The German Federal Patent Court invalidates the Janumet SPC and refuses to refer questions to the CJEU

MSD’s German SPC covering its diabetes drug Janumet was invalidated by the German Federal Patent Court (“FCC”) on June 23, 2021 (Case Nos. 3 Ni 2/20, 3 Ni 24/20, 3 Ni 3 /21). The judgment is one of many in the area of ​​SPCs for the combination of active ingredients and takes into account previous decisions in SPCs Ezetimib and Actavis of the CJEU and Teva/Gilead case. MSD has since appealed the judgment to the German Federal Court of Justice (“FCJ”) (Case No. X ZR 64/21). In addition, the Finnish Market Court asked about the interpretation of the CCP Regulation with regard to the parallel Finnish case of MSD Janumet CPS at the Court of Justice of the European Union (“CJEU”). The procedure in detail:

CCP in question

Janumet is a drug approved for the treatment of patients with type 2 diabetes mellitus. The underlying substance combination contains two active substances with combined effect for this treatment, namely sitagliptin and metformin hydrochloride. It received marketing authorization in 2008. In Germany, it was covered by an SPC filed by Merck Sharp & Dohme Corp (MSD) in 2008 (File No. DE 12 2008 000 046.7, “CSP Janumet”). the Janumet The validity of the SPC has been challenged by several generic manufacturers on a number of grounds, including that the product had previously been subject to MSDs Januvia SPC, an earlier SPC (File No. DE 12 2007 000 056.1) based on the same patent (EP 1 412 357 B1). MSD’s drug Januvia is also approved for the treatment of patients with type 2 diabetes mellitus, but is based on only one active ingredient, namely sitagliptin. The validity attack therefore argued that the Janumet The SPC has failed to meet the requirement of Article 3(c) of EU Regulation No 469/2009 (“SPC Reg.”). The plaintiffs alleged that the other grant conditions pursuant to SPC Reg. Art. 3 a) and c) had also not been fulfilled.

Legal issue

The case concerned the question whether the combination of active substances covered by the Janumet The SPC could be considered – in whole or in part – as the same product for which MSD had already obtained a SPC, namely Januvia.

Under SPC Reg. Art. 1, point b), “product” means the active ingredient or the combination of active ingredients of a medicinal product. The Actavis case law of the CJEU requires that, in order to satisfy the grant condition of SPC Reg. Art. 3(c), the products must not only be different, but also disclosed as independent inventions in the basic patent. On the other hand, a simple incarnation of a patentable innovation devoid of its own inventive content, and therefore simply covered by the scope of protection of the basic patent, could not serve as the basis for a (new) SPC. Thus, the legal question was whether the basic patent could be interpreted as disclosing the combination of active ingredients sitagliptin and metformin hydrochloride as a different and independent innovation compared to the monoactive ingredient sitagliptin.

The decision of the Federal Patent Court

The Federal Patent Court considered that the sitagliptin-metformin combination did not constitute an independent innovation compared to the active ingredient sitagliptin alone.

In agreement with Actavis/Sanofi and its own Ezetemib decision, the FPC held that if a basic patent protected several products, it was mainly possible to obtain a certificate of protection for each of these products if they were independent innovations.

However, applying Actavis/Boehringer while assessing whether Janumet’s SPC was for a different product in accordance with SPC Reg. Art. 3(c), the FPC was unable to recognize the sitagliptin-metformin combination as a different and independent innovation according to the basic patent. Rather, it considered that the sitagliptin-metformin combination fell within the scope of protection of the basic patent in relation to the single active ingredient. Under Actavis/Boehringerthis excludes the right to an SPC for this combination of active ingredients subsequently placed on the market.

To that extent, the FPC found that metformin was a commonly prescribed agent for the treatment of type 2 diabetes on the relevant priority date. Moreover, it was known according to the basic patent that the application of the insulin-sensitizing metformin in combination with a sulfonylurea or a meglitinide has a beneficial effect in the treatment of type 2 diabetes. profession knew that a combination of metformin and a serum insulin insulinotropic agent, such as a sulfonylurea or meglitinide, would be beneficial in the treatment of type 2 diabetes. serum insulin level is also attributed to sitagliptin. Consequently, the person skilled in the art expects an effect similar to that of the known combinations of metformin and of a sulphonylurea or of a meglitinide for the combination of metformin and sitagliptin for. A surprising effect resulting from this last combination was neither described in the basic patent nor made plausible by a technical concept and could therefore not be recognized as an independent innovation. In applying Teva/Gilead, the FPC did not consider disclosures about the sitagliptin-metformin combination being particularly effective after the publication of the basic patent.

In this regard, the FPC concluded that the principles of Actavis applied to the case. It did not follow MSD’s argument which challenged these principles. On the contrary, the FPC distinguished the case from Teva/Gilead and Pharmaceutical royalty insofar as they concerned the conditions for issuing a first SPC and not – like the Actavis cases – a second SPC on the basis of the same patent. Therefore, the CPF did not consider Teva/Gilead as a departure from the CJEU’s Actavis case law. Thus, he refused to refer the case to the CJEU on the grounds that the correct application of European Union law was sufficiently clear for the present case. The CPF considered that the divergent national judgments did not raise other questions of interpretation and that it did not see the CJEU’s case law called into question in the present case.

Appeal to the Federal Court of Justice

MSD appealed the decision to the FCJ (Case No. X ZR 64/21). Appeals to the FCJ regularly take between 18 and 24 months, sometimes even 24 months and more (see FCJ annual statistics 2021). It is likely that the FCJ will exercise its discretion to stay the appeal pending the outcome of the Finnish Court’s referral to the CJEU.

Referral from the Finnish Court to the CJEU

Although the Federal Patent Court refused to refer the case to the CJEU, the CJEU has in the meantime also been assigned a question on the interpretation of Reg. Art. 3(a) and (c) in the context of the Janumet SPC. Information currently available suggests that the Finnish Market Court notified affected parties in November 2021 that it was suspending the nullity attack against the Finnish parallel Janumet SPC pending the outcome of the CJEU judgment.

The CJEU has jurisdiction to rule for a preliminary ruling on the interpretation of the CCP Regulation. Since SPCs are an economically relevant and highly contentious intellectual property right, questions relating to the interpretation of the SPCs Regulation are frequently referred to the CJEU, particularly when clarifications are sought due to divergent rulings in a number of states. members. In the context of SPCs for the combination of active ingredients, it has also been argued that the case law of the CJEU itself needs clarification due to a perceived divergent interpretation of the requirements for granting SPCs of Reg. Art. 3(a), (c) and (d).

Irish referral in related case

In this context, it should be mentioned that the Supreme Court of Ireland, by judgment of 21 February 2022, also referred questions on the interpretation of SPC Reg. Art. 3(a) and (c) in relation to SPCs for combination products at the CJEU (case no. [2022] CIES 11). The Irish case concerns MSD’s CCP for Engineering (file no. 2005/001), an anti-cholesterol drug based on the combination of the active substances ezetimibe and simvastatin. The issues raised by the Irish referral revisit the discussion underlying the CJEU’s decisions in Actavis/Boehringer (see above) and Santen.

TW Comments

The judgment of the Federal Patent Court is one of several divergent national judgments, which seem to have in common only the certainty that combined SPCs are likely to be invalidated. However, that this fate results from SPC Reg. Art. 3 (a), (c) or (d) seems uncertain. Therefore, the CJEU ruling on the Finnish and Irish referrals could promise guidance and clarity to pharmaceutical companies across Europe in applying the CCP Regulation in practice.

James R. Rhodes