TITLE: Administrative Council of the European Patent Office amends Implementing Regulations to the European Patent Convention: Biotechnological Inventions AUTHOR: Dan Leskien (European Coordination, Friends of the Earth) PUBLICATION: Submitted by the author to BIO-IPR DATE: August 1999 ADMINISTRATIVE COUNCIL OF THE EUROPEAN PATENT OFFICE AMENDS IMPLEMENTING REGULATIONS TO THE EUROPEAN PATENT CONVENTION: BIOTECHNOLOGICAL INVENTIONS The Administrative Council of the European Patent Office adopted on 16 June 1999 a far-reaching decision concerning the protection of plant biotechnological innovations.[1] According to the decision, the Directive 98/44/EC on the legal protection of biotechnological inventions[2], adopted by the European Union on 6 July 1998, shall be used by the European Patent Office as a supplementary means of interpretation. The decision might imply that notwithstanding the exclusion of plant varietes and animal races from patentability (Art. 53 b EPC, [3]), the European Patent Office will as of 1 September accept claims relating to plants and animals (irrespective of whether they embrace plant or animal varietes) if the technical feasibility of the invention is not confined to a particular plant or animal variety. The European patent system Patent protection is ensured in the European Union by two different systems, neither of which is based on EU legislation: the national patent systems of the Member States and the European patent system. The European patent system is primarily based on international law, the European Patent Convention (EPC). The EPC does not create a uniform patent but provides applicants with protection in as many of the signatory states as the applicant wishes. Patent applicants may apply for a national patent to the national patent offices; alternatively, they may choose to apply for a European patent to the European Patent Office (EPO). These European patents granted by the EPO fall, once they have been granted, into a bundle of national patents whose validity and effects are determined by the national laws. Consequently, any infringement or revocation actions have to be brought before the national courts of each country for which the European patent has been granted. The European Patent Directive In May 1998, the European Parliament (EP) approved the proposal for a European Directive on the Legal Protection of Biotechnological Inventions. The Directive entered into force on 30 July 1998 and will have to be implemented by the member states of the European Union (EU) within two years. However, in October 1998 the Netherlands filed a suit at the European Court of Justice against the Directive questioning the need for harmonization of European law in this field and the Directive's compatibility with international law. In the meanwhile, Italy joined this legal action. The Directive only aims at harmonizing the national patent laws of the EU member states with regard to biotechnology. The Directive does not establish a separate patent system. More importantly, the Directive is NOT binding for the EPO. The decision of the Administrative Council aims now at bringing the EPC in line with the European Patent Directive, although there is no such legal obligation and although the European Patent Directive might not comply with the EPC with regard to the exclusion of plant varieties from patentability. Patentability of plant and animal varieties Under the EPC, plant and animal varieties are excluded from patentability. The Technical Board of Appeal of the EPO concluded in 1993, in its decision Plant cells/Plant Genetic Systems, that every genetically modified plant is to be considered a plant variety if the genetic modification is stable. Consequently, claims relating to transgenic plants and seeds were generally held to be prohibited. In contrast, the Directive now allows for the patenting of exactly this sort of innovation. Although the Directive verbally excludes plant and animal varieties from patentability, inventions which concern plants or animals shall be patentable if the technical feasibility of the invention is not confined to a particular plant or animal variety. More explicitly, the Directive even states that plant groupings are patentable even if they comprise new varieties of plants. Thus, patents must not be granted for a single plant or animal variety, but may be granted for more than a single variety. This interpretation of the patent exclusion means that specific embodiments of an invention, namely the actual plant variety, shall not be patentable, but that it shall nevertheless be possible to have a broad claim to plants whose scope includes all such varieties. As the Technical Board of the EPO stated recently in a referral decision (T 1054/96 - Transgenic Plant/ NOVARTIS AG, OJ EPO 1998, 511-553), this approach is quite alien to patent law in general. The Board even stated that the approach would leave a fundamental anomaly at the heart of patent law as it relates to plants. In fact, the interpretation seems to be no more reasonable than a law which prohibits bigamy, but allows for polygamy. The interpretation also means that the outcome of applications relating to plant genetic innovations will depend on the verbal skills of the patent attorneys concerned. The Administrative Council decision The Administrative Council decision comes as a surprise for two reasons. The competence of the Administrative Council to take such a decison is at least questionable. Although it has been argued that given the importance of modern plant biotechnology, the EPC should be interpreted in a way supportive of this new technology, the Technical Board stated unambigously in Transgenic Plant/ NOVARTIS AG that it is not the normal function of judges to override existing prohibitions in the law even in response to the field of application of the law changing as a result of major developments such as gene technology. This is a matter for the legislator. More specifically, the Board indicated that the decision might be a matter for a conference of the Contracting States rather than for the Administrative Council. Moreover, the Administrative Council took its decision at a time when the Enlarged Board of Appeal has yet to take a decision on questions relating to the patentability of claims comprising plant varieties (G 1/98). These questions had been referred to the Enlarged Board of Appeal by the Technical Board of Appeal in 1997 (OJ EPO 1997,551). Third parties had been asked to file written statements by the end of March 1999 (OJ EPO 1998,509). Given this pending case, the Administrative Council's decision could be seen as an attempt to influence the outcome of the decision which the Enlarged Board of Appeal is expected to hand down by the end of this year. However, pursuant to Art. 164 (2) EPC the provisions of the EPC shall prevail where they are in conflict with the Implementing Regulations (see G 2/95; G 6/95). Thus, the Enlarged Board of Appeal seems still free to question the legality of the interpretation given by the Administrative Council's decision and may even be free to decide that the Administrative Council's decision is in breach of Art. 53 (b) EPC. Whether this is likely to happen is, of course, a different question. The Board's decision may also have quite some impact on the interpretation of other patent exclusions. If patents notwithstanding the patent exclusion for plant varieties may be granted for more than a single variety, the question arises whether also claims relating to mammals would be allowable although the human body is excluded from patentability. Dan Leskien European Coordination, Friends of the Earth Email: 100703.771(at)compuserve.com Links to the legal texts in English: [1] http://www.european-patent-office.org/epo/ca/e/16_06_99_imp l_e.htm size=3> [2] http://europa.eu.int/eur-lex/en/lif/dat/1998/en_398L0044.ht ml