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.
Go further
Selected matters
Therapeutic antibodies: patent infringement and validity
Involvement in a patent infringement action for a biotechnology company in the field of therapeutic antibodies. The matter combined analysis of claim scope, the debate on validity and their interplay with parallel proceedings abroad.
Biotechnology: evidence and protection strategy
Strategic advice to a biotechnology company on protecting manufacturing processes for biological medicines. Preparation of an evidence strategy, analysis of the saisie-contrefaçon options and review of the routes open before the French courts and the Unified Patent Court.
Further reading and publications
Frequently asked questions
Why do antibody patents need particular scrutiny?
The claimed scope must be assessed against the examples, experimental data and description, including whether the teaching enables the invention across that scope.
What information should be prepared before biotechnology litigation?
Research timelines, protocols, results and technical records connect arguments with the facts. Sensitive information should be identified so that its protection can be organised.
How can French and European proceedings be coordinated?
Claims, relevant markets and parallel proceedings need to be assessed together. Patent and evidence analysis supports a strategy adapted to the product timetable.