The International Consortium on Agricultural Biotechnology Research (ICABR)



The Legal and Economic Implications of the European Patent Office’s December 1999 Decision on the Patentability of Transgenic Plants


John Harbison, Eric Wailes, University of Arkansas





The Convention on the Grant of European Patents, like other regional and global conventions on patents, is intended, inter alia, to alleviate a problem faced by many inventors: The potentially enormous cost of registering the invention in every country in which the inventor intends to enter the market. The European Patent Convention (EPC) entered into force in 1977 and is open to the accession of the members of the European Union. Under the EPC, any patent granted by the European Patent Office (EPO) is treated as if it were granted as a national patent in each signatory country. The use of this mechanism should substantially reduce the transaction costs associated with patent applications.

As originally drafted, EPC Article 53(b) provides an exception to patentability for "plant or animal varieties or essentially biological processes for the production of plants or animals." Apparently, at the time the EPC was drawn up, negotiators thought the International Union for the Protection of New Varieties of Plants (UPOV) would protect commercial rights to new varieties. UPOV has proven unsuitable for transgenic plants, however, and the EPC Article 53(b) exception has meant that the cost savings promised by the EPC have been unavailable to inventors in the biotechnology field.

On several occasions, EPO Boards of Appeal have ruled that EPC Article 53(b) claims to transgenic plants were not patentable. In 1999, however, the Administrative Council of the EPO promulgated new interpretive rules to implement the EU Directive on Legal Protection of Biotechnological Inventions. Under the new rules, biotechnological inventions are patentable if the technical feasibility of the invention is not confined to a particular plant variety. Subsequently, an Enlarged Board of Appeal of the EPO, which hands down decisions that bind other EPO boards, held that the new rules are consistent with EPC Article 53(b). Arguably, generic claims to plants may now be patentable under the EPC.

We propose to examine the legal and economic implications of this significant change in the rules governing the patentability of transgenic plants in Europe. We shall do so within the context of the new Biosafety Protocols, which allow countries to refuse the entry of transgenic materials, and the World Trade Organization Agreements, which recognize that health and safety measures used to justify refusal of entry may be trade barriers in disguise.


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