The Advocate General shows the way in which the SPC Regulation should be interpreted

In 2021 and 2022, both the Finnish Market Court and the Supreme Court of Ireland referred questions to the CJEU regarding the scope of the Regulation on the supplementary protection certificate for combination medicinal products. The courts mainly demand explanations regarding the interpretation of Art. 3 letter a) and art. 3 letter c).

The CJEU Advocate General, Nicholas Emiliou, has now issued an opinion on referrals.

Different drugs, same problems

The Finnish case concerns the antidiabetic drug from MSD Janumet based on a combination of sitagliptin and metformin (case ID: C-119/22). The Irish case concerns MSD’s cholesterol drug Inegy, based on a combination of ezetimibe and simvastatin (Case ID: C-149/22). SPCs protect the combination of active ingredients in both products. Teva attacked Janumet and Clonmel attacked Inegy. Because both cases involve very similar issues, the court combined the cases.

The mixed law firm Roschier represents long-term client MSD in Finland. Partner Rainer Hilli, head of the firm’s intellectual property practice, is prosecuting the case in the Market Court. Ben Rapinoja, a partner at full-service firm Borenius, is leading the Teva case.

In Ireland, MSD is represented by Whitney Moore based in Dublin. However, Aoife Murphy, who originally handled the case with Robin Hayes, moved to DLA last spring. On the other hand, law firm William Fry represents Clonmel, headed by partner Laura Scott.

The Finnish and Irish courts asked the CJEU to clarify whether and to what extent an SPC can be issued for a combination of active ingredients used in a product where a previous SPC has already been issued for one of these ingredients. Even though these issues have already been the subject of CJEU case law, national patent courts are still struggling with this issue.

Hope for generic drugs

In a recently published opinion, Advocate General Nicholas Emiliou proposed the following interpretation of the SPC Regulation:

(1) Article 3 lit. (a) of Regulation (EC) No 469/2009 must be interpreted as meaning that, in order for a ‘product’ to be considered ‘protected by a basic patent’ within the meaning of that provision, the ‘product’ must not only be expressly mentioned or at least ‘possibly specifically identified” in the claims, but also covered by the invention which is the subject matter of this patent.

(2) Article 3(a) (c) of Regulation No 469/2009 must be interpreted as not precluding the issuance of a supplementary protection certificate (SPC) for a combination of active ingredients where a previous SPC has been issued for one of those ingredients. The concepts of “inventive essence” and “subject matter of the invention” are irrelevant for the assessment of the premise contained in this provision.

Provided that the CJEU follows the opinion of the Advocate General, such an interpretation of Art. 3 letter a) would be good news for generic drug manufacturers. They argued that although in both cases the relevant active ingredients were cited in the claims of the respective basic patents, the combination of the two was not protected by the basic patent within the meaning of that provision.

In his opinion, the Advocate General has now concluded that a product – in this case a combination of active ingredients – should also be covered by an invention patent.

The Advocate General also stated that an existing SPC for one of the active ingredients does not necessarily constitute an obstacle to issuing an SPC for the combination.

Pan-European battle

The final decision of the CJEU will also have an impact on ongoing proceedings. In both cases, MSD was involved in parallel proceedings across Europe with various generic drug manufacturers.

In infringement proceedings against Inegy in Germany, the District Court of Düsseldorf withdrew a previously issued interim injunction. He argued that because an expired SPC for the active substance ezitimibe already existed, issuing another SPC for this combination was not justified. The Higher National Court followed the first-instance judgment. The president of the court of second instance at that time was Thomas Kühnen. He emphasized that the CJEU had not yet clearly clarified in its previous case law under what conditions the SPC also applies to combinations of active substances. The German Federal Patent Court found MSD’s SPC for Inegy and Janumet invalid. In the Janumet case, an appeal against the invalidity decision is pending before the Federal Court of Justice until the CJEU judgment is issued.

All patent firms involved in German cases maintain long-term relationships with their clients, advising them from the beginning of the dispute. MSD relies on a team consisting of two Hogan Lovells partners, Miriam Gundt and Andreas von Falck. They lead the company’s strong life sciences team and have a strong reputation in litigation against pharmaceutical developers.

Bird & Bird regularly litigates for major client Teva and its subsidiaries Ratiopharm and AbZ Pharma. Anne Wolters-Höhne represented Ratiopharm and its subsidiary AbZ in the German proceedings. Düsseldorf partner Oliver Jüngst advised Stada and its subsidiary Aliud. However, Wolters-Höhne left Bird & Bird and, after a two-year break, joined Allen & Overy, now A&O Shearman.

Mylan (now Viatris) and 1APharma approached Taylor Wessing for representation. Munich partners Jan Rektorschek and Christoph de Coster often advise generic drug companies in extensive disputes with drug manufacturers.

French affairs suspended

In France, MSD competes with Teva and Biogaran for Janumet. Initially, the Court of Appeal in Paris found the disputed SPC invalid under Art. 3 letter a) and art. 3 letter c). The court interpreted the patent as covering only one invention, leaving out the simvastatin combination as a separate combination covered by the same patent.

However, MSD filed a complaint to the Supreme Court (Cour de Cassation) regarding the interpretation of Art. 3 letter c). The highest French instance suspended the case regarding the interpretation of Art. 3 letter a) and 3 letter c until the CJEU issues its judgment.

From the outset, all parties relied on their principal advisors, and MSD turned to Allen & Overy (now A&O Shearman). Partners Laëtitia Bénard and Charles Tuffreau also represent the originator in the dispute regarding Inegy.

Biogaran recommended his favorite law firm, Casalonga. Lawyer Marianne Gabriel has impressive experience in representing a French company producing generic medicines. August Debouzy’s partner, François Pochard, has also represented Teva from the beginning.

However, in the Inegy dispute, the Court of Appeal in Paris recently upheld the preliminary injunction issued by the first instance. While A&O Shearman again represented MSD, generic drug company Viatris (formerly Mylan) relied on trusted advisor Denis Schertenleib of Schertenleib Avocats.

The patent community expects that the CJEU’s decision will clarify the existing case law. Experts therefore hope that this will lead to a unified approach by patent offices across Europe regarding the conditions under which parties can obtain a second SPC. In most cases, the CJEU follows the guidelines of the Advocate General.