Industrial Property Law

The scope of protection conferred by patents relating to genetic information or biological material has been clarified by the Bioethics Law of 6 August 2004  and the Law of 8 December 2004 on the protection of biotechnological inventions , which transpose Directive  No 98/44/EC of 6 July 1998 . 
1.	Genetic information 
The scope of a claim covering a gene sequence is limited to the part of the seq …

Genetic information and biological material

The scope of protection conferred by patents relating to genetic information or biological material has been clarified by the Bioethics Law of 6 August 2004  and the Law of 8 December 2004 on the protection of biotechnological inventions , which transpose Directive  No 98/44/EC of 6 July 1998 . 

The scope of a claim covering a gene sequence is limited to the part of the sequence directly linked to the specific function provided in the description (Article L. 613-2-1, para. 1, IP Code). Furthermore, the rights created by the grant of the patent cannot be asserted against a subsequent claim which relates to the same sequence if this claim satisfies the conditions of Article L. 611-18 of the Intellectual Property Code  and sets out another specific application of this sequence (Article L. 613-2-1, para. 2, IP Code).

The protection conferred by a patent for a product containing or consisting of genetic information extends to any material in which the product is incorporated and in which the genetic information is contained and performs the function indicated. However, this protection does not apply in the event of the fortuitous or accidental presence of patented genetic information in seeds, plant propagating material, seedlings and plants or parts of plants (Article L. 613-2-2 IP Code). 

The Court of Justice has clarified the conditions of application of the above principles at European level. It ruled that a patent covering a genetic sequence designed to make a soybean plant resistant to the herbicide Roundup does not include the genetic sequence when it is present in soy flour, where it does not perform the function for which it is patented, even though it would possibly be able to perform this function again after being extracted from the flour and introduced into a cell of a living organism .

The protection conferred by a patent on a biological material endowed, by virtue of the invention, with specific properties extends to any biological material obtained from this biological material by reproduction or multiplication and endowed with those same properties (Article L. 613-2-3 IP Code). However, it does not extend to biological materials with the same properties obtained independently of the patented biological material and by an essentially biological process, nor to biological materials obtained from the latter by reproduction or multiplication (Article L. 613-2-3, para. 3, IP Code). Nor does it cover the manufacture of a biological material when this necessarily results from the use for which the biological material was placed on the market (Article L. 613-2-4 IP Code).

Where the patent relates to a process for producing a biological material endowed, as a result of the invention, with specific properties, its protection extends to the biological material directly obtained by this process and to any other biological material obtained from it by reproduction or multiplication and endowed with these same properties (Article L. 613-2-3, para. 2, IP Code).

Law No 2004-800 of 6 August 2004 on bioethics, OJ of 7 August 2004. 

Law No 2004-1338 of 8 December 2004 on the protection of biotechnological inventions, OJ of 9 December 2004. 

Directive No 98/44 of 6 July 1998 on the legal protection of biotechnological inventions, OJEC of 30 July 1998, 13. 

Article L. 611-18 limits the protection of an element of the human body to the technical application of its function. 

Case C-428/08 Monsanto Technology LLC, Judgment of 6 July 2010, LawLex202300007699JBJ.

Industrial Property Law

301. Genetic information and biological material

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301. Genetic information and biological material

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Les décisions de justice citées dans ce paragraphe :

Les notions juridiques connexes

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au contenu exclusif Livv – juristes d’entreprise