Pharmaceutical patent litigation
In the pharmaceutical industry, what is at stake is often the date on which generics and biosimilars enter the market. Basic patents, secondary patents and supplementary protection certificates combine with regulatory exclusivities, and every month of protection carries considerable value.
Issues specific to the sector
Litigation concentrates around a few moments: the approaching expiry of the basic patent and the supplementary protection certificate, the generic marketing authorisation, pricing and reimbursement, then launch. Provisional measures play a central role, as do nullity actions brought to clear the way before a launch.
Validity issues are specific: second medical use claims, dosage regimes, crystalline forms, formulations, and the plausibility of the claimed technical effect, as clarified by the EPO Enlarged Board of Appeal in G 2/21.
Regulatory law cannot be separated from patent law: the Bolar exemption (Article L. 613-5 of the French Intellectual Property Code), the SPC manufacturing waiver, data exclusivity and market protection for medicinal products.
How we act
- Patent and SPC litigation, for originator companies and for generic and biosimilar manufacturers.
- Provisional measures before the French courts and the Unified Patent Court, for claimants and defendants.
- Regulatory advice aligned with the patent strategy.
- Monitoring of pharmaceutical decisions, published in the Pharma Litigation Watch.
Preparing a launch, or facing generic entry? Let us discuss it.
Go further
Selected matters
Generic medicines: SPC litigation
Taking part in supplementary protection certificate litigation for a generic manufacturer, concerning a combination of active ingredients. Work on the challenge to the certificate and on the applications for a preliminary injunction.
Pharmaceuticals: preparing the defence before launch
Taking part in preparing a defence in interim proceedings for a generic manufacturer in connection with a launch in France. Analysis of a patent on a dosage regimen, of the insufficiency and inventive step arguments, and of decisions handed down in parallel foreign proceedings.
Further reading and publications
- The launch letter before the UPC: what generics and biosimilars must write to avoid creating urgency, analysis by the firm.
- Plausibility and the right of priority: the French courts and apixaban, analysis by the firm.
- Matthieu Dhenne, The Santen judgment: the end of the beginning for the protection of new treatments in Europe?, Propriétés intellectuelles, bibliographic notice. Bibliographic record.
- Droit des brevets (patent law treatise), LexisNexis, 2024.
Frequently asked questions
Why is the launch timetable central?
Patent expiry, SPCs, indications and preparatory acts must be assessed together. Launch communications can also matter in interim relief proceedings.
Does the firm act for originators and generic manufacturers?
The firm examines title, evidence and relief in claimant and defendant cases, subject to conflict checks.
Do regulatory approval and patent infringement raise the same issues?
Marketing authorisations, regulatory exclusivities and patent rights have distinct purposes and timelines, which must be coordinated when assessing market entry.