be established that following the teachings in the prior publication would inevitably lead to the invention covered by the patent. The prior disclosure must not only identify the subject matter of the claim in the later patent, it must do so in a way that enables the skilled man to make or obtain it, a kind of enabling disclosure.

F Minimum Documentation r40 3.21 The primary aim of the search process conducted by the Examiner is to identify as

much relevant prior art as possible. Hence, even though Section 14(2) defines the state of the art to comprise all matter (whether a product, a process, information about either, or anything else) which has at any time before the priority date of that invention been made available to the public (whether in Singapore or elsewhere) by written or oral description, by use or in any other way, rule 40 of the Patent Rules prescribes the minimum set of documentation that should be referred to in the course of search.

Minimum documentation for search 40.—(1) The documentation prescribed for the purposes of section 29 (3) and (6) (“minimum documentation”) shall consist of —

(a) the patents issued by or registered in Singapore; (b) the patent applications published in Singapore; (c) the “national patent documents” as specified in paragraph (2); and (d) the published international (Patent Co-operation Treaty) applications.

(1A) The documentation prescribed for the purposes of section 38A (7) (“minimum documentation”) shall consist of —

(a) the patents issued by or registered in Singapore; (b) the patent applications published in Singapore; (c) the “national patent documents” as specified in paragraph (2); and (d) the published international (Patent Co-operation Treaty)


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applications. (2) Subject to paragraphs (3) and (4), the “national patent documents” shall be the following:

(a) the patents issued by Australia, France, the former Reichspatentamt of Germany, Japan, Switzerland (in French and German languages only), the United Kingdom and the United States of America; (b) the patents issued by the Federal Republic of Germany; and (c) the patent applications, if any, published in the countries referred to in sub-paragraphs (a) and (b).

(3) The patent documents of Japan, for which no abstracts in the English language are generally available, need not form part of the “minimum documentation” referred to in paragraph (1) or (1A).

(4) Only those patents issued and those patent applications published, after a date not more than 50 years before the declared priority date or, where there is no declared priority date, the date of filing of the application being subjected to a search, need form part of the “minimum documentation” referred to in paragraph (1) or (1A).

S38A S80

3.22 Hence, rule 40 only specifies the minimum extent that Examiners should consider but it does not cover the extent mentioned in Section 14. Examiners may refer to other documents if they have access to them. Disclosures (e.g. oral) not captured by the Examiner can be raised after a patent is granted, by anyone who wishes to challenge the validity of the patent under Section 80 of the Patents Act. Anyone can also file a search and examination request after grant under Section 38A of the Patents Act if they wish to have an assessment of that disclosure which was previously not considered.

3.23 The Registry has also made available an on-line access to published patent applications and patents in Singapore through this portal http://www.epatents.gov.sg/PE/. This enables anyone, anywhere in the world with internet access to conduct such searches. Our Examiners should use this site when conducting search. In the event where the Examiners encounter any potential prior art from this Singapore patent database, they can pull out the published patent specification from it as well as the relevant extract from the patent register. The documents are available free of charge.


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G Internet disclosures 3.24 Internet Disclosures can be relevant and may fall within the ambit of Section 14.

There are however challenges arising when considering such disclosures.

3.25 The PCT International Search and Preliminary Examination Guidelines provide some guidance on this subject. (http://www.wipo.int/pct/en/texts/pdf/ispe.pdf)

• Disclosure on the Internet 11.13 Prior art disclosure on the Internet or on an on-line database is considered in the same manner as other forms of written disclosure. Information disclosed on the Internet or on-line database are considered to be publicly available as of the date the disclosure was publicly posted. When citing an Internet disclosure (a web page), problems may arise in establishing the date of publication and whether or not the disclosure has been modified over time. When establishing the publication date of a web page, it is important to distinguish between two types of Internet disclosure, viz.: those made on the web sites of trusted publishers and those made on web sites of unknown reliability.

• Disclosure Made on the Web Sites of Trusted Publishers 11.14 Examples of these are on-line scientific journals (which make available the contents of a paper journal on-line, or may be uniquely on-line publications). The web sites of newspapers, periodicals, television and radio stations will usually fall into this category as well. This type of Internet disclosure gives the publication date of the disclosure which, in the absence of evidence to the contrary, should be taken at face value. The examiner should cite the Internet disclosure in the International search report and use it in the written opinion of the International Searching Authority and in preliminary examination accordingly. The onus is on the applicant to prove otherwise.

11.15 It may happen that the publication date is not sufficiently identified to know if it is published in time to be considered to be state of the art according to Rule 64.1(b) (that is, it is not clear if the disclosure occurred before or after the valid priority date). This may happen, for example, where only the month or year of publication is given and this is the same as the month or year of the valid priority of the international application. In these cases, the Authority may need to make enquiries with the owner of the web site in order to establish the publication date to a sufficient degree of accuracy to know if it is relevant state of the art in accordance with Rule 64.1(b) in the same way as it would act in order to establish a more accurate publication date for a paper published document.


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• Disclosures Made on Web Sites of Unknown Reliability 11.16 Examples of such web sites include those belonging to private individuals, private organizations (for example, clubs), commercial web sites (for example, advertising) etc. Where such an Internet disclosure is retrieved during the international search and it does not give any explicit indication of the publication date in the text of the disclosure, the Authority may consider using those technical means available to it to attempt to reveal the publication date. 11.17 Such technical means include:

(a) information relating to the publication date embedded in the Internet disclosure itself (date information is sometimes hidden in the programming used to create the web site, but is not visible in the web page as it appears in the browser), (b) indexing dates given to the web page by search engines (these are usually later than the actual publication date of the disclosure since the search engines usually take some time to index a new web site) and (c) information available relating to the web site on commercial Internet archiving databases (for example, the “Internet Archive Wayback Machine”).

11.18 Where the examiner obtains an electronic document which establishes the publication date for the Internet disclosure, he should make a print-out of this document, which must mention both the URL of the relevant Internet disclosure and the date of publication of that relevant Internet disclosure. The examiner must then cite this print-out in the international search report as an “L” document and cite the relevant Internet disclosure according to the relevance of its content (“X”, “Y”, “A”) and according to the date as established (“X”, “Y”, “A”, “P,X”, “P,Y”, “P,A”, “E”1 etc). Where the examiner is unable to establish the publication date of the relevant Internet disclosure and it is relevant to the inventive step and/or novelty of the claimed invention, he should cite it in the international search report with the category “L” for those claims which it would have affected if it were published in time and giving it the date it was printed out as the publication date (see paragraph 16.69(b)).

11.19 Where this type of Internet disclosure does explicitly mention a

1 The category "E" document refers to an earlier patent application and it may have been mistakenly referenced in this paragraph of the PCT International Search and Preliminary Examination Guidelines. PCT has been informed and they agree that category “E” should not have been so referenced and they will make the changes accordingly.


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publication date and this publication date:

(i) is not contradicted by the information sources mentioned above (in this regard it should be noted that the indexing date given by a search engine is usually later than the actual publication date and so where the examiner uncovers an indexing date for an Internet disclosure which is later than the publication date given in the Internet disclosure itself; this does not necessarily mean that the Internet disclosure was made available later than it claimed, it simply means that it was indexed by that search engine after it was made available); and

(ii) is accurate enough to establish if the document was published early enough to be considered relevant according to Rule 33.1(a) and Rule 64.1(b), then the examiner should trust the date given and give this as the publication date in the search report and use this publication date in preliminary examination. The onus is on the applicant to prove otherwise.

11.20 In the absence of evidence to the contrary, the examiner should assume that the content of the Internet disclosure has not changed over time.

H Prior Art Consideration: Standard of proof 3.26 Paragraph 2.29.1 of the UK Manual of Patent Practice (Jul 2010) specifies the level

of assessment required when considering evidence relating to prior use in general.

2.29.1 In cases of alleged prior use, the required standard of proof is the balance of probabilities. Within this standard, the Patents County Court in Kavanagh Balloons Pty Ltd v Cameron Balloons Ltd [2004] RPC 5 held that a flexible degree of probability should be applied to evidence relating to prior use. The cogency of the evidence had to match the occasion and be proportionate to the subject matter. Because of the nature of the monopoly itself and question of public interest, no stricter standard should be applied. It was held that it was not necessary for an opponent to prove his case “up to the hilt” as had been required by the EPO Technical Board of Appeal in Sekisui/shrinkable sheet [1998] OJEPO 161 (T 472/92). The hearing officer in Colley's Application [1999] RPC 97 also distinguished from Sekisui by not requiring proof “up to the hilt”, but followed this decision and Demmeler Maschinenbau GmbH & Co KG (T 908/95) in holding that mere assertion of prior use was insufficient: place, time and detail were essential.

3.27 In Singapore, we would apply the PCT approach taken on internet disclosures as well as the standard of proof i.e. “balance of probabilities” adopted in the UK for prior art consideration This should guide the Examiner in his consideration on whether a


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certain disclosure falls within the ambit of section 14(2).

I Medical Use Claims

S14(7) 3.28 Section 14(7) corresponds with section 2(6) of the UK Patents Act (prior to the 2004 amendments) and is similar to section 4A of the UK Patents Act (after the 2004 amendments) and Article 54 of the European Patent Convention. In brief, it provides an exception to the general understanding of novelty as it says that the fact that a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body is not new, this fact shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method is new.

3.29 Paragraphs 4A.16, 4A.26 and 4A.27 of the UK Manual of Patent Practice (Jul 2010) explains how the current UK provisions are interpreted.

4A.16 Section 4A(3) has the effect that a known substance or composition may be patented for use in a method of treatment by surgery or therapy or of diagnosis provided that its use in any such method is new ("first medical use"). That is to say, if a known substance or composition not previously used in surgery, therapy or diagnosis is found to be useful in treating, say a human disease, or to obtain a specific "therapeutic" effect (eg analgesic or antibiotic), a patent for the substance or composition for use in therapy (unspecified) may be obtained, i.e. the claim need not be limited to the specific therapeutic effect; additional claims directed towards more than one specific therapeutic effect may be allowed in the same patent application, provided of course that they are supported by the description. The terms surgery, therapy and diagnosis are discussed in more detail in paragraphs 4A.02-4A.14. 4A.26 Before implementation in 2007 of the medical provisions of the 2000 revision of the EPC (EPC 2000 – introduced into UK law by the Patents Act 2004), a second or subsequent medical use could only be protected by a claim in the “Swiss type” format of “the use of substance X for the manufacture of a medicament to treat disease Y”. Section 4A(4) now enables patent protection to be obtained for a second, or subsequent, different use of a substance or composition in a method of treatment or diagnosis by a direct claim in the form “substance X for use in the treatment of disease Y”. A claim of this type for a known substance or composition for use in a specific method of treatment or diagnosis is treated as new if that specific use was previously unknown. This does not extend the availability of patent protection in respect of an invention consisting of a substance or a composition for use in a method of treatment or diagnosis; it simplifies and clarifies the manner in which patent protection may be obtained for such inventions.


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4A.27 Following implementation of the EPC 2000, the practice in both this Office and the EPO was to allow inventions relating to second medical uses to be claimed using either the direct second medical use claim format under Section 4A(4), or the Swiss-type format, or both, pending guidance from the UK courts and/or the EPO Boards of Appeal. In February 2010, the EPO Enlarged Board of Appeal issued its decision on G 02/08 ABBOTT RESPIRATORY/Dosage regime. This decided that applicants may no longer claim second medical use inventions in the Swiss format. The Enlarged Board held that Swiss-type claims were previously accepted (in G 05/83 EISAI/Second medical indication [1985] 3 OJEPO 64) as the only possible means of protecting inventions relating to second medical uses in order to fill a loophole in the provisions of the EPC 1973. The new Article 54(5) (equivalent to Section 4A(4)) fills this loophole by explicitly allowing claims to the further specific use of a known drug, and so the reason for this special, “judge-made” law no longer exists.

3.30 A table of comparison between the various provisions from Singapore, UK and the EPC is reproduced below to highlight the similarities and differences.

Table 3: Comparison of Medical Use provisions (Novelty)

Current SINGAPORE UK (Pre 2004 amendments)

Current UK Current EPC

Section 16(2) (2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application. Section 14(7) (7) In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of

Section 4(2) (2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application. Section 2(6) (6) In the case of an invention consisting of a substance or composition for use in a method of treatment of the human or animal body by surgery or therapy or of

Section 4A 4A.-(1) A patent shall not be granted for the invention of-

(a) a method of treatment of the human or animal body by surgery or therapy, or (b) a method of diagnosis practised on the human or animal body.

(2) Subsection (1) above does not apply to an invention consisting of a

Article 53 (c) European patents shall not be granted in respect of: (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Article 54(4) (4) Paragraphs 2 and 3


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Table 3: Comparison of Medical Use provisions (Novelty)



diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.

diagnosis practised on the human or animal body, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art.

substance or composition for use in any such method. (3) In the case of an invention consisting of a substance or composition for use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if the use of the substance or composition in any such method does not form part of the state of the art. (4) In the case of an invention consisting of a substance or composition for a specific use in any such method, the fact that the substance or composition forms part of the state of the art shall not prevent the invention from being taken to be new if that specific use does not form part of the state of the art.

shall not exclude the patentability of any substance or composition, comprised in the state of the art, for use in a method referred to in Article 53(c), provided that its use for any such method is not comprised in the state of the art. Article 54(5) (5) Paragraphs 2 and 3 shall also not exclude the patentability of any substance or composition referred to in paragraph 4 for any specific use in a method referred to in Article 53(c), provided that such use is not comprised in the state of the art.

3.31 Section 14(7) of the Singapore Patents Act corresponds to Section 2(6) of the UK Patents Act prior to the amendments made in 2004. Paragraph 76 of the "Examination Guidelines for Patent Applications relating to Medical Inventions in the UKIPO" updated as of August 2008, explains that the “case law relating to first medical use under the repealed Section 2(6) (or the equivalent Article 54(5) of the EPC 1973) will continue to govern our practice under Section 4A(3). The exception to this is the case law relating to the novelty of claims of the form “substance X, for use in treating disease Y”, which is now governed by Section 4A(4)…”. Singapore currently does not have a provision in the Singapore Patents Act which


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corresponds to Section 4A(4) of the UK Patents Act. Instead, our laws in this regard continue to correspond with the UK patent provisions (prior to the 2004 amendments). Hence, our Examiners shall continue to examine the Swiss type claim format in Singapore patent applications. Second or subsequent medical use claim in the “Swiss type” format of “the use of substance X for the manufacture of a medicament to treat disease Y” is acceptable. On the other hand, claims drafted in a manner that corresponds to Section 4A(4) of the UK Patents Act would not be novel under Section 14 of the SG Patents Act if substance X had been used in ANY medical method in the prior art.


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J NOVELTY ASSESSMENT: IN A NUTSHELL 3.32 The following table summarises the steps to be taken by the Examiner.

Table 4: Steps Involved in assessing novelty under section 14 Step 1 Identify the Date of Filing of the invention in question for novelty

assessment, regardless of whether there is a priority declaration made in the patent application. Then proceed to Step 2.

Step 2 Ensure that Examiner has access to the Minimum Documentation which includes Singapore published patent applications. Then proceed to Step 3.

Step 3 Apply the Novelty Test mentioned in this Chapter on the subject matter in question.

Step 3A Examiners shall continue to examine the Swiss type claim format in Singapore patent applications. Claims drafted in a manner that corresponds to Section 4A(4) of the UK Patents Act would not be novel under Section 14 of the SG Patents Act if substance X had been used in ANY medical method in the prior art.


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4 INVENTIVE STEP A Statutory requirements

S15 4.1 Inventive step

Section 15. An invention shall be taken to involve an inventive step if it is not obvious to a person skilled in the art, having regard to any matter which forms part of the state of the art by virtue only of Section 14 (2) and without having regard to Section 14 (3).

4.2 Consideration of inventive step occurs during the substantive examination phase of a patent application. This occurs after the completion of the search process.

B Inventive Step Test

4.3 The test that our Examiners should use when assessing inventive step is as follows. Tay Yong Kwang J in Mühlbauer AG v Manufacturing Integration Technology Ltd [supra] at paragraph 34, relied on the approach taken by our Court of Appeal in First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd [2007] SGCA 50 where the court adopted the oft-cited four-step test laid down by the English Court of Appeal in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59 at 73-74 (see [41] and [44] of our Court of Appeal’s judgment) (hereinafter referred to as “Windsurfing”) which said:

There are, we think, four steps which require to be taken in answering the jury question. The first is to identify the inventive concept embodied in the patent in suit. Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question. The third step is to identify what, if any, differences exist between the matter cited as being “known or used” and the alleged invention. Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.

4.4 This test was slightly modified by Lord Justice Jacob in the UK Court of Appeal’s

decision of Pozzoli SPA vs. BDMO SA et anor. [2007] EWCA Civ 588 (“Pozzoli”) where he explained in [15] and [16], that the Windsurfing [supra] test:


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15 …requires some restatement and elaboration. First one must actually conduct the first two operations in the opposite order – mantle first, then concept. For it is only through the eyes of the skilled man that one properly understand what such a man would understand the patentee to have meant and thereby set about identifying the concept. 16 Next, that first step actually involves two steps, identification of the attributes of the notional “person skilled in the art” (the statutory term) and second identification of the common general knowledge of such a person.

4.5 Whichever test is applied to assist in deciding on the inventive step issue, V K Rajah

JA (delivering the judgment of the court) in First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd and Another Appeal [supra] reminds us at [42]-[45] of his judgment as follows:

42 An appraisal of the relevant English and Singapore decisions dealing with the issue of obviousness suggests that the courts often refer to the first three questions in the Windsurfing test (see [41] above) in a matter-of-fact way before proceeding almost immediately to deal with the fourth and final question: Is the alleged invention obvious? Some critics have gone further to say that the courts are often merely paying lip service to the Windsurfing test. 43 In this respect, the Windsurfing test ([41] above) has been criticised for over- elaborating the statutory definition of “inventive step” without reducing the confusion and uncertainty that has long been associated with it. David I Bainbridge in Intellectual Property (Pearson, 6th Ed, 2007) at p 400 contends that the first three steps of the Windsurfing test are, in reality, redundant. He notes that s 3 of the Patents Act 1977 (c 37) (UK) (“the 1977 English Act”) (which is equivalent to s 15 of the Act) seems straightforward and requires a one-step test only, namely, whether the alleged invention is “not obvious to a person skilled in the art”. The Windsurfing test, in Bainbridge’s view, does not provide any intrinsic guidance on the statutory provision itself, but “merely affords a structured method of assessing whether the requirement of inventive step has been satisfied” (see Intellectual Property at p 400). Bainbridge further cautions that in breaking down the test in s 3 of the 1977 English Act, there is a latent danger that artificiality will be introduced, which might distort the test. He persuasively suggests (ibid) that a simpler formulation is to ask:

[W]hether, from the point of view of a person who had total knowledge of the state of the art, the invention was obvious at the priority date. It goes without saying that the person concerned cannot be endowed with inventive faculties...


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It is also pertinent to note that the European Patent Office does not appear to have adopted a structured approach along the lines of the Windsurfing test in determining whether an invention involves an inventive step.

44 Nonetheless, the Windsurfing test ([41] above) appears to be here to stay. It was astutely observed by the English Court of Appeal in Wheatley v Drillsafe Ltd [2001] RPC 7 at [45] that the failure to follow the structured Windsurfing approach led the trial judge in that case to apply ex post facto reasoning erroneously, resulting in a failure to distinguish what was actually known from what was common general knowledge. When all is said and done, the Windsurfing approach has its advantages. The first three steps of this test lay the ground work for the final question – which is ultimately the only critical question – namely: Is the alleged invention obvious? (See Terrell ([22] supra) at para 7-53.) As aptly pointed out by Neuberger J in DSM NV’s Patent [2001] RPC 35 at [58]:

By adopting the structured approach, one ensures that there is a measure of discipline, reasoning and method in one’s approach. Indeed, it helps to ensure that there is consistency of approach in different cases involving the issue of obviousness.

45 Be that as it may, simplicity is certainly to be appreciated, and, in assessing the obviousness of an alleged invention, it may sometimes suffice in straightforward cases to refer to the test formulated by Lord Herschell in Vickers, Sons And Co, Limited v Siddell (1890) 7 RPC 292, where he stated (at 304) that an invention lacked an inventive step if what was claimed was “so obvious that it would at once occur to anyone acquainted with the subject, and desirous of accomplishing the end”. Quite often, it is difficult, in practice, to break down the Windsurfing test ([41] above) into its component parts. Thus, while the Windsurfing test remains a useful guide, it is no more than that. Above all, it should be borne in mind that the Windsurfing test is merely a manifestation of judicial inventiveness on how best to pragmatically interpret and elucidate the requirements of s 15 of the Act.

4.6 Paragraph 3.46 of the UK Manual of Patent Practice (Jul 2010) also reminds us that

when considering an inventive step objection, the examiner should always bear in mind this warning from Jacob LJ in Angiotech Pharmaceuticals v Conor Medsystems Inc [2007] EWCA Civ 5:

…one can overelaborate a discussion of the concept of “obviousness” so that it becomes metaphysical or endowed with unwritten and unwarranted doctrines, sub-doctrines or even sub-sub-doctrines. …. In the end the question is simply “was the invention obvious?


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C The Inventive Concept

“The first is to identify the inventive concept embodied in the patent in suit” Re: Windsurfing [supra].

4.7 Lord Walker of Gestingthorpe in delivering the House of Lord’s decision of Generics

(UK) Limited and others (Appellants) v H Lundbeck A/S (Respondents) [2009] UKHL 12 explained at [30] that:

“Inventive concept” is concerned with the identification of the core (or kernel, or essence) of the invention—the idea or principle, of more or less general application (see Kirin-Amgen [2005] RPC 169 paras 112-113) which entitles the inventor’s achievement to be called inventive.

4.8 Tan Lee Meng J in ASM Assembly Automation Ltd v Aurigin Technology Pte

Ltd and Others [2009] SGHC 206 at paragraph 39 said:

It is noteworthy that in Unilever v Chefaro [1994] RPC 567, Jacob J stated at p 580 as follows: It is the “inventive concept” of the claim in question which must be considered, not some generalised concept to be derived from the specification as a whole. Different claims can, and generally will, have different inventive concepts. The first stage of identification of the concept is likely to be a question of construction: what does the claim mean? It might be thought that there is no second stage – the concept is what the claim covers and that is that. But that is too wooden and not what courts applying Windsurfing stage one, have done. It is too wooden because if one merely construes the claim, one does not distinguish between portions which matter and portions which, although limitations on the ambit of the claim, do not. One is trying to identify the essence of the claim in this exercise.

4.9 The above case precedents provide the framework for our Examiners to use, when

identifying what an “inventive concept” is, in the course of examination.

D The skilled addressee

“Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question.” Re Windsurfing.


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4.10 Tan Lee Meng J in FE Global Electronics Pte Ltd and others [supra] said at [22] of the judgment that:

22 Admittedly when construing a patent, the court determines what a skilled reader would think and not what the expert thinks. This is not to say that an expert’s view on what a skilled reader would think is totally irrelevant.

4.11 V K Rajah JA in the case of First Currency Choice Pte Ltd v Main-Line Corporate

Holdings Ltd and another Appeal [supra] explained in [27] and [28] of the judgment, that:

27 Clearly then, the starting point in patent construction is to ask the threshold question: What would the notional skilled person have understood the patentee to mean by the use of the language of the claims? In this endeavour, the language that the patentee has adopted is more often than not of utmost importance (see Kirin-Amgen ([25] supra) at [34]). The notional skilled person with the common general knowledge of the art 28 As stated above, the “audience” whom the patentee is addressing is the person skilled in the art (per Lord Hoffman in Kirin-Amgen ([25] supra) at [33]; FE Global Electronics ([26] supra) at [14]). As a general rule, the notional skilled person should be taken to be the workman or technician who is aware of everything encompassed in the state of the art and who has the skill to make routine workshop developments, but not to exercise inventive ingenuity or think laterally (per Laddie J in Pfizer Ltd’s Patent [2001] FSR 16 at [62]–[63]). His level of skill will depend on the scope of the subject matter of the patent in question (see Dyson Appliances Ltd v Hoover Ltd [2001] RPC 26 (“Dyson v Hoover”) at [30]). The notional skilled person is, thus, usually defined according to the qualities which he possesses. As stated in McGhan Medical UK Limited v Nagor Limited Case No CH 1999 1720 (28 February 2001) at [23]–[24] and followed in Ng Kok Cheng v Chua Say Tiong [2001] 3 SLR 487 at [21]:

This notional person is deemed to possess the common general knowledge of the subject matter in question. It is through the eyes of the skilled addressee that the [p]atent will fall to be interpreted. And it is by the standards of this person that the question of inventive step is to be judged when this topic is addressed in the counterclaim. A patent is addressed to persons who are likely to have a practical interest in its subject matter or to act on the directions given in it for it to be put into practice. The addressee is deemed to be unimaginative and uninventive but is equipped nevertheless with a reasonable degree


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of intelligence and with a wish to make the directions in the patent work.

4.12 Judith Prakash J in Ng Kok Cheng v Chua Say Tiong [2001] SGHC 143 summed up the essential indicators of a skilled person in the art as a person who:

(1) possesses common general knowledge of the subject matter in question; (2) has a practical interest in the subject matter of the patent or is likely to act on the directions given in it; and (3) whilst unimaginative is reasonably intelligent and wishes to make the directions in the patent work.

4.13 Further guidance can be found in the UK Court of Appeal’s decision of

Schlumberger Holdings Ltd v Electromagnetic Geoservices AS [2010] EWCA Civ 819 where Jacob LJ said at paragraphs 65, 71 to 75:

65. In the case of obviousness in view of the state of the art, a key question is generally "what problem was the patentee trying to solve?" That leads one in turn to consider the art in which the problem in fact lay. It is the notional team in that art which is the relevant team making up the person skilled in the art. If it would be obvious to that team to bring in different expertise, then the invention will nonetheless be obvious. Likewise if the possessor of the "extra expertise" would himself know of the other team's problem. But if it would not be obvious to either of the notional persons or teams alone and not obvious to either sort of team to bring in the other, then the invention cannot fairly be said to be obvious. As it was put in argument before us the possessors of the different skills need to be in the same room and the team with the problem must have some reason for telling the team who could solve it what the problem is.

The correct approach in this case

71. It follows that the correct approach in this case is to start with the real problem faced by exploration geophysicists. Did they appreciate they had a solvable problem? How could they determine whether a thin layer of porous rock identified by seismics as potentially hydrocarbon bearing in fact does so or is just a false positive bearing only brine or water? One then asks whether the notional exploration geophysicist who read the cited prior art would see that the answer was to use CSEM, or if not that, at least that CSEM had a sufficient prospect of being useful that it was worth asking a CSEM expert.

72. The problem must also be approached the other way round, from the point


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of view of the CSEM expert. Would he or she know of the exploration geophysicists' problem and, if so, would he or she appreciate that CSEM had a real prospect of being useful to solve the problem?

73. In short: was the marriage obvious to either notional partner?

74. One further approach is not necessary: that is to ask whether the notional team including both types of expert would see that CSEM would solve or stood a very good chance, of solving the problem. That is because Mr Thorley's concession provides the answer here.

75. There is danger to be avoided. There are cases where, even though you can, in retrospect, clearly see that there was a problem and articulate what it was, workers at the time did not do that. They did not say: "this is our problem. If only we had a solution to it." Instead they simply put up with things as they were. Then the essence of the invention is the insight that there was a solvable problem at all. The Haberman case, see below, is a good example.

NB. CSEM (Controlled Source Electromagnetic)

4.14 The above case precedents provide the framework for our Examiners to use, when identifying who the skilled addressee should be, in the course of examination.

E Common General Knowledge

“Thereafter, the court has to assume the mantle of the normally skilled but unimaginative addressee in the art at the priority date and to impute to him what was, at that date, common general knowledge in the art in question.” Re: Windsurfing [supra].

4.15 It is recalled that in assessing novelty, the prior art must, in order to invalidate the

patent, be such that a person of ordinary skill and knowledge of the subject would at once perceive and understand and be able to practically apply the discovery without the necessity of making further experiments. Is this knowledge the same as common general knowledge in the art in question that is imputed onto a normally skilled but unimaginative addressee in the art at the priority date, when assessing inventive step?

4.16 The Court of Appeal in the case of First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd and Another Appeal [supra] explained at [38]-[41] of the judgment that:

38 At first blush, there does not appear to be a clear distinction between the


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requirements of novelty and obviousness because both the question of whether an invention is novel and that of whether it involves an inventive step appear to be determined by the state of the art at the priority date. This can be rather confusing because it is well established that the test for obviousness is significantly narrower than that for novelty. It is also trite law that the state of the art, as contemplated by s 15 of the Act, ought to be viewed in relation to the common general knowledge of the notional skilled person, as opposed to that of “the public” (see s 14(2)). This would exclude knowledge which is not available to the public. While this genre of knowledge (i.e., knowledge which is not available to the public) is excluded from the common general knowledge which the notional skilled person is deemed to possess for the purpose of assessing obviousness, such knowledge is nonetheless taken into account in assessing whether an invention is novel under s 14 of the Act. As explained by Aldous J (as he then was) in Lux Traffic Controls Limited v Pike Signals Limited [1993] RPC 107 at 133, the requirement of novelty entails that:

[A]n anticipating description in a book will invalidate a patent if the book is on a shelf of a library open to the public, whether or not anybody read the book and whether or not it was situated in a dark and dusty corner of the library.

39 This conundrum was observed by Lord Reid in Technograph Printed Circuits Limited v Mills & Rockley (Electronics) Limited [1972] RPC 346 (“Mills & Rockley (Electronics) Limited”), where he stated that it was doubtful whether the words “having regard to what was known or used” which appeared in both sub-ss (e) and (f) of s 32(1) of the Patents Act 1949 (c 87) (UK) (“the 1949 English Act”), the then statutory equivalents of ss 14 and 15 of the Act, were intended to bear the same meaning in each case. He justified his views as follows (at 355):

If they were [intended to mean the same thing,] there would now be little, if any, difference between novelty and obviousness. Obviousness would cover practically every case of lack of novelty. In head (e) [which deals with novelty] these words are used in an artificial sense and are held to include matter which in fact no one in the United Kingdom ever knew or was likely to know, such as the contents of some foreign specification which no one had ever looked at and which the most diligent searcher would probably miss. I think that in head (f) [which deals with obviousness] the words should have the more natural meaning of what was or ought to have been known to a diligent searcher.

40 However, Lord Reid’s approach was seriously queried in the same case by


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Lord Diplock, who proposed that the phrase “what was known or used” should not be treated differently under the two subsections. This has led some academics to question the suitability of using the concept of common general knowledge to test whether an alleged invention involves an inventive step (see, inter alia, Lorraine Keenan, “Time to Put Windsurfing to Bed?” Intellectual Property & IT Law (31 January 2002)). Interestingly, in Australia, in an attempt to resolve this dilemma, the Patents Act 1990 (Cth) (“the Australian Act”) encapsulated the concept of common general knowledge in a statutory form. Section 7(2) of the Australian Act, which deals with the concept of “inventive step”, states that:

For the purposes of this Act, an invention is to be taken to involve an inventive step when compared with the prior art base unless the invention would have been obvious to a person skilled in the relevant art in the light of the common general knowledge as it existed in the patent area before the priority date of the relevant claim …

41 In any event, the English courts have remained fixated with the use of the notional skilled person’s common general knowledge in the test for obviousness, despite the above criticisms. There are, admittedly, inherent difficulties in defining both “common general knowledge” and “state of the art”. Nevertheless, the explanation proffered by Lord Reid in Mills & Rockley (Electronics) Limited ([39] supra) appears to be the preferable approach as it injects substance into the legislative intent underlying s 15 of the Act. The reliance on common general knowledge in the test for obviousness is also embodied in the oft-cited four-step “Windsurfing test” laid down by the English Court of Appeal in Windsurfing International Inc v Tabur Marine (Great Britain) Ltd [1985] RPC 59 (“Windsurfing”) at 73–74 (and adopted by this court in Merck & Co Inc v Pharmaforte Singapore Pte Ltd [2000] 3 SLR 717 at [50])…

4.17 The above case precedents provide the framework for our Examiners to use, when identifying what “common general knowledge” entail, in the course of examination.

F Third and fourth steps mentioned in the Windsurfing case

”The third step is to identify what, if any, differences exist between the matter cited as being “known or used” and the alleged invention. Finally, the court has to ask itself whether, viewed without any knowledge of the alleged invention, those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention.” Re: Windsurfing [supra].


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4.18 The third step requires the Examiner to drill out the differences in features that exist between the prior art and the invention in question.

4.19 With the differences at hand, the Examiner will then begin his assessment on whether “those differences constitute steps which would have been obvious to the skilled man or whether they require any degree of invention”.

4.20 The Court of Appeal in First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd and Another Appeal [2007] SGCA 50 was similarly faced with this question and they opined at paragraphs 51 and 54 as follows:

51 This final component of the Windsurfing test (see [41] above) formed the crux of the present appeals. It is up to the court to decide the question, which is “a kind of jury question” (Windsurfing ([41] supra) at 71): Is the invention in question obvious? The importance of striking the apposite balance between encouraging and stifling innovation has been succinctly summarised in Glaxo Group Ltd’s Patent [2004] RPC 43 at [41] as follows:

It is a question of fact in every case. Both the Scylla of considering nothing obvious except that to which the skilled man is driven and the Charybdis of considering every invention obvious that can be decomposed into a sequence of obvious steps must be avoided. The former is unfair to industry because it stifles natural development. The latter is unfair to investors and not countenanced by English patent law ...

Furthermore, in assessing the obviousness of an alleged invention, it must always be remembered that simplicity is not equivalent to obviousness.

54 The crucial point was that at the material time, no other party had introduced an automatic system to implement the process of deciphering a payment card’s operating currency. Although the step might have seemed, when all was said and done, Lilliputian, it was no less significant a step forward, a step which nobody else had taken before (see Peng Lian Trading Co v Contour Optik Inc [2003] 2 SLR 560 (“Peng Lian Trading”) at [31]). A helpful analogy can be drawn with the decision in FE Global Electronics ([26] supra). In that case, it was held that the patentee had an inventive concept for a new type of data storage device that was quite different from and more convenient to use than the conventional data storage devices. This court went on further to say that, admittedly, all the elements required for that invention were available to those skilled in the art. Yet, before the patentee applied for the patent in question, no one else had thought of combining those elements together to form a new type of data storage device. Although some might have viewed the invention as a simple one, this court noted that


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simplicity in itself had never been a bar to inventiveness, and reiterated that ex post facto analysis could often be unfair to inventors (FE Global Electronics at [45]–[46]; Peng Lian Trading at [29]). Indeed, it cannot be gainsaid that the hallmark of many truly remarkable inventions is precisely their simplicity.

4.21 The following approaches have been considered by our courts in assessing this last step and we have extracted a few below for our Examiner’s easy reference:

a. Workshop variation of existing prior art This was one of the factors that laws considered when assessing whether the invention was obvious in ASM Assembly Automation Ltd v Aurigin Technology Pte Ltd and Others [2009] SGHC 206 [at paragraph 55]

b. Commercial success

Tay Yong Kwang J at paragraph 47 in Mühlbauer AG v Manufacturing Integration Technology Ltd [2009] SGHC 45 explains the inconclusive of this test.

47 Where commercial success of an invention is concerned, this factor alone is not conclusive. A product that sells well is not necessarily novel or one involving an inventive step. Good advertising, marketing and pricing could also play a part. The converse is also true. As stated in Main-Line Corporate Holdings Ltd v United Overseas Bank Ltd [2007] 1 SLR 1021 at [71]:

Something that is new and inventive does not automatically become an overnight success or “the next big thing”. Even if it is not, like the plaintiff’s Teh Kor Lak said, “a big deal”, it is nevertheless something new and inventive which, after the invention is known, others may wish they had thought of or wonder why they had never thought of it. Some patents achieve much more commercial success and are more life-changing than (many) others. The fact that the invention has not been widely adopted in the credit card industry is therefore not an adverse reflection on its inventive quality.

c. So obvious The Court of Appeal in First Currency Choice Pte Ltd v Main-Line Corporate Holdings Ltd and Another Appeal [2007] SGCA 50 said


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45 Be that as it may, simplicity is certainly to be appreciated, and, in assessing the obviousness of an alleged invention, it may sometimes suffice in straightforward cases to refer to the test formulated by Lord Herschell in Vickers, Sons And Co, Limited v Siddell (1890) 7 RPC 292, where he stated (at 304) that an invention lacked an inventive step if what was claimed was “so obvious that it would at once occur to anyone acquainted with the subject, and desirous of accomplishing the end”. Quite often, it is difficult, in practice, to break down the Windsurfing test ([41] above) into its component parts. Thus, while the Windsurfing test remains a useful guide, it is no more than that.

4.22 A list of such approaches can also be found at paragraph 3.74 in Chapter 3 of the UK

Manual of Patent Practice (Jul 2010) and use of these approaches will depend upon the particular circumstances of the case in question. They include:

• Lying in the road • Why was it not done before? • Fulfilling a need • Advantages of the invention • Obvious to try

G Combining Prior Art

4.23 Paragraph 3.40 of the UK Manual of Patent Practice (Jul 2010) shed light as follows:

3.40 While it is not possible to combine the disclosure of a given document with other matter to demonstrate lack of novelty (see 2.09), it is permitted to combine any of the prior art (whether published documents, instances of prior use or common knowledge) in order to argue that an inventive step is lacking. However, although a single disclosure, however remote, of the whole invention will destroy novelty, in order to establish that a combination of teachings from the prior art shows an invention to be obvious, it must be likely that the skilled person would have considered those teachings together. Laddie J in Pfizer Ltd’s Patent [2001] FSR 16 at paragraph 66 stated:

“When any piece of prior art is considered for the purposes of an obviousness attack, the question asked is “what would the skilled addressee think and do on the basis of the disclosure?” He will consider the disclosure in the light of the common general knowledge and it may be that in some cases he will also think it obvious to supplement the disclosure by consulting other readily accessible publicly available information. This will be particularly likely where the pleaded prior art encourages him to do so because it expressly cross-refers to other material. However, I do not think it is limited to


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cases where there is an express cross-reference. For example if a piece of prior art directs the skilled worker to use a member of a class of ingredients for a particular purpose and it would be obvious to him where and how to find details of members of that class, then he will do so and that act of pulling in other information is itself an obvious consequence of the disclosure in the prior art.”.

H No rule of thumb

4.24 Finally on this subject, we find an extract in the UK Manual of Patent Practice (Jul 2010) to be very relevant and we have reproduced it below.

No rules of thumb; precedents to be treated with caution 3.54 The decision to raise an objection of lack of inventive step must be made on a proper consideration of the facts of the particular case and any kind of rule of thumb approach should be avoided. Caution should be exercised in relying on precedent cases, since, more than with any other topic to be decided by the substantive examiner, attempts to line up a particular case with some decided case can mislead.


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I INVENTIVE STEP ASSESSMENT: IN A NUTSHELL

4.25 The following table summarises the steps to be taken by the Examiner.

Table 5: Steps Involved in assessing inventive step under section 15

Step 1 Identify the date of filing of the invention in question for inventive step assessment. Then proceed to Step 2.

Step 2 If there is a priority date claim and a prior art falling between the date of filing and the priority date claimed, proceed to examine the validity of the priority date claim. The Examiner may inform the IPOS Officer in the Patents Search and Examination Unit who had previously forwarded the Search/Examination Request to the Examiner, of the need to assess the priority document. In the event where the priority document is not in English, the Examiner may inform the IPOS Officer in the Patents Search and Examination Unit who had previously forwarded the Search/Examination Request of the need for a translation. Then proceed to Step 2A.

Step 2A

In the event where the Examiner considers the Search results furnished by the applicant and the search results refer to any non English document, in the interest of managing costs, the Examiner should first attempt to find an English family equivalent and/or use online free machine translations to get a better idea of the disclosure in the non English document before deciding to ask for English translations from the applicant through the IPOS Officer in the Patents Search and Examination Unit who had previously forwarded the Examination Request. Then proceed to Step 3.

Step 3 Apply the Inventive Step Test mentioned in this Chapter on the subject matter in question.


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5 INDUSTRIAL APPLICATION

A Statutory requirements

S16 5.1 Industrial application Section 16.—(1) Subject to subsection (2), an invention shall be taken to be capable of industrial application if it can be made or used in any kind of industry, including agriculture. (2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application. (3) Subsection (2) shall not prevent a product consisting of a substance or composition from being treated as capable of industrial application merely because it is invented for use in any such method.

5.2 A table of comparison between the various provisions from Singapore, UK and the EPC is reproduced below to highlight the similarities and differences. It is noted that all 3 laws share the same phrase “if it can be made or used in any kind of industry, including agriculture”. On inventions relating to methods of treatment & diagnosis, in Singapore and in UK (pre 2004 amendments), they are excluded from being capable of industrial application. The Patents Act in UK (post 2004 amendments) is aligned with the EPC where patents will not be granted for inventions relating to methods of treatment & diagnosis. The provisions share a common underlying objective i.e. inventions relating to methods of treatment & diagnosis should not considered as patentable inventions in the interests of the public.

Table 6: Comparison of Industrial Application & Method of Treatment & Diagnosis provisions



Industrial application 16.—(1) Subject to subsection (2), an invention shall be taken to be capable of industrial application if it can be

Industrial application 4.-(1) Subject to subsection (2) below, an invention shall be taken to be capable of industrial application if it can be

Industrial application 4.-(1) An invention shall be taken to be capable of industrial application if it can be made or used in any kind of industry,

Article 57 Industrial application 57. An invention shall be considered as susceptible of industrial application if it can be made or used


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Table 6: Comparison of Industrial Application & Method of Treatment & Diagnosis provisions



made or used in any kind of industry, including agriculture. (2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application. (3) Subsection (2) shall not prevent a product consisting of a substance or composition from being treated as capable of industrial application merely because it is invented for use in any such method.

made or used in any kind of industry, including agriculture. (2) An invention of a method of treatment of the human or animal body by surgery or therapy or of diagnosis practised on the human or animal body shall not be taken to be capable of industrial application. (3) Subsection (2) above shall not prevent a product consisting of a substance or composition being treated as capable of industrial application merely because it is invented for use in any such method.

including agriculture. (2) [repealed] (3) [repealed] NB: Methods of treatment or diagnosis 4A.-(1) A patent shall not be granted for the invention of- (a) a method of treatment of the human or animal body by surgery or therapy, or (b) a method of diagnosis practised on the human or animal body. (2) Subsection (1) above does not apply to an invention consisting of a substance or composition for use in any such method.

in any kind of industry, including agriculture. NB: Article 53 (c) European patents shall not be granted in respect of: (a) … (b) … (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

B Industry

5.3 Paragraph 4.02 of the UK Manual of Patent Practice [Jul 2010] explains what the term “industry” refers to.

4.02 "Industry" should be understood in its broad sense as including any useful and practical, as distinct from intellectual or aesthetic, activity. It does not necessarily imply the use of a machine or the manufacture of a product, and covers such things as a process for dispersing fog or a process for converting energy from one form to another. In Chiron Corp v Murex


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Diagnostics Ltd and other [1996] RPC 535 (page 607) the Court of Appeal held that the requirement that the invention can be made or used "in any kind of industry" so as to be "capable of industrial application" carries the connotation of trade or manufacture in its widest sense and whether or not for profit. The Court went on to hold that industry does not exist in that sense to make or use that which is useless for any known purpose. Many of the matters which are excluded as lacking industrial application would have been rejected under previous laws as not being manners of manufacture, and in fact the views of the High Court of Australia in NRDC's Application, [1961] RPC 134, give a good guide to the meaning to be attributed to industrial application; there must be a product, but this need not be an article or substance, but must be something in which a new and useful effect, be it creation or alteration, may be observed. It may for example be a building, a tract or stratum of land, an explosion or an electrical oscillation, but it must be useful in practical affairs. A method of eradicating weeds was held to give rise to a product (an improved crop) because this was an artificially created state of affairs; moreover it was one whose significance was economic.

5.4 The above UK practice provides a good reference point for our Examiners to use, when identifying what is “industrial application”, in the course of examination.

C Capable of industrial application: Insufficient if vague and speculative

5.5 The UK Court of Appeal in the case of Eli Lilly & Co v Human Genome Sciences Inc [2010] EWCA Civ 33 at paragraphs 66 to 70 referred to the EPO case of Max-Planck T 0870/04 (May 2005).

66.… Max-Planck was an ex parte appeal from a refusal to grant by the examining division. The applicants had identified what they called a "BDP1 polypeptide". They sought to justify a claim to it on the basis that it could be made and used as a tool for research. That was rejected. It is now settled that the "research tool" justification for a new polypeptide or the nucleotide sequence encoding for it is not enough to satisfy the Art. 57 test. As the Board said:

[21] In the board's judgment, although the present application describes a product (a polypeptide), means and methods for making it, and its prospective use thereof for basic science activities, it identifies no practical way of exploiting it in at least one field of industrial activity. In this respect, it is considered that a vague and speculative indication of possible objectives that might or might not be achievable by carrying out further research with the tool as described is not


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sufficient for fulfilment of the requirement of industrial applicability. The purpose of granting a patent is not to reserve an unexplored field of research for an applicant.

67. That last sentence is full of importance. If you allow patenting of chemicals whose use you do not really know you will subvert the patent system and be likely to stultify research by others rather than encourage it. A merely "vague and speculative indication of possible objectives" is not enough.

68. The present case indeed provides an example of the danger of what can happen if patenting too far upstream is allowed. Both sides (HGS in collaboration with GlaxoSmithKline) are conducting clinical trials but each is trying a different antibody to Neutrokine-α and for different conditions. As a matter of interest the HGS trials are for the treatment of lupus, one of the few diseases not mentioned in the patent. If the patent were valid, the valuable research and development work done by Lilly into a field apparently not researched (and certainly not taken through to clinical trial) by HGS would potentially be rendered futile. The patent system would not be working as it should. It would be operating to prevent research, not to encourage it.

69. It is also important to note an earlier paragraph of Max Planck, for the Boards still regard it as good law:

[6] In cases where a substance, naturally occurring in the human body, is identified, and possibly also structurally characterised and made available through some method, but either its function is not known or it is complex and incompletely understood, and no disease or condition has yet been identified as being attributable to an excess or deficiency of the substance, and no other practical use is suggested for the substance, then industrial applicability cannot be acknowledged. While the jurisprudence has tended to be generous to applicants, there must be a borderline between what can be accepted, and what can only be categorized as an interesting research result which per se does not yet allow a practical industrial application to be identified. Even though research results may be a scientific achievement of considerable merit, they are not necessarily an invention which can be applied industrially.

70. So the question here is which side of the borderline the case lies – a question of degree turning on the facts and not a pure question of law.


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5.6 The above reveals the UK and EP approach converging on this point and given that our provisions are identical in this regard, coupled with the reasoned analysis of what is required to meet the “industrial application” requirement, our Examiners should refer to the UK and EP approach, in the course of examination.

D “Methods of treatment & diagnosis” Exception

5.7 Section 16(2) corresponds with UK section 4(2) of the Patents Act prior to the UK 2004 amendments. In Bristol-Myers Squibb v Baker Norton Pharmaceuticals Inc [1999] RPC 253, Jacob J held as follows at paragraphs 50 and 51:

50. Nor do I accept that on his construction the claim amounts to merely to a method of treatment. It is to the manufacture of the medicines to be used in that treatment. I am reinforced in that view by the consideration that the Article 54(4) provision about methods of treatment is an exception to patentability and as an exception should be construed narrowly…

51. A like approach is indicated in Plant Genetic Systems/Plant Cells (EPO [1995] 545, T0356/93 OJ). There is also the limited purpose of the exception to be considered. It is not so broad as to stop doctors using whatever they feel they need to treat patients. If that were the purpose then one would not allow patents for medicines or medical implements at all. The purpose of the limitation is much narrower, merely to keep patent law from interfering directly with what the doctor actually does to the patient. Patent monopolies are permitted to control what he administers to, or the implements he uses on, the patient. The thinking behind the exception is not particularly rational: if one accepts that a patent monopoly is a fair price to pay for the extra research incentive, then there is no reason to suppose that that would apply also to methods of treatment. It is noteworthy that in the US any such exception has gone, and yet no-one, so far as I know, suggests that its removal has caused any trouble.

5.8 In Singapore, our Examiners should read the exception under section 16(2) narrowly.


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E INDUSTRIAL APPLICATION ASSESSMENT: IN A NUTSHELL

5. 9 The following table summarises the steps to be taken by the Examiner.

Table 7: Steps Involved in assessing industrial application under section 16 Step 1 Determine whether the subject matter disclosed is "vague and

speculative indication of possible objectives". If so, this is not sufficient to fall within this section.

Step 2 Section 16(2) should be construed narrowly.


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6 OFFENSIVE, IMMORAL OR ANTI-SOCIAL BEHAVIOUR

A Statutory requirements S 13

6.1 Patentable inventions

Section 13.—(1) Subject to subsection (2), a patentable invention is one that satisfies the following conditions:

(a) the invention is new; (b) it involves an inventive step; and (c) it is capable of industrial application.

(2) An invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention. (3) For the purposes of subsection (2), behaviour shall not be regarded as offensive, immoral or anti-social only because it is prohibited by any law in force in Singapore.

B Legislative History

6.2 This provision shares its roots with section 1 of the UK Patents Act 1977 and even though both Section 13 of the Singapore Patents Act and Section 1 of the UK Patents Act had undergone changes since, the provisions relating to morality continue to exist albeit in a differently worded text.

6.3 Sections 13(2) & 13(3) of the Singapore provisions correspond generally with Sections 1(3) & 1(4) of the UK provisions.

Table 8: Comparison of Morality provisions

Current SINGAPORE UK (before the 2000 amendments)


Patentable inventions Section 13. (2) An invention the publication or exploitation of which would be generally expected to encourage

Patentable inventions Section 1. (3) A patent shall not be granted-

(a) for an invention the publication or exploitation of which

Patentable inventions Section 1. (3) A patent shall not be granted for an invention the commercial exploitation of which would be contrary to

Article 53 Exceptions to patentability European patents shall not be granted in respect of: (a) inventions the


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Table 8: Comparison of Morality provisions

Current SINGAPORE UK (before the 2000 amendments)


offensive, immoral or anti-social behaviour is not a patentable invention.

would be generally expected to encourage offensive. immoral or anti-social behaviour. (b)….

public policy or morality.

commercial exploitation of which would be contrary to "ordre public" or morality; such exploitation shall not be deemed to be so contrary merely because it is prohibited by law or regulation in some or all of the Contracting States; (b) plant or animal varieties or essentially biological processes for the production of plants or animals; this provision shall not apply to microbiological processes or the products thereof; (c) methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practised on the human or animal body; this provision shall not apply to products, in particular substances or compositions, for use in any of these methods.

(3) For the purposes of subsection (2), behaviour shall not be regarded as offensive, immoral or anti-social only because it is prohibited by any law in force in Singapore.

(4) For the purposes of subsection (3) above behaviour shall not be regarded as offensive, immoral or anti-social only because it is prohibited by any law in force in the United Kingdom or any part of it.

(4) For the purposes of subsection (3) above exploitation shall not be regarded as contrary to public policy or morality only because it is prohibited by any law in force in the United Kingdom or any part of it.


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6.4 An extract taken from paragraph 1.33 of the UK Manual of Patent Practice (Jul 2010) explains the changes in UK as follows:

1.33 Sections 1(3) and 1(4) were amended by the Patents Regulations 2000 (SI 2000 No.2037) so that the wording would more closely reflect the wording of article 27(2) of the TRIPS agreement. Section 1(3)(a) had previously stated that a patent would not be granted for an invention whose “publication or exploitation” would “be generally expected to encourage offensive, immoral or antisocial behaviour”. In practical terms, the effect of s.1(3) remains the same, which is to prevent the grant of patent rights for inventions which the general public would regard as abhorrent or from which the public need protection. It provides a reasonably objective test which has to be applied to each invention and its particular set of facts and circumstances. Clearly what is to be regarded as contrary to public policy or morality will vary according to changes in social attitudes and on no account ought examiners to allow their own personal and individual beliefs to colour their judgment on this matter. The decision of Aldous J in the case of Masterman's Design [1991] RPC 89 under a similar provision of the Registered Designs Act 1949 deals with issues broadly corresponding with those which may arise under s.1(3). The Patents Act 1977 (Isle of Man) Order 2003 (SI 2003 No. 1249) amended sections 1(3) and 1(4) for the Isle of Man.

[Only in the clearest cases should examiners invoke this subsection and then only following consultation with their Deputy Director. Any genuine doubt should be exercised in favour of the applicant with an appropriate minute being created. ]

6.5 The UK also amended her laws to implement Articles 1 to 11 of the European Directive 98/44/EC on the legal protection of biotechnological inventions. As the European Directive does not apply to Singapore, they are not replicated in our Patents Act.

6.6 What is instructive from reading the UK provisions and also the corresponding provisions in the European Directive 98/44/EC is that these are standards established within the European Community on the patentability of biotechnological inventions. For example, they have steered clear from saying that patenting of processes for cloning human beings, the commercial exploitation of which would be contrary to public policy or morality. Instead, they merely declare that such inventions are not patentable inventions, even though the background to such a declaration could have arisen from an agreement that the commercial exploitation of such processes would be contrary to public policy or morality.

6.7 In any event, these foreign practices serve as a reference guide for our Examiners in that they provide assessment tools and tests to be use in the course of Examination.


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C WHAT IS OFFENSIVE, IMMORAL OR ANTI-SOCIAL BEHAVIOUR

6.8 In the absence of local case precedents, we looked into UK’s and EPO’s practice to see if they can shed any guiding principles which may be relevant to our consideration under sections 13(2) and (3).

i. Examiner’s personal beliefs should not colour their judgment

6.9 Paragraph 1.33 of the UK Manual of Patent Practice (Jul 2010) reminds us that “Clearly what is to be regarded as contrary to public policy or morality will vary according to changes in social attitudes and on no account ought examiners to allow their own personal and individual beliefs to colour their judgment on this matter ”

ii. Abhorrent

6.10 Paragraph 4.1 of the Guidelines for Examination in the European Patent Office explains as follows:

4.1 Matter contrary to "ordre public" or morality Any invention the commercial exploitation of which would be contrary to "ordre public" or morality is specifically excluded from patentability. The purpose of this is to deny protection to inventions likely to induce riot or public disorder, or to lead to criminal or other generally offensive behaviour … Anti-personnel mines are an obvious example. This provision is likely to be invoked only in rare and extreme cases. A fair test to apply is to consider whether it is probable that the public in general would regard the invention as so abhorrent that the grant of patent rights would be inconceivable …

iii. Offensive and non-offensive use

6.11 On “offensive and non-offensive use”, paragraph 4.3 of the Guidelines for

Examination in the European Patent Office explains as follows:

4.3 Offensive and non-offensive use In some cases refusal of a patent application may be unjustified. This may result when the invention has both an offensive and a non-offensive use, e.g. a process for breaking open locked safes, the use by a burglar being offensive but the use by a locksmith in the case of emergency non


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offensive. In such a case, no objection arises under Art. 53(a). Similarly, if a claimed invention defines a copying machine with features resulting in an improved precision of reproduction and an embodiment of this apparatus could comprise further features (not claimed but apparent to the skilled person) the only purpose of which would be that it should also allow reproduction of security strips in banknotes strikingly similar to those in genuine banknotes, the claimed apparatus would cover an embodiment for producing counterfeit money which could be considered to fall under Art. 53(a). There is, however, no reason to consider the copying machine as claimed to be excluded from patentability, since its improved properties could be used for many acceptable purposes…However, if the application contains an explicit reference to a use which is contrary to "ordre public" or morality, deletion of this reference should be required under the terms of Rule 48(1)(a).

6.12 In sum, we would recall that section 13(2) states that an invention the publication

or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention. The above tests are useful as a guide and we would advise our Examiners to apply the above tests with section 13(2) in mind.

D Section 13(3)

6.13 Section 13(3) states that “For the purposes of subsection (2), behaviour shall not be regarded as offensive, immoral or antisocial only because it is prohibited by any law in force in Singapore.”

6.14 Paragraph 1.36 of the UK Manual of Patent Practice (Jul 2010)

1.36 Section 1(4) is a rider to section 1(3) to make it clear that an act or action prohibited by a law is not to be considered as necessarily the same thing as contrary to public policy or morality. (One reason for this is that a product which could not lawfully be used in the UK may be manufactured lawfully in the UK for export to countries where its use is not illegal). However the existence of a law or regulation may be a material fact to be taken into consideration in determining whether to refuse an application under s.1(3). The nature and probable uses of the invention will need to be considered as well as the exact terms of the prohibition. Thus if the prohibition is directed unconditionally to the very act which the inventor proposes very careful deliberation must be given as to whether to invoke s.1(3). In such cases a useful test is to consider why the prohibition exists. For example it is considered that the Landmines Act 1998 (implementing the Ottawa Convention) was passed because the public in the UK generally


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now consider the development, manufacture and use of anti-personnel mines to be immoral. Alternatively in cases in which an invention can be exploited legally albeit in accordance with stringent regulations, it would be very difficult to argue that s.1(3) applies and the application for a patent refused.

6.15 Hence, the mere fact that a particular behaviour is prohibited by any law (in force in Singapore) does not necessarily lead one to conclude that the behaviour is regarded as offensive, immoral or antisocial. On the other hand, a finding of Section 13(2) can still be raised notwithstanding the presence of a legal prohibition if the behaviour is regarded as offensive, immoral or antisocial in any event.

6.16 An example is the Human Cloning and Other Prohibited Practices Act in Singapore. Notwithstanding the existence of this law, an objection under Section 13(2) of the Patents Act should still be raised in a case when the invention relates to human reproductive cloning. There should still be a finding that the invention the publication or exploitation of which would be generally expected to encourage offensive, immoral or anti-social behaviour and is not a patentable invention.

6.17 The Bioethics Advisory Committee (BAC) issued a report in 2001 and it stated (at paragraph 39, page 31) that:

“There is consensus from all sectors in opposing reproductive cloning. The BAC is of the view that the implantation of a human embryo created by any cloning technology in a womb, known as reproductive cloning, or any other treatment of a human embryo intended to result in its development into a viable infant, should be prohibited. There are strong public policy reasons for this position. These include: (a) the view that human reproductive cloning goes against moral ideas that holds that a human being is not to be treated as a means to an end, but only as an end. This translates into the fear that a whole human being may be brought into existence for a utilitarian purpose; (b) that the social and legal implications of reproductive cloning are very serious, including issues of identity and responsibility; and (c) the fear that it will result in a reduction in biodiversity.”

Following the issuance of the BAC report, the Human Cloning Human Cloning and Other Prohibited Practices Act was enacted and it came into force in Singapore on 1st October 2004. In the Second Reading of the Bill as it then was, the Senior Minister of State & Health Dr Balaji Sadasivan said that:-

“There will be no unanimous view on this subject and my Ministry recognises and respects the diversity of views. But in the area of human reproductive cloning, there is almost unanimous agreement from the international community, local scientific and religious groups as well as our


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general public that reproductive cloning of human beings is abhorrent and should not be allowed under any circumstances.".

6.18 The prohibition of human reproductive cloning was codified into law in Singapore

as it is almost unanimous from the international community, local scientific and religious groups as well as our general public that reproductive cloning of human beings is abhorrent and should not be allowed under any circumstances. This is prohibited by law in Singapore because it is regarded as offensive, immoral or antisocial and as such objections under Section 13(2) should be made over such inventions.

E Patentability (Sections 13(2)) of inventions relating to genes

6.19 An assessment on patentability according to Section 13 will be required on the invention regardless of its area of technology. Inventions relating to genes should be assessed accordingly. On the issue of morality with regard to gene inventions, we are reminded of the case before the Opposition Division of the EPO in Howard Florey Institute [Relaxin], V8/94 Relaxin, OJ EPO 6/1995 where it separated the arguments from the patent issues that had to be decided on.

6.20 In Howard Florey Institute [Relaxin], it held that with regard to the isolation of mRNA from tissue taken from pregnant women, the proprietor stated that the women who donated tissue consented to do so within the framework of necessary gynaecological operations. The Opposition Division of the EPO held that the allegation that human life is being patented is unfounded. They pointed out that DNA is not "life", but a chemical substance which carries genetic information and can be used as an intermediate in the production of proteins which may be medically useful. The patenting of a single human gene has nothing to do with the patenting of human life. Even if every gene in the human genome were cloned (and possibly patented), it would be impossible to reconstitute a human being from the sum of its genes.

6.21 In Singapore, when assessing the issue of morality with regard to gene inventions, we need to approach the issue in a similar objective manner as was done by the Technical Board of the EPO in the Howard Florey Institute [Relaxin] case. Through this process, it allows one to identify the issues at hand before one begins to apply the Guiding Principles mentioned this Guide to the facts.

6.22 We share the EPO’s view that the patenting of a single human gene has nothing to do with the patenting of human life. Even if every gene in the human genome were


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cloned (and possibly patented), it would be impossible to reconstitute a human being from the sum of its genes. Hence, when faced with a claimed subject matter involving genes per se, the Examiner should proceed to assess whether it meets the section 13(1) requirements. A section 13(2) issue does not arise.

F Patentability Section 13(2) of inventions relating to chimeric animals

6.23 Once again, an assessment on patentability according to Section 13 will be required on the invention regardless of its area of technology. Inventions relating to transgenic and/or Chimeric animal should be assessed accordingly. Chimeras in the mythical sense reared their heads in Book 6 of the Iliad (Homer). In that book, a Chimera was described as a monster, where its head was that of a lion, its tail was that of a serpent, and its body, was that of a goat. However, in the modern world when scientists talk about human-animal combinations in biological medical research, they do not plan the creation of such monsters. In science, a chimera is an animal or a human whose body contains cells or tissues from another animal or human. Thus a person with a pig heart valve transplant is, scientifically speaking, a chimera. Putting animal and human tissues or cells together, for scientific purposes or for treatment is not new. Chimeras are usually created in research by introducing human cells such as stem cells into an animal, or an animal embryo or foetus, and this process does not involve creating monsters as mentioned in the Iliad.

6.24 Hence, inventions have to be examined as a whole and the term “chimeric animal” should be read in perspective. It is only in the clearest cases should Section 13(2) be invoked. Section 13(2) will apply if the grant of patent rights for inventions which the general public would regard as abhorrent or from which the public need protection.

G Patentability (Sections 13(2)) of inventions relating to transgenic animals

6.25 The case of the Harvard/Oncomouse patent was summarised in an Article published by the World Intellectual Property Organisation (WIPO) dated June 2006 at http://www.wipo.int/wipo_magazine/en/2006/03/article_0006.html. In brief, it explained the technological background as follows and highlighted the patent issues that arose:


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Researchers at Harvard Medical School in the early 1980s produced a genetically modified mouse that was highly susceptible to cancer, by introducing an oncogene that can trigger the growth of tumors. The oncomouse (from the Greek word for tumor) was conceived as a valuable means of furthering cancer research. Harvard College sought patent protection in the United States and several other countries. The case raised general ethical issues regarding transgenic technology in itself. But it also raised two key issues for the patent system:

• should patents be granted at all for animals or animal varieties,

particularly for higher-order animals such as mammals, even if they do otherwise meet patentablility criteria (novelty, industrial applicability/usefulness, inventive step etc.)?

• how should moral implications be addressed in relation to specific

cases, e.g. the question of suffering caused to the transgenic animal? The WIPO article also summarised the positions taken in the US, EPO and Canada then.

6.26 In Singapore, we would refer to paragraph 14 of the BAC’s Consultation Paper on

“Human-Animal Combinations for Biomedical Research”, where it acknowledged that:

“…transgenic animals are already widely used in research. Besides enabling scientists to understand the cause of diseases, and to develop more effective treatment for these diseases, they have also been used to test the safety of new products and vaccines and to study the possibility of producing organs for transplantation that will not be rejected. As transgenic animals are not thought to raise any new ethical difficulties, they are not considered further in this Consultation Paper.”.

6.27 In the absence of local laws prohibiting the creation of such transgenic non-human mammals coupled with the scientific and medical benefits arising from such researches involving the use of these transgenic non-human mammals, mere offence to a section of the public, in the sense that that section of the public would consider the invention distasteful, is not enough for Section 13(2) to apply. Section 13(2) will apply only if the general public would regard the grant of patent rights for such inventions as abhorrent or where the public need protection from the publication or exploitation of the invention. Inventions involving transgenic animals do not attract a section 13(2) objection.


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H Patentability (Sections 13(2)) of inventions relating to the use of human embryonic stem cells

6.28 The use of the human embryo for commercial or industrial purposes is not patentable under the UK Patents Act Schedule A2. European Directive 98/44/EC. However, in Singapore, such use is governed under the Singapore Human Cloning and other Prohibited Practices Act (http://statutes.agc.gov.sg/) which prohibits the use of the human embryo after 14 days of its development after fertilisation.

6.29 Methods for generating cloned human embryonic stem cell lines as well as methods where human blastocysts (an early stage of the embryo) are generated from fertilised human oocytes should not run foul with the Human Cloning Human Cloning and Other Prohibited Practices Act. The Senior Minister of State for Health (Dr Balaji Sadasivan) in the Second Reading of the Human Cloning Human Cloning and Other Prohibited Practices Bill (as it then was) explained:

Clause 5 of the Bill bans the implantation of any human clone in the body of a human or animal. Since reproductive cloning, as we know it today, requires implantation of the embryo into a womb, this effectively prohibits the development of a human clone. Clause 7 prohibits against developing human embryo created other than by fertilisation of human egg by human sperm for a period of more than 14 days. In addition, clause 8 prohibits against developing any human embryo outside the body of a woman for a period of more than 14 days. I understand that embryos less than 14 days old compose of undifferentiated cells. So the Bill allows for stem cell research to be done on these cells for as long as it takes and so long as the embryo is not further developed. I understand that the 14-day point was recommended because it is at this time that the primitive streak appears. Many groups believe that human life begins to exist only later. Thus, clauses 7 and 8, read together, address our objections against experimenting with human life forms while allowing stem cell research.

6.30 Inventions arising from use of human blastocysts in stem cell research not prohibited under the Singapore Human Cloning and other Prohibited Practices Act (http://statutes.agc.gov.sg/) will not attract a Section 13(2) objection.


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I SECTION 13(2) ASSESSMENT: IN A NUTSHELL

6.31 The following table summarises the steps to be taken by the Examiner.

Table 9: Steps Involved in assessing the subject matter under section 13(2) Step 1 Determine whether the subject matter in question is “abhorrent” or

“offensive” mentioned in this Chapter. If so, to proceed with Step 2.

Step 2 Determine whether the publication or exploitation of the subject matter in question would be generally expected to encourage offensive, immoral or anti-social behaviour is not a patentable invention.

Step 3 When in doubt, raise the issue to the Patent Quality Management Unit (Search & Examination), IPOS.


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ANNEX LIST OF PATENT DECISIONS IN SINGAPORE

CASE NAME COURT/IPOS CASE CITATION*

KEY WORDS Referred in this Guide (Paragraphs)

1 Merck & Co, Inc v Pharmaforte Singapore Pte Ltd

High Court — Suit No 413 of 1999 Lai Kew Chai J 23–27 August, 14 October, 22 December 1999 Court of Appeal — Civil Appeal No 9 of 2000 Yong Pung How CJ, LP Thean and Chao Hick Tin JJA 24 May, 28 July 2000

[1999] SGHC 323 [2000] SGCA 39

Pharmaceutical product-Product claims-Process claims-Scope of claims-Purposive or realistic claim construction-Infringement-Lack of novelty-Anticipation by disclosure-Lack of inventive step-Utility-Industrial application- -Invalid patent-Difference in purity unpatentable-Unsuccessful shift of burden of proof of infringement to infringer defendants by s68(1) Patents Act

3.17 2.14, 3.20, 4.16

2 Genelabs Diagnostics Pte Ltd v Institut Pasteur & Anor

High Court — Suit No 1762 of 1998 Tay Yong Kwang JC 31 March 2000

Court of Appeal — Civil Appeal No 14 of 2000 Yong Pung How CJ, LP Thean and Chao Hick Tin JJA 21 August, 2 November 2000

[2000] SGHC 53 [2000] SGCA 60

Virus test kit- European patent- Transitional provision s116(3) Patents Act-Purposive construction-Infringement-Validity-Novelty- Inventive step- Prior art-Disclosure-Innocent infringement-Acquiescence-Grant of licence s43 Patents Act-Registration of exclusive licence s75 Patents Act

3.18, 3.19 3.20

3 Bean Innovations Pte Ltd and Another v Flexon (Pte) Ltd

High Court — Suit No 1549 of 1999 Rubin J 21, 23–25 February, 18 April, 12, 23 May, 31 October 2000 Court of Appeal — Civil Appeal No 78 of 2000 Yong Pung How CJ, LP

[2000] SGHC 219 [2001] SGCA 42

Letterbox mechanism-Groundless threats-infringement-claims construction-specification

-


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Thean and Chao Hick Tin JJA 23 April, 26 May 2001

4 Ng Kok Cheng v Chua Say Tiong

High Court — Suit No 783 of 2000 Judith Prakash J 12–16, 19–20 March, 24–25 April, 22 June 2001

[2001] SGHC 143

Lock-infringement-inventive step-enabling disclosure-insufficiency

4.11, 4.12

5 Peng Lian Trading Co v Contour Optik Inc and others

High Court — Suits Nos 147/2000 and 371/2001 Lee Seiu Kin JC 3-16 October 2001, 30 September-4 October, 14 October 2002 Court of Appeal — Civil Appeal No 126 of 2002 Yong Pung How CJ, Chao Hick Tin JA and Judith Prakash J 29 April; 24 June 2003

[2002] SGHC 238 [2003] SGCA 25

Spectacle frames-lack of inventive step-definition-material difference-revocation-groundless threats-recordals-

4.20

6 FE Global Electronics Pte Ltd and Others v Trek Technology (Singapore) Pte Ltd

High Court — Suits Nos 609, 604 and 672 of 2002 Lai Kew Chai J 12–30 April; 4–5 May; 10 November 2004; 12 May 2005 Court of Appeal — Suits Nos 69/2005, 70/2005 Yong Pung How CJ, Chao Hick Tin JA and

[2005] SGHC 90 [2005] SGCA 55

Computer peripheral-Innocent Infringement-Purposive approach-subject matter in amendments-added matter-disclosure-lack of inventive step-novelty-assignment of rights-groundless threat-revocation-misrepresentation-conspiracy-joint tortfeasorship-undue delay

3.16, 4.10, 4.11, 4.20


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Tan Lee Meng J 11 November, 30 December 2005

7 Dextra Asia Co Ltd and another v Mariwu Industrial Co (S) Pte Ltd and another suit

High Court — Suits Nos 641/2004 and 339/2005 Tan Lee Meng J 5-16 September; 10 October 2005; 27 January 2006 High Court — Suit No 641 of 2004 Tan Lee Meng J 20–21 November 2006; 12 January 2007; 12 April 2007

[2006] SGHC 7 [2007] SGHC 51

Construction manufacturing process-Infringement-inventive step-novelty-prior use-prior disclosure-commercialisation

-

8 Main-Line Corporate Holdings Limited v United Overseas Bank Limited and Another (First Currency Choice Pte Ltd, Third Party)

High Court — Suit No 806/2004 Tay Yong Kwang J 21 Dec 2006 Court of Appeal — Suit Nos CA 4/2007 and 5/2007 Andrew Phang Boon Leong JA, Belinda Ang Saw Ean J, V K Rajah JA 31 Oct 2007 High Court — Suit No 806/2004, RA 327/2008, 328/2008 Belinda Ang Saw Ean J 16 October 2009

[2006] SGHC 233 [2007] SGCA 50 [2009] SGHC 232

Method and system-Innocent Infringement-Inventive step-Novelty objection-Burden of proof-Disclosure-Statutory Tort-Damages -Remedies

4.21 4.3, 4.5, 4.11, 4.16, 4.20


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9 Seiko Epson Corp v Sepoms Technology Pte Ltd and Another

High Court — Suit No 699/2005, RA 375/2006 Lai Siu Chiu J 25 May 2007 Court of Appeal — Suit No CA 19/2007 Andrew Phang Boon Leong JA and V K Rajah JA 16 November 2007

[2007] SGHC 81 [2007] SGCA 52

Ink cartridges-manufacturing-Innocent infringement-defence to liability-accounting records

-

10 Mühlbauer AG v Manufacturing Integration Technology Ltd

High Court — Suit No 80/2007 Tay Yong Kwang J 23 February 2009 Court of Appeal — Civil Appeal No 34 of 2009 Chao Hick Tin JA, Andrew Phang Book Leong JA, V K Rajah JA 23 February 2010

[2009] SGHC 45 [2010] SGCA 6

Machine-Electronic components-Inspection-Placement-Infringement-Invalidity-Novelty-Anticipation-Inventive step-Threat of infringement s77 Patents Act-Expert Evidence-Mosaic of prior art-Commercial success not conclusive

3.16, 4.3, 4.21

11 ASM Assembly Automation Ltd v Aurigin Technology Pte Ltd and Others

High Court — Suit No 163/2007 Tan Lee Meng J 16 September 2009

[2009] SGHC 206

Apparatus-Method-Place-Array of solder balls-Substrate-Infringement-Injunction-Revocation-Novelty- Inventive step-Serious and effective preparations to manufacture s71(1) Patents Act-Groundless threats of infringement s77 Patents Act

4.8, 4.21

12 Cargill International Trading Pte Ltd v Martek Biosciences

IPOS Danielle Yeow DR and

[2009] SGIPOS 12 Infant formula-Arachidonic acid-Eicosapentaneoic acid-Triglyceride-

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Page 72 of 72





Corporation

Isabel Chng PAR 3 November 2009

Revocation-Patentability-Novelty-Inventive step-Foreign decisions-Independence of expert witnesses-Former or current employees-Claim construction-Dimensional limitation-Enabling disclosure-Submission of evidence after close of proceedings without leave

13 Cargill International Trading Pte Ltd v Martek Biosciences Corporation

IPOS Chiam Lu Lin DR and Simon Seow PAR 31 December 2009

[2009] SGIPOS 16 Infant formula-Arachidonic acid-Eicosapentaneoic acid-Triglyceride-Revocation-Patentability-Novelty-Inventive step-Insufficiency not just lack of clarity-Allowability of amendments-Extend scope of protection-Independence of expert witnesses-Foreign decisions-Independence of expert witnesses-Former or current employees

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* SG Case citations refer to the revised case citations.

Patent Quality Management Unit (Search & Examination) Registry of Patents Intellectual Property Office of Singapore 51 Bras Basah Road #04-01 Plaza By The Park Singapore 189554 Tel: (65) 63398616 Fax (General): (65) 63390252 Fax (Patents): (65) 63399230 http://www.ipos.gov.sg [email protected] (attention: Patent Quality Management Unit (Search & Examination)

Documents

IPOS Examination (Patentability) Guidelines 2010