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.