Abstract
International patent regime faces a great challenge to cope up with the new biotechnological advances. The international patent regime struggles to provide effective patent protection to biotechnology inventions (especially genetic inventions). The TRIPS Agreement sets minimum standards for the member nations to follow while granting patents; however, it leaves potential gaps and uncertainties as to the scope of numerous terms such as invention, microorganisms, microbiological processes and essentially biological processes. These gaps and uncertainties affect developing countries seriously given their relatively slow pace of scientific and technological development. The technology-neutral character of TRIPS does not allow special treatment to biotechnology inventions. International patent regime is the result of the efforts made by member nations to harmonise the patent laws and provide a uniform set of standards for the world. However, in the context of biotechnology patents, the divergence in patent practices among member nations makes it difficult to provide a uniform standard for the whole world. Moreover, there is a political divide between developed and developing countries as developed countries push for expanding the scope of patent eligible subject matter boundary by eliminating the exceptions from the text of TRIPS while developing countries are against this approach. In the biotechnological context, creating a single set of patenting guidelines for the entire world has proved very difficult to achieve given the controversy over issues such as patenting plants and animals. Both uniformity and diversity have potential and pitfalls, and the relevant question is to what extent inter-jurisdictional diversity and competition should be sacrificed to achieve global uniformity.
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Notes
- 1.
Loughlan (1998).
- 2.
Bera (2009).
- 3.
Smith (2000).
- 4.
Ibid.
- 5.
Ibid.
- 6.
Ibid.
- 7.
Ibid.
- 8.
Habiba (2009).
- 9.
Id. at 65.
- 10.
McManis (2003).
- 11.
Art. 27.1 of the TRIPS Agreement.
- 12.
McManis, supra note 10, at 83–84.
- 13.
Id. at 88.
- 14.
Id. at 88–89; referring to Carlos M. Correa, Intellectual Property Rights, The WTO and Developing Countries; The TRIPS Agreement and Policy Options, 63 (2000).
- 15.
Id. at 89.
- 16.
Ibid.
- 17.
Ibid. See Brazilian Patent Law Article 10.1X, Law 9279, (1996).
- 18.
Id. at 89–90.
- 19.
Dutfield (2009).
- 20.
Palombi (2003).
- 21.
The Netherlands (supported by Italy and another) v European Parliament and another (supported by the European Commission) [2002] All ER (EC) 97.
- 22.
Palombi, supra note 20, at 34.
- 23.
Ibid.
- 24.
Id. at 35.
- 25.
Ibid.
- 26.
Ibid.
- 27.
Ibid.; quoting Rebecca S. Eisenberg, ‘Re-examining the role of patents in appropriating the value of DNA Sequences’, 49 Emory Law Journal 783 (2000).
- 28.
Ibid.
- 29.
Art. 27.2 of the TRIPS Agreement.
- 30.
Id. Art. 27.3.
- 31.
McManis, supra note 10, at 83–84.
- 32.
Dutfield, supra note 19.
- 33.
Resource Book on TRIPS and Development 375 (Cambridge University Press, New York, 2005).
- 34.
Available at http://www.thefreedictionary.com/Moral+system (last visited on June 20, 2012).
- 35.
Supra note 33.
- 36.
Id. at 376.
- 37.
Ibid.
- 38.
Habiba, supra note 8, at 70.
- 39.
Smith, supra note 3.
- 40.
Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980).
- 41.
Curci (2005).
- 42.
Ibid.
- 43.
Enrico Bonadio, “Biotechnology and patent law”, available at http://www.dpsd.unimi.it/Italian_Intellectual_Property/archive/biotech.pdf. (last visited May 2, 2012).
- 44.
Green Peace Ltd v. Plant Genetic System N.V. (Case no. T 0356/93-334 dated 21-02-1995) Point 34.
- 45.
Sekar and Kandavel (2004).
- 46.
Bonadio, supra note 41; See the position taken by the European Community in the WTO document IP/C/W/383; See also Blakeney (2002).
- 47.
Smith, supra note 3.
- 48.
Art. 27.3(b) of TRIPS.
- 49.
Smith, supra note 3.
- 50.
Ibid.; According to this notion, “classical breeding methods are not patentable,” but genetic engineering methods are patentable.
- 51.
Art. 27.3(b) of TRIPS Agreement.
- 52.
Smith, supra note 3 (Non-biological processes would also include cultivation methods).
- 53.
Ibid.
- 54.
See Art. 2.2 of the EC Directive.
- 55.
Bonadio, supra note 43.
- 56.
Supra note 44 (See point 28 of the Decision).
- 57.
Bonadio, supra note 43.
- 58.
Ibid.
- 59.
Art. 27.3(b) of TRIPS Agreement.
- 60.
Smith, supra note 3.In Europe, plant varieties are protected under “breeder’s rights” and may not be patented. In both Japan and the United States, however, plant varieties are patentable.
- 61.
Ibid. (For example, a system combining patents with other forms of IPR protections might allow for incorporation of “farmer’s rights” which recognize and compensate for the “ancestral contributions” of traditional farmers in developing new plant varieties).
- 62.
Ibid. (The three-sentence article contains nine terms whose meanings are open to debate: “plants, animals, micro-organisms, essentially biological processes, non-biological, microbiological, plant varieties, effective and sui generis system”).
- 63.
Dutfield, supra note 19 at 250.
- 64.
Smith, supra note 3; Art. 27.3(b) of TRIPS Agreement. (The provisions of this subparagraph shall be reviewed 4 years after the date of entry into the force of the WTO Agreement. The WTO Agreement entered into force on January 1, 1995.)
- 65.
Ibid.
- 66.
Ibid.
- 67.
Ibid.
- 68.
This is the approach advocated by most developed nations. Although these countries would eventually like to see many of the vague terms of Article 27.3(b) defined or deleted, they are concerned that any immediate attempt to change the terms will lead to a weakening of IPR provisions. Ibid.
- 69.
Ibid. (This is the viewpoint espoused by many developing nations unhappy with any delineation of plants and animals as patentable materials).
- 70.
McManis, supra note 10 at 93–94.
- 71.
Ibid.
- 72.
Ibid.
- 73.
Ibid.
- 74.
Ibid.
- 75.
Ibid; See Doha WTO Ministerial 2001: Ministerial Declaration, WT/MIN(01)/DEC/1, Nov. 20, 2001, adopted Nov. 14, 2001, para. 17 and 19 [hereinafter Doha Declaration] para. 19; See also para. 17 (stressing the importance of implementing and interpreting the TRIPS Agreement “in a manner supportive of public health, by promoting both access to existing medicines and research and development into new medicines,” in connection with which the Doha Ministerial issued a separate, and more detailed declaration.
- 76.
Id. at 93–94.
- 77.
Ibid. (If isolated genetic sequences as such or isolated genetic sequences as inserted in an organism in which they do not appear in nature are indeed patentable subject matter, it will make little practical difference whether the larger macroorganisms into which they are inserted are or are not themselves patentable, as their genetic sequences, in any event, cannot be `made used, offered for sale, sold, or imported without the consent of the patent owner).
- 78.
Id. at 82.
- 79.
Ibid.
- 80.
European Patent Convention, Oct. 5, 1973, as amended Dec. 21, 1978.
- 81.
McManis, supra note 10, at 82.
- 82.
Id.at 82–83; Compare Arts. 52(4) and 53 of the EPC with Art. 27.2 and 27.3. The text of EPC Articles 52(4) and 53 are as follows: “Article 52: Patentable Inventions (4) Methods for treatment of the human or animal body by surgery or therapy and diagnostic methods practiced on the human or animal body shall not be regarded as inventions which are susceptible of industrial application within the meaning of paragraph 1. This provision shall not apply to products, in particular substances or compositions, for use in any of these methods. Article 53: Exceptions to Patentability European patents shall not be granted in respect of: (a) inventions the publication or exploitation of which would be contrary to “ordre public” or morality, provided that the 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 does not apply to microbiological processes or the products thereof.”
- 83.
Id. at 83.
- 84.
Ibid.
- 85.
Ibid.
- 86.
Smith, supra note 3.
- 87.
Ibid.
- 88.
Ibid.
- 89.
Ibid.
- 90.
Ibid.
- 91.
Ibid; Article 71.2 of the TRIPs Agreement outlines the limited situation in which modification actions may be taken by force of recommendation from the TRIPs Council, stating that:
[a]mendments merely serving the purpose of adjusting to higher levels of protection of intellectual property rights achieved, and in force, in other multilateral agreements and accepted under those agreements by all Members of the WTO may be referred to the Ministerial Conference for action in accordance with paragraph 6 of Article X of the WTO Agreement on the basis of a consensus proposal from the Council for TRIPs.
It is unlikely that a more general ability to circumvent the amendment procedure was intended in Article 71.1.
- 92.
Ibid.;It is noteworthy, however, that the potential bypass of the consensus-based decision making of the Ministerial Conference was suggested specifically in relation to revision of Article 27.3(b).
- 93.
Ibid.
- 94.
Ibid.;Article 27.3(b) is not the only provision of the TRIPs Agreement susceptible to interpretation and expansion through the DSU mechanism. For example, Article 41.5 gives member states the right not to augment their judicial and administrative systems in order to provide for TRIPs-required IPR protection. Many developing countries have rudimentary infrastructures and limited resources to administer the requisite IPR framework. Dispute panels are likely to be faced with the challenge of distinguishing between will full non-compliance with the obligations of the agreement and genuine lack of capacity to do so.
- 95.
Ibid.
- 96.
Ibid.
- 97.
Ibid.; Governments may refrain from following reasonable and appropriate interpretations of the Article’s terms out of fear of opening themselves to costly legal challenges.
- 98.
Ibid.
- 99.
- 100.
Ibid.
- 101.
Ibid.
- 102.
Ibid.; The degree of flexibility granted to countries to determine the level of inventive step requirement is illustrated by the history of the European patent system:… There is no reasonable exact measure for inventive step. It was known that the Dutch Patent Office has used such a high degree [of inventive step] that the percentage of grants was relatively low there. This was also known by the first President of the European Patent Office, Mr. Van Benthem, who was earlier the President of the Dutch Patent Office. Because of this experience, Mr. Van Benthem convened, before starting work at the European Patent Office, a conference of practitioners who submitted their views whether they preferred “a high, middle or lower degree of inventive step for the examination of European patent applications.” See Heinz Bardehle, Regional Approaches: European Patent System, presentation to the Conference on The International Patent System, WIPO, Geneva, Mar. 25–27, 2002.
- 103.
Ibid.; See World bank, global economic prospects and the developing countries 2002, at 143 (2001).
- 104.
Art. 29 of TRIPS Agreement.
- 105.
Habiba, supra note 8, at 73.
- 106.
Sekar & Kandavel, supra note 45 at 214.
- 107.
Id. at 214–215.
- 108.
Smith, supra note 3.
- 109.
Ibid.
- 110.
Ibid.
- 111.
Ibid.
- 112.
Ibid.
- 113.
Art. 27(1) of the TRIPS Agreement provides “patents shall be available…without discrimination as to…the field of technology”
- 114.
Keim (2007).
- 115.
Ibid.
- 116.
Ibid.
- 117.
Ibid.
- 118.
Ibid.; See Grain, “TRIPS-plus” through the back door: How bilateral treaties impose much stronger rules for IPRs on life than the WTO (2001) (available at http://www.grain.org/briefings/?id=6, last visited May 8, 2012).
- 119.
Ibid.; See The US-Jordan FTA, Arts. 18(a), 18(b).
- 120.
Ibid.; See WIPO Magazine, Patent Law Harmonization: What Happened?, (2006) (available at http://www.wipo.int/wipo_magazine/en/2006/03/article_0007.html, last visited May 8, 2012).
- 121.
Ibid.; See 2006 Patent cooperation treaty conference: transcript of proceedings, 32 Wm. Mitchell L. Rev. 1603,1655–1657 (2006).
- 122.
Correa, supra note 99.
- 123.
Ibid.
- 124.
Ibid.; See World bank, global economic prospects and the developing countries 2002, at 129 (2001).
- 125.
Ibid.; See World bank, global economic prospects and the developing countries 2002, at 147 (2001).
- 126.
Ibid.
- 127.
Ibid. (Thus, the Brazilian patent law (1996), stipulates that no patents shall be granted with respect to living beings or “biological materials found in nature,” even if isolated, including the “genome or germplasm” of any living being).
- 128.
Ibid.; See, e.g., The proposal for review of article 27.3(b) of the TRIPS Agreement submitted by Kenya on behalf of the African countries, WT/GC/W/302, Aug. 6, 1999.
- 129.
Duffy (2002).
- 130.
Ibid.
- 131.
Smith, supra note 3.The primary benefit of harmonization is the encouragement of research in beneficial areas and the stimulation of the marketing and distribution of the fruits of those labors worldwide. In the short term, these benefits will accrue most directly to developed countries. Id. In the long run, however, developing countries are also expected to reap these benefits and profit from an attendant increase in the transfer of technology.
- 132.
Smith, supra note 3.
- 133.
Ibid.
- 134.
Ibid.
- 135.
Ibid.
- 136.
Ibid.
- 137.
Ibid.
- 138.
Bera, supra note 2.
- 139.
Reichman and Dreyfuss (2007).
- 140.
Bera, supra note 2.
- 141.
Art. 1.1 of the TRIPS Agreement.
- 142.
Bera, supra note 2.
- 143.
Ibid.; See Art. 27(3)(a) of the TRIPS Agreement.
- 144.
Ibid.; See Art. 27(2) of the TRIPS Agreement.
- 145.
Bera, supra note 2 at 456.
- 146.
Ibid.
- 147.
Ibid.
- 148.
Dutfield, supra note 19 at 273.
- 149.
Ibid.
- 150.
Ibid.
- 151.
Id. at 274.
- 152.
Ibid.
- 153.
Id. at 285.
- 154.
Id. at 286.
- 155.
Ibid.
- 156.
Ibid.
- 157.
Ibid.
- 158.
Id. at 287.
- 159.
GRAIN (2002), “WIPO moves toward “world” patent system”, available at http://www.grain.org/system/old/docs/wipo-patent-2002-en.pdf (last visited on May 10, 2012).
- 160.
Ibid.
- 161.
Ibid.
- 162.
Ibid.
- 163.
Ibid.
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Singh, K. (2015). Patentability of Biotechnology Under the International Patent Regime: Differentiation v. Harmonisation. In: Biotechnology and Intellectual Property Rights. Springer, New Delhi. https://doi.org/10.1007/978-81-322-2059-6_3
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