In the recent decisions of 17 August 2017, the Regional Court of Munich has dismissed 'Gilead Sciences’ (“Gilead”) requests for preliminary injunctions against, in total, seven generics manufacturers, holding that the validity of Gilead’s supplementary protection certificate (“SPC”) relating to Truvada is doubtful (published: 7 O 11152/17, BeckRS2017, 126085). In this judgment, the Court introduces a new and quite narrow interpretation of the CJEU case law on combination SPCs (in particular Medeva, Eli Lilly and Actavis; for further details on this case law, please refer to our January 2014 Synapse article).

Background

The preliminary injunction proceedings in question centre on the issue of whether the defendants can distribute their generics of the anti-HIV drug TRUVADA after Gilead’s basic patent EP 0 915 894 relating to the active substance of TRUVADA – Tenofovirdisoproxil (“TD”) – had expired. In its applications for preliminary injunctions, Gilead tried to rely on its SPC DE122000041.8 granted for the combination of the active ingredients of TRUVADA, i.e. the combination of TD and Emtricitabine (“FTC”), which does not expire before February 2020. The defendants, however, contended that this SPC is not valid, because the combination of TD and FTC is not protected by a basic patent, as required by Art. 3 (a) of the SPC Regulation. Insofar, the defendants referred to a qualified notice of the German Federal Patent Court (“BPatG”) in the pending nullity proceedings (case 4 Ni 12/17), in which the BPatG had explicitly expressed its preliminary view that the SPC in question is not valid, because FTC – applying the Medeva and in particular Eli Lilly case law – is not identified in a sufficiently specific way in subclaim 27 of the basic patent, which reads as follows: “a pharmaceutical composition comprising a compound according to any one of claims 1-25 together with a pharmaceutically acceptable carrier and optionally other therapeutic ingredients”.

The decisions of the Regional Court of Munich

In its decisions of 17 August 2017, the Regional Court of Munich starts by outlining, in some detail, its assessment standard with regard to the requirement of validity of the patent or SPC in suit in preliminary injunction proceedings. It comes to the conclusion that the qualified notice of the BPatG in the case at hand has to be treated like a first instance decision revoking the patent. Accordingly, the preliminary injunctions could only be granted, if the legal view expressed in the qualified notice is evidently wrong (diagnosis) and if it can be assumed that the German Federal Supreme Court will uphold the SPC in question with certainty (prognosis).

The Chamber then concludes that such a diagnosis / prognosis is not justified in the case at hand. First of all, it agrees with the BPatG that in the case of combination SPCs, the requirement of Art. 3 (a) of the SPC Regulation – as outlined by the CJEU in the Medeva and Eli Lilly case law – can only be considered fulfilled, if two requirements are met:

1. the combination of active ingredients must be the subject of the invention of the basic patent; and

2. the active ingredients must either be identified in the claims of the basic patent by means of a structural formula, or they must be given a functional definition in the claims of the basic patent in a way that the claims can be considered to relate implicitly but necessarily and specifically to the active ingredient in question.

The Regional Court of Munich then agrees with the BPatG, that the second requirement is not met. In the Eli Lilly decision, the CJEU decided that a compound is sufficiently identified in the claims of the basic patent not only if it is identified by a structural formula, but a functional formula might be sufficient provided that the claims can be considered to relate implicitly but necessarily and specifically to the active ingredient in question. The question in this case was whether the term “and optionally other therapeutic ingredients” could be considered a functional formula comprising FTC. The Regional Court of Munich denied this by relying on a particularly narrow interpretation of the CJEU’s Eli Lilly decision. According to the Court, a structural formula means the “explicit” specification of the compound in the claims; whilst a functional formula only “implicitly” specifies the compound. The Court then argues that a functional formula can only sufficiently specify a certain combination of active ingredients, if this functional formula is as specific as an explicit structural formula of the combination. Hence, in the present case, the crucial question should be, whether only FTC can be considered an “other therapeutic ingredient” in the sense of the claims of the basic patent and no other active substance. The Court concludes that this is not the case, but that there are at least 18 different therapeutic ingredients that might be used in combination with TD.

Furthermore, the Court also explicitly denies that the first requirement is met, i.e. that the combination of FTC and TD is subject to the invention of the basic patent. Insofar the Court argues that the basic patent only discloses TD as a mono-compound. While stating that it is possible and not harmful to combine TD with other ingredients, the basic patent does not disclose that TD should be combined with another therapeutic ingredient, and least of all that TD should be specifically combined with FTC. Finally, the Chamber points out that for the hypothetical case that Gilead had already been granted an SPC for the mono-compound TD, the grant of a second SPC for the non-inventive combination (TD + FTC) would not have been possible (pursuant to the Actavis decision of the CJEU). The situation should be the same in the case at hand where no SPC for the mono-compound had been granted.

Parallel proceedings in UK

In parallel proceedings in the UK, Mr Justice Arnold has stayed proceedings and has again asked the CJEU on the relevant criteria for determining whether a product is protected by a basic patent, as he contends that the relevant test still remains unclear. In its decision, Arnold J also comes to the conclusion that the combination of TD and FTC is not protected by the basic patent in question, arguing that this requirement is only fulfilled if the combination does embody the inventive advance of the basic patent (for further details on this decision, please refer to our January 2017 Synapse article).

Conclusions

The decision of the Regional Court of Munich is notable because of its strict interpretation of the Eli Lilly case law, which can be broken down to the summary that in case of a combination claim where the first compound is explicitly specified while the second is only implicitly referred to (functional formula), a selection out of two possibilities for the second compound is not specific enough. It remains to be seen if the CJEU agrees with the German and UK courts and further limits the possibility to receive combination SPCs.

The decision of the Regional Court of Munich is not yet final and binding and can still be appealed.