New SPC reference to the CJEU on Article 3(c) – Novartis (C-354/19)

Carpmaels & Ransford and Awa have kindly prepared the following summary on a recent SPC reference to the CJEU:

"The Swedish Patent and Market Appeal Court has made a reference to the CJEU relating to the interpretation of Article 3(c) of the SPC Regulation for Medicinal Products, in light of Article 3(2) of the SPC Regulation for Plant Protection Products. In brief, the court is asking whether, in a case such as the present, an SPC to a new therapeutic indication is available where the applicant has an earlier SPC to the same active ingredient.

Article 3(c) of the Medicinal Products Regulation states that one of the requirements for SPC grant is that “the product has not already been the subject of a certificate” in the same member state and at the date of the SPC application. Article 3(2) of the Plant Protection Regulation provides that “[t]he holder of more than one patent for the same product shall not be granted more than one certificate for that product. However, where two or more applications concerning the same product and emanating from two or more holders of different patents are pending, one certificate for this product may be issued to each of these holders”, while Recital 17 of the Plant Protection Regulation suggests that Article 3(2) is also valid for the interpretation of Article 3 of the Medicinal Products Regulation.

The Swedish SPC application underlying this reference is based on Novartis’s marketing authorisation for the medicinal product Ilaris®, which contains the anti-IL1beta antibody canakinumab. The marketing authorisation supporting the SPC application is a decision from 2013 which for the first time authorises canakinumab for the treatment of systemic juvenile idiopathic arthritis (SJIA), which is a serious condition responsible for high childhood mortality and severe morbidity. The corresponding basic patent is limited to the use of antibodies such as canakinumab in the treatment of juvenile rheumatoid arthritis.

Novartis has an earlier granted SPC based on a separate patent which protects the canakinumab antibody per se. The SPC is supported by a marketing authorisation for canakinumab in the treatment of Cryopyrin-Associated Periodic Syndromes (CAPS), which is a different indication from SJIA and which falls outside of the scope of the patent that supports the later SPC application.

In view of the existence of the earlier SPC, the Swedish court is asking whether Article 3(c) in light of Article 3(2) precludes the grant of the later SPC application, which relates to a new therapeutic indication protected specifically by its own basic patent. The Swedish court has therefore referred the following question to the CJEU (our translation):

Against the background of the basic objective that supplementary protection for medicinal products aims to accommodate and which consists of stimulating pharmaceutical research in the Union, does Article 3(c) of the Regulation concerning Supplementary Protection Certificates for medicinal products, considering Article 3(2) of the Regulation concerning the creation of a Supplementary Protection Certificate for plant protection products, constitute an obstacle against an applicant, that has previously been granted a Supplementary Protection Certificate concerning a product which is protected by a basic patent in force for the product as such, being granted a Supplementary Protection Certificate concerning a new use of the product in a case such as the present where the new use constitutes a new therapeutic indication which is protected specifically by a new basic patent?

Carpmaels & Ransford represents Novartis AG in respect of its Ilaris® product. AWA represented Novartis AG before the Swedish patent office and courts in relation to the Swedish SPC application."

Germany - District Court lifts several ex-parte preliminary injunctions granted for Merck Sharpe & Dohme Corp.

Recently, the District Court in Düsseldorf lifted several ex-parte preliminary injunctions granted for Merck Sharpe & Dohme Corp. (MSD) against various generic companies. The District Court’s decision in German language can be found (HERE) as well as the English translation thereof (HERE). Phillip Rektorschek (Taylor Wessing) and Derk Vos (Maiwald), who acted i.a. for Hexal AG and 1A Pharma, have provided the following summary on the case: 

"Earlier this year MSD, based on SPC DE 12 2004 000 026.1, applied for preliminary injunctions against eight generic companies in order to prevent market entry of generic versions of MSD’s cholersterol-lowering combination product Inegy®. Inegy® is a fixed dose combination of the actives ingredients ezetimibe and simvastatin. While, the present SPC in question, DE 12 2004 000 026.1 is directed to a product covering ezetimibe or pharmaceutically acceptable salts thereof in combination with simvastatin, MSD had also held an earlier SPC in Germany on the very same basic patent EP 1 720 599 B1, which covered the mono-product of ezetimibe (tradename EZETROL®), which expired in April 2018. 

In May 2018 the District Court in Düsseldorf granted MSD ex-parte preliminary injunctions against the generic companies.  

Seven of these generic companies appealed against the preliminary injunction granted by the District Court. It was argued that the SPC-in-suit is invalid and was granted contrary to the requirements of Art. 3 a), 3 c) and 3 d) SPC-Regulation. 

With the decision of 1 October, 2018, these seven injunctions have now been lifted. According to the District Court’s assessment, the validity of SPC DE 12 2004 000 026.1 is not sufficiently secured and the SPC is expected to be invalidated. 

In the District Court’s opinion, the requirements of Art. 3 a) SPC-Regulation were fulfilled for the combination product in question, since the combination of ezetimibe and simvastatin was mentioned in the claims as well as in the specification of the basic patent. Further, the skilled person would have known from the prior art that simvastatin would also be a suitable drug for reduction of cholesterol. Based on the fact that ezetimibe and simvastatin would act via a different mechanisms of action, the skilled person would expect achieving an additive effect with the administration of the two active ingredients. 

However, the District Court concluded that the requirements of Art. 3 c) SPC-Regulations were not fulfilled for the product-in-suit. 

Contrary to MSD’s submission, ezetimibe would be the sole subject matter of the invention protected in the basic patent in an SPC specific meaning. The combination of ezetimibe and simvastatin would not be the core of the technical teaching of the basic patent and should therefore not be awarded a separate SPC. 

The Court made clear that according to their interpretation of the CJEU’s case law, an SPC should be granted for compensating for the duration of the authorization procedure but not for the effort/cost associated with the authorization procedure. Moreover, the extension of protection should only be granted once for a product which may be understood as an active ingredient or combination of active ingredients in the narrower meaning. This approach may lead to situations wherein a combination of active ingredients is in fact considered to be protected in the meaning of Art. 3 a) SPC-Regulaiton, but in view of Art. 3 c) SPC-Regulation there should only be awarded an SPC if a product represents the core inventive advance of the basic patent at its priority date. 

This requirement was considered not to be fulfilled in the present case since the combination of ezetimibe and simvastatin is not the core inventive advance of the basic patent, but only ezetimibe. According to the District Court, the technical contribution for which the SPC should be rewarded must represent the actual technical teaching of the basic patent. In particular for combination preparations, the combination must address a specific problem in the treatment, prevention or diagnosis of a disease, for which the technical solution must be different from the solution provided by the mono product.In the District Court’s opinion not only a synergism of the two actives would qualify for such a different effect but also a reduction of side effects or the like, under the condition that this effect is different from the one observed for the mono-product. However, for the difference relied upon, there must be disclosure in the basic patent at the priority date. Referring to the recent decision C-121/17 – Teva, the District Court stated that it is not sufficient that such differences or effects were only revealed during the authorization procedure. In such a case the aim of the Regulation, namely to compensate for the duration of the authorization procedure would not be fulfilled. 

The District Court further stated that also the other effects relied upon by the Claimant were not disclosed in the basic patent and have been classified as “surprising” by the Claimant itself. It is therefore apparent, that the effect relied upon by the Claimant are based on additional insight gained only during the authorization procedure, but are not disclosed in the basic patent. 

Moreover, in the Court’s view the fact that the majority of the relevant clinical studies for the marketing authorization of the combination product were already conducted for the authorization of the mono-product aggrevates the situation. Only marginal additional data on the effectiveness were provided with the marketing authorization for the combination product, which, however, did not provide any additional gain in knowledge in view of the data contained in the earlier authorization of the mono-product Ezetrol®.
According to the District Court, the mere fact that the combination is provided as a “fixed dose” cannot chance the situation, since it was known to the skilled person at the priority date that patient compliance is improved by fixed dose preparations. In addition, there is no indication that the provision of the fixed dose preparation was associated with any difficulties for the skilled person. 

Summarizing, the District Court found that the SPC was granted contravening the requirements of Art. 3 c) SPC-Regulation and thus the validity of the SPC is not secured and therefore the preliminary injunctions had to be revoked."

MSD has filed an appeal against the first instance decision.

Many thanks to Derk Vos and Philip Rektorschek!