Patent litigation in biotechnology

Biotechnology raises questions of patentability and scope of protection rarely found elsewhere. Antibodies, sequences, cell lines, production processes: functional claim drafting and biological variability complicate validity and infringement alike.

Issues specific to the sector

The framework is set by Directive 98/44/EC on the legal protection of biotechnological inventions, implemented in the French Intellectual Property Code. Protection for a gene sequence is limited to the part of the sequence linked to the function disclosed in the patent, and certain inventions are excluded on public policy grounds.

Antibody claims defined by function or target are particularly exposed to insufficiency objections. Biosimilars, by definition not identical to the reference product, shift the debate towards claim interpretation and equivalence.

Evidence often requires biological or biochemical analysis of the opponent’s product, which saisie-contrefaçon and evidence preservation orders make it possible to organise.

How we act

• Patent litigation concerning biological products, antibodies and production processes.
• Attack and defence in the context of biosimilar entry.
• Coordination with oppositions conducted before the EPO by patent attorneys.
• Ownership disputes over inventions arising from research collaborations between universities, start-ups and companies.

Is a biological product at stake? Let us discuss it.