Biotechnological inventions

Biotechnological inventions are inventions which concern a product consisting of or containing biological material, or a process by which biological material is produced, processed or used. Their regime derives from Directive 98/44/EC on the legal protection of biotechnological inventions, implemented in Articles L. 611-18 and L. 611-19 and Articles L. 613-2-1 et seq. of the French Intellectual Property Code and, before the European Patent Office, from Article 53 of the European Patent Convention and the rules that supplement it.

Scope of patentability

Biological material which is isolated from its natural environment or produced by means of a technical process may be the subject of a patent even if it previously occurred in nature, which distinguishes an invention from a mere discovery. An element isolated from the human body, including the sequence of a gene, may constitute a patentable invention provided that its industrial application is specifically disclosed in the application. The human body itself and the mere discovery of one of its elements are not patentable. Patentability is then assessed under the ordinary conditions of novelty, inventive step and industrial application, and a deposit of the biological material with a recognised institution may supplement the description.

Exclusions

Plant varieties, which are protected by plant variety rights, animal breeds and essentially biological processes for the production of plants or animals are not patentable, whereas microbiological processes and the products thereof remain patentable. On grounds of public policy and morality, inventions whose commercial exploitation would be contrary to human dignity are also excluded, in particular processes for cloning human beings, processes for modifying the germ line genetic identity of human beings and uses of human embryos for industrial or commercial purposes.

Scope of the right and its limits

The protection conferred by a patent on biological material possessing specific characteristics extends to any material derived from it through propagation or multiplication and possessing the same characteristics. French law, however, limits the scope of a claim covering a gene sequence to the part of that sequence directly linked to the specific function disclosed in the application, a rule more restrictive than European Patent Office practice. Farmers enjoy a privilege allowing them to use the product of their harvest for further propagation on their own farm.

Key points

Biotechnological inventions are patentable where the biological material is isolated or produced by a technical process and its industrial application is disclosed, excluding the human body, plant varieties, animal breeds, essentially biological processes and inventions contrary to human dignity. Protection extends to the generations derived from the patented material, within the limits set for gene sequences and by the farmers’ privilege. Before filing, the disclosure of the function and industrial application should be checked and the deposit of the biological material arranged.

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This glossary entry is general in scope and does not constitute legal advice.

Dhenne Avocats litigates patent disputes before the Paris Judicial Court, the Paris Court of Appeal and the Unified Patent Court. When the question arises in a real case, the right moment is almost always before proceedings are issued.

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