French law will soon exclude product claims from patentability where the claimed products have been generated by an essentially biological process

The “Projet de loi pour la reconquête de la biodiversité, de la nature et des paysages” currently debated before French Parliament includes various measures for the protection and promotion of biodiversity, among which this important limitation brought to the scope of patentability.

The bill aims at amending article L. 611-19 of the French Intellectual Property Code on the exceptions to patentability, to extend the exclusion not only to essentially biological processes for obtaining plants and animals, but also to the “products obtained from such processes, as well as their parts and genetic components”. This part of the bill has already been adopted by both chambers of Parliament and should enter into force this summer.

This comes in reaction to the decisions rendered by the European Patent Office on March 25th, 2015 (“Tomato II” and “Broccoli II”, G2/12 and G2/13), by which the Enlarged Board of Appeals has ruled that the patentability exclusion for essentially biological processes does not extend to the products themselves, obtained through those processes. The Board reminded that its role is to interpret the European Patent Convention, using generally accepted principles of interpretation of international treaties, and that it is not mandated to engage in legislative policy. It invited national legislators to take initiatives to amend national texts, if they deem it necessary.

Farmers and breeders’ associations as well as environmentalist organizations expressed their concerns about the EPO Tomato and Broccoli cases, considering them as an important threat for biodiversity and as an incentive for market concentration, making farmers increasingly dependent on a small number of international corporations obtaining exclusive rights on native genes. Farmers mainly agreed that they would be obliged to stop their activity or to seek licenses at a very high price.

In a press release, French Government which is at the origin of the currently debated Bill, showed its determination to “remove obstacles to innovation caused by the multiplication of patent applications on life and the growing concentration of the patent holders, at the expense of the plant varieties certificates […] which allow any third party to reuse any protected variety to create a new variety” (http://www.developpement-durable.gouv.fr/IMG/pdf/2016-01-20_-_Biodiversite_Genes_natifs.pdf).

The National Company of Industrial Property Attorneys (CNCPI) and the French Association of Industry Specialists in Industrial Property (ASPI) agreed on the idea that products obtained through essentially biological processes should be excluded from patentability. However, they supported an amendment with the aim to limit the scope of the exclusion to animals and plant products (http://aspi.asso.fr/Projet-de-loi-relatif-a-la-Biodiversite-position-commune-adoptee-par-l-ASPI-et-la-CNCPI_a404.html). They were of the view that “other implementations of biological processes allow to obtain useful and innovative products, the patentability of which may not alter biodiversity. Excluding them from the scope of patentability would limit the possibilities of innovation without valuable reason”. This has not been heard by the Senate who validated the general exclusion in January 2016.

By the Biodiversity bill, French Government said it wants to send a strong political message to the rest of Europe, knowing that the Netherlands (article 3 d of the Dutch Patent Act, http://english.rvo.nl/sites/default/files/2013/12/ROW95_ENG_niet_officiele_vertaling_0.pdf) and Germany (Article §2a of the Patentgesetz, https://www.gesetze-im-internet.de/patg/BJNR201170936.html) have already enacted similar provisions in 2010 and 2013.  It remains to be seen whether this call will be heard. 

This article is part of the International Life Sciences Update for April 2016

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