Abstract
Despite the aims of harmonisation under the General Agreement on Tariffs and Trade under its Trade Related Aspects of Intellectual Property Rights Agreement, and subsequent trade agreements, there are still non-harmonised aspects of many intellectual property regimes. Depending on jurisdiction, the plant breeding exemption, which allows breeders to use biological material protected under intellectual property regimes for creating new plant varieties, are handled in different ways. In some cases, such as China, the Plant Variety Protection Act provides for a breeding exemption, for any purpose, but the Patent Act’s research exemption does not extend to plants. This is in contrast to Australia where both patents and plant breeders protection hold a limited research exemption, but the patent exemption does not extend to breeding new varieties for commercial use. This paper explores the dimensions surrounding such exemptions, looking to China and Australia for different approaches, within the context of Free Trade Agreements. Some exemptions are available under the International Convention for the Protection of New Varieties of Plants 1991 (UPOV 1991), to which Australia is a party, and although this is a different version to UPOV 1978 to which China is a party, the breeding exemption is essentially preserved. Naturally, it is desirable to design a harmonised regime that promotes the development of new varieties, to maximise desirable outcomes for breeders, farmers and civil society as a whole, whilst allowing for needed jurisdictional differences. Notably, the Trans Pacific Partnership requires all members to sign up to UPOV 1991.
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Notes
- 1.
See International Union for the Protection of New Varieties of Plants, What It Is, What It Does, UPOV Publication No 437(e) (UPOV, 2011) p. 1.
- 2.
In Europe, Australia and Canada, this is often referred to as Plant Breeders Rights (PBR), in China, Plant Variety Rights (PVR) is the official name of the right conferred by law.
- 3.
Sir Isaac Newton expressed this sentiment in a letter to Robert Hooke, February 5, 1676 “If I have seen further it is by standing on the shoulders [sic] of giants”, although the idea of relying on earlier work to make advances had been expressed some centuries prior to Newton. See discussion in Perry, Mark (ed) (2016) Global governance of intellectual property in the 21st century: reflecting policy through change. Springer, Berlin.
- 4.
Breeding exemption sometimes called breeders' exemption, breeders' exception, breeders' privilege, and so on.
- 5.
Agreement on Trade-Related Aspects of Intellectual Property Rights, adopted 15 April 1994, 1869 UNTS 299 (entered into force 1 January 1996). The various versions of the International Union for the Protection of New Varieties of Plants (UPOV) provide the protection of new plant varieties satisfying the need for an effective sui generis system in proviso to Article 27.3 (b) of TRIPs.
- 6.
Patents Act 1990 (Cth), No. 3, 1990.
- 7.
S.16 Plant Breeder’s Rights Act 1994, No. 110, 1994.
- 8.
The variety protection system provides for breeders’ rights on the plant variety as whole, patents provide for a protection by covering not only plants, but parts of plants, single genes, and production methods.
- 9.
Article 5(3) of the UPOV 1961 Convention.
- 10.
It is worth noting that the stipulation on EDV was not seen in the previous UPOV1978 Convention.
- 11.
Article 13.2 of EC 2100/94 states that: …the following acts in respect of variety constituents, or harvested material of the protected variety … shall require the authorization of the holder: (a) production or reproduction (multiplication); (b) conditioning for the purpose of propagation; (c) offering for sale; (d) selling or other marketing; (e) exporting from the Community; (f) importing to the Community; (g) stocking for any of the purposes mentioned in (a) to (f).
- 12.
Plant Variety Act 1997 s 8.
- 13.
Plant Variety Protection Act 1997, Article 10(a) (1).
- 14.
Article 30 Indent 3, the Netherlands’ Seeds and Planting Material Act 2005.
- 15.
The Plant Patent Act 1990 (PPA) provides for asexual reproduction protection. In parallel with that, the Plant Variety Protection Act 1970 (PVPA) later amended in 1994 based on the UPOV 1991 Convention, grants protection for sexual and tuber plants, provided all UPOV requirements have been met. Regardless of either plant patent or PVR protection, breeders of new varieties can obtain utility patent protection, if all requirements are met.
- 16.
7 U.S.C. § 2544.
- 17.
Blair Debra L (1999) Intellectual Property Protection and Its Impact on the U.S. Seed Industry. 4 Drake J. Agric. L. 297, 313.
- 18.
Chen Jim (2005) The Parable of the Seeds: Interpreting the Plant Variety Protection Act in Furtherance of Innovation Policy. Notre Dame L Rev 81(4): 105, 135–136.
- 19.
7 U.S.C. §2483(a) (1).
- 20.
According to the House report on the PVPA, the “use of [a] protected variety in producing the commercial class of seed of [that] variety constitutes infringement.” See H.R. REP. No. 91-1605(1970), 11.
- 21.
Chen, supra note 18,138–139.
- 22.
McEowen Roger (2004) A Legal Issues Related to the Use and Ownership of Genetically Modified Organisms. Washburn L J 43: 611, 631 n.120.
- 23.
S.16 Plant Breeder’s Rights Act 1994, No. 110, 1994.
- 24.
Ibid.
- 25.
Ibid.
- 26.
Davison Mark J, Monotti, Ann L and Wiseman, Leanne (2015) Australian Intellectual Property Law. Cambridge University Press, Cambridge, p. 683.
- 27.
Roberts, Tim (2002) Plant Variety Rights—the Breeder’s Exemption. Paper presented at the WIPO–UPOV Symposium on the Coexistence of Patents and Plant Breeders’ Rights in the Promotion of Biotechnological Developments, Geneva, Switzerland, October 25, p. 13. http://www.upov.int/edocs/pubdocs/en/upov_pub_792.pdf. Accessed 1 August 2018.
- 28.
Muscati Sina Muscati (2005) Terminator Technology: Protection of Patents or a Threat to the Patent System. IDEA 45: 477, 497.
- 29.
Prifti V (2015) The Breeder’s Exception to Patent Rights, International Law and Economics. Springer International Publishing, Switzerland, p. 97.
- 30.
Hsu Shun-Liang (2016) A comparative study on research exemptions in plant breeding under intellectual property rights protection. Queen Mary Journal of Intellectual Property. 6(1): p. 102.
- 31.
Essentially derived varieties may be obtained, for example by the selection of a natural or induced mutant, or of a somaclonal (tissue cultured plant) variant, the selection of a variant individual from plants of the initial variety, backcrossing, or transformation by genetic engineering. See Article 14 (3) of UPOV 1991.
- 32.
Chongxi Li (2002) The research on intellectual property rights and regulatory systems of agricultural biotechnology. Dissertation, Taiwan University, p. 67.
- 33.
Roberts, supra note 27, p. 5.
- 34.
Section 22 Plant Breeders Rights Act 1994 (Australia).
- 35.
Xuhong Yang (2005) Australia plant breeders’ rights law “and the characteristics of our country” and New Plant Varieties Protection Ordinance, and Wang Limin, Huang Wushuang, editor in chief: “The research of intellectual property law” (second volume), Peking University Press, p. 54.
- 36.
Rives Elisa (2001/2002) Comment: Mother Nature and the Courts: Are Sexually Reproducing Plants and Their Progeny Patentable under the Utility Patent Act of 1952? Cumb. L. Rev. 32:187, 204.
- 37.
Prifti, supra note 29, pp. 93–94.
- 38.
Whittemore v Cutter .29F.Cas.1120, 1121 (C.C.D. Mass. 1813). (No. 17600).
- 39.
Sawin v. Guild, 21F. Cas. 554 (C.C.D. Mass. 1813) (No. 12391).
- 40.
Robinson William (1890) The Law of Patents for Useful Inventions §898, quoted in Mueller Janice M (2001) No “Dilettante Affair”: Rethinking the Experimental Use Exception to Patent Infringement for Biomedical Research Tools’. Washington Law Review, 86: 1, 21.
- 41.
Jones v Pearce, Webster’s Patent Case 122 (K.B. 1832).
- 42.
Roche Prods., Inc. v. Bolar Pharm. Co., 733 F.2d 858, 860 (Fed. Cir.1984).
- 43.
35 U.S.C. § 271(e)(1) (2010).
- 44.
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661, 675-76 (1990).
- 45.
775 F. Supp. 1269 (1991).
- 46.
Deuterium Corp.v. United States, 19 Cl. Ct. 624, 634. (Fed. Cir. 1990).
- 47.
Embrex Inc. V. Service Engineering Corp. 216 F. 3d 1343, 1349. (Fed. Cir. 2000).
- 48.
Madey v. Duke University, 307 F. 3d 1351 (Fed. Cir. 2002), cert. denied, 469 U.S. 856. (U.S. 2003).
- 49.
See Cai Michelle (2004) Madey v. Duke University: Shattering the Myth of universities’ Experimental Use Defense. Berkeley Technology Law Journal. 175–192.
- 50.
See Pate Gregory N (2002) Analysis of the Experimental Use Exception. N.C. J. L. & Tech 3: 253, 261–2.
- 51.
Johnson Jennifer J (2003) The Experimental Use Exception in Japan: A Model for U.S. Patent Law? Pac. Rim L. & Pol’y 12(3) pp. 501–502.
- 52.
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- 53.
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- 54.
Section 60(5)(b) Patent Act, United Kingdom.
- 55.
Section 60(5) (a) and (b) of the United Kingdom Patent Act provides: “(5) An act which, apart from this subjection, would constitute an infringement of a patent for an invention shall not do so if (a) It is done privately and for purposes which are not commercial; (b) It is done for experimental purposes relating to the subject-matter of the invention”.
- 56.
BOOK VI Protection of Inventions and Technical Knowledge, Intellectual Property Code, English translation at https://www.legifrance.gouv.fr/content/download/1959/13723/…/3/…/Code_35.pdf. Accessed 21 August 2018.
- 57.
See Smith Kline & French Labs. Ltd. v. Evans Med. Ltd., (1989) 1 F.S.R. 513 (U.K.), 1988 WL 623784.
- 58.
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- 59.
A notice of the National Institutes of Health published in 1999 made the definition of a wide range of research tools, including cell lines, monoclonal antibodies, reagents), animal models, growth factors, combinatorial chemistry and DNA libraries, clones, cloning tools, methods and experimental device laboratory equipment and machines.
- 60.
Mueller, J. M. (2001) No ‘Dilettante Affair’: Rethinking the experimental use exception to patent infringement for biomedical research tools’. Washington Law Review, 76:72.
- 61.
Strandburg Katherine J (2004) What Does The Public Get? Experimental Use and the Patent Bargain. Wis. L. Rev. 81: 123.
- 62.
Article XI.34.b Code of Economic Law, Belgium; Prifti, V (2015) The Breeder’s Exception to Patent Rights, International Law and Economics, Conceptualizing the Breeding Exception to Patent Rights: A Legal and Economic Appraisal. Springer International Publishing, Switzerland p. 94.
- 63.
Details on the court and signatories to date, are available at, http://www.consilium.europa.eu/en/documents-publications/treaties-agreements/agreement/?id=2013001&DocLanguage=en. Accessed 21 August 2018.
- 64.
Prifti, supra note 29, p. 96.
- 65.
Straus Joseph (2002) Measures Necessary for the Balanced Co-Existence of Patents and Plant Breeders’Rights—A Predominantly European View, WIPO-UPOV Symposium on the Co-Existence of Patents and Plant Breeders’ Rights in the Promotion of Biotechnological Developments, Geneva, October 25 2002. http://www.upov.int/meetings/en/Symposium2002/index.html Accessed 15 August 2016.
- 66.
Harabi N (1996). Patents in theory and practice: Empirical results from Switzerland. Munich Personal RePEc Archive. http://mpra.ub.uni-muenchen.de/9606/. Accessed 15 August 2016.
- 67.
Prifti, supra note 29, p. 97.
- 68.
Janis Mark D. (2001) Sustainable Agriculture, Patent Rights, and Plant Innovation. Indiana Journal of Global Legal Studies 9(1) Article 6, p. 117.
- 69.
Hovenkamp Herbert, Janis, Mark D Lemley, Mark A, Leslie, Christopher R and Carrier, Michael A (2002) IP and Antitrust: An Analysis of Antitrust Principles Applied to Intellectual Property Law. Wolters Kluwer Legal & Regulatory, US.
- 70.
Most countries have taken UPOV as the basis for the sui generis system for plant protection demanded by TRIPS Article 27(3), even if they allow for patents. Symposium on possible interrelations between the International Treaty on Plant Genetic Resources for Food and Agriculture and the International Convention for the Protection of New Varieties of Plants, 26 October 2016 in Geneva, Switzerland. http://www.fao.org/3/a-bs781e.pdf. Accessed 21 August 2018.
- 71.
Prifti, supra note 29, pp. 218–239.
- 72.
For Germany, see section 11.2.b of the Patent Gesetz, 2005; For France, article L. 613-5-3 of the Code de la Propriete Intellectuelle 2004, and for Switzerland, article 9(e) of the Loi fe´de´rale sur les brevets d’invention, 2008. It should be noted that article 27(c) of the recent Agreement on a Unified Patent Court (Unitary Patent) also provides for a breeding exemption. It remains to be seen whether European Union (EU) countries will implement such provision into their national patent laws.
- 73.
Article 27(1) TRIPS Agreement provides:
1. Subject to the provisions of paragraphs 2 and 3, 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. Subject to paragraph 4 of Article 65, paragraph 8 of Article 70 and paragraph 3 of this Article, patents shall be available and patent rights enjoyable without discrimination as to the place of invention, the field of technology and whether products are imported or locally produced.
(Article 65 relates to Transitional Arrangements and Article 70 to Existing Subject Matter at the time of the agreement.).
- 74.
Janis, supra note 68, p. 116.
- 75.
McManis Charles R (2002) Are There TRIPS-Compliant Measures for a Balanced Co-Existence of Patents and Plant Breeders’ Rights? Some Lessons from the United States of America’s Experience to Date, WIPO–UPOV. Intellectual Property Rights. http://14.139.60.114:8080/jspui/bitstream/123456789/730/8/Are%20There%20TRIPS-compliant%20Measures%20for%20a%20Balanced%20Co-existence.pdf. Accessed 15 August 2016.
- 76.
Prifti, supra note 29, p 235.
- 77.
Hall, B., & Harhoff, D. (2012). Recent research on the economics of patents. Annual Review of Economics, 4, pp. 541–565.
- 78.
Prifti, V (2015) The Breeder’s Exception to Patent Rights, International Law and Economics. Springer International Publishing, Switzerland p. 146.
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Wan, Z., Perry, M. (2019). Breeding Exemption in Plants Under Intellectual Property Regimes. In: Corbin, L., Perry, M. (eds) Free Trade Agreements. Springer, Singapore. https://doi.org/10.1007/978-981-13-3038-4_6
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