Abstract
Regulating biotech patents means balancing the different needs of ethics, economy and scientific research. In order to face this difficult task, the international perspective is fundamental. Directive 98/44/EC regulates the issue, and it went through a complex path before seeing the light: different proposals were presented, amended and rejected. Also after the final approval the directive was challenged in front the Court of Justice. The applicants in particular denounced the breach of the principle of legal certainty, of obligations under International Law, of fundamental rights. Italy implemented the Directive with many difficulties and, in the end, Law 22 February 2006 n.78 adopted a very restrictive perspective. The normative difficulties that have been developing in the last decade are still very topical and controversial: that’s why it is necessary to continue discussing.
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Notes
- 1.
See V. Di Cataldo, Biotecnologie e diritto. Verso un nuovo diritto, e verso un nuovo diritto dei brevetti, in Contratto e Impresa, 2003. Ricolfi defines such position “orthodox” in La brevettazione delle invenzioni riguardanti gli organismi geneticamente modificati, in Riv. Dir. Ind., 2003, I, p. 33.
- 2.
Association Internationale pour la Protection de la Propriété Intellectuelle, a NGO founded in 1897 and based in Zurich.
- 3.
Then modified by Directive 98/81/EC, Directive 2001/204/EC, Regulation (EC) No 1882/2003, Directive 2005/174/EC.
- 4.
Repealing Council Directive 90/220/EEC and then modified by Regulation (EC) No 1829/2003, Regulation (EC) No 1830/2003, Directive 2008/27/EC.
- 5.
Art.145: “Differences in intellectual property laws have a direct and negative impact on intra- Community trade and on the ability of enterprises to treat the common market as a single environment for their economic activities”.
- 6.
Proposal for a Council Directive on the Legal Protection of Biotechnological Inventions of 17 October 1988.
- 7.
Official Journal C 295, 07/10/1996 P. 0011.
- 8.
Proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions (COM (95)0661 - C4-0063/96 - 95/0350(COD)).
- 9.
Opinion n.8/1996.
- 10.
Opinion n.8/1996. Amended proposal for a European Parliament and Council Directive on the legal protection of biotechnological inventions. COM (97) 446 final, 29 August 1997.
- 11.
Official Journal L 213, 30/07/1998 P. 0013-0021.
- 12.
Case C-377/98.
- 13.
The EPC, or, more properly, he Convention on the Grant of European Patents, was signed in Munich on 5 October 1973.
- 14.
Paragraph 17 of the Judgement.
- 15.
Paragraph 20 of the Judgement.
- 16.
Paragraph 25 of the Judgement.
- 17.
Industrial development: Recital 1. Research: Recitals 2, 10, 11, 14, 17, 18, 45.
- 18.
Paragraph 27 of the Judgement.
- 19.
“Under the principle of subsidiarity, in areas which do not fall within its exclusive competence, the Union shall act only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States, either at central level or at regional and local level, but can rather, by reason of the scale or effects of the proposed action, be better achieved at Union level”.
- 20.
“Whereas differences exist in the legal protection of biotechnological inventions offered by the laws and practices of the different Member States; whereas such differences could create barriers to trade and hence impede the proper functioning of the internal market”.
- 21.
“Whereas such differences could well become greater as Member States adopt new and different legislation and administrative practices, or whereas national case-law interpreting such legislation develops differently”.
- 22.
“Whereas uncoordinated development of national laws on the legal protection of biotechnological inventions in the Community could lead to further disincentives to trade, to the detriment of the industrial development of such inventions and of the smooth operation of the internal market”.
- 23.
Paragraph 33 of the Judgement.
- 24.
Quoted in Artt.4, 8, 9 and in Recitals 31 and 32.
- 25.
“Members may exclude from patentability inventions, 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 exclusion is not made merely because the exploitation is prohibited by their law”.
- 26.
“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”.
- 27.
“Trademarks covered by this Article may be neither denied registration nor invalidated except in the following cases: […] (iii) when they are contrary to morality or public order and, in particular, of such a nature as to deceive the public. It is understood that a mark may not be considered contrary to public order for the sole reason that it does not conform to a provision of the legislation on marks, except if such provision itself relates to public order”.
- 28.
“The Contracting States shall not be bound to provide for the grant of patents 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 a law or regulation”.
- 29.
For instance in Artt. 36, 45, 52 TFEU.
- 30.
Art.7.1 f), Art.66.
- 31.
Art.3.
- 32.
Official journal NO. L 227, 01/09/1994 P. 0001-0030. Artt. 13, 63 e).
- 33.
Recital 16, Art.8.
- 34.
Van Duyn, Case 41/74 of 4 December 1974.
- 35.
30/77, E.C.R. 1999, 2014, (1977).
- 36.
Rutili v. Minister for the Interior, Case 36/75, E.C.R. 1219, 1231, (1976).
- 37.
As quoted before, Regina v. Bouchereau, Case 30/77, E.C.R. 1999, 2014, (1977).
- 38.
Art.6.
- 39.
Art.6.2.
- 40.
See the famous “oncomouse case”: the so called “oncomouse” was a mouse genetically modified in the Harvard University laboratories with a particular gene (an activated oncogene) that made it particularly adapt for cancer research. It was patented in the US, Canada, Japan and also in Europe through the EPO (European patent n. 0169672), raising strong reactions, appeals and subsequent amendments.
- 41.
Environment is quoted in Recital 36 of the Directive (which is inspired by Art.27 TRIPS) and in Art.3 paragraph 3 TFEU. Also In the praxis of EPO the environment is part of morality (see the Plants/Novartis case decided by t he Enlarged Board of EPO on 21 December 1998, case G1/98).
Hybrids are quoted in Recital 38 and according to the European Parliament they are also part of the exceptions of Art.6.2.
As regards vegetal varieties, it is not possible to patent a modification of the variety, but it is allowed to patent a species. Protection is given also to products that come from reproduction or multiplication. Then the Directive regulates a system of compulsory cross-licensing (Art.12) in case of reciprocal violation of biotech patents and plant patents.
- 42.
This, as stated before, prohibits patentability of inventions whose commercial exploitation would be contrary to ordre public or morality.
- 43.
This is referred to publication and exploitation of inventions contrary to ordre public.
- 44.
Paragraph 61 of the judgement.
- 45.
Paragraph 64 of the judgement.
- 46.
“An element isolated from the human body or otherwise produced by means of a technical process, including the sequence or partial sequence of a gene, may constitute a patentable invention, even if the structure of that element is identical to that of a natural element”.
- 47.
“Whereas if an invention is based on biological material of human origin or if it uses such material, where a patent application is filed, the person from whose body the material is taken must have had an opportunity of expressing free and informed consent thereto, in accordance with national law”.
- 48.
About consent see Moore v. Regents case, decided by the Supreme Court of California on 9 July 1990. John Moore had leukaemia and he underwent removal of the spleen. From that organ, the doctors and scientists of the UCLA Medical Centre created a cell line, the famous T lymphocytes then called “Mo cells”, that were commercialized as medicine for many pathologies. The Court of Appeals recognized that Mr. Moore was the owner of the cells, but the last grade reversed the situation: the cells were considered as the result of the inventive efforts of the scientists and Mr. Moore had only the right to damages.
- 49.
Decision 2 march 1983 of the European Commission, Appl. 9974/82.
- 50.
It would have requested a Conference of the Parties.
- 51.
Chapter I is entitled “Patentability”, while the other Chapters of the Directive are: Chapter II Scope of protection, Chapter III Compulsory cross-licensing, Chapter IV Deposit, access and re-deposit of a biological material, Chapter V Final provisions.
- 52.
See C. Campiglio, Brevetti biotecnologici: da Lussemburgo a Strasburgo?, in Dir. del Comm. Intern., 2002, at 187 ff.
- 53.
Patent 695 351 EPO, paragraph [0011].
- 54.
Dr. Christian Gugerell, a patent attorney head of the biotechnology section of EPO declared to the British newspaper The Daily Telegraph: “we’ve committed a very serious error. It’s not our practice to grant patents on human beings”.
- 55.
PE 289.398, PE 289.401, PE 289.403, PE 289.409, PE 289.411.
- 56.
Such Law has to be coordinated with the New Code of Industrial Property, in particular Artt.45 ff.
- 57.
Italy authorized the ratification of the Convention with Law 28 March 2001, n.145, but then didn’t deposit the ratification and didn’t emanate the requested implementing regulations.
References
V. Di Cataldo, Biotecnologie e diritto. Verso un nuovo diritto, e verso un nuovo diritto dei brevetti, in Contratto e Impresa, 2003. Ricolfi defines such position “orthodox” in La brevettazione delle invenzioni riguardanti gli organismi geneticamente modificati, in Riv. Dir. Ind., 2003, I, p. 33.
C. Campiglio, Brevetti biotecnologici: da Lussemburgo a Strasburgo?, in Dir. del Comm. Intern., 2002, at 187 ff.
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Zorzoli, C. (2012). Biotechnology Patents Norms: Emerging Difficulties. In: Bin, R., Lorenzon, S., Lucchi, N. (eds) Biotech Innovations and Fundamental Rights. Springer, Milano. https://doi.org/10.1007/978-88-470-2032-0_6
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