16 November 2017

EPO changes approach to the patentability of products of essentially biological processes

Plants and animals obtained from essentially biological processes are no longer patentable in Europe. This move comes after years of controversy and conflicts with earlier decisions of the Enlarged Board of Appeal of the European Patent Office (EPO).

The “Biotech” Directive (Directive 98/44/EC of the European Parliament and of the Council of 6 July 1998 on the legal protection of biotechnological inventions), was implemented by the EPO in 1999. The Directive was highly controversial and the process leading to the adoption of the Directive lasted for more than 10 years. The purpose of the Directive was to harmonise national law on the patentability of inventions relating to biological material, and as a result of the directive, various exclusions to patentability are provided in the European Patent Convention (EPC).

For example, the Biotech Directive dictates that plant and animal varieties are excluded from patentability (this is implemented by Article 53(b) and Rule 27(b) EPC). Plant varieties are excluded from patentability because separate protection for specific plant varieties has been available since the 1960s via the plant variety rights system. Provided that the feasibility of the invention is not restricted to a particular plant variety, however, plants, plant parts, and plant products are patentable in Europe.

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