Novartis v Sanofi-Aventis France and others (Cass. com., 13-10.189, 2014)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The French Court of Cassation dismissed Novartis’s appeal against the Paris Court of Appeal judgment of 11 December 2012, which had set aside the ex parte order of 27 October 2011 provisionally prohibiting generics combining valsartan and hydrochlorothiazide. The SPC, extended by a paediatric extension, expired on 13 November 2011, seventeen days after the application. The judgment, published in the Bulletin, confirms that a provisional measure under Article L. 615-3 of the Intellectual Property Code may be granted without hearing the other side only where the circumstances so require, a matter for the sovereign assessment of the lower courts.

Question

Did the circumstances require a provisional prohibition to be ordered ex parte, a few days before the SPC expired?

Decision

The Court of Appeal found that the SPC expired seventeen days after the application, that an inter partes decision could still be obtained before 13 November 2011 through urgent summary proceedings at a fixed hour or a very early hearing, that there was doubt as to whether the generics were about to be marketed, and that the harm caused by a launch seventeen days before expiry could be compensated by damages. On those sovereign findings, and leaving aside a superfluous ground on whether delay alone can amount to irreparable harm, it was entitled to conclude that the circumstances did not require an ex parte measure. The Court also rejected the complaint that the Court of Appeal had raised a point of its own motion: when hearing an application to set aside, it could review whether the first judge had been properly seised without inviting the parties’ observations.

Key points for practice

• The imminent expiry of an SPC does not in itself justify an ex parte order where urgent inter partes proceedings remain available.
• Practical point: the application must show concretely why an inter partes hearing is impossible, that marketing is imminent and that the harm is difficult to repair.

Provisions applied

National law

French Intellectual Property Code, Articles L. 615-3 and L. 615-5; Code of Civil Procedure, Articles 15, 16, 132, 700 and 906; Civil Code, Article 1134

EU law (relied on in the grounds of appeal)

Regulation (EC) No 469/2009, Arts 2 to 5; Directive 2004/48/EC, Art. 9(4)

Other provisions

European Convention on Human Rights, Article 6(1)

Prepared by Dhenne Avocats from the text of the decision (Légifrance), consulted on 11 October 2026. Only the official text is authoritative.