Supplementary Protection Certificate Update – November 2018

Application of C-121/17 in Teva UK Limited & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat)

The case related to whether Gilead’s combination product of “tenofovir disoproxil (TD), in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with a second active ingredient, emtricitabine” is entitled to an SPC.

The question referred to the CJEU by the UK High Court related to compliance with Article 3a of the Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 (SPC Regulation). Specifically, the UK High Court asked what are the criteria for deciding whether “the product is protected by a basic patent in force”? For further background and details on the referral please see Chris Newcombe’s summary article.

After answering the question referred by the UK High Court and preliminarily opining that Gilead’s SPC would not satisfy the requirements of Article 3a of the SPC Regulation, the CJEU referred the case back to the UK High Court to decide on the facts of the case. Mr Justice Arnold determined that the following two prong test must be applied in light of the C-121/17 decision:

1. “From the point of view of a person skilled in the art and on the basis of the prior art at the priority date, the combination of active ingredients must necessarily, in the light of the description and drawings of the patent, fall under the invention covered by that patent” (emphasis added); and
2. “From the point of view of a person skilled in the art and on the basis of the prior art at the priority date, each of the active ingredients must be specifically identifiable, in the light of all the information disclosed by the patent” (emphasis added).

In relation to the first requirement, Mr Justice Arnold commented that it is necessary to determine whether the combination (TD and emtricitabine) is one that the skilled person would understand, on the basis of the description and drawings and their common general knowledge, to embody the technical contribution made by the patent. It was further noted that emtricitabine was not mentioned in the patent. The patent only mentioned that claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients of which emtricitabine was subsequently found to be. It was therefore not possible for the skilled person to understand that the combination of TD and emtricitabine could embody the technical contribution of the patent. As such, the first test was not satisfied.

In relation to the second test, Mr Justice Arnold commented that not only was emtricitabine not specifically mentioned in the patent, it was not even a member of a specific class of compounds mentioned in the patent as being suitable for combination with TD. As such, the second test was not satisfied and Gilead’s was therefore invalidated.

Related Article 3a referrals to CJEU

It may not be surprising that the Gilead’s SPC was invalidated in light of the decision in C-121/17, however, there are still outstanding decisions regarding the interpretation of Article 3a of the SPC Regulation. In particular, we are still awaiting the decision of the CJEU in C-650/17 and C-114-18 and the clarification that these decisions are expected to provide.

C-650/17 (Sitagliptin): The referral by the German Federal Patent Court to the CJEU relates to whether a single active ingredient is protected by a basic patent if it is not specifically mentioned but is covered by a functionally defined claim. Please see Siân Gill’s article in Inside IP Spring 2018 for a full discussion of the questions raised.

C-114-18 (Sandoz v Searle): The referral by the UK Court of Appeal to the CJEU relates to whether a single active ingredient is protected by a basic patent if it is a member of class of compounds that fall within a Markush definition in a claim.

We will monitor developments in these cases and report as they become available.

MSD’s preliminary injunctions lifted by the German District Court

A decision handed down by the German District Court in Düsseldorf on 1 October 2018 has lifted the preliminary injunctions obtained by Merck Sharpe & Dohme Corp. (MSD) granted on the basis of MSD’s SPC for the their combination product Inegy®. The preliminary injunctions had barred market entry for generic versions of Inegy® and were predictably appealed by a number of generic companies on the grounds that the SPC on which the preliminary injunctions were based was invalid.

In deciding whether the preliminary injunctions were to be upheld, the District Court considered the validity of MSD’s SPC in light of Article 3a and 3c of the SPC Regulation. As a combination product, the court considered the teachings of C-121/17 and concluded that because the combination of active ingredients in Inergy® (ezetimibe and simvastatin) were explicitly mentioned as a combination (claim 17 of the basic patent – EP 0720599 B1) that the requirements of Article 3a were met.

However, the District Court continued to assess whether the SPC in question would be likely to fulfil the requirement of Article 3c of the SPC Regulation (that the product has not already been the subject of an SPC). The Court highlighted that MSD has already obtained an SPC based on the same basic patent for the mono-product ezetimibe (Ezetrol ®). Considering the CJEU decisions in C443/12 and C-577/13 the District Court noted that a combination product for which a single component has already obtained an SPC (based on the same basic patent) but that obtained later market authorisation should not be entitled to a second SPC unless the combination product constituted the “core inventive advance” of the basic patent at its priority date.

In determining whether the combination product (Inergy ®) constituted the core inventive advance of the basic patent in question, the District Court considered whether the combination resulted in a synergistic effect (an additive effect would not be sufficient), or whether there were further relevant effects that the skilled person would not expect. Although the effects of the combination product had been demonstrated in market authorisation, these effects were not disclosed in the basic patent and as such did not contribute to the core inventive advance required. The core inventive advance of the basic patent was found to be the provision of ezetimibe which was already the subject of an (expired) SPC.

The District Court therefore opined that the SPC that formed the basis of the previously granted preliminary injunctions would be unlikely to satisfy Article 3c of the SPC Regulation. The preliminary injunctions were therefore lifted in light of the likely invalidity of MSD’s SPC. MSD has filed an appeal against this decision.

Although MSD’s preliminary injunctions have been lifted, the District Court has not invalidated MSD’s SPC for the combination product Inegy®, which remains in force at the time of writing.

C-527/17: An end to medical device SPCs

Article 2 of the SPC Regulation requires that any medicinal product to be considered for an SPC must have been subject, prior to being placed on the market as a medicinal product, to an administrative authorisation. Specifically, the medicinal product must have been granted marketing authorisation in accordance with the Medicinal Products Directive (Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use).

Medical devices (addressed in separate European Directives), which do not necessarily undergo this authorisation, may require similar market authorisation and thereby obtain CE-certifications that acknowledge that the medical device meets the requirements of all relevant European Medical Device Directives. However, the similarity of the corresponding authorisation procedures has led to divergent appliance in national patent offices.

In the case in question, Boston Scientific obtained a CE certificate of conformity in relation to the medical device TAXUS™ Express2 Paclitaxel-Eluting Coronary Stent System (‘the TAXUS medical device’), a Paclitaxel-coated stent. The Paclitaxel-coated stent does not fall within the definition of the term ‘medicinal product’ which is defined in the Medicinal Products Directive as:

“any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”

However, as the medical device comprised Paclitaxel, which in theory would be considered a medicinal product, the German Federal Court asked the CJEU to clarify whether a CE certificate for such a combination medical device could be treated in the same way as the market authorisation required under the SPC Regulation.

In the CJEU’s decision, it was emphasised that the terms ‘medical device’ and ‘medicinal product’ are mutually exclusive and that the stent in question falls into the medical device category in so far that Paclitaxel performs only an action ancillary to that of the medical device into which it is incorporated. Paclitaxel cannot be classified independently from that device and therefore does not fall within the scope of the SPC Regulation.

Furthermore, the CJEU further highlighted that the two authorisation procedures, market authorisation for a medicinal product and CE-certification for a medical device, are not equivalent. The CJEU highlighted that any testing of Paclitaxel in the CE-certification procedure was in context of the medical device as a whole and was therefore not equivalent to market authorisation for Paclitaxel as a medicinal product separately.

The decision of the CJEU therefore clarifies the ineligibility of medical devices comprising substances that may otherwise be considered medicinal products. However, it seems likely that this decision will be applicable to all medical devices in so far as they cannot be classified as medicinal products.

Referral from the Court of Appeal of Paris

Since the CJEU’s ‘Neurim’ decision (C-130/11) the test for determining whether a market authorisation for a medicinal product is the ‘first market authorisation’ (in accordance with Article 3(d) of the SPC Regulation) has been interpreted in divergent ways. In summary, the Neurim decision opened the doors to the availability of SPC protection for medicinal products that relate to a different use from that which was covered by an earlier market authorisation. In the decision it was stated that:

“ […] if a patent protects a therapeutic application of a known active ingredient which has already been marketed as a medicinal product, for veterinary or human use, for other therapeutic indications, whether or not protected by an earlier patent, the placement on the market of a new medicinal product commercially exploiting the new therapeutic application of the same active ingredient, as protected by the new patent, may enable its proprietor to obtain an SPC, the scope of which, in any event, could cover, not the active ingredient, but only the new use of that product.”

The CJEU also emphasised that the mere existence of an earlier market authorisation for a different use does not preclude the grant of an SPC for a different application of the same product provided that the application is within the limits of the protection conferred by the basic patent relied upon for the purposes of the application for the supplementary protection certificate.

In light of the test set out in the Neurim decision the Court of Appeal of Paris has referred two questions to the CJEU.

The first question relates to the requirement that the medicinal product must exploit a ‘different application’ and how strictly this requirement should be interpreted. The question highlights that a narrow interpretation could require that the different application is for example: human vs veterinary application; application in a new therapeutic field; or potentially a more stringent criteria. Alternatively, a broader interpretation might require only different formulations, dosages and/or modes of administration. Clarification was therefore requested by the CJEU.

The second question requests clarification as to whether the basic patent relied upon for the second SPC should be consistent and limited to the medical use of the therapeutic indication of the market authorisation. Clarification as to the scope of the basic patent required for second medical use SPC was therefore requested by the CJEU.

We will provide our analysis of this outstanding decision as soon as it becomes available.

If you have any questions regarding Supplementary Patent Protection please be sure to contact Venner Shipley’s Pharmaceutical or Agrochemical teams.