extending patentability to include plant and animal inventions under the trips agreement and the...
TRANSCRIPT
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 1 of 24
EXTENDING PATENTABILITY TO INCLUDE PLANT AND ANIMAL
INVENTIONS UNDER THE TRIPS AGREEMENT AND THE PATENTS ACT 1990
(CTH)
Australia is a party to numerous international treaties and agreements in relation to
intellectual property and more specifically patents. As a party to these treaties and
agreements, Australia is required to implement the international regime’s substantive
provisions into domestic legislation. Intellectual property law is an ever changing and
expanding field, especially in relation to the law of patents which deals with all fields of
technology. Recently, the most controversial area of patent law is the patentability of plant
and animal inventions, especially in relation to farmers’ rights and ethical considerations.
This paper investigates how intellectual property rights, specifically the exclusion of plant
and animal inventions from patentability, are governed under the current international and
domestic patent regimes. This paper will argue that the current exclusion of the patentability
of plant and animal inventions under the World Trade Organisation’s (“WTO”) Trade-
Related Intellectual Property Rights Agreement 19941 (“TRIPS Agreement”) is justified and
despite numerous, persuasive arguments, should not be amended at this time; although
amendment may become relevant in the future.
1. OVERVIEW OF THE CURRENT INTERNATIONAL INTELLECTUAL
PROPERTY REGIME
Intellectual property includes copyrighted materials, patents, trade marks, industrial designs,
trade names and know-how. All forms of intellectual property can be divided into two broad
categories: copyright and related rights; and industrial property.2 Industrial property mainly
refers to patents, trade marks, geographical indications, know-how and trade secrets.
Intellectual property that is related to international trade in goods and services is regulated by
1 Trade-Related Intellectual Property Rights Agreement, opened for signature on 15 April 1994 (entered into
force 1 January 1995). 2 Mo, International Commercial Law (LexisNexis Butterworths, Australia, 5
th ed, 2013), 7.75.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 2 of 24
the WTO. Australia became a member of the WTO on 1 January 19953 and is bound by its
agreements, including the TRIPS Agreement.
The current TRIPS Agreement is Annex 1C to the Agreement Establishing the World Trade
Organisation and contains 73 articles and a Preface. It forms one of the four pillars of the
WTO trade system: the General Agreement on Tariffs and Trade 1994 (and associated
agreements), the General Agreement on Trade in Services 1994, the dispute settlement
mechanism and the TRIPS Agreement.
The current international regime in respect of intellectual property is vast. The agreements
most relevant to Australian patent law include:
TRIPS Agreement;
Paris Convention for the Protection of Industrial Property 18834 (“Paris
Convention”);
Patent Cooperation Treaty 19705 (“PCT”);
Patent Law Treaty 20006 (“PLT”);
Budapest Treaty on the International Recognition of the Deposit of Microorganisms
for the Purposes of Patent Procedure 19777 (“Budapest Treaty”); and
Australia-US Free Trade Agreement8 (“AUSFTA”).
9
The agreement most relevant to the patentability of plant and animal inventions is the TRIPS
Agreement. However, a brief overview of each other international patent treaty is useful to
understand how the general patent process works internationally.
3 World Trade Organisation, Member Information: Australia and the WTO (2014) World Trade Organisation
<http://www.wto.org/english/thewto_e/countries_e/australia_e.htm>. 4 Paris Convention for the Protection of Industrial Property, opened for signature on 20 March 1883 (entered
into force 10 October 1925). 5 Patent Cooperation Treaty, opened for signature on 19 June 1970 (entered into force 31 March 1980).
6 Patent Law Treaty, opened for signature on 2 June 2000 (entered into force 16 March 2009).
7 Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the Purposes of the
Patent Procedure, opened for signature on 19 June 1970 (entered into force 7 July 1987). 8 Australia-US Free Trade Agreement, opened for signature on 18 May 2004, ATS 1 (entered into force 1
January 2005). 9 Davidson, Monotti and Wiseman, Australian Intellectual Property Law (Cambridge University Press,
Australia, 2nd
ed, 2012), 12.14.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 3 of 24
1.1. TRIPS Agreement
Australia became a signatory to the TRIPS Agreement when it became a member of the WTO
on 1 January 1995.10
The TRIPS Agreement regulates all forms of intellectual property rights,
and is the most influential intellectual property treaty with respect to Australian domestic
intellectual property law. The Patents (World Trade Organisation Amendments) Act 1994
(Cth) was enacted to amend the Patents Act 1990 (Cth) in order to bring Australian law into
line with the standards and principles prescribed for patents in the TRIPS Agreement.11
The main features of the TRIPS Agreement include the general requirement to comply with
the substantive provisions in the Paris Convention. With respect to patents, the TRIPS
Agreement includes the following provisions: the National Treatment Principle under Article
3(1); the Most-Favoured-Nation Principle under Article 4; the general provisions on
patentability of subject matter and the relevant exceptions to patentability under Article 27;
the exclusive rights of inventors under Articles 28, 30 and 31; the general patent application
process under Articles 29 and 34; and the twenty year minimum term of protection under
Article 33.
a. National Treatment Principle
Article 3(1) TRIPS Agreement grants national treatment to all WTO Members. Under this
principle a WTO member is obliged to treat foreign nationals and its own nationals equally
when complying with the TRIPS Agreement. However, the operation of the National
Treatment Principle is, in respect of patents, subject to the exceptions provided in the Paris
Convention.12
b. Most Favoured Nation Principle
Article 4 TRIPS Agreement applies the Most Favoured Nation Principle:
any advantage, favour, privilege or immunity granted by a Member to the nationals of
any other country shall be accorded immediately and unconditionally to the nationals of
all other Members.
10
World Intellectual Property Organisation, Agreement on Trade-Related Aspects of Intellectual Property
Rights (TRIPS Agreement), WIPO
<http://www.wipo.int/wipolex/en/other_treaties/parties.jsp?treaty_id=231&group_id=22>. 11
Davidson, above n 4, 12.14.2. 12
Trade-Related Intellectual Property Rights Agreement, opened for signature on 15 April 1994 (entered into
force 1 January 1995), Article 3(1).
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 4 of 24
The general purpose of the Most Favoured Nation Principle is to ensure that all nationals of
WTO Members are treated equally by an individual WTO member.13
However, the
application of the Most Favoured Nation Principle, with respect to patents, is subject to the
following exceptions:
if a privilege is derived from international agreement on judicial assistance of law
enforcement of a general nature; and
if a privilege is derived from an international agreement made prior to the entry into
force of the TRIPS Agreement provided that the agreement is consistent with the
WTO Agreement.14
These exceptions ensure the effective operation of the Most Favoured Nation Principle and
are necessary to regulate international trade and commerce.15
1.2. Paris Convention
Australia acceded to the Paris Convention on 30 July 1925, and it entry came into force on 10
October 1925.16
The Paris Convention was the first major international treaty designed to
assist inventors obtaining protection for intellectual property rights in more than one country.
The Convention contains three categories of substantive provisions: the National Treatment
Principle, the right of priority and some other general rules. The National Treatment
Principle is the same as the National Treatment Principle in the TRIPS Agreement. The right
of priority, in the case of patents, enables a means of access into national patent systems for
foreign patentees without loss of the priority date given to their first filing. The priority date
of a patent is the date that the inventor files its complete specification of the invention (the
complete patent application).
13
Mo, above n 1, 7.81. 14
Mo, above n 1, 7.82. 15
Ibid. 16
World Intellectual Property Organisation, Paris Convention, WIPO
<http://www.wipo.int/treaties/en/ShowResults.jsp?treaty_id=2>.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 5 of 24
1.3. PCT
Australia’s entry into force of the PCT came into effect on 31 March 1980.17
The PCT
established an International Patent Cooperation Union ‘for cooperation in the filing,
searching, and examination, of specifications for the protection of inventions, and for
rendering special technical services’. The PCT regulates how inventors may seek patent
protection in a number of selected PCT contracting states with a single specification. Chapter
I PCT regards this single specification as equivalent to a regular national filing as prescribed
under the Paris Convention. Chapter II PCT allows the inventor the opportunity to delay the
entry into the national phase by asking for a preliminary examination on the basis of an
international search report. The objective of this examination is to provide a preliminary and
non-binding opinion on whether the claimed invention appears to be novel, to involve an
inventive step and to be industrially applicable.18
1.4. PLT
Australia acceded to the PLT on 16 December 2008, and its entry into force occurred on 16
March 2009.19
The PLT harmonises formal patent procedures such as the requirements to
obtain a filing date for a patent specification, the form and content of a patent specification,
and representation.
1.5. Budapest Treaty
Australia acceded to the Budapest Treaty on 7 July 1987.20
The Budapest Treaty establishes
the International Depository Institution system. The International Depository Institution
system requires inventors, of inventions that are micro-organisms, which cannot be described
adequately in the words of the complete specification to deposit a sample of their invention
with the International Depository Institution. The provisions also apply where an invention
involves the use, modification or cultivation of a micro-organism which is not reasonably
available to a person skilled in the relevant art.21
17
Davidson, above n 3, 12.6.2. 18
Patent Cooperation Treaty, opened for signature on 19 June 1970 (entered into force 31 March 1980), Article
33. 19
World Intellectual Property Organisation, Patent Law Treaty, WIPO
<http://www.wipo.int/treaties/en/ShowResults.jsp?lang=en&treaty_id=4>. 20
Davidson, above n 3, 12.14.3. 21
Ibid.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 6 of 24
1.6. AUSFTA
The AUSFTA entered into force on 1 January 2005. Chapter 17 of the AUSFTA deals with
intellectual property rights, including patents. The Australian parliament enacted the US Free
Trade Agreement Implementation Act 2004 (Cth) to comply with the AUSFTA, as the
AUSFTA includes limitations on the substantive provisions of patent law compared to the
TRIPS Agreement. In particular, amendments were made to the grounds for opposition and
revocation of a patent as well as for amendments to patent requests or complete patent
specifications.22
The Paris Convention, the PCT, the PLT, the Budapest Treaty and the AUSFTA do not
regulate the scope of patentability, the term of the patent or what subject matter may be
excluded from patentability. Substantive provisions of this nature are found in the TRIPS
Agreement.
2. OVERVIEW OF THE CURRENT AUSTRALIAN DOMESTIC REGIME
Patent law and plant breeder’s rights in Australia is generally governed by the Patents Act
1990 (Cth) and the Plant Breeder’s Rights Act 1994 (Cth). Both pieces of legislation reflect
the patent law requirements under the above international treaties.
2.1. Patents Act 1990 (Cth)
Under the Patents Act 1990 (Cth), a patent is a right granted by the Crown, which confers
private property rights in the form of a limited monopoly over the invention of products,
methods and processes. There are two types of patent that may be granted: a standard patent23
and an innovation patent.24
An invention is defined to mean ‘any manner of new manufacture
the subject of letters patent and grant of privilege within section 6 of the Statute of
Monopolies’25
, and includes alleged invention.26
If a patent is granted, the patentee is given
exclusive rights, during the term of the patent (twenty years for a standard patent27
and eight
22
Ibid 12.14.6. 23
Patents Act 1990 (Cth), s 18(1). 24
Patents Act 1990 (Cth), s 18(1A). 25
Statute of Monopolies 1624 (Imp). 26
Patents Act 1990 (Cth), Schedule 11. 27
Patents Act 1990 (Cth), s 67.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 7 of 24
years for an innovation patent28
), to exploit the invention.29
In order to be patentable, an
invention needs to be:
1. a manner of manufacture within the meaning of section 6 of the Statute of
Monopolies;30
2. novel and involve either an inventive step (standard patent) 31
or an innovative step
(innovation patent),32
when compared to the prior art base as it existed before the
priority date (date of the patent specification) of the invention;
3. useful;33
and
4. not used in secret.34
It has long be accepted that methods of calculation, discoveries, abstract ideas, laws of nature,
scientific theories, intellectual information and theoretical business schemes are not
patentable unless that are applied for a new and useful purpose.35
The threshold requirement for patentability is that the invention must be a manner of
manufacture36
, within the meaning of the Statute of Monopolies.37
The term “manner of
manufacture” is not defined in the Patents Act 1990 (Cth), and the explanatory memorandum
simply states that ‘an invention must belong to the useful arts rather than the fine arts’.38
The
term “manner of manufacture” has been considered in a number of Australian and
international cases and represents a contentious area of patent law.
28
Patents Act 1990 (Cth), s 68. 29
Patents Act 1990 (Cth), s 13(1). 30
Patents Act 1990 (Cth), ss 18(1)(a), 18(1A)(a). 31
Patents Act 1990 (Cth), s 18(1)(b). 32
Patents Act 1990 (Cth), s 18(1A)(b). 33
Patents Act 1990 (Cth), ss 18(1)(c 18(1A)(c). 34
Patents Act 1990 (Cth), ss 18(1)(d), 18(A)(d). 35
J Lahore, ‘Computers and the Law: The Protection of Intellectual Property’ (1978) 9 Federal Law Review 15,
22. Approved in CCOM v Jiejing (1994) 122 ALR 417, 447. 36
NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655, 663. 37
Patents Act 1990 (Cth), ss 18(1), 18(1A). 38
Patents Bill 1990 (Cth), cl 31.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 8 of 24
2.2. Plant Breeder’s Rights Act 1994 (Cth)
The Plant Breeder’s Rights Act 1994 (Cth) adopts the minimum standards prescribed under
the Convention for the Protection of New Varieties of Plants 1961 (“UPOV”) and complies
with Article 27.3(b) TRIPS Agreement.39
There is no protection under the Plant Breeder’s Rights Act 1994 (Cth) for merely breeding a
variety.40
Rather, the Plant Breeder’s Rights Act 1994 (Cth) provides plant breeders with
certain exclusive rights (“Plant Breeder’s Rights”) in relation to other plant breeders being
unable to propagate material of a protected plant variety.41
Propagating material means any
part or product from which (whether alone or in combination with other parts of product of
that plant) another plant with the same essential characteristics can be produced. Propagating
material includes seeds, seedlings, tubers and bulbs, cuttings and cell lines.42
“Essential
characteristics” means heritable traits or determinants that contribute to the principle features,
performance or value of the variety of plant.43
To be registrable under section 44 Plant Breeder’s Rights Act 1994 (Cth), the plant variety
must: have a plant breeder; be distinctive; be uniform; be stable (DUS criteria); not have been
exploited by or with the permission of the plant breeder (unless that exploitation occurred
only recently);44
and be given a name. To satisfy the DUS criteria (stability of the plant
variety), a comparative growing trial of the plant variety must be undertaken in Australia by
an accredited qualified person for the species of plant, or the plant variety’s stability could be
based upon a certified test report obtained from a UPOV contracting state.45
Plant breeders who are able to register a plant variety receive a monopoly protection in
Australia for twenty-five years for trees and vines, and twenty years for other plant
varieties.46
39
Davidson, above n 3, 16.1. 40
The Grain Pool of Western Australia v The Commonwealth of Australia (2000) 202 CLR 479, 510. 41
Plant Breeder’s Rights Act 1994 (Cth), s 11. 42
Plant Breeder’s Rights Act 1994 (Cth), s 3(1). 43
Plant Breeder’s Rights Act 1994 (Cth), s 3(1). 44
Plant Breeder’s Rights Act 1994 (Cth), s 43. 45
Plant Breeder’s Rights Act 1994 (Cth), s 3(1). 46
Plant Breeder’s Rights Act 1994 (Cth), s 22.2.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 9 of 24
3. PATENTABILITY OF PLANT AND ANIMAL INVENTIONS UNDER THE
TRIPS AGREEMENT, THE PATENTS ACT 1990 (CTH) AND THE PLANT
BREEDER’S RIGHTS ACT 1994 (CTH)
Article 27 TRIPS Agreement provides the requirements for ‘patentable subject matter’.
Article 27.1 TRIPS Agreement states that, subject to Articles 27.2 and 27.3 TRIPS Agreement,
‘patents shall be available for any inventions, whether products or processes, in all fields of
technology, provided that they are new, involve an inventive step and are capable of
industrial application’.
Article 27.2 TRIPS Agreement provides a general exception to patentability by allowing
Member states to exclude from patentability inventions where:
the prevention within their territory of the commercial exploitation of which is necessary
to protect ordre public or morality, including to protect human, animal or plant life or
health or to avoid serious prejudice to the environment, provided that such an exclusion is
not made merely because the exploitation is prohibited by law.
Article 27.3(b) TRIPS Agreement is the most relevant to the patentability of plant and animal
inventions. Article 27.3(b) provides:
Members may also exclude from patentability:
…
(b) plants and animals other than micro-organisms, and essentially biological processes
for the production of plants or animals other than non-biological and microbiological
processes. However, Members shall provide for the protection of plant varieties
either by patents or by an effective sui generis system, or any combination thereof.
Article 27 TRIPS Agreement clearly provides, despite an overarching requirement of
patentability of all inventions in all fields of technology, a discretionary prohibition on the
patentability of plant or animal inventions, unless the plant invention is in the form of a plant
variety.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 10 of 24
Australia chose to adopt the discretionary exclusion of the patentability of plant and animal
inventions in section 18(3) Patents Act 1990 (Cth), which provides:
For the purposes of an innovation patent, plants and animals, and the biological processes
for the generation of plants and animals, are not patentable inventions.
There is currently no express prohibition for obtaining a standard patent for a plant or animal
invention. However, it is highly unlikely that a plant or animal invention could satisfy the
high threshold tests of novelty and inventive step required for a standard patent under section
18(1) Patents Act 1990 (Cth).
Australia complies with the requirement that plant varieties must be protected with the
enactment of the Plant Breeder’s Rights Act 1994 (Cth).
4. SHOULD THE CURRENT DISCRETIONARY PROHIBITION ON THE
PATENTABILITY OF PLANT AND ANIMAL INVENTIONS UNDER THE
TRIPS AGREEMENT, AS ENACTED IN THE PATENTS ACT 1990 (CTH) BE
AMENDED?
A number of papers have been commissioned and released in relation to the patentability of
plant and animal inventions under the TRIPS Agreement and the Patents Act 1990 (Cth),
including the 2004 Australian Advisory Council on Intellectual Property’s paper, “Should
plant and animal subject matter be excluded from protection by the innovation patent”, and
the 2006 Council for Trade-Related Aspects of Intellectual Property Rights paper, “Review of
the provisions of Article 27.3(b)”. These papers demonstrate the controversial and complex
nature of any amendment to the Patents Act 1990 (Cth) or Article 27 TRIPS Agreement.
4.1. The Exclusion under Article 27.3(b) TRIPS Agreement and Section 18(3)
Patents Act 1990 (Cth)
Generally, the main arguments for and against expanding the current patent protection in
Australia to include plant and animal inventions is public policy based. This includes
arguments relating to private rights, public good, domestic and international trade, economic
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 11 of 24
interests, ethics and environmental safety. There is lively debate for both sides of the
argument.
Briefly, the main objections to extending patentability to include plant and animal inventions
are:
Living matter forms part of our common heritage, and should not be regarded as a
commodity over which exclusive rights are awarded;
The patenting of plants and animals encourages interference with nature, and will lead
to a decline in genetic diversity; and
Devaluation of animal life and the suffering of laboratory animals.47
Another objection to extending patent protection is that the grant of exclusive rights over
plant and animal inventions will lead to an increase in costs of, and a restriction in access to,
re-use and exchange of seeds by farmers.48
Also, an unavoidable consequence of granting
inventors exclusive rights is the creation of barriers to entry into the market and a stifling of
competition. 49
There is also a fear that removing the exclusion would interfere with
longstanding industry practice and would therefore have a serious negative impact on access
to, particularly, plant material and varieties for farmers and researchers. 50
However, proponents of the extension of patent law to include the patentability of plant and
animal inventions argue that the main objective of patent law is to promote private sector
investment in incentive activities that contribute to new technologies to solve problems. As
patent protection facilitates the transfer of technology between sectors (including public and
private) and the dissemination of research, allowing plant and animal inventions to be
patentable would contribute to solving problems in developed and developing countries in
47
Commonwealth, Advisory Council on Intellectual Property, Should plant and animal subject matter be
excluded from protection by the innovation patent (Professor Paul Greenfield, Chairman), 2004, 9 citing
Australian GeneEthics Network, Submission no. 71 to House of Representatives Standing Committee on
Primary Industries and Regional Services Report on Primary Producer Access to Gene technology, titled “Work
in Progress, Proceed with Caution” (2000) 11; Animal Patents: The Legal, Economical and Social Issues, Ed.
W. H. Lesser, Macmillan Publishers Ltd, 1989 New York; E.S. Van de Graff, “Patent Law and Modern
Biotechnology”, 1997, 68. 48
World Trade Organisation, Council for t=Trade-Related Aspects of Intellectual Property Rights, Review of the
provisions of Article 27.3(b): Summary of issues raised and points made (Secretariat), 2006, 3 citing Minutes of
the Council for TRIPS Meeting, [106], [15]. 49
Commonwealth, above n 41, 16. 50
Ibid.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 12 of 24
areas such as agriculture, nutrition, health and the environment. 51
In fact, the exclusion may
be considered to be actively detrimental to research in Australia, 52
as the patent system
provides an important incentive to the private sector to conclude licensing agreements, and to
discourage confidentiality and trade secret arrangements. 53
Extending patentability to include plant and animal inventions may encourage the
development and use of new technologies that may otherwise never occur. Inventors are
encouraged to continue to research and develop new plant and animal inventions as, under
the patent law system’s exclusive rights, they will obtain a return on their investment in the
research. Further, the patent law system’s requirement for full, open and honest disclosure of
all parts of the invention enables other inventors and innovators to both build on and around
the existing inventions. 54
In addition, the patentability of plant and animal inventions exclusion was introduced into
section 18(3) Patents Act 1990 (Cth) without any evidence to prove that material harm would
occur if innovation patents for plant or animal inventions were made available. Particularly in
respect of animal inventions, there is not even any potential for conflict with a sui generis
system of protection, as none exists in Australia.55
Numerous stakeholders have argued that plant and animal inventions should be accorded
adequate patent protection in the same manner that other inventions in other fields of
technology have been protected. 56
There is a general view, that the current Australian and
international patent protection systems have a ‘gap’ in relation to plant and animal inventions,
due to the broad prohibition and, in relation to animal inventions, the absence of a sui generis
system (similar to the sui generis system for plants created by the Plant Breeder’s Rights Act
1994 (Cth)). ‘If it can be demonstrated that there are social benefits in closing any gap in
protection, then all [intellectual property] mechanisms must be considered, including a sui
generis system for animals.’57
51
World Trade Organisation, above n 42, 2-3. 52
Commonwealth, above n 41, 16. 53
World Trade Organisation, above n 42, 2-3. 54
Commonwealth, above n 41, 16. 55
Ibid, 16-17. 56
World Trade Organisation, above n 42, 2-3. 57
Commonwealth, above n 41, 16.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 13 of 24
4.2. Ethical Exceptions to Patentability and Article 27.2 TRIPS Agreement
Due to the ethical considerations that need to be contemplated whenever animals are included
in scientific research, the ordre public and morality exception in Article 27.2 TRIPS
Agreement creates a direct link to the exclusion of plant and animal inventions in Article
27.3(b) TRIPS Agreement. In particular, the following specific concerns should be
considered: those relating to public health, restrictions on research materials, limitation on
competition as in the case of gene use restriction technologies, human rights, agricultural
security, bio-piracy, traditional knowledge and farmers rights and the concern that the current
provisions of Article 27.3 TRIPS Agreement does not prevent the abuse of patent systems.58
Opponents of the patentability of plant and animal inventions believe that the ‘patenting of
life forms is in itself unethical and harmful and therefore should be unconditionally
prohibited’.59
They argue that the ordre public and morality exception embodied in Article
27.2 TRIPS Agreement is insufficient to prohibit the patentability of plant and animal
inventions as the exception is ‘unnecessary and cumbersome’.60
The basis of this argument is
that the exception does not prevent the commercial exploitation of the invention. The
exception in Article 27.2 TRIPS Agreement amounts to redefining morality for Members. The
patentability of plant and animal inventions make the exceptions in Article 27.2 TRIPS
Agreement meaningless for those Members that consider patents on ‘life forms to be
immoral, contrary to the fabric of their society and culture’. 61
Opponents argue that the
minimum amendment to the TRIPS Agreement that is acceptable in this regard is to clarify
Article 27.3 TRIPS Agreement so that it does not in any manner restrict the rights of
Members to resort to the exceptions in Article 27.2 TRIPS Agreement. 62
However, proponents argue that Article 27.2 TRIPS Agreement adequately reflects ethical
concerns as far as patent law is concerned and any other ethical concerns should be addressed
in other laws, such as the protection of the environment, public health or animal welfare.
Patents do not guarantee inventors unfettered exploitation of the invention. Rather such
exploitation is subject to the domestic laws, including matters relating to ethics, welfare and
58
World Trade Organisation, above n 42, 10, citing Minutes of the Council for TRIPS Meeting, [87], [112],
[127],[152], [184]. 59
Ibid citing Minutes of the Council for TRIPS Meeting, [105], [143]. 60
Ibid. 61
Ibid citing IP/C/W “Taking Forward the Review of Article 27.3(b) of the TRIPS Agreement”, 2. 62
Ibid citing IP/C/W “Taking Forward the Review of Article 27.3(b) of the TRIPS Agreement”, 4.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 14 of 24
bio-piracy. Therefore, there is no need to specifically exclude inventions in order to prevent
their exploitation:
Explicitly excluding particular subject matter from patentability will not of itself prevent
either research or exploitation of such technology. Instead, it could make it more difficult
to control, for example by encouraging secrecy.63
Further, the current disclosure requirements of the patent law system and the control over
exploitation of patents facilitate the operation of laws designed to protect public morality,
health and the environment. 64
4.3. Conditions of Patentability in Article 27.1 TRIPS Agreement and Plant and
Animal Inventions
Another concern raised by opponents of extending the patent system relates to the grant of
excessively broad patents which do not necessarily fully meet the tests of patentability. This
concern also includes the consideration of the costs and burdens of the revocation of such
patents. 65
The absence of clear definitions in Article 27.1 TRIPS Agreement for the elements
of patentability has left vague areas in the patent law system; particularly with respect to the
definition of “invention”, and the scope of patentable micro-organisms and microbiological
and non-biological processes. There are concerns that allowing Members to have complete
discretion could result in a number of concerns, including unduly low thresholds for novelty,
inventive step and industrial applicability due to the processes in place in certain Member
states regarding patent specifications. 66
Another view is that the specific definitions and scope of patentability need to be left to the
discretion of individual Member states in order to allow Members to exert their own morals
and culture on patents within their jurisdiction. This freedom constitutes part of the
flexibilities inherent in the TRIPS Agreement. 67
63
Ibid citing IP/C/W “Communication from Switzerland: Review of Article 27.3(b): The View of Switzerland”. 64
Ibid citing IP/C/W “Communication from Switzerland: Review of Article 27.3(b): The View of Switzerland”. 65
Ibid citing IP/C/W “Communication from Switzerland: Review of Article 27.3(b): The View of Switzerland”. 66
Ibid 11. 67
Ibid 11.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 15 of 24
The Patents Act 1990 (Cth) already provides definitions of each of the terms of patentability
including: “invention”, “exploit” and” prior art base”. These definitions, and others (such as
“novel”, “inventive”, “innovative” and “useful”), have been considered and interpreted in
numerous Australian cases. This practice of creating precedent for patents appears to allow
Australian patent law to remain flexible so that it may capture and protect new types of
inventions and technologies now and into the future. This is the flexibility and freedom the
TRIPS Agreement attempts to protect by including the discretionary exclusions in Articles
27.2 and 27.3 TRIPS Agreement.
5. HOW COULD THE CURRENT INTERNATIONAL AND DOMESTIC
REGIMES BE AMENDED?
A number of suggestions have been made to the Council for Trade-Related Aspects of
Intellection Property Rights for the amendment of the TRIPS Agreement. These include:
amending the TRIPS Agreement to remove the exceptions, as the exceptions to
patentability authorised by Article 27.3(b) TRIPS Agreement are unnecessary and
patent protection should be extended to all patentable inventions of plants and
animals;
maintaining Article 27.3(b) TRIPS Agreement as the provision provides Members
with flexibility to decide whether or not to exclude plants and animals from
patentability in light of their specific domestic interests and needs;
retaining the exception contained in Article 27.3(b) TRIPS Agreement but including
definitions of certain terms to clarify the distinction between plant, animals and
micro-organisms; and
amending or clarifying Article 27.3(b) TRIPS Agreement to prohibit the patenting of
all life forms, including plants and animals, micro-organisms and all other living
organisms and their parts, including genes, as well as natural processes that produce
plants, animals and other living organisms.68
68
Ibid 3-4.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 16 of 24
To ensure that the objectives of patent law are met, if extending patent protection to plant and
animal inventions, it is necessary to have international agreement on the rules for the
protection of plant and animal inventions, rather than simply relying only on domestic
legislation.69
International agreement is also important when considering whether to amend
the Patents Act 1990 (Cth), due to Australia’s current obligations under the numerous
international patent and intellectual property treaties and agreement.
5.1. Extending Patentability to Include Plant and Animal Inventions vs
Maintaining Article 27.3(b) TRIPS Agreement and the Section 18(3) Patents Act
1990 (Cth) Exclusion
Article 27.3(b) TRIPS Agreement provides considerable flexibility to Members to choose
whether or not to include or exclude the patentability of plant and animal inventions in their
domestic legislative regimes.70
In Australia, it is possible to obtain an innovation patent under
section 18(1A) Patents Act 1990 (Cth) for a plant or animal invention if the inventor can
demonstrate that the invention is a manner of manufacture, is novel and involves an
innovative step, is useful, was not used in secret,71
and was not a biological process for the
generation of plants and animals.72
Many stakeholders believe that innovation patents are
becoming a more appropriate form of protection of plant inventions due to the incredibly
complex technology in the field. The Department of Primary Industries Queensland and the
Australia Research Council have both argued that the generation of genetically modified
plants using molecular biology and plant transformation techniques is increasing, and there
appears to be a corresponding increase in the use of the patent system to protect inventions in
this area.73
However, opponents believe that the innovation patent is ill suited for plant and animal
inventions because it limits the commercialisation of ‘incremental spin-off innovations and
improvements, reduces the efficiency and competitiveness of the industry and significantly
reduces levels of innovation’.74
One particular argument against extending the patentability of
plant inventions was raised by the Grains Research and Development Corporation during
69
Ibid 3. 70
Ibid 6. 71
Patents Act 1990 (Cth), s 18(1A). 72
Patents Act 1990 (Cth), s 18(3). 73
Commonwealth, above n 41, 20. 74
Ibid 22.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 17 of 24
submissions to the Australian Advisory Council on Intellectual Property. The Grains
Research Development Corporation claimed that farm saved seed is crucially important to
Australian growers for technical and economic reasons. Farm saved seed allows farmers to
minimise costs and remain internationally competitive as farmers do not receive subsidies,
face high risks of crop failure due to a variable climate and produce yields that are typically
one third of other countries. The Grain Research Development Corporation was of the view
that farmers would ‘revolt’ if they no longer had access to farm saved feed, as would occur
should the exception to patentability of plant and animal inventions be removed.75
Nevertheless, there is a gap in the protection of animal inventions as there is no requirement
for a sui generis system like that of plant breeder’s rights. Innovators should be able to
choose between different forms of protection according to their circumstances and the nature
of the innovation.76
However, it appears from submissions made to the Advisory Council on
Intellectual Property that, at least in Australia, there is little research being conducted, or
inventions based on, animals.
5.2. Define Terms in Article 27.3(b) TRIPS Agreement
The absence of clear definitions may lead to legal uncertainty regarding the scope of
patentability. Zimbabwe has argued that the difficulty in WTO Members agreeing on
definitions should not deter the Council for Trade-Related Aspects of Intellectual Property
Rights from developing definitions of certain terms. However, the absence of definitions at
an international level affords Members flexibility in the use and interpretation of these
terms.77
5.3. Conclusions
The Australian Advisory Council on Intellectual Property considered the above arguments
and concluded that the current exclusion from the innovation patent of plants and animals and
biological processes for their generation should be maintained at this time. However, this
recommendation does not take into account the absence of a sui generis system for animal
inventions similar to the Plant Breeder’s Rights Act 1994 (Cth), despite the possible social
benefits in encouraging research and innovation in this area and closing the gap between
75
Ibid 22. 76
Ibid 17. 77
World Trade Organisation, above n 42, 7.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 18 of 24
plant and animal rights. A possible argument against establishing a sui generis system for
animals is the higher level of ethics that need to be considered before an inventor is approved
a research grant. The response to this argument, from a legal perspective, is that the ethics
relating to animal research is governed by other areas of law and pieces of legislation.
6. WHO SHOULD BE RESPONSIBLE FOR AMENDING THE CURRENT
INTERNATIONAL AND DOMESTIC REGIMES
6.1. International Regime
Article 27.3(b) TRIPS Agreement ‘is a result of a carefully negotiated balance.’78
Article
27.3(b) TRIPS Agreement already allows Members considerable freedom with regard to the
patentability of biotechnological inventions, therefore, it is the responsibility of each Member
to strike the correct balance when accounting for economic, ethical and other concerns,
without losing sight of the fact that granting intellectual property rights to biotechnology
inventions is one of the factors for developing domestic skill in this sector. Further, ethical
and moral matters are not factors to be considered in commercial calculations, and ‘their
force should not be affected by reasoned commercial concerns’: 79
Cultural and social values of many societies cannot countenance the appropriation or
marketing of life in any form or at any stage.80
In addition, biological materials are research ingredients and patents for these materials
should be granted as long as the patentability requirements are met and the commercial
exploitation of such living organisms does not go against public order.81
Therefore, the superiority of such intrinsic values in particular countries is a matter for
domestic legislative process to determine, and not for the WTO, whose ‘trade mandate is
narrow and insufficient to decide on these matters’. 82
78
Ibid 11. 79
Ibid 11. 80
Ibid 11. 81
Ibid 11. 82
Ibid 11.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 19 of 24
6.2. Domestic Regime
The Intellectual Property Research Institute of Australia have also argued that it is the
responsibility of the legislature to amend the current Patents Act 1990 (Cth) if necessary:
in such a controversial area … the legislature should bear the burden to prove that the
benefits of stimulation of innovation in this area outweigh the possible risks involved …
it is not enough to argue that there are no reasons to justify the exclusion of plant and
animal subject matter … empirical evidence is required on whether the current patent
regime is operating effectively in this sector or whether increased [intellectual property]
rights in the form of innovation patents are needed to stimulate greater investment in
research, development and commercialisation … in the absence of evidence showing
further [intellectual property] rights are required, the extension of the innovation patent to
plant and animal subject matter should not occur.83
7. CONCLUSION
Australia’s current patent regime, in the form of the Patents Act 1990 (Cth) and the Plant
Breeder’s Rights Act 1994 (Cth), adequately reflects and implements the international patent
regime in respect of the patentability of plant and animal inventions. Article 27(3)(b) TRIPS
Agreement provides WTO Members with a discretion to exclude from patentability plant and
animal inventions, as long as the Members make a sui generis system available to protect
plant varieties. Australia has used the discretion in Article 27.3(b) TRIPS Agreement in the
Patents Act 1990 (Cth) to exclude the patentability of plant and animal inventions, and also
enacted the Plant Breeder’s Rights Act 1994 (Cth) as the Australian sui generis system
protecting plant breeder’s rights.
However, there have been numerous arguments for and against the exclusion of the
patentability of plant and animal inventions under section 18(3) Patents Act 1990 (Cth) and
Article 27.3(b) TRIPS Agreement. The majority of these arguments have been submitted to
the Australian Advisory Council on Intellectual Property Rights and the WTO Council for
Trade-Related Aspects of Intellectual Property. Both Councils have considered these
arguments and have released papers in 2004 and 2006, respectively.
83
Commonwealth, above n 41, 16 citing the Intellectual Property Research Institute of Australia.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 20 of 24
Opponents of the extension of the patents system to include the patentability of plant and
animal inventions assert that extending the patent protection will lead to an increase in cost
of, and a restriction in access to, re-use and exchange of seeds by farmers, as well as a
general barrier to entry into the market and a stifling of competition. The opponents argue
that extending the patent protection is also unethical as the ‘patenting of life forms is in itself
unethical and harmful and therefore should be unconditionally prohibited’.84
They argue that
the ordre public and morality exception embodied in Article 27.2 TRIPS Agreement is
insufficient in its current form, as it allows for the interpretation that it will be superseded by
Article 27.3 TRIPS Agreement, should the patent protection be extended. Finally, opponents
to the extension state that the current form of Article 27 TRIPS Agreement is vague and open
to liberal interpretation as it does not define certain important terms, such as “invention”.
However, proponents of the extension of the patent system contend that the main objective of
patent law is to encourage the private sector to continue to innovate in new technologies in
order to solve new problems, transfer technologies and disseminate new knowledge. They
argue that the patent system aids problem solving in developed and developing countries by
creating an incentive for inventors, by granting those inventors exclusive proprietary rights.
In fact, the exclusion of the patentability of plant and animal research may be considered to
be actively detrimental to research in Australia as the patent system provides an important
incentive to the private sector to conclude licensing agreements, and to discourage
confidentiality and trade secret arrangements. Proponents also argue that plant and animal
inventions should be accorded the same patent protection as other fields of technologies,
especially in relation to animal inventions where there is not even a requirement for a sui
generis system similar to that for plant varieties.
Proponents point out that the ordre public and morality exception in Article 27.2 TRIPS
Agreement is flexible in order to allow Member states to reflect their own social and cultural
values in their domestic legislation. This is the same argument proponents use to address the
issue of the absence of definitions in Article 27 TRIPS Agreement.
Ultimately, despite the numerous and persuasive arguments put forward by the proponents of
extending the patent system to include the patentability of plant and animal inventions, the
84
World Trade Organisation, above n 42, 10 citing Minutes of the Council for TRIPS Meeting, [105], [143].
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 21 of 24
Australian Advisory Council on Intellectual Property’s recommendation that the current
patent system remain unchanged is a sensible one. Although there is undoubtedly a ‘gap’ in
the protection of plant and animal inventions, especially animal inventions of any kind (as
there is no equivalent sui generis system), there is no empirical research proving Australia’s
current need for plant or animal invention protection, at least under the patent system. Issues
of ethics and morals are dealt with under other areas of law, as is the exploitation of any life
form invention. In addition, it is already possible to obtain an innovation patent under section
18(1A) Patents Act 1990 (Cth) for a plant or animal related invention if the inventor can
demonstrate novelty, an innovative step and usefulness.
However, this is a controversial area of law, and an ever changing field of technology. Due to
the current discretion to exclude from patentability plant or animal inventions under Article
27.3 TRIPS Agreement, there is no reason why, in the future, Australia may not amend the
Patents Act 1990 (Cth) or introduce a sui generis system for animal inventions similar to the
Plant Breeder’s Rights Act 1994 (Cth). If this change were to occur, it would be a matter for
the legislature to approve and implement.
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 22 of 24
BIBLIOGRAPHY
1. Books
Davidson, Monotti and Wiseman, Australian Intellectual Property Law (Cambridge
University Press, Australia, 2nd
ed, 2012)
Mo, International Commercial Law (LexisNexis Butterworths, Australia, 5th
ed, 2013)
2. Journals
J Lahore, ‘Computers and the Law: The Protection of Intellectual Property’ (1978) 9 Federal
Law Review 15
3. Cases
CCOM v Jiejing (1994) 122 ALR 417
NV Philips Gloeilampenfabrieken v Mirabella International Pty Ltd (1995) 183 CLR 655
The Grain Pool of Western Australia v The Commonwealth of Australia (2000) 202 CLR 479
4. Legislation
Patents Act 1990 (Cth)
Patents Bill 1990 (Cth)
Plant Breeder’s Rights Act 1994 (Cth)
Statute of Monopolies 1624 (Imp)
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 23 of 24
5. Treaties
Australia-US Free Trade Agreement, opened for signature on 18 May 2004, ATS 1 (entered
into force 1 January 2005)
Budapest Treaty on the International Recognition of the Deposit of Microorganisms for the
Purposes of the Patent Procedure, opened for signature on 19 June 1970 (entered into force 7
July 1987)
Paris Convention for the Protection of Industrial Property, opened for signature on 20 March
1883 (entered into force 10 October 1925)
Patent Cooperation Treaty, opened for signature on 19 June 1970 (entered into force 31
March 1980)
Patent Law Treaty, opened for signature on 2 June 2000 (entered into force 16 March 2009)
Trade-Related Intellectual Property Rights Agreement, opened for signature on 15 April 1994
(entered into force 1 January 1995)
6. Other
Commonwealth, Advisory Council on Intellectual Property, Should plant and animal subject
matter be excluded from protection by the innovation patent (Professor Paul Greenfield,
Chairman), 2004
World Intellectual Property Organisation, Agreement on Trade-Related Aspects of
Intellectual Property Rights (TRIPS Agreement), WIPO
<http://www.wipo.int/wipolex/en/other_treaties/parties.jsp?treaty_id=231&group_id=22>
World Intellectual Property Organisation, Paris Convention, WIPO
<http://www.wipo.int/treaties/en/ShowResults.jsp?treaty_id=2>
Krysiu Smith (07176228)
LWN075 International Commercial Transactions – Research Paper
Page 24 of 24
World Intellectual Property Organisation, Patent Law Treaty, WIPO
<http://www.wipo.int/treaties/en/ShowResults.jsp?lang=en&treaty_id=4>
World Trade Organisation, Council for t=Trade-Related Aspects of Intellectual Property
Rights, Review of the provisions of Article 27.3(b): Summary of issues raised and points
made (Secretariat), 2006
World Trade Organisation, Member Information: Australia and the WTO (2014) World
Trade <Organisation http://www.wto.org/english/thewto_e/countries_e/australia_e.htm>