Mylan v Merck Sharp & Dohme (CA Paris, RG 22/16673, 2024)

Dhenne Avocats · 11 October 2026

Our analysis

Summary

The Paris Court of Appeal upheld the interim order that had prohibited Mylan and Viatris, until 8 April 2023, from marketing their sitagliptin and metformin generics under Merck’s SPC No 08C0033 (Janumet). The validity challenges were not considered serious. Where each active ingredient of the combination is expressly named in the claims, the two-part test of Teva v Gilead (C-121/17) and Royalty Pharma (C-650/17) is unnecessary. Article 3(c) refers to a granted certificate, not an application, so the combination SPC granted first was not affected by the sitagliptin SPC, applied for earlier but granted later. The claim for an interim payment for enforcement of the injunction was dismissed.

Facts and procedure

Merck owned European patent EP 1 412 357, filed on 5 July 2002 and expired on 5 July 2022, covering dipeptidyl peptidase IV inhibitors including sitagliptin. SPC No 07C0041 (sitagliptin alone, Januvia), applied for on 27 August 2007, was granted only on 26 September 2016 and expired, after a paediatric extension, on 23 September 2022. SPC No 08C0033 (sitagliptin and metformin, Janumet), applied for on 20 August 2008, was granted on 17 December 2010 and expired on 8 April 2023. On 16 February 2022 Mylan obtained two French marketing authorisations for generics of the combination, marketed by Viatris Santé, which contended that SPC 033 was invalid under Article 3(c). By order of 20 September 2022 the interim relief judge of the Paris Judicial Court prohibited marketing subject to a penalty of EUR 1,000 per box and awarded EUR 120,000 under Article 700 of the Code of Civil Procedure.

The applicable law

The court ruled under Article L. 615-3 of the Intellectual Property Code, read in light of Directive 2004/48: the judge weighs the proportionality of the measures against the alleged infringement, in view of the risks on each side, and assesses how serious the validity challenge is. The SPC was examined under Articles 1 and 3(a) and (c) of Regulation 469/2009, the basic patent under Articles 56 and 138 EPC.

Question

Were the challenges under Article 3(a) and (c) of Regulation 469/2009 and for lack of inventive step of the basic patent serious enough to prevent the provisional injunction?

Decision

On Article 3(a), independent claim 25 covers a composition combining a compound of claims 1 to 15 with a biguanide, the description identifying metformin as the preferred biguanide; claim 15 names sitagliptin and claim 30 expressly refers to metformin. The two-step test applies only where the product is not explicitly mentioned in the claims, and the CJEU does not require the combination to appear in a single claim naming all its components. On Article 3(c), the clear wording refers to « a certificate », meaning a granted SPC: SPC 033, granted before SPC 041, could not be invalidated by reason of the latter’s earlier application. On inventive step, the attack concerned sitagliptin itself, the subject of an SPC whose validity Mylan accepted; the description sets out the test protocol at paragraphs [0043] et seq., and it is for the generic company to prove the absence of effect, which it had not done. Infringement not being disputed, the order was upheld, reopening the hearing for a preliminary reference was refused, the EUR 1,242,143 interim payment claim was dismissed and EUR 60,000 was awarded to the respondents.

Key points for practice

• The Teva v Gilead two-part test does not apply where each component of the combination is named in a claim, even a separate one.
• Under Article 3(c), priority between certificates turns on their grant dates, not on the application dates.
• A generic company challenging the effect of the patented compound in interim proceedings bears the burden of proving its absence.
• Practical point: a challenge to a combination SPC in interim proceedings must rest on a substantiated invalidity ground, a mere dispute over the order of certificates or the reach of Teva v Gilead being held not serious enough.

Relevance before the UPC

As the UPC hears applications for provisional measures based on SPCs derived from a European patent, this reading of Article 3(a) and (c) may be debated before it.

Provisions applied

Regulation (EC) No 469/2009 (SPC)

Arts 1 and 3

Directive 2004/48/EC

recital 22

European Patent Convention

Art. 56; Art. 138(1)

National law

French Intellectual Property Code, Article L. 615-3; Code of Civil Procedure, Articles 699, 700, 834 and 835

Case law cited

CJEU, Grand Chamber, 25 July 2018, Teva v Gilead, C-121/17; CJEU, 30 April 2020, Royalty Pharma, C-650/17

Related decisions

• Teva v Gilead, CJEU, 25 July 2018, two-part test held unnecessary for an expressly claimed combination.
• Royalty Pharma, CJEU, 30 April 2020, point 37 confining the test to products not explicitly mentioned.

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