Formulations and Article 3(a) - a decision from the German Federal Patent Court

The German Federal Patent Court (Bundespatentgericht) recently issued a decision in ex parte appeal proceedings relating to the interpretation of Art. 3(a) of the SPC Regulation in regard to a patent protecting a formulation of known actives (Decision 14 W (pat) 10/16 of 23 January 2018, English translation here).  Many thanks to Bianca-Lucia Vos and Klemens Stratmann of Hoffmann Eitle for pointing this case out to us and for providing a thorough commentary, below:

The decision addresses an important aspect for determining whether a given product is “protected” by a basic patent in the sense of Art. 3(a) of Regulation (EC) no. 469/2009, which to date has not been addressed by any higher court in the EU. 

In the case underlying the decision, the GPTO had rejected SPC application 12 2010 000 015.7 submitted by GlaxoSmithKline Biologicals S.A. (“GSK”) for a combination of six antigens with reference to Art. 3(a). The Patent Division of the GPTO asserted in the appealed decision that, in view of the CJEU decisions Actavis/Sanofi (C-443/12), Georgetown II (C-484/12) as well as Actavis/Boehringer (C-577/13), a product is only then protected pursuant to Art. 3 (a) of the Regulation if the respective active ingredient or the active ingredient composition is protected by the basic patent “as such”.  

According to the GPTO, for protection “as such” to be affirmed within these terms, the product in question has to constitute the “core inventive advance” of the basic patent. To support this view, the Patent Division relied for instance on par. 29 of C-443/12, where the CJEU stated that it is possible, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) and (c) of that regulation.  

Since GSK’s basic patent (EP 0 835 663) related to formulations of previously known antigens with special adjuvants to provide hexavalent combination vaccines, the Patent Division opined that the inventive advance of the basic patent lay in the use of specific adjuvants and not in the provision of a new (and inventive) combination of antigens. From this, the Patent Division concluded that the product defined in the SPC application, i.e. “Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b conjugate, combination vaccine”, did not embody the inventive advance of the patent, respectively was not protected as such, and rejected the SPC application. 

The Federal Patent Court set aside this decision and granted the SPC for the requested product definition. In its decision, the Federal Patent Court first clarified that Actavis/Sanofi, Georgetown II as well as Actavis/Boehringer pertain primarily to the conditions for granting more than one SPC for the same product pursuant to Art. 3 (c) of Regulation (EC) No. 469/2009 and do not contain any assessment criteria going beyond the principles established by the CJEU in Medeva (C-322/10) and Eli Lilly (C-493/12) regarding the application of Art. 3 (a) of Regulation (EC) No. 469/2009. The Federal Patent Court highlighted that the circumstances of Actavis/Sanofi, Georgetown II and Actavis/Boehringer required an assessment as to whether the combination of active ingredients A+B has to be regarded as the “same innovation” as compared to the individual active ingredient A (for which the patent proprietor had already obtained an SPC), and therefore no further SPC should have been granted for the combination of active ingredients A + B under Art. 3(c) of the Regulation.  

Only for the purpose of examining under Art. 3(c), whether the combination of A + B embodies the inventive advance of the patent, it is therefore of relevance whether the individual actives (A and/or B) are protected as such by the basic patent.  

The Federal Patent Court acknowledges with this decision that formulation patents are eligible for an SPC extension to the same extent as other patent types such as use or process patents. This decision is of fundamental importance since the approach taken by the GPTO in the contested decision would have rendered it impossible to extend the vast majority of formulation patents. The reason being that, as a rule, formulation patents do not protect the product, i.e. the active ingredient or the combination of active ingredients in the sense of Article 1(b) of the Regulation, “as such”. It is rather the formulation of known actives by means of specific auxiliary substances, such as adjuvants (as in the case of vaccines) or excipients, that renders the claimed subject matter patentable and embodies the inventive advance of the patent.  

The decision of the Federal Patent Court appears to put into question as to whether the interpretation of Art. 3(a) of the Regulation proposed by J. Arnold would also be applicable in the event that the basic patent is not a product patent but rather a formulation, process or use patent. J. Arnold repeatedly suggested to the CJEU in proceedings before the UK High Court of Justice that Article 3(a) should be interpreted as meaning that the product is "protected" by the basic patent if (i) the product falls within the scope of the claim when interpreted in accordance with the Extent of Protection Rules and (ii) the product does so because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the patent (cf. par. 97 of Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017) and par. 11 of Sandoz Ltd & Anor v G.D. Searle LLC & Anor [2017] EWHC 987 (Pat) (3 May 2017). It would appear that this test is not suitable for determining if a given formulation, use or process patent protects the product in the sense of Article 3(a). By contrast, the test developed by J. Warren seems to have a broader applicability and would, in our view, also lead to the correct result in the case of formulation, use or process patents (cf. par. 65 to 71 of Eli Lilly v Human Genome Sciences [2014] EWHC 2404 (Pat) (18 July 2014)). J. Warren suggested that a given product will be protected within Article 3(a), if it falls within the claims, subject to one proviso relating to circumstances where the claims contain some general word or words extending their extent beyond the principal scope of the claims, typically by the use of a word such as "comprises". 

Meanwhile, three referral proceedings are pending before the CJEU all of which concern the interpretation of Article 3(a) of the Regulation and the criteria for determining whether a given product is protected by the basic patent or not (Reference for a preliminary ruling from the High Court of Justice (Chancery Division) (United Kingdom) made on 8 March 2017 – Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) trading as "Mylan" v Gilead Sciences Inc. (Case C-121/17); Request for a preliminary ruling from the Bundespatentgericht (Germany) lodged on 21 November 2017 (Case C-650/17); and Sandoz et al. v. G.D. Searle et. al [2018] EWCA Civ 49, UK Court of Appeal, Judgment of 25 January 2018). It would be desirable if the CJEU does not limit the forthcoming judgements to the concrete facts of the respective referral decision but rather develops a generally applicable test which allows to ascertain whether a given product is protected in the sense of Article 3(a) in all possible circumstances including those addressed by the Federal Patent Court in the recently issued decision.