Palombi, Luigi --- "Patentable Subject Matter, TRIPS and the European Biotechnology Directive: Australia an Patenting Human Genes" [2003] UNSWLawJl 53; (2003) 26(3) UNSW Law Journal 782
[*] The author has been an Australian solicitor and barrister for 22 years. He practiced exclusively in the field of intellectual property law in Australia from 1986 until 1997 and since then has consulted exclusively to the biotechnology and pharmaceutical industry in the US and the European Community. In 2001, his primary focus turned to the development and reform of Australian patent law with respect to genetic sequence patents. He is presently a PhD candidate in the Faculty of Law at the University of New South Wales. Between 1989 and 1994 he served on the national committee of the Intellectual Property Society of Australia and between 1991 and 1994 served as chairman of the NSW chapter and national joint vice president of the Society.
[1] Agreement on Trade-Related Aspects of Intellectual Property Rights, opened for signature 15 April 1994, 1869 UNTS 299, 33 ILM 1197 (entered into force 1 January 1995) (‘TRIPS’).
[2] Directive of the European Parliament and of the Council on the Legal Protection of Biotechnological Inventions, 98/44/EC, (6 July 1998), 13–21 (‘European Biotechnology Directive’).
[3] European Biotechnology Directive, 98/44/EC, recital 18.
[4] European Biotechnology Directive, 98/44/EC, art 1.1.
[5] European Biotechnology Directive, 98/44/EC, art 3.2.
[6] Section 76A of the Patents (Amendment) Act 2000 (UK) states:
(1) An invention shall not be considered unpatentable solely on the ground that it concerns –
(a) a product consisting of or containing biological material; or
(b) a process by which biological material is produced, processed or used.
(2) Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of an invention even if it previously occurred in nature.
(3) 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 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.
[7] Biotechnological invention is defined to mean ‘an invention which concerns a product consisting of or containing biological material or a process by means of which biological material is produced, processed or used’.
[8] Biological material is defined to mean ‘any material containing genetic information and capable of reproducing itself or being reproduced in a biological system’.
[9] The Netherlands v European Parliament [2002] All ER (EC) [97].
[10] Ibid [36].
[11] Diamond, Commissioner of Patents v Chakrabarty, [1980] USSC 119; 447 US 303, 310 (1980) (‘Diamond v Chakrabarty’). The Court held:
Here, by contrast, the patentee has produced a new bacterium with markedly diferent characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under s 101: 310 (emphasis added).
[12] Commission of The European Communities, Development and Implications of Patent law in the Field of Biotechnology and Genetic Engineering, Final Report, (2002) 545.
[13] Ibid 17, [2] (emphasis added).
[14] [1980] USSC 119; 447 US 303 (1980).
[15] Commission of The European Communities, above n 12, 17, [4] (emphasis added).
[16] TRIPS, art 27.1 (emphasis added).
[18] Ibid 663, lines 3–12, 17, 26–33.
[19] Ibid 670, lines 35–40.
[20] Miranda Duigan and Michael Dowling, ‘Threshold Test of Manner of Manufacture in Australia – What Next?’ (1998) 105 Patent World 26; Mary Padbury, ‘Inventiveness Apart From Novelty and Inventive Step – The High Court Decisions of Manner of Manufacture in Philips and Ramset’, (1998) 9 Australian Intellectual Property Journal 161.
[21] Intellectual Property and Competition Review Committee, Parliament of Australia, Review of Intellectual Property Legislation Under the Competition Principles Agreement (2000).
[22] Ibid 16.
[23] Philips (1995) 183 CLR 655, [8]–[9]:
The primary focus of inquiry should, as we have indicated, be upon the opening words (‘a patentable invention is an invention that’) of that sub-section which impose a threshold requirement which must be satisfied before one reaches that contained in the body of para (a). The effect of those opening words of s 18(1) is that the primary or threshold requirement of a ‘patentable invention’ is that it be an ‘invention’.
[24] 35 USC s 101 (patentable subject matter); 102 (novelty); 103 (obviousness). See introductory section in Donald L Zuhn, Jr, ‘DNA Patentability: Shutting The Door To The Utility Requirement’ (2001) 34 John Marshall Law Review 973 for an explanation of the test applied by United States’ Courts.
[25] Patents Act 1990 (Cth) sch 1.
[26] Patents Act 1990 (Cth) sch 1.
[27] TRIPS, art 27.1.
[28] Section 6 of the Statute of Monopolies 1623 (Imp) 21 Jac I, c 3 provides:
That any Declaration before-mentioned shall not extend to any Letters Patents and Grants of Privilege for the Term of Fourteen Years or under, hereafter to be made, of the sole Working or Making of any Manner of new Manufactures within this Realm, to the true and first Inventor and Inventors of such Manufactures, which others at the Time of Making such Letters Patents and Grants shall not use, so as also they be not contrary to the Law, nor mischievous to the State, by raising Prices of Commodities at home, or Hurt of Trade, or generally inconvenient: The said Fourteen Years to be accounted from the Date of the first Letters Patents, or Grant of such Privilege hereafter to be made, but that the same shall be of such Force as they should be, if this Act had never been made, and of none other.
[29] ‘The industrial capability requirement arises from the reference to s 6 of the Statute of Monopolies and the words “manner of … manufacture”’: Industrial Property Advisory Committee, Parliament of Australia, Patents, Innovation and Competition in Australia, Report to the Minister for Science and Technology (1984) 40.
[30] Genentech Inc’s Patent [1987] RPC 553, 566 (Whitford J); See also Gale’s Application [1991] RPC 305.
[31] [1959] HCA 67; (1959) 102 CLR 252.
[32] Ibid 264.
[33] [1980] USSC 119; 447 US 303 (1980).
[34] Recital 18 of the European Biotechnology Directive, 98/44/EC.
[35] For example, in April 2003, Chiron Corporation, a US biotechnology company, announced its takeover of PowderJect Pharmaceuticals, a European biotechnology company. See also Andrew Scott, ‘Tough Times for European Biotech’ (2003) 17(15) The Scientist 52.
[36] European Commission, Communication from the Commission to the European Parliament, to the Council and to the European Economic and Social Committee Life Sciences and Biotechnology – A Strategy for Europe Progress Report and Future Orientations (2003) 96.
[37] Ibid 3.
[38] Ibid 9.
[39] Ibid 15.
[40] (Case C-377/98) [2002] All ER (EC) [97].
[41] Ibid [229].
[42] Rebecca S Eisenberg, ‘Re-examining the Role of Patents in Appropriating the Value of DNA Sequences’ (2000) 49(3) Emory Law Journal 783.