MSD’s German SPC covering its diabetes drug Janumet was invalidated by the German Federal Patent Court (“FPC”) on 23 June 2021 (case nos. 3 Ni 2/20, 3 Ni 24/20, 3 Ni 3/21). The judgment is one of many in the field of SPCs for the combination of active ingredients and takes into account the prior rulings in the FPC’s Ezetimib and the CJEU’s Actavis and Teva/Gilead cases. MSD has since appealed the judgment before the German Federal Court of Justice (“FCJ”) (case no. X ZR 64/21). In addition, the Finnish Market Court has referred a question on the interpretation of the SPC Regulation with a view to MSD’s parallel Finnish Janumet SPC to the Court of Justice of the European Union (“CJEU”). The proceedings in detail:
SPC at issue
Janumet is a drug approved for the treatment of patients with type 2 diabetes mellitus. The underlying substance combination contains two active ingredients with a combined effect for this treatment, namely sitagliptin and metformin hydrochloride. It received market 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, “the Janumet SPC”). The Janumet SPC’s validity was challenged by several generic manufacturers on a number of grounds, including that the product had already been the subject of MSD’s 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 equally approved for the treatment of patients with type 2 diabetes mellitus, but relies on only a single active ingredient, namely sitagliptin. The validity attack therefore argued that the Janumet SPC failed to meet the requirement of Article 3 (c) of EU Regulation No. 469/2009 (“SPC Reg.”). Plaintiffs alleged that the further granting conditions according to SPC Reg. Art. 3 a) and c) had equally not been met.
Legal issue
The case turned on whether the combination of active substances covered by the Janumet SPC could be regarded – wholly or in part – as the same product for which MSD had already been granted an SPC, namely Januvia.
Under SPC Reg. Art. 1 (b), ‘product’ means the active ingredient or combination of active ingredients of a medicinal product. CJEU’s Actavis case law requires that in order to satisfy the granting condition of SPC Reg. Art. 3 (c), the products must not only be different, but also disclosed as independent inventions in the basic patent. By contrast, a mere embodiment of a patentable innovation lacking its own inventive content, and thus merely covered by the scope of protection of the basic patent, could not be a basis for a (further) SPC. Thus, the legal issue was whether the basic patent could be interpreted as disclosing the combination of active ingredients sitagliptin and metformin hydrochloride as a different, independent innovation compared to monoactive ingredient sitagliptin.
The Federal Patent Court’s decision
The Federal Patent Court held that the sitagliptin-metformin combination did not constitute an independent innovation compared to the single active ingredient sitagliptin.
In line with Actavis/Sanofi and its own Ezetemib decision, the FPC held that if a basic patent protected several products, it was principally possible to obtain a protection certificate for each of these products if they were independent innovations.
However, applying Actavis/Boehringer while assessing whether the Janumet SPC related to a different product pursuant to SPC Reg. Art. 3 (c), the FPC was unable to recognise the sitagliptin-metformin combination as a different and independent innovation according to the basic patent. Rather, it held that the sitagliptin-metformin combination falls within the scope of protection of the basic patent in connection with the single active ingredient. Under Actavis/Boehringer, this precludes the right to an SPC for this active ingredient combination subsequently placed on the market.
Insofar, the FPC found that metformin was a commonly prescribed agent for the treatment of type 2 diabetes at the relevant priority date. Further, it was known according to the basic patent that applying insulin sensitizer metformin in combination with a sulfonylurea or a meglitinide has a beneficial effect in the treatment of type 2 diabetes. Thus, those skilled in the art were aware 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. According to the basic patent, a serum insulin level-increasing effect 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 a sulfonylurea or a meglitinide for the combination of metforminand sitagliptin for. A surprising effect arising from the latter combination was neither described in the basic patent nor made plausible by a technical concept and therefore could not be recognised as in independent innovation. Applying Teva/Gilead, the FPC did not take into consideration disclosures on the sitagliptin-metformin combination being particularly effective filed post publication of the basic patent.
In this regard, the FPC found the Actavis principles to be applicable to the case. It did not follow MSD’s argument that called these principles into question. Rather, the FPC distinguished the case from Teva/Gilead und Royalty Pharma insofar as they pertained to the requirements for granting a first SPC and not – like the Actavis cases – a second SPC on the basis of the same patent. Therefore, the FPC did not regard Teva/Gilead as a departure from the CJEU’S Actavis case law. Thus, it refused to refer the case to the CJEU citing that correct application of European Union law was sufficiently clear for the present case. The FPC found that any diverging national judgments did not raise further questions of interpretation and that it did not see the CJEU’s case law drawn into question in the present case.
Appeal before the Federal Court of Justice
MSD has appealed the decision before the FCJ (case no. X ZR 64/21). Appeals before the FCJ regularly take between 18 and 24 months, sometimes even 24 months and longer (cf. 2021 annual statistics of the FCJ). 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.
Finnish Court’s referral to the CJEU
Although the Federal Patent Court refused to refer the case to the CJEU, the CJEU has in the meantime also been tasked with a question on the interpretation of SPC Reg. Art. 3(a) and (c) in the context of the Janumet SPC. The information currently available suggests that the Finnish Market Court let the relevant parties know in November 2021 that it was suspending the nullity attack against the parallel Finnish Janumet SPC pending the outcome of the CJEU’s ruling.
The CJEU has jurisdiction to give preliminary rulings concerning the interpretation of the SPC Regulation. With SPCs being an economically relevant and highly litigated intellectual property right, questions relating to the interpretation of the SPC Regulation are frequently referred to the CJEU, in particular where clarification is sought due to divergent decisions in a number of Member States. In the context of SPCs for the combination of active ingredients, it has also been argued that the CJEU’s case law itself necessitates clarification due to perceived divergent interpretation of the SPC grant requirements of SPC Reg. Art. 3(a), (c) and (d).
Irish referral in a related matter
In this context, it should be mentioned that the Supreme Court of Ireland by judgment of 21 February 2022 has also referred questions on the interpretation of SPC Reg. Art. 3(a) and (c) in relation to SPCs for combination products to the CJEU (case no. [2022] IESC 11). The Irish case relates to MSD’s SPC for Inegy (file no. 2005/001), a cholesterol-reducing drug relying on the combination of active substances ezetimibe and simvastatin. The questions raised by the Irish referral revisit the discussion underlying the CJEU’s decisions in Actavis/Boehringer (see above) and Santen.
TW comments
The Federal Patent Court’s judgment is one decision in a number of diverging national judgments, which appear to have in common only the certainty that combination-SPCs are likely to be invalidated. However, whether this fate results from SPC Reg. Art. 3 (a), (c) or (d) appears to be uncertain. Therefore, the CJEU’s ruling on the Finnish and Irish referrals could promise guidance and clarity for pharmaceutical companies throughout Europe in applying the SPC Regulation in practice.
