The SPC blog

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. You can email The SPC Blog here

Tuesday, 18 December 2018

Call for comments for C-673/18 (Santen v INPI)



The UK IPO is seeking comments on CJEU case C-673/18 by 2 January 2019 with a view to lodging observations with the CJEU.  The case was previously reported on the SPC Blog here. If you would like to comment on this case, please email policy@ipo.gov.uk referencing the case number in the subject heading. 

As a refresher, the questions referred to the CJEU in this case is 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?” 

Thursday, 13 December 2018

C-443/17 - Abraxis - AG's opinion out

The Advocate General of the CJEU has provided his opinion in C-443/17 (Abraxis Bioscience) today (here).

As a refresher, the questions referred to the CJEU by Mr Justice Arnold were:
"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?"
The Advocate General has advised the Court to rule as follows:
Article 3(d) 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 precludes the grant of such a certificate where the marketing authorisation relied upon in support of the application for a supplementary protection certificate under Article 3(b) of that regulation is not the first marketing authorisation for the active ingredient or combination of active ingredients at issue as a medicinal product. This is so even in a situation, such as that at issue in the main proceedings, where the marketing authorisation relied upon is the first to cover the formulation protected by the basic patent relied upon in support of the application for a supplementary protection certificate under Article 3(a) of that regulation.

Sunday, 18 November 2018

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!



Friday, 2 November 2018

An analysis of the CJEU’s ruling in Teva (C-121/2017) and a proposal for its implementation

Dr. Roberto Romandini of the Max Planck Institute for Innovation and Competition in Munich has published a MPI- Research Paper on Art. 3(a) Reg. 469/2009 that includes an analysis of CJEU’s ruling in Teva (C-121/2017) and a proposal for its implementation. The abstract is reproduced below, the paper is available at https://papers.ssrn.com/sol3/papers.cfm?abstract_id=3270898
Comments and critique are welcome and may be sent to roberto.romandini@ip.mpg.de.
Abstract: On 25 July 2018 the Grand Chamber of the CJEU delivered the eagerly awaited decision on Art. 3(a) Reg. 469/2009 following the referral by Justice Arnold in Teva (C-121/2017). In answering the question what it means to be protected by the basic patent under Art. 3(a) Reg. 469/2009, the CJEU formulated a two-pronged requirement. In order to be eligible for a supplementary protection certificate (SPC) the product (i) must necessarily fall under the invention covered by the basic patent and (ii) be specifically identifiable in that patent. This further formula in the case law following Medeva (C-322/10) is open to a number of interpretations, the most restrictive of which is that the CJEU has adopted a core-inventive-advance test with the first prong and required an individual disclosure of the product with the second prong. This article proposes a purposive implementation of the decision which takes into account the policy goals underlying the CJEU case law. These goals are to prevent multiple SPCs for the same product in conjunction with a number of other active ingredients (“evergreening”), unless such combinations represent a “totally separate innovation” (C-443/12), and to prevent the grant of a certificate for monotherapy products that were developed by a third unrelated entity after the priority date of the basic patent. In order to achieve the first goal, an inventive-advance test is necessary, but also sufficient. In order to ensure the second goal, requiring a disclosure of the product in an individualized form is in some cases sufficient, but not necessary where the patentee has, after the priority date of the basic patent, developed the product and obtained the MA submitted in support of the application for a certificate. In view of the persistent lack of clarity of the case law, the article concludes with some thoughts on the role of the CJEU, the task of the lawmakers and the implication of the Unified Patent Court Agreement (UPCA) for the operation of the SPC system.

Saturday, 27 October 2018

C-527/17 ruling is out: No SPCs for CE-marked devices

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!

Thursday, 18 October 2018

France - Court of Appeal of Paris refers questions to the CJEU

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.

Sunday, 23 September 2018

UK - Truvada SPC does not comply with Article 3(a)

Last week, Mr Justice Arnold handed down his judgement in Teva UK Limited & Ors v Gilead Sciences Inc [2018] EWHC 2416 (Pat) (here), following the CJEU's  preliminary ruling in C-121/17 (here).

In brief, Teva UK Limited, Accord Healthcare Limited, Lupin Limited and Generics UK Limited challenged the validity of Gilead's SPC (SPC/GB05/041) for a "composition containing both Tenofovir disproxil, optionally in the form of a pharmaceutically acceptable salt, hydrate, tautomer or solvate, together with Emtricitabine".  They contended that the SPC does not comply with Article 3(a) of the SPC Regulation.  Gilead contended that the product described in the SPC was protected by the basic patent, EP (UK) 0 915 894.   In his first judgement (here), Mr Justice Arnold referred the following question to the CJEU: "what are the criteria for deciding whether 'the product is protected by a basic patent in force' in Article 3(a) of the SPC Regulation?".  The CJEU provided its judgement in C-121/17 in July 2018.  Mr Justice Arnold applied the two tests described in C-121/17 and found that the SPC does not comply with Article 3(a).  His reasoning is set out below:
  1. The first test is that, 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. As explained above, this is not a simple extent of protection test. Rather, the combination must be 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.
  1. As the Court of Justice rightly says at [56], the Patent says nothing about the possibility that TD and emtricitabine may be combined to treat HIV. Indeed, it does not even mention emtricitabine. All it says at [0047] is that the claimed compounds may be administered as pharmaceutical formulations with optionally other therapeutic ingredients. Accordingly, as the Court rightly indicates, there is no basis for the skilled person to understand that the combination embodies the technical contribution of the patent. TD embodies the technical contribution of the Patent, but that is a different matter.
  1. The second test is that, 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. There is no dispute that TD is specifically identifiable. In my view it is clear that emtricitabine is not specifically identifiable. Once again, it is not mentioned in the Patent. It is not even a member of a specific class of compounds mentioned in the Patent, whether by reference to their structure or activity, as being suitable for combination with the compounds of the invention. Furthermore, although emtricitabine was known at the priority date, there is no evidence that it was known that emtricitabine was an effective agent for the treatment of HIV in humans, still less that this was common general knowledge to the person skilled in the art to whom the Patent is addressed.
  1. As counsel for the Claimants submitted, this result is perfectly consistent with the objectives of the SPC Regulation. As noted in my first judgment at [24], Gilead obtained a marketing authorisation in respect of Viread, which contains TDF, on 5 February 2002, less than five years after the application for the Patent was filed. Thus Gilead did not suffer sufficient regulatory delay in exploiting the Patent to warrant the grant of an SPC in respect of Viread. Moreover, although Gilead applied for and was granted a patent for the combination in Truvada, that patent was revoked by the Opposition Division of the European Patent Office and Gilead's appeal against that decision was dismissed. Thus Gilead made no invention in devising the combination which warranted the grant of a patent, let alone an SPC.


Wednesday, 15 August 2018

Combination SPCs: shaken and stirred - an article

"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

Wednesday, 25 July 2018

C-121/17 - Teva ruling out now

The CJEU gave its ruling today in C-121/17 (here), Teva UK Ltd and others v Gilead Sciences Inc.

In brief, the question referred by Justice Arnold, was:
What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/2009?
The Court has ruled as follows:
"Article 3(a) of Regulation 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 product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent: 
–        the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
–        each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent."

Thursday, 19 July 2018

Study on SPCs for the Dutch Parliament published

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 ips@technopolis-group.com."