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DE – Merck Sharp & Dohme Corp. v. ratiopharm – Ezetimibe/Simvastatin

09 Oct 2018

Merck Sharp & Dohme Corp. vs. ratiopharm GmbH et al., District Court of Düsseldorf, 1 October 2018, docket no. 4b O 39/18 – Ezetimibe/Simvastatin

The Düsseldorf District Court recently overturned several preliminary injunctions (“PIs”) that it had initially granted ex parte against generic companies, including ratiopharm GmbH.

The case concerns the German supplementary protection certificate (short: “SPC”) for the combination product of ezetimibe and simvastatin. In this case, the Court particularly deals with the issue whether the SPC can be considered sufficiently valid in view of art. 3 a) and c) of Regulation No 469/2009 (“SPC Regulation”) and whether the requirements for a PI under German law are met. The Court ultimately held that the SPC for ezetimibe and simvastatin likely did not meet the requirements of art. 3 c) of the SPC Regulation.

I. Facts and Background of the Case
Merck Sharp & Dohme Corp. (“MSD”) is the owner of basic patent EP 0 720 599 B1 (“EP 599”), which has already lapsed. The basic patent contains claims regarding ezetimibe (claims 1 and 8), as well as a claim regarding the combination of ezetimibe and a cholesterol-biosynthesis-inhibitor (claim 9). It also claims inter alia a combination of ezetimibe and simvastatin (claim 17).

Based hereon, MSD had previously obtained an SPC on the mono-product ezetimibe (“SPC I”). This SPC I expired in April 2018. Consequently, several generic companies tried to enter the market with an ezetimibe mono-product but also with a combination product containing ezetimibe and simvastatin.

Hence, MSD requested the grant of an ex parte preliminary injunction against these generic companies based on its further combination SPC on ezetimibe and simvastatin (“SPC II”). The Düsseldorf District Court initially followed said request and granted the PIs in mid-may. As a reaction, the generics lodged objections (in German “Widerspruch”) with the District Court against these PI decisions and argued that the requirements for a preliminary injunction are not met.

Under German law, both an injunction claim and an injunction ground have to be present for the grant of a PI. The latter inter alia requires a sufficient expectation of validity of the protective right. The generics (successfully) argued that the SPC II cannot be considered valid in view of Article 3 of the SPC Regulation.

II. Assessment of the Court
The Düsseldorf District Court thoroughly assesses the requirements of art. 3 a) and c) of the SPC Regulation including the relevant case law of the Court of Justice of the European Union (“CJEU”). Its findings are summarized below.

1) Art. 3 a) SPC Regulation
The District Court finds that the combination product (ezetimibe + simvastatin) is protected by the basic patent in terms of art. 3 a) of the SPC Regulation.

In this respect, the Düsseldorf District Court basically relies on the CJEU judgment Teva/Gilead of July 25, 2018 (C-121/17) and states that a product is protected by a basic patent as long as the patent claims necessarily and specifically relate to this product, even if it is not expressly mentioned in the claims. In the case at hand, the Düsseldorf District Court concludes that these requirements are fulfilled, particularly as the combination of ezetimibe and simvastatin is included in claim 17 of the basic patent.

The Düsseldorf District Court does not apply further requirements for Art. 3 a) SPC Regulation, such as the assessment whether the combination relates to the core inventive advance of the invention.

2) Art. 3 c) SPC Regulation
However, the Court holds that the requirements of art. 3 c) of the SPC Regulation are not met and referred to the CJEU decisions Actavis/Sanofi (C-443/12) and Actavis/Boehringer (C-577/13). The Court held that the owner of an SPC for a mono-product is not allowed to obtain a second SPC for a combination of active substances, which is based on the same patent, but a later marketing authorization of another pharmaceutical product which contains the active substance already contained by the mono-product, together with another active substance which is as such not protected by the basic patent. Rather, a product would only be entitled to an SPC under art. 3 c) of the SPC Regulation if it constitutes the “core inventive advance” (in German: “zentraler Erfindungsfortschritt”) of the basic patent on the priority date.

In this respect the Düsseldorf District Court clarifies that this should not be confused with an assessment of inventive step, since this would conflict with the principle that this issue is considered under national law. Rather, the criterion of the “core inventive advance” has to be understood in the context of the SPC Regulation and thus independent from a purely patent-law perspective. It is an SPC-specific evaluation, serving as a correction means.
The Düsseldorf District Court then turns to assessing when a product can be said to be the core inventive advance of the basic patents.

For this, the following considerations can be relevant:

• Whether the effect of the combination product is additive or synergistic. While a synergistic effect can be sufficient, a mere additive effect will not suffice. The latter means that a combination has the same therapeutic effect as a separate administration of both substances.
• If the combination has any further effects. Effects leading to, for instance, a reduction of side effects or a secure and easier administration can be sufficient.
• However, if these are only effects that the skilled person would expect due to his general knowledge (e.g. improving compliance and facilitating doses with “fix doses”), these are not sufficient to assume a product to be at the core inventive advance of a basic patent.

In any case, the District Court additionally requires that the effect has to be different from the effect of the mono-product and that the Basic Patent must contain reliable indications on the priority date that prove that the combination of active ingredients will achieve this form of effect. It is not sufficient if these effects only arise during the regulatory procedure to obtain a marketing authorization for a medicinal product.

Against this backdrop, the Düsseldorf District Court concludes that the SPC II does not meet the requirements of art. 3 c) of the SPC Regulation. The Court held that the combination of ezetimibe and simvastatin only has an additive effect in comparison to the single active substances. Even possible further effects (such as reduced side effects), are not addressed by the basic patent but were rather only (surprisingly) identified during the marketing authorization procedure. Therefore, the SPC II regarding ezetimibe and simvastatin does not represent the core inventive advance of the basic patent. Only the provision of ezetimibe constitutes the core inventive advance. However, there was already the previous SPC I for ezetimibe. Therefore, the Court held that the validity of the SPC II is not sufficiently certain in view of art. 3 c) of the SPC Regulation so that there is no injunction ground which would justify a PI.

III. Prospects
Currently, many Courts in Europe are seized with this matter. For example, there have been decisions in the Netherlands and France (with slightly differing reasoning) where the courts dismissed MSD’s requests for a preliminary injunction based on the SPC on ezetimibe and simvastatin. It will be interesting to see how the case law with respect to this matter will evolve.

A copy of the judgment can be found here (German original) and here (English translation).

Reported by Dr. Anna Wolters-Höhne and Dr. Annika Schneider, LL.M. (both Bird & Bird LLP)