FRANCE Trends and Developments Contributed by: Liliana Eskenazi and Pauline Lecrenais, Fréget Glaser & Associés
of the parent filings (and the differences) are dis- closed and clearly explained; • its overall IP strategy cannot reasonably be regard- ed as being aimed at artificially prolonging legal uncertainty and delaying generic/biosimilar entry – for example, by filing cascades of divisional patent applications at different times, defending those patents before the European Patent Office, enforc- ing them before national courts, and then strategi- cally withdrawing them shortly before revocation to avoid a formal invalidity decision. Settlement to resolve a patent validity dispute, yes; settlement to delay competitors’ market entry, no A generic company may challenge the validity of an originator’s parent patent or its secondary patent(s) before they expire, and the two companies may ulti- mately reach an agreement to settle the dispute. Such agreements can produce pro‑competitive effects by bringing legal disputes to an end, thereby helping to eliminate invalid intellectual property rights or, con- versely, to preserve valid ones. However, they may also raise competition law con- cerns where they result in so-called pay for delay agreements. Settlement agreements between origina- tor and generic companies may indeed be anti-com- petitive where the generic agrees to delay or restrict its market entry in return for a value transfer from the originator – whether through direct payments or oth- er advantages – and this leads to consumers paying higher prices than they would have in the absence of the agreement. Such “pay for delay” agreements have given rise to well-established case law based on Article 101 TFEU, including very recent decisions of the Court of Justice (CJEU, 27 June 2024, Servier , 9 decisions; CJEU, 23 October 2025, Teva/Cephalon , C-2/24 P). Key competition law takeaways – before entering into any settlement that involves a value transfer between an originator and a generic/biosimilar company, the parties should: • verify that the transfer is objectively justifiable – for example, compensation for litigation costs or pay- ment for goods or services provided by the gener- ic/biosimilar – and that the settlement does not risk
going beyond “normal” competition on the merits by acting as an incentive for the generic/biosimilar to stay out of the market or to delay its entry (eg, a payment that offers the generic a risk‑free profit without having to launch its product, etc); and • keep all evidence that explains the economic/com- mercial rationale for their settlement and dem- onstrates that it facilitates, rather than restricts, competition. Limited contact with health authorities regarding competing products Pharmaceutical companies may communicate with health authorities in the context of their statutory and regulatory obligations, provided they comply with the applicable rules. However, the situation is different for an originator company that approaches a health authority before the expiry of its patent to draw attention to a compet- ing generic product. Under EU and French law, a generic product is defined as one whose key characteristics – safety, efficacy, and bioequivalence with the reference (originator) medicine – have been recognised by the competent health authorities. This assessment by the health authorities cannot, in principle, be challenged by originator companies, and competition authorities have treated any “unjustified” interference with it as abusive conduct. For example, the European Commission reiterated in the recent Teva Copaxone decision that there is “no room for scientific debate” on generic products prop- erties (case AT.40588, pt 1531). An originator com- pany would therefore not be entitled to challenge a generic product, and any scientific debate concerning a generic product could emerge (i) only if “new rel- evant evidence” were available and (ii) on condition that this evidence is brought to the authorities that are competent to modify the generic product’s marketing authorisation through the “appropriate procedures” (pt 1531) (the Commission also specifies that if Teva had genuine doubts about the generic products, it should have used the appropriate procedures “for pharmacovigilance”, see pt 1620).
102 CHAMBERS.COM
Powered by FlippingBook