MSD vs. Viatris sees Paris Court of Appeal depart from previous SPC case law

At the centre of the dispute between MSD and Viatris over diabetes drug Janumet is the interpretation of Articles 3(a) and 3(c) of the SPC Regulation No. 469/2009. This is also the subject of parallel proceedings between MSD and generics manufacturers concerning the cholesterol-lowering drug Inegy in France, as well as two referrals from Finland and Ireland to the CJEU.

Combination at the core

The current dispute at the Paris Court of Appeal concerns an SPC covering the combination of sitagliptin and metformin. These form the basis of MSD’s drug Janumet, which is used for treating diabetes mellitus.

The original patent EP 1 412 357, which covers the active ingredient sitagliptin, expired in July 2022. The SPC 07C0041 on this original patent was still valid until September 2022. After the expiry of this SPC on the single active ingredient sitagliptin, Mylan (now Viatris) wanted to launch a generic version in France.

However, another SPC for the combination sitagliptin and metformin, SPC 08C0033, which was valid until 8 April 2023, was also in existence. With reference to this, MSD applied for a preliminary injunction against Mylan/Viatris in summer 2022 to prevent the company from entering the market.

To test or not to test?

In turn, the defendant challenged the validity of EP 357 and SPC 033 on the combination of the active ingredients. It challenged the original patent for lack of inventive step. In addition, the generics manufacturer considered the SPC for the combination of active ingredients invalid according to Article 3(a) and 3(c) of the SPC Regulation No. 469/2009.

For validity under Article 3(a), Viatris argued that the two-part test set out in the CJEU’s Teva/Gilead decision (C-121/17) must be applied. MSD, on the other hand, interpreted the CJEU’s decision in Teva/Gilead to mean that the test was not necessary, as the claims of the original patent EP 357 specifically mention the combination product of sitagliptin and metformin.

However, Viatris countered that the test applies even if the claims of the basic patent explicitly mention the active ingredients. Viatris also argued that Article 3(c) only allows the granting of an SPC if, “the product has not already been the subject of an SPC”. However, this was already the case with SPC 041 for the mono active ingredient sitagliptin alone. Metformin, on the other hand, has been known for its efficacy in diabetes for many years.

PI in both instances

In the first instance, the 3rd Chamber of the Judicial Court of Paris dismissed the nullity actions in September 2022. The judges found that the generic product probably infringed MSD’s intellectual property rights and prohibited Mylan/Viatris from launching its generic product in France until the expiry of the SPC in April 2023 (case ID: 22/55128).

The generics manufacturer appealed against this decision. In January 2024, the Court of Appeal upheld the preliminary injunction (case ID: 22/16673). This makes it one of the very rare cases in which the French second instance court has upheld an injunction issued by the first instance in a patent battle.

Inegy in France

This was also a departure from the court’s previous rulings in similar cases. For example, in a dispute between MSD and Teva over the cholesterol-lowering drug Inegy, in 2020 the Court of Appeal invalidated the SPC for the combination of ezitimib and simvastatin. In doing so, the court overturned a first-instance ruling. Similar decisions followed in the dispute between MSD and Biogaran over the same SPC.

Laëtitia Bénard

These disputes also concern whether an SPC can be granted for a combination of active ingredients, if an SPC already exists for one of the individual active ingredients in the combination.

The Inegy litigation is currently pending before the French Supreme Court. However, the court has stayed proceedings pending two rulings by the CJEU on this issue.

Janumet and Inegy at the CJEU

The Finnish Market Court and the Supreme Court of Ireland both referred cases to the CJEU, asking the court to clarify the granting of second SPCs for combination products. The Finnish case concerns diabetes drug Janumet (case ID: C-119/22), while the Irish case concerns cholesterol-lowering drug Inegy (case ID: C-149/22).

These cases also concern the interpretation of Articles 3(a) and 3(c) of the SPC Regulation. The Advocate General will likely issue an opinion in April.

Denis Schertenleib

Illustrious round

From the outset, the parties relied on their trusted advisors, with MSD turning to its go-to law firm, Allen & Overy.

Paris-based partners Laëtitia Bénard and Charles Tuffreau have represented the pharmaceutical company in litigation for years. This includes in the Inegy dispute before the Supreme Court. The team is known for its work for originator companies such as Novartis and Bayer.

Schertenleib has also worked for Viatris for many years, representing its predecessor Mylan in numerous proceedings before French courts. Most recently, the team won a case for the client against Lilly France.

In the parallel proceedings, August Debouzy is acting for Teva, while Biogaran relies on its advisors from the mixed IP boutique Casalonga. (Co-author: Christina Schulze)

For MSD
Allen & Overy (Paris): Laëtitia Bénard, Charles Tuffreau (both partners); associates: Elise Romelly, Manon Perret

For Viatris
Schertenleib (Paris): Denis Schertenleib (lead), Ombeline Degrèze-Péchade (both partners); associates: Nevyn Fournel, Célia Benmesbah

Court of Appeal, Paris, Division 5, 2nd chamber
Véronique Renard (presiding judge), Laurence Lehmann, Agnès Marcade (judges)