A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights.
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.
The CJEU handed down its ruling on C-527/17 (Boston Scientific)- available here. It decided:
Article 2 of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products must be interpreted as meaning that a prior authorisation procedure, under Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, as amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007, for a device incorporating as an integral part a substance, within the meaning of Article 1(4) of that directive as amended, cannot be treated in the same way, for the purposes of applying that regulation, as a marketing authorisation procedure for that substance under 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, as amended by Directive 2004/27/EC of the European Parliament and of the Council of 31 March 2004, even if that substance was the subject of the assessment provided for in the first and second paragraphs of section 7.4 of Annex I to Directive 93/42, as amended by Directive 2007/47.
In essence, the CJEU has ruled that a CE-mark approval for a medical device comprising an active ingredient as an integral part cannot be considered as an approval in accordance with the Medicinal Products Directive, even if the ingredient was assessed using the consultation process.
Many thanks to Oswin Ridderbusch and Alexa von Uexkuell (Vossius & Partner) for spotting the ruling!
Thomas Bouvet and Laura Romestant (Jones Day) kindly report below on a recent decision (here, in French only) of the Court of Appeal of Paris to refer questions to the CJEU:
On 9 October 2018, the Court of Appeal of Paris issued a decision which refers two questions to the CJEU intended to clarify the terms “different application” and “falling within the scope of protection conferred by the basic patent” as addressed in the CJEU Neurim decision.
Background Santen is the holder of:
European patent № 1 809 237, entitled “Ophthalmic oil-in-water type emulsion with stable positive zeta potential”, filed on 10 October 2005 and granted on 31 December 2008;
a central marketing authorization № EU/1/15/990 valid in the entire European Union, granted on 19 March 2015 and notified on 23 March 2015, for the medicinal product with the proprietary name Ikervis, whose active ingredient is ciclosporin in the formulation, covered by EP 1 809 237, indicated for the treatment of severe keratitis in adult patients with dry eye disease, for which ciclosporin has not been approved before.
By a decision dated 6 October 2017, the Director General of the INPI dismissed the application to grant an SPC for ciclosporin eye drop emulsion, filed by Santen on 3 June 2015.
The Director of the INPI considered that the marketing authorization, on which the application is based, would not be the first authorization to place the product on the market as a medicinal product:
it considered that the sole active ingredient of the specialty object of MA № EU/1/15/990 for “ciclosporin for use in the treatment of keratitis” is ciclosporin which should be considered as the product object of the requested SPC, within the meaning of Article 1(b);
it considered that the previous MA for ciclosporin had been granted on 23 December 1983 for the medicinal product Sandimmun;
it considered that CJEU Neurim decision C-130/11 would not apply in the circumstances of the case because:
- the application for which Ikervis is authorized is not a different application from that of Sandimmun as both relate to inflammatory diseases of the eye; - the basic patent does not protect a new application of ciclosporin, but a new formulation containing no specific use limitation.
Santen lodged an appeal against this decision by declaration of 3 November 2017. In its written submissions filed before the Court of Appeal of Paris, Santen requested:
as a main request, that the Court of Appeal hold the decision of the Director General of the INPI null, as it is contrary to the case law of the CJEU as set out in the Neurim judgment of 19 July 2012 as well as to the case law of the Court of appeal itself as it is set out in the Merck & Co decision of 15 February 2013;
as an auxiliary request, that the Court of Appeal refer a question for a preliminary ruling to the CJEU, in the terms set out in its written submissions before the Court.
The decision of the Court of Appeal of Paris of 9 October 2018 The decision of the Court of Appeal (here) refers two questions to the CJEU, which read in working translation as follows:
“1 - Should the notion of different application within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, be strictly understood, i.e.:
- be limited to the case of a human application following a veterinary application, - or concern an indication in a new therapeutic field, in the sense of a new medical specialty, compared to the previous MA, or a drug in which the active principle exerts an action different from that which it exerts in the drug that was the subject of the first MA; - or more generally, in the light of the objectives of Regulation (EC) No 469/2009 aiming at establishing a balanced system taking into account all the interests at stake, including those of public health, be assessed according to more stringent criteria than those used for the assessment of the patentability of the invention;
or, on the contrary, should it be understood in an extensive way, i.e. including not only different therapeutic indications and diseases, but also different formulations, dosages and/or modes of administration?
2 - Does the notion of application falling within the scope of protection conferred by the basic patent within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11, imply that the scope of the basic patent should be consistent with that of the MA invoked and, therefore, limit itself to the new medical use corresponding to the therapeutic indication of said MA?”
The Court of Appeal found it necessary to ask two questions resulting from the Neurim decision:
- the first one is intended to clarify the meaning of the term “different application” within the meaning of the CJEU Neurim decision of 19 July 2012, C-130/11; - the second one intended to clarify to what extent the basic patent should cover said different application, in particular whether it should be limited to the new medical use.
Thomas Bouvet and Laura Romestant represented Santen.
"Combination SPCs: shaken and stirred" is the title of a recently published article in Life Sciences Intellectual Property Review (LSIPR) by Joel Beevers and Michael Pears (Potter Clarkson). It deals with the history of Article 3(a) as a 'spectrum of specificity' and provides a summary and commentary on the recent Teva v Gilead CJEU judgement. It is accessible for free for the next seven days here.
The Technopolis group has recently completed a study on SPCs for the Dutch parliament entitled "Effects of supplementary protection mechanisms for pharmaceutical products". A copy of the study is available for downloading here.
Alfred Radauer of the Technopolis Group writes:
"The study investigates the impacts of the interaction of supplementary protection certificates (SPCs), paediatric extensions, data and market exclusivity as well as orphan drug protection on innovation in pharma and on the healthcare system. The 173-page report is in English and builds on a legal analysis as well as an economic analysis involving an interview programme, secondary data analysis as well as case studies for seven drugs that have used the said supplementary protection instruments.
The study was performed by Technopolis in collaboration with experts from the University of Liverpool and University of Amsterdam. It was commissioned by the Dutch Ministries of Health and Economics.
We hope that this study makes for good reading and adds to the debate on SPCs and regulatory protection of pharmaceutical products. We would be delighted to receive comments and suggestions at email@example.com."
In a recent decision, the Swiss Federal Supreme Court confirmed the validity of Gilead’s Swiss TRUVADA® SPC and provided some guidance for combination products. A copy of the decision is available here.
Simon Holzer, Kilian Schärli and Marco Borer of Meyerlustenberger Lachenal AG, who acted for Gilead, have provided the summary and comments below along with an English translation of the decision (here).
"The Swiss Federal Supreme Court issued a landmark decision concerning the requirements for Supplementary Protection Certificates (SPCs) for combination products. Until recently, Switzerland stood solid as a rock and defended the so-called infringement test for SPCs for combination products. The Federal Supreme Court has now ruled that while the infringement test shall still apply to existing SPCs, new SPCs for combination products shall be examined in light of the Medeva ruling and other decisions of the CJEU concerning combination products. Whether the Swiss SPC in dispute meets the requirements of the EU case law is not relevant and, therefore, has not been decided by the Swiss Federal Supreme Court.
The Swiss dispute in a nutshell The Swiss litigation is about the validity of Gilead Sciences Inc.’s Swiss SPC C00915894/01 for the combination of tenofovir disoproxil fumarate plus emtricitabine. The SPC was granted by the Swiss Institute of Intellectual Property on 29 August 2008 based on the marketing authorization for TRUVADA®, a medication used to treat (and in some jurisdictions also to prevent) HIV/AIDS. It is a fixed-dose combination of the two antiretroviral medications tenofovir disoproxil fumarate and emtricitabine.
On 3 January 2017 Mepha Pharma AG, a Swiss subsidiary of Teva, filed a revocation action against Gilead’s Swiss SPC. Mepha essentially argued that the ratio legis of the Swiss law on SPCs requires that the “infringement test”, which had been confirmed in a decision of the Swiss Federal Supreme Court in 1998 (BGE 124 III 375), be set aside, and that this change of practice shall be applicable with immediate effect even for existing SPCs. Mepha was of the opinion that Swiss courts should apply EU case law and if it did, Gilead’s SPC would be invalid in light of the practice of the CJEU for combination products because the two active ingredients were not specified in the claims of the basic patent and did not correspond to the basic patent’s core inventive advance.
Gilead argued several lines of arguments. First, it was of the opinion that Switzerland should stick to the infringement test. Second, it argued that even if the EU practice for SPCs for combination products were to be introduced in Switzerland, this practice would only apply to new SPCs whose applications were filed after the change of practice. A change of practice could not have a retroactive effect according to Gilead. Third, Gilead took the position that even if the criteria established by the CJEU would apply to existing Swiss SPCs, those requirements – if correctly interpreted and applied – would be fulfilled by the SPC for TRUVADA®.
In October 2017 the Swiss Federal Patent Court ruled that it was not appropriate to move away from the infringement test that had been applied in Switzerland since the Supreme Court’s decision BGE 124 III 375 (Fosinopril) in 1998. The Federal Patent Court examined several decisions of the CJEU dealing with SPCs for combination products (i.e. C-322/10 – Medeva, C-518/10 – Yeda, C-630/10 – University of Queensland, C-6/11 – Daiichi Sankyo, C-493/12 – Eli Lilly, and C-443/12 – Actavis/Sanofi) and came to the conclusion that the requirements of Article 3(a) of the EU SPC-Regulation No 469/2009, i.e. whether the product of an SPC is protected by the basic patent, are unclear and, therefore, there was no reason to move away from the infringement test.
According to previous Swiss case law, it was not necessary that the product of the SPC be named and described in the basic patent. Rather, it was sufficient if the product was covered by the scope of the basic patent. The Federal Patent Court therefore dismissed the revocation action brought by Mepha against Gilead’s Swiss SPC.
The decision of the Federal Supreme Court Mepha filed an appeal against the verdict of the Federal Patent Court with the Swiss Federal Supreme Court. On 11 June 2018 the Federal Supreme Court dismissed Mepha’s appeal, but the dismissal is based on other grounds.
The Federal Supreme Court concluded that SPCs for combination products granted under the infringement test (as confirmed by the Federal Supreme Court in 1998) were still to be assessed in light of the requirements of the infringement test. In an obiter dictum, however, the Federal Supreme Court ruled that new SPCs for combination products must comply with the requirements of the Medeva et al. case law of the CJEU in the future.
Whether Gilead’s SPC for TRUVADA® meets these requirements was left open by the Federal Supreme Court, as this question is irrelevant since this SPC will continue to be judged according to the infringement test.
Change of practice The Federal Supreme Court held that a diverging practice between the CJEU and the Swiss courts in the field of SPCs could be a serious reason for a change in practice of the Swiss law. The Federal Supreme Court was of the opinion that Swiss lawmakers wanted to harmonize the Swiss law on SPCs with the laws in the EU. In this context, the Federal Supreme Court emphasized that the interpretation of the requirement “protected by a patent” according to Article 140b para. 1 lit. a of the Swiss Patent Act in the Fosinopril decision in 1998 (BGE 124 III 375) differed from the interpretation of “protected by a basic patent in force” according to Article 3(a) of the EU SPC-Regulation No 469/2009 by the CJEU according to the previous Swiss case law.
Due to the fact that the Swiss legislature wanted to bring the protection of SPCs into harmony with that of the neighboring jurisdictions the Federal Supreme Court advocates an adaptation to the concept of the CJEU case law as expressed in the decisions of Medeva et al. However, the CJEU case law shall only apply to new SPCs according to the Federal Supreme Court.
Existing SPCs are still subject to the infringement test The Federal Supreme Court examined whether a change of practice could and should have an effect on SPCs that had already been granted, and, thus, whether Gilead’s SPC is valid even in the (not conclusively assessed and therefore hypothetical) case that the requirements for granting an SPC in light of the case law of the CJEU might not be fulfilled.
The Federal Supreme Court emphasized that Gilead’s SPC had been legally granted in light of the infringement test in force at the time of the application and grant of Gilead’s SPC. The nullity grounds of the Swiss Patent Act refer to the question of whether the conditions for granting the SPC were fulfilled at the time of filing the SPC application. In the opinion of the Federal Supreme Court, this was clearly the case, since the infringement test was undisputedly the relevant test at the time Gilead’s SPC application was submitted to the Swiss Institute of Intellectual Property.
The Federal Supreme Court then examined whether, as an exception, a validly granted SPC can be revoked only because of a later change of practice, or more generally speaking, whether a legally binding administrative decision like the grant of an SPC could be reconsidered or revised as a result of a legal change of practice. As a general rule, the grant of an SPC cannot be revoked due to a later change of practice if the interest of the holder of the SPC in protecting his exclusive rights precedes the interest in the uniform implementation of the new law. Although this rule does not apply in absolute terms, the Federal Supreme Court could not see any particularly significant interest that would clearly demand a revocation of Gilead’s lawfully granted SPC simply because a change of practice has taken place many years after the grant. In the opinion of the Federal Supreme Court, Gilead’s interest in protecting its exclusive rights is clearly higher than the interest that in Switzerland all SPCs for combination products must be subject to exactly the same rules in the future.
Comments The recent ruling of the Federal Supreme Court strikes an interesting balance between the confidence of the owners of existing SPCs in the current practice and the industry’s interest in creating an EU-compatible system for Swiss SPCs. The judgment tries to protect the interests of patent owners and marketing authorization holders of originator pharmaceutical products who have made time-consuming and costly efforts in the authorization and marketing of their products on the one hand and the interest of the industry in bringing Swiss case law in line with the European Union practice.
One question seems to remain open even after the decision of the Federal Supreme Court: According to the language of the decision of the Federal Supreme Court, the infringement test seems to apply to already granted SPCs. However, what happens with pending applications for SPCs for combination products? Those applications have been filed in light of the previous practice (i.e. by relying on the infringement test) as well. The Swiss Federal Patent Act explicitly provides that an SPC shall be granted if the requirements for the grant of the SPC are met at the filing date of the application. The applications for SPCs for combination products that are still pending before the Swiss Institute of Intellectual Property were filed in light of the then valid infringement test. It remains to be seen whether the fact that those applications have not yet resulted in a formal grant will make a major difference in whether they are examined in light of the infringement test or the EU case law.
For example, on 11 January 2007 the Grand Chamber of the European Court of Human Rights decided that a trademark application had to be protected as private property in the sense of Article 1 of the Protocol to the Convention for the Protection of Human Rights and Fundamental Freedoms (Anheuser-Busch, Inc. v. Portugal, Case No. 73049). Although Switzerland has not ratified this protocol the considerations of the Grand Chamber of the European Court of Human Rights nevertheless seem to be relevant when examining the legal nature of an SPC application."