Higher Regional Court Düsseldorf, 15 March 2019, docket no. I-2 U 62/18 – Ezetimibe/Simvastatin

On March 15, 2019 the Higher Regional Court Düsseldorf finally dismissed MSD’s request for a preliminary injunction based on their SPC for ezetimibe and simvastatin and thereby confirmed the result of the first instance decision of the Regional Court Düsseldorf of October 2018.

The facts and background of the case, including the course of the proceedings before the Regional Court Düsseldorf, have already been reported on the EPLAW blog previously here.

In the appeal decision, the Higher Regional Court provides a detailed reasoning, particularly with respect to art. 3c) of Regulation (EC) No. 469/2009 (“SPC-Regulation”) which provides helpful guidance for future litigation on SPCs.

Here is an overview of the key findings:

Applicable Standard
The CJEU decisions in re Actavis/Sanofi (C-443/12) and Actavis/Boehringer (C-577/13) are decisive for the assessment of art. 3c) of the SPC-Regulation. The Higher Regional Court stresses that all decisions by the CJEU are binding for the national courts in order to ensure a uniform application of the EU-provisions. This is particularly true if the facts in the case in dispute are sufficiently similar to the already decided scenarios. Therefore, it is irrelevant whether the parties or the national Courts may have a different view.

In this context, the Higher Regional Court also clarifies that the decision in re Teva/Gilead (C-121/17) is irrelevant for the interpretation of art. 3c) of the SPC-Regulation. This decision only relates to art. 3a) of the SPC-Regulation and a national Court may not disregard the absolute binding effect of CJEU decisions (particularly the relevant Actavis-decisions).

Application of Actavis/Sanofi and Actavis/Boehringer
It follows from the Actavis-decisions that the mere fact that a combination is encompassed by the claims of the basic patent is not sufficient for fulfilling the requirements of art. 3c) of the SPC-Regulation. However, the Higher Regional Court points out that the CJEU has not named clear criteria with which one can determine whether several products can be identified. Therefore, the Higher Regional Court uses clues taken from the facts and findings of the CJEU Actavis-cases:

• To ascertain whether one or two SPCs can be granted, it needs to be determined how many inventions the basic patent contains. If, as in the Actavis-cases, the combination product is not more than a mere modification of the inventive mono product, only one SPC can be granted (namely for the mono product, which represents the relevant technical contribution).

• In light of this, a mere additive effect would not be sufficient to grant a second SPC on the combination product (cf. Actavis/Sanofi).

• However, according to the Higher Regional Court, unexpected synergistic effects or unexpected additive therapy effects including lesser side effects or surprisingly lower side effects could render the combination to be a distinct product (invention) of the basic patent – with the consequence of a second SPC.

The Higher Regional Court then indicates that in its view the existence of one or several inventions should be determined on the basis of the basic patent specification, i.e. what the skilled person would identify as the invention(s) in view of the claims, specification and drawings of the basic patent.

Combination of ezetimibe and simvastatin
The Higher Regional Court concluded that an SPC for the combination of ezetimibe and simvastatin could not be granted because the combination is already the subject of the previous SPC for ezetimibe (art. 3 c) of the SPC Regulation).

In particular, the Higher Regional Court stresses that the case at hand is quite similar to Actavis/Sanofi, for which the CJEU already rejected a second SPC.

According to the appeal decision, the basic patent would not include sufficient clues that the combination of ezetimibe and simvastatin provides unpredictable benefits at the priority date, which could indicate that the combination is more than just an embodiment of the ezetimibe-invention. Rather, the combination of ezetimibe and simvastatin would only provide a mere additive effect. This would even be shown by the current studies, which were the basis for the MA grant. What is more, the Higher Regional Court determines that it is a “technical triviality” that the side effects are lesser, if the dose of an ingredient with high side effects is reduced (Simvastatin) and replaced by an active ingredient with lower side effects (Ezetimibe).

In addition, the Higher Regional Court was not persuaded by deviating decisions in other jurisdictions. Rather, the Court holds that these foreign decisions are already not based on a correct legal starting point, because the strict binding to the preliminary rulings already handed down by the CJEU in the Actavis/Sanofi and Actavis/Boehringer cases is disregarded.

Prospects for future SPC litigation
• A preliminary injunction only seems realistic, where the case in dispute deviates so greatly from the cases already negatively decided by the CJEU that a different assessment cannot reliably be presumed. The Higher Regional Court Düsseldorf made quite clear that there can be no interim relief that anticipates the main proceedings where the legal validity of the asserted property right is uncertain, which must be presumed without a preliminary ruling by the CJEU.

• There may be further referrals to the CJEU in the near future. Notably, even the Higher Regional Court indicates that it expects the CJEU to clarify criteria as to when one can assume a basic patent to contain several products or only one product.

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, who represented one of the generics.