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

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."

Friday, 6 July 2018

France - ezetimibe and simvastatin combination SPC - Paris Court of Appeal refuses request for preliminary injuction

Gérard Dossmann and Marianne Gabriel (Cassalonga) have kindly provided the SPC Blog with a copy of the original French text of a recent decision of the Paris Court of Appeal refusing a request for a preliminary injunction based on the SPC of the combination of ezetimibe and simvastatin.  In addition, they have kindly sent us a summary of the case, below.
By decision dated June 26, 2018, and on the basis of Articles 3 (c) and 3 (d) of Regulation (EC) No 469/2009, the Paris Court of Appeal upheld the interim order issued on April 5, 2018 by the Paris Court of First Instance (here), dismissing the requests for preliminary injunction against Biogaran based on SPC n° 05C0040 protecting a combination product of ezetimibe and simvastatin. 
The basic patent and the SPC
In this case, the basic patent EP 0 720 599 (hereinafter EP 599), filed on September 14, 1994, and now expired, concerned "hydroxy-substituted azetidinone compounds effective as hypocholesterolemic agents", and referred in particular to ezetimibe in claim 8 and to the combination of ezetimibe with simvastatin in claim 17. 
This EP 599 patent is the basic patent of a first SPC No. 03C0028 (hereinafter SPC 028) relating to ezetimibe (corresponding to a marketing authorization for the Ezetrol®) which expired on April 17, 2018 and of a second SPC no. 05C0040 (hereinafter SPC 040) relating to the "ezetimibe optionally in the form of its pharmaceutically acceptable salts in combination with simvastatin" expiring on April 2, 2019 (corresponding to a marketing authorization for Inegy®). 
These two SPCs had been issued before the decisions of the CJEU in Medeva & Co. 
The proceedings
In December 2017, Biogaran filed an action on the merits before the Paris Court of First Instance for the invalidation of SPC 0040. 
Biogaran was subsequently summoned in interlocutory proceedings on February 15, 2018 by the owner of the SPC 040, accusing it of an imminent infringement of its rights and seeking interim measures against it. 
The interim order of 5 April 2018
By an interim order issued on April 5, 2018, the Paris Court of First Instance dismissed the holder of its application for preliminary injunction, considering : 
- if "claim 17 meets the condition laid down by the CJEU since it specifically targets simvastatin in combination with ezetimibe (...) however, to obtain a second SPC from the same basic patent, the combination must not only be specified as such in a claim, it must still be in itself the center of the invention", 
- and that in this case, "only the compounds of the substituted azetidinone family among which ezetimibe are the heart of the invention, simvastatin being already known", and "if this association corresponds to the novelty criterion as far as the validity of SPC 05C0040 is concerned, it does not correspond to the additional criterion defined by the CJEU which imposes that the claim relating to the combination discloses the center of the invention. However, this association is only the juxtaposition of two characteristics or active ingredients, one that can exist without the other and does not require the implementation of the other to come true, what companies also admit [the claimants]. The patent does not teach any advantage in taking ezetimibe and simvastatin in the same tablet compared to taking a drug containing ezetimibe alone and another medicine containing simvastatin alone”, "thus, this proposed combination does not correspond to the center of the invention","therefore, failing to fulfill the second condition defined in Georgetown namely that the claimed combination is also the center of the invention, SPC 05C0040 is not valid and will be declared invalid". 
Confirmation by the Court of Appeal: the decision of June 26, 2018
Ruling in summary proceedings, the Paris Court of Appeal has just confirmed the order in all its provisions, ruling not only in the light of Article 3 (c) but also of Article 3 (d) of Regulation (EC) No 469/2009. 
After referring to the Case Law of the Court of Justice, the Paris Court of Appeal ruled: 
Implementation of Article 3 (c) of Regulation (EC) No 469/2009:
"It is not disputed in the present case that simvastatin, an active ingredient in the category of statins or "HMG CoA reductase inhibitors", is not protected as such by this patent or, elsewhere, by another patent;
It follows that Article 3 (c) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of May 6, 2009, as interpreted by that judgment, precluded that SPC 040 be granted;
Whereas, however, in order to oppose the foregoing, the companies[respondent] claim, as stated above, that EP 599 would cover two inventions, one relating to a new class of compounds, of which ezetimibe and the other on the use of ezetimibe in combination with statins for the reduction of cholesterol level in the blood and within the meaning of Articles 1 and 3 (a) of the SPC Regulation, the combination of active ingredients ezetimibe and simvastatin would constitute a "product" protected by the basic patent;
But whereas it follows from the foregoing reasons that only ezetimibe is the novel active ingredient protected by EP 599, while simvastatin, a known medicinal product, is not protected by that patent, the claim regarding the inventive nature of their combination is inoperative in the light of the foregoing reasons in the aforementioned judgment C-443-12; (...)” 
Implementation of Article 3 (d) of Regulation (EC) No 469/2009:
Considering finally, even assuming, what is denied above, that EP 599 protects, within the meaning of Articles 1 and 3 (a) of the SPC Regulation, as such two distinct products, on the one hand ezetimibe, on the other hand, the combination of ezetimibe with simvastatin, it is rightly that in case of appeal the company Biogaran opposes that the marketing authorization of July 28, 2005 covering this second combination product under the trademark Ezetrol® would not have been the first within the meaning of Article 3 (d) of the Regulation; 
It is apparent from the summary of the characteristics of the product Ezetrol® that gave rise to the marketing authorization of June 11, 2003 that this medicinal product, proposed in the form of a 10 mg tablet of ezetimibe, is the subject of a therapeutic indication in association with a statin for the treatment of hypercholesterolemia, for the prevention of cardiovascular events and homozygous familial hypercholesterolemia; that its dosage, when prescribed with a statin, is the subject of particular developments; that its administration in association with a statin is contraindicated in certain cases, especially in case of pregnancy; more generally, the 17 pages of this document all refer to the administration of the drug Ezetrol® either alone or in combination with a statin; that more specifically, developments are devoted on pages 10, 11, 12, 13, 14 and 15 to the administration of Ezetrol with simvastatin; 
It follows from the foregoing analysis that the combination product of ezetimibe with simvastatin has already been the subject of a first marketing authorization on June 11, 2003, and that the second authorization obtained on July 28, 2005 did not allow the grant of a supplementary protection certificate under Article 3 (d) of the Regulation; 
Since the imminent infringement of a private right is not characterized, there is no need for summary proceedings and the order will be confirmed to that effect". 
The case is currently pending on the merits before the Paris Court of First Instance.
 Cassalonga acted for Biogaran.

Tuesday, 26 June 2018

Switzerland - Truvada and moving away from the "infringement test" for future SPCs for combination products

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."
Many thanks!

Friday, 8 June 2018

Carpmaels' "SPC Summer Review" - 14 June 2018

Daniel Wise of Carpmaels & Ransford has written in to the Blog to say that there are a few last places available for Carpmaels’ annual “SPC Summer Review” event taking place next Thursday, 14th June 2018, from 17:30 (for a 18:00 start) at their offices in central London (One Southampton Row, WC1B 5HA). 

The seminar will focus on the latest interpretations of the CJEU’s test for a basic patent to “protect” the active ingredient, including the recent opinion from the CJEU Advocate General in Teva v Gilead (C-121/17), the concept of the “product” in SPC law, and Hugh Goodfellow will review the recommendations from the EU Commission’s review of the SPC system.  Drinks and canapés will be served afterwards. 

If you would like to join, please send an email to anastasia.duncan@carpmaels.com, with the subject line “I would like to attend the SPC Summer Review 2018”.  Attendance is free of charge.

Tuesday, 29 May 2018

France - Paris Court of First Instance nullifies Truvada SPC

Moving on to France on the tour of national court rulings on Gilead's SPC on the combination of tenofovir disoproxil and emitricitabine: Gerard Dossmann and Marianne Gabriel, who acted for Biogaran, report below the recent decision of the Paris Court of First Instance to nullify Gilead's SPC FR05C0032.  A copy of the judgement can be found here.
By judgment of May 25th, 2018, the Paris Court of First Instance canceled the SPC on the combination of "tenofovir disoproxil and its salts, hydrates, tautomers and solvates in combination with other therapeutic compounds such as emtricitabine". 
The basic patent mentioned, in its claim 27, a "pharmaceutical composition comprising a compound according to any of claims 1 to 25 [i.e., tenofovir disoproxil], together with a pharmaceutically acceptable carrier, and optionally, other therapeutic ingredients.
The Paris Court of First Instance held that "the patent on the basis of which the SPC 0032 was delivered does not mention, in the wording of its claims, emtricitabine, the active ingredient on which the SPC relates in combination with the tenofovir disoproxil, neither makes it necessarily and specifically identifiable, nor does it mention a functional formula implicitly but necessarily and specifically aiming at emtricitabine, so that the product is not protected by the basic patent and that the condition laid down in Article 3 (a) of Regulation (EC) No 469/2009 is not fulfilled ". 
After citing the case-law of the General Court of Justice and the brief of the General Attorney Wathelet, the Court specified the conditions to which a claim must comply in order for a product to be considered protected by the basic patent and therefore meet the requirement of Article 3 (a) of Regulation (EC) No 469/2009. 
Thus, according to the Court, "the requirement for that product to be protected by a basic patent in force "presupposes":
  • "that the product is mentioned in the wording of one of the claims or at least, if not mentioned by name, that it is necessarily and specifically identifiable as such by a person skilled in the art"
  • “and that where – in the case of a combination of active ingredients – each active ingredient be also mentioned in the claims or, failing that, necessarily and specifically identifiable individually',
  • “one must note that if it may considered that - to be considered protected by the basic patent – an  active ingredient is not mentioned in the claims of the basic patent by means of a structural definition but simply by means of a functional definition, it is also important to establish that these claims, interpreted inter alia in light of the invention’s description, as provided by Article 69 of the Convention of 5 October 1973 on the Grant of European Patents (EPC ) and its interpretative protocol, implicitly but necessarily aim in a specific manner at the active principle in question.
The Court of First Instance also ruled on the interpretation of Article 69 EPC and held that "the interpretation pursuant to which, for the person skilled in the art, in the context of European Patent No 894, the sentence 'and, where appropriate other therapeutic ingredients' would target an active ingredient with therapeutic properties which may be capable of being combined with tenofovir disoproxil, such as emtricitabine, clearly exceeds what is permitted by Article 69 EPC and its interpretative protocol in this respect, therefore leading to the admission that "the protection also extends to what, in the opinion of a person skilled in the art having examined the description and the drawings, the patent owner intended to protect", and may therefore disregard the reasonable degree of legal certainty that third parties are entitled to expect.
The Court noted, for the sake of completeness, that the purpose of Regulation (EC) No 496/2009 had been respected in the present case, since the owner had a 15-year monopoly between February 5th,  2002, date on which the marketing authorization was granted for the drug on the tenofovir disoproxil subject of the patent no. 894 and July 25th, 2017, the patent’s expiry date, so that it did not suffer from any lack of protection within the meaning of recital (9) of the Regulation.
This very recent judgment is not yet final.
Many thanks to Gerard and Marianne!

Monday, 28 May 2018

European Commission proposal for manufacturing waiver

Today, the European Commission published its proposal to amend Regulation (EC) No 469/2009 on SPCs to introduce a manufacturing waiver, i.e. an exception to allow manufacturers of generics and biosimilars to manufacture certain pharmaceuticals for export outside the EU during the SPC term. A copy of the proposal is available here.

The results of the studies on the legal aspect of SPCs by the Max Planck Institute (here) and on the economic impact of SPCs, pharmaceutical incentives and rewards in Europe by Copenhagen Economics (here) were also published on the Commission website today. 

Thursday, 24 May 2018

GDPR notification

As you may be aware, on 25 May 2018 the EU General Data Protection Regulation EU (2016)/679 (GDPR) comes into force in all EU member states. The GDPR applies to ‘personal data’ meaning any information relating to an identifiable person who can be directly or indirectly identified by reference to an identifier. It requires that personal data be processed lawfully, fairly and in a transparent manner, and that personal data be collected for specified and legitimate purposes.

For those who subscribe to this blog, the SPC Blog collects email addresses which can include personal data such as the whole or part of a name.  The SPC Blog relies on its legitimate interests to process this data to keep you up to date with developments as reported on the SPC blog.  The SPC Blog does not make any other use of this data.

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Many thanks to the IPKat for allowing the SPC Blog to make use of its notification wording.


Wednesday, 23 May 2018

Germany - Gilead's SPC for Truvada nullified by the Federal Patent Court

Last week, the German Federal Patent Court nullified Gilead's German SPC for the combination of tenofovir disoproxil and emtricitabine.  Eva Geschke (Wildanger) and Derk Vos (Maiwald), who acted for Generics UK, have provided the following summary on the case:
"On May 15 the 4th Nullity Senate of the German Federal Patent Court (FPC) nullified Gilead’s German SPC DE 2005 000 0041.8, which had been granted for tenofovir disoproxil in combination with emtricitabine. 
This combination of active ingredient is present in various anti-HIV drugs marketed by Gilead and other companies such as TRUVADA® and ATRIPLA®. Four claimants (Teva GmbH, Hexal AG, Generics [U.K.] Ltd., and Hormosan Pharma GmbH) had challenged the validity of the SPC arguing that the product in question was not protected by claim 27 of the basic patent.  While tenofovir disoproxil was specified in the claim, the parties were in dispute on the issue whether the active ingredient emticitabine was specified in the wording of claim 27 of the basic patent by the term “other therapeutic ingredients” for the purpose of Art. 3 (a) SPC-Regulation according to the criteria set by the CJEU in Eli Lilly (C-493/12). 
The FPC in its preliminary opinion had outlined its interpretation on the criteria set by the Eli Lilly decision (C-493/12) in that a functional definition – as a broad generic term, under which various actives may fall – only relates implicitly, but necessarily and specifically, to the active in question as defined in the SPC, i.e. emtricitabine in the present case – if said active forms an active ingredient which is comprised by said generic term. The FPC demands at the same time that it is excluded that other active ingredients are representatives of said generic term, which, however, do not share the specific medicinal characteristics of the active ingredient in question. 
In defending their SPC, Gilead took the position that the CJEU’s case law, and in particular the Eli Lilly decision, does not require any further criteria than the assessment of Art. 69 EPC and the protocol of its interpretation for the determination whether a product is protected by the basic patent or not. 
It appears that the FPC did not follow the interpretation advanced by Gilead on the Eli Lilly decision but considered that further criteria are to be met in addition to the coverage of the product by Art. 69 EPC for an active ingredient to be implicitly, but necessarily and specifically referred to in a claim of the basic patent. 
The Claimants argued that the generic term “other therapeutic ingredients” was completely unspecific and covered various compound classes with different medicinal characteristics and thus the wording used in claim 27 was not suitable to specifically identify the active ingredient emtricitabine of the product in question. 
The FPC decided that the wording “other therapeutic ingredients” was insufficient to specify the active ingredient emtricitabine according to the criteria set by the Eli Lilly decision. Consequently, the requirements of Art. 3 (a) SPC-Regulation were not fulfilled for the product in dispute.

The decision taken by the FPC is in line with the decision taken by the Munich District Court in the preliminary injunction proceedings initiated by Gilead in August 2017, where the District Court rejected Gilead’s request on the grounds that Art. 3 (a) of the SPC-Regulation is not met. 
In addition, the position from the FPC is also in agreement with the opinion of the AG Wathelet, issued on April 25, 2018 in the CJEU referral C-121/17, which referral originates from the parallel invalidation proceedings in the UK
The reasons for the decision will be issued by the FPC in due time. "

Many thanks to Eva and Derk!

Thursday, 17 May 2018

China - patent term extensions allowable soon?

There have been reports (here and here) of rumors that China will start allowing patent term extensions for pharmaceutical patents.  Does any SPC Blog reader have more information on this exciting development?  If so, please leave a comment below or email us here

Wednesday, 9 May 2018

Update from Finland - rectifying the term of an SPC

Kirsikka Etuaho, Jukka Taskinen and Janina Hakanpää of Espatent have sent us the following update on the rectification of an SPC term in Finland:
The Finnish Patent Office recently published two announcements, one in January and one in April 2018, regarding the relevant dates for the term of supplementary protection certificates. 
According to a judgement of the Court of Justice of the European Union given on 20 December 2017 in case C-492/16 (Incyte Corporation), the authority that has granted a SPC must rectify the term of valid SPCs at the request of the holder. The Finnish Patent Office has individually contacted by letter all SPC holders in position to make such a request. Since January, many of the requests have already been processed and requestors informed accordingly. 
The rectification possibility applies to SPCs granted on the grounds of both a centralized marketing authorization and a national marketing authorisation. The date of the relevant marketing authorisation is set to be the date on which notification was given of the marketing authorisation decision (case C-471/14 (Seattle Genetics)). 
In their announcements, the Finnish Patent Office further gave some practical advice to the requestors on the information and enclosures needed.

Many thanks!

Wednesday, 2 May 2018

European Commission paper on Brexit and SPCs

The European Commission recently published a short document on the consequences of Brexit on SPCs.

The general message is:
Subject to any transitional arrangement that may be contained in a possible withdrawal agreement, as of the withdrawal date, 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 and Regulation (EC) No 1610/96 of the European Parliament and of the Council of 23 July 1996 concerning the creation of a supplementary protection certificate for plant protection products will no longer apply to the United Kingdom. 
The document highlights the following consequences:

- on the calculation of the duration of SPCs:
  • An authorisation to place the product on the market granted by a United Kingdom competent authority as of the withdrawal date will not be considered a first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.
  • However, an authorisation to place the product on the market granted by a United Kingdom competent authority before the withdrawal date is to be considered as the first authorisation to place the product on the market in the European Union for the purposes of Article 13 of Regulation (EC) No 469/2009 and Regulation (EC) No 1610/96.
- on applications for SPCs as of the withdrawal date in the United Kingdom
As of the withdrawal date, the Medicinal Products and Plant Products regulation no longer apply to the United Kingdom.  The document footnote does indicate that for applications for an SPC filed before the withdrawal date, the EU is trying to agree solutions with the UK in the withdrawal agreement.
 Watch this space.



Tuesday, 1 May 2018

Update on IL PTE practice on biological drugs and PTE filing deadlines

Liad Whatstein of Liad Whatstein & Co has kindly provided the following updates on patent term extensions on biological drugs and filing deadlines in Israel.
Israeli PTO clarifies rules on Patent Term Extensions for Biological Drugs 
In a recent precedential decision, the IL PTO held for the first time that biological products which contain an earlier approved protein may be eligible for PTE if it can be shown that structural differences between the proteins such as differences in glycosylation have an impact on the activity or pharmacokinetic profile of the protein. If sufficient evidentiary basis is provided with the PTE petition, this important decision will make it possible to obtain PTE orders for biological drugs which contain as the active ingredient proteins that carry the same INN (international nonproprietary name) as in previously approved drugs. 
The decision involved a petition filed by Bayer to extend the term of a patent claiming the production method of the drug KOVALTRY, a recombinant human coagulation Factor VIII. Under Israeli law, patent term extension can only be granted when the regulatory approval “is the first regulatory approval permitting the use of the compound in Israel for pharmaceutical purposes”. The examiner cited against the PTE petition several earlier registrations of Factor VIII products and, in particular, an earlier Bayer Factor VIII product, KOGENATE. The examiner’s position was that earlier registrations of products containing Factor VIII preclude the eligibility for PTE of later products containing Factor VIII, irrespective of differences in the properties or methods of manufacture of the protein. 
On appeal, the Commissioner upheld the rejection of the PTE petition for KOVALTRY but adopted a significantly more flexible approach. The Commissioner recognized that an approach whereby any earlier registration of a protein of the same name precludes eligibility for PTE for later products does not take into account potential differences between biological products. The Commissioner therefore set a two-step test to determine eligibility for PTE for biological products. First, a biological drug that has been approved as a biosimilar will not be eligible to PTE. Second, if the drug was approved as a new drug, it will be necessary to evaluate whether the protein is structurally different from similar proteins which have been previously approved and whether such structural differences have an impact on activity. Structural differences can among others be in the amino acid sequences, the three-dimensional conformation or glycosylation. Functional differences can among others relate to pharmacokinetic parameters of the drug such as bioavailability or half-life or to different immunogenic effects. 
In the present matter, the drug was approved as a new biological drug. The patentee demonstrated that it manufactured the drug using a recombinant process which is different from the recombinant process used to manufacture the earlier Factor VIII drug. The patentee also showed that the later Factor VIII product differs from the previous product in the level of highly branched sialylated glycans and the level of α-gal-linked glycans. The Commissioner recognized that even minor structural differences can result in functional differences which will support a PTE. However, the patentee failed to produce evidence to establish that the structural differences are translated into a different pharmacokinetic profile or to any benefit to patients. Therefore, even under the Commissioner’s flexible approach, the PTE petition was denied but the principles determined in the decision are very significant for future reference by patentees (Decision dated April 16, 2018 in Petition to extend IL 124123 in the name of Bayer Healthcare LLC). 
New rules for determining the 90-day deadline for filing a PTE petition under Israeli law 
Under Israeli law, a petition for Patent Term Extension must be submitted within 90 days from “the date of registration of the pharmaceutical preparation” in the Israeli Drug Register. The deadline is non-extendable. Late filing will result in the loss of eligibility for PTE. 
Under the PTO traditional practice, the PTO has counted the deadline as of the date of registration which appears on the Marketing Approval. In a new decision, the Commissioner of Patents held that the 90-day deadline is to be counted from the date of delivery of the marketing approval by the Ministry of Health to the owner of the registration and not from the date of registration. The date of delivery may be a few days after the date of registration. Furthermore, if the registrant proves that the marketing approval did not reach it on the delivery date, the 90-day deadline will start upon the date of actual notice that a marketing approval was issued (Decision dated April 16, 2018 in Petition to extend IL 124123 in the name of Bayer Healthcare LLC). 
This new decision should also be seen as another favorable development following the 2016 PTO change in practice with regard to the determination of the date of the earliest Marketing Approval in the Recognized Countries for the calculation of the 14 years cap for the PTE duration. The PTO aligned its position with the CJEU ruling in case C 471/14 Seattle Genetics which held that the calculation of the duration of supplementary protection should be based on the EMA MA notification date rather than the EMA MA grant date. In late 2017, after discussions at the Knesset Law Committee in which Liad Whatstein & Co. took part and despite protest by the Israeli generic industry, new Regulation 2(c)(3) of the PTE Regulations endorsed the 2016 PTO change in practice. 
Thanks Liad!

Wednesday, 25 April 2018

C-121/17 - The Advocate General advises the CJEU

The Opinion of Advocate General Wathelet in the UK reference for a preliminary ruling from the Court of Justice of the European Union in Case C-121/17 (Teva UK Ltd and others v Gilead Sciences Inc.) was posted on the Curia website (here) this morning.  At the time of this blogpost, the Opinion was only available in French.

As a recap, the referring court asked the following question:
What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/20091 ?
The Advocate General has advised the Court to rule as follows (thanks to Google translate):
"Article 3 (a) 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 issue of a certificate supplementary protection relating to active ingredients which do not appear in the wording of the claims of the basic patent. The fact that a substance or composition falls within the scope of the protection of the basic patent is a necessary, but not sufficient, condition for constituting a product protected by a patent within the meaning of Article 3 (a) of Regulation No 469/2009. 
A product is protected by a patent within the meaning of Article 3 (a) of that Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and specifically identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically and precisely as well as individually identifiable in the wording of the claims of the basic patent."

Friday, 6 April 2018

An SPC Hat-trick: a THIRD referral under Article 3(a) heads to the CJEU

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on the latest referral to the CJEU on SPCs from the UK Court, which will be published in Bio-Science Law Review.

In short summary, the UK Court of Appeal referred another question to the CJEU seeking clarity concerning the correct interpretation of Article 3(a) of the SPC Regulation. This makes it a hat-trick of referrals (England 2 – Germany 1) trying to understand what it means for a product to be ‘protected’ by a patent. This referral follows Sandoz’s appeal of Arnold J’s first instance decision, in which the outcome was held to be clear (in favour of SPC grant), even if the legal test was not. The UK Court of Appeal has overturned Arnold J’s decision, stayed the appeal and referred another question to the CJEU.

The question asked by the Court of Appeal is:
“Where the sole active ingredient the subject of a supplementary protection certificate issued under [the SPC Regulation] a member of a class of compounds which fall within a Markush definition in a claim of the patent, all of which class members embody the core inventive technical advance of the patent, is it sufficient for the purposes of Article 3(a) of the SPC Regulation that the compound would, upon examination of its structure, immediately be recognised as one which falls within the class (and therefore would be protected by the patent as a matter of national patent law) or must the specific substituents necessary to form the active ingredient be amongst those which the skilled person could derive, based on their common general knowledge, from a reading of the patent claims?”
Following the CJEU hearing the Teva v Gilead referral on Article 3(a) on 20 February (sitting as a Grand Chamber of 15 Judges) it will be interesting to see whether they deliver an overarching decision on Article 3(a) or approach this step-wise via the subsequent referrals from Germany and now the UK. We have heard that there will be an AG opinion in that case on or around 25 April so watch this space.

Thursday, 29 March 2018

Denmark - Gilead successfully enforces its SPC for Truvada

Last year, the SPC Blog reported (here) the decision of the Danish Maritime and Commercial High Court not to grant a preliminary injunction against Accord Healthcare Limited on the basis of Gilead's SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine.

On 7 March 2018, the Eastern High Court in Denmark overturned this decision and granted the preliminary injunction against Accord.

Mikkel Vittrup and Jeppe Brinck-Jensen at Plesner (who assisted Gilead in this case) have kindly provided the summary below of the Eastern High Court's decision.
The Eastern High Court (the court of appeal) in Denmark has granted a preliminary injunction against Accord Healthcare Limited on the basis of Gilead's Danish SPC for TRUVADA®, overturning the first instance decision of the Maritime and Commercial High Court. The Eastern High Court did not accept that Accord had proven that Gilead's SPC was invalid. Furthermore, it found that the SPC was infringed even though the title of the SPC mentioned a specific salt of the active ingredient tenofovir disoproxil, and Accord's product was not sold as such a salt.  
In relation to validity of the SPC, the question was whether the active ingredient emtricitabine was specified in the wording of claim 27 of the basic patent by the wording "other therapeutic ingredients", for the purposes of Article 3(a) of the SPC Regulation. Gilead's SPC is for the combination of active ingredients tenofovir disoproxil and emtricitabine, and it was not in dispute that tenofovir disoproxil is explicitly named in the claims of the basic patent. 
Accord argued that claim 27 did not relate implicitly, but necessarily and specifically, to the combination of tenofovir disoproxil and emtricitabine, and therefore that the SPC did not meet the requirements of Article 3(a) as interpreted by the CJEU in Eli Lilly (Case C-493/12). At first instance, the Maritime and Commercial High Court agreed with Accord.  
The Eastern High Court did not agree.  
It stated, referring to the Protocol on the Interpretation of Article 69 EPC and the Eli Lilly decision, that the claims of the basic patent - including in relation to the question of which active ingredients are covered by the claims - should be interpreted in the light of the common general knowledge of the skilled person. 
The Eastern High Court referred to a declaration and oral testimony of Gilead's expert (a Danish HIV clinician) and found that the skilled person at the priority date of the basic patent (July 1996) would have understood "other therapeutic ingredients" as compounds contributing to antiviral activity, including in particular for the treatment of HIV, and therefore that the skilled person would think of a combination of tenofovir disoproxil with another NRTI, a NNRTI or a protease inhibitor. The Eastern High Court concluded that the term "other therapeutic ingredients" in claim 27 only concerned a limited number of compounds.  
Consequently, the Eastern High Court found that it could not be rejected with the sufficient degree of certainty that claim 27 implicitly, but necessarily and specifically also related to emtricitabine. 
The Eastern High Court also gave weight to the existing doubt as to the interpretation of Article 3(a), in particular in view of the pending referral to the CJEU (Case C-121/17).
The Eastern High Court's decision - overturning the first instance decision from the Maritime and Commercial High Court - also confirms the well-established Danish case law according to which a preliminary injunction will rarely be rejected on the basis of alleged invalidity of the asserted IP rights.  
In relation to infringement, the High Court concluded that Gilead had rendered it probable that the fumaric acid salt and the free base of tenofovir disoproxil should be considered the same active ingredient within the meaning of the SPC Regulation. Consequently, Gilead's SPC was infringed by a combination product containing the free base of tenofovir disoproxil, even though the title of the SPC mentioned tenofovir disoproxil as a fumaric acid salt. 

Friday, 23 March 2018

Forum Institut SPC Seminar 2018

From Rechtassessor Jean-Claude Alexandre Ho (IP conference manager at FORUM Institut für Management GmbH) comes news of an SPC-related seminar which he is organising:
'Quo vadis, SPC?', the update seminar in which Dr Christopher Brückner, the author of the SPC commentary noted here (participants will receive the second edition on top of course documentation), will speak on the CJEU's referrals from 2011 to 2018 and on how to understand the decisions and which practical consequences we may expect for the future. A half-day pre-course will be offered for attendees without prior SPC knowledge/education.

Date: 16 May 2018 (pre-course: 15 May 2018); venue: Amsterdam. 
More information is available here.   
To register, just forward this blogpost to Jean-Claude at jc.alexandreho@forum-institut.de or click here.

Thursday, 22 March 2018

Belgian Office for Intellectual Property issues practice note on the calculation of the duration of SPCs

The Belgian Office for Intellectual Property recently issued a circular letter (here in Dutch and here in French) providing details on the calculation of the duration of SPCs in view of the CJEU Seattle Genetics (C-471/14) and Incyte (C-492/16) decisions.  Stijn Lagaert of Gevers provides below an overview of the practice at the Belgian office.
Background
In 2015, the Court of Justice of the European Union (CJEU) issued a decision in C-471/14 (Seattle Genetics). As discussed in more detail here, it ruled that the date for calculating the SPC duration is the date of notification of the decision granting Marketing Authorization (MA), rather than the decision date itself. While Belgium previously already calculated the duration based on the notification date of EU marketing authorizations, it issued a 2016 circular letter to detail its practice. More recently, the CJEU provided more details about the correction of SPC durations that were granted based on the decision date (C-492/16 – Incyte). 
Circular letter of March 2018
The Belgian Office for Intellectual Property has recently issued a circular letter providing further details about the practice in Belgium in relation to the date of the MA. While the practice remains the same for an MA granted by the European Commission (i.e. the notification date published in the Official Journal), the circular letter is perhaps more interesting in relation to the notification date of a national MA. The Belgian Office states that it will consider the date of the decision to be the date of the MA if there is no official publication of the notification date. The applicant has the option to provide proof that it was only notified at a later date in order to use that notification date as the date of the MA. 
Fellow practitioners will appreciate that the circular letter links its practice for the ‘date of the MA’ to both Art. 7 and Art. 13 of the SPC Regulations. Thus, the Belgian Office will use the notification date both for the calculation of the SPC duration and for calculating the deadline for filing the SPC application.  
After Seattle Genetics, some SPC specialists cautioned that the CJEU decision only ruled in relation to the date used for determining the duration of the SPC (Art. 13), but did not necessarily read on the grant date of the MA for the calculation of the deadline for filing the SPC application (Art. 7). In addition, it did not provide guidelines for determining the notification date of national MAs, beyond referring to national law. These issues were e.g. raised by Mike Snodin and Michael Pears. The circular letter provides some welcome clarifications about both aspects, at least under Belgian practice. 
Advice
As the notification date of a national MA will likely be a few days after its decision date, we suggest saving and filing proof of the date of notification in these instances to enjoy the longer SPC duration in Belgium. The proof can be an official publication of the notification date or any other proof. This is of course only relevant in those cases were the national MA is the first to place the product on the European market.

Thursday, 8 March 2018

Sweden, Incyte and the correction of the duration of SPCs

Many thanks to Hampus Rystedt (Zacco) for providing the following summary of interesting developments in Sweden on the correction of the duration of SPCs.
Correction of the duration of an SPC in view of the CJEU’s decision in Seattle (C-471/14) was dealt with in the CJEU’s decision in Incyte (C-492/16, here). The CJEU found that the term of an SPC is set by the rules of the Regulation 469/2009 and the factual circumstances of the application, and cannot be set by a national patent office. Also, if the national patent office has anyway decided on a different duration, such an erroneous decision can be corrected at any time before the expiry of the SPC term.
While the CJEU was preparing its decision in Incyte, the Swedish courts were also busy considering the question on whether it is possible to correct the duration of an SPC. Eight separate cases were considered, with slightly different factual circumstances.

Correction of decisions by Swedish government agencies (such as the Patent Office) may be corrected under certain circumstances. These circumstances are partly codified, but are also developed in case law. The first instance court (Patent and Market Court) found that SEPTO was competent to decide on the duration of an SPC and that a correction was not possible due to the need for legal certainty for third parties (i.e. generic pharma companies). The second instance court (Patent and Market Court of Appeal) also found that SEPTO was competent to decide on the duration of an SPC and also that there was no need to refer this question to the CJEU, or even stay the proceedings until the CJEU decided in Incyte. The PMCA then decided that an SPC can be corrected, but only if the request for correction was filed prior to the expiry of the basic patent.

The decision of the PMCA was appealed to the Supreme Court by the SEPTO in all eight cases and by one proprietor who had filed a request for correction only after the expiry of the basic patent. The appeals were filed on 23 October 2017. The CJEU then issued its decision in Incyte on 20 December 2017. On 19 February 2018, the Supreme Court decided to not hear the cases and the decision of the PMCA is thereby final.
There is thus prima facie a not insignificant conflict in Sweden between the decisions of the PMCA and the CJEU. While the CJEU of course is the top instance in these matters, it must be borne in mind that the PMCA did consider the question pending in Incyte and obviously found them not relevant to the situation in the pending cases, as it was decided to not stay the proceedings in view of Incyte.

New cases requesting correction, where the request was filed after the expiry of the basic patent but before the expiry of the SPC are now making their way through the system and it will be interesting to see if the Swedish office or courts will find a way to reconcile the decisions of the PMCA and the CJEU, or if the CJEU decision is considered to simply overrule the PMCA.

This will also be relevant for future cases dealing with other issues with SPCs in Sweden. The PMC and PMCA are developing a body of national case law on SPCs and have not yet referred any SPC case to the CJEU. It is no bold guess that this will create further small discrepancies between national Swedish and European case law that have to be handled in various decisions. One such issue is the interpretation of Article 3(d) in view of Neurim (C-130/11), where the PMC has refused to stay cases pending the outcome in Abraxis (C-442/17). The present matters will probably give some hints on how the Swedish courts will try to handle this.


Friday, 2 March 2018

Formulations and Article 3(a) - a decision from the German Federal Patent Court

The German Federal Patent Court (Bundespatentgericht) recently issued a decision in ex parte appeal proceedings relating to the interpretation of Art. 3(a) of the SPC Regulation in regard to a patent protecting a formulation of known actives (Decision 14 W (pat) 10/16 of 23 January 2018, English translation here).  Many thanks to Bianca-Lucia Vos and Klemens Stratmann of Hoffmann Eitle for pointing this case out to us and for providing a thorough commentary, below:

The decision addresses an important aspect for determining whether a given product is “protected” by a basic patent in the sense of Art. 3(a) of Regulation (EC) no. 469/2009, which to date has not been addressed by any higher court in the EU. 
In the case underlying the decision, the GPTO had rejected SPC application 12 2010 000 015.7 submitted by GlaxoSmithKline Biologicals S.A. (“GSK”) for a combination of six antigens with reference to Art. 3(a). The Patent Division of the GPTO asserted in the appealed decision that, in view of the CJEU decisions Actavis/Sanofi (C-443/12), Georgetown II (C-484/12) as well as Actavis/Boehringer (C-577/13), a product is only then protected pursuant to Art. 3 (a) of the Regulation if the respective active ingredient or the active ingredient composition is protected by the basic patent “as such”.  
According to the GPTO, for protection “as such” to be affirmed within these terms, the product in question has to constitute the “core inventive advance” of the basic patent. To support this view, the Patent Division relied for instance on par. 29 of C-443/12, where the CJEU stated that it is possible, on the basis of a patent which protects several different ‘products’, to obtain several SPCs in relation to each of those different products, provided, inter alia, that each of those products is ‘protected’ as such by that ‘basic patent’ within the meaning of Article 3(a) of Regulation No 469/2009, in conjunction with Article 1(b) and (c) of that regulation.  
Since GSK’s basic patent (EP 0 835 663) related to formulations of previously known antigens with special adjuvants to provide hexavalent combination vaccines, the Patent Division opined that the inventive advance of the basic patent lay in the use of specific adjuvants and not in the provision of a new (and inventive) combination of antigens. From this, the Patent Division concluded that the product defined in the SPC application, i.e. “Diphtheria, tetanus, pertussis, hepatitis B, poliomyelitis, and Haemophilus influenzae type b conjugate, combination vaccine”, did not embody the inventive advance of the patent, respectively was not protected as such, and rejected the SPC application. 
The Federal Patent Court set aside this decision and granted the SPC for the requested product definition. In its decision, the Federal Patent Court first clarified that Actavis/Sanofi, Georgetown II as well as Actavis/Boehringer pertain primarily to the conditions for granting more than one SPC for the same product pursuant to Art. 3 (c) of Regulation (EC) No. 469/2009 and do not contain any assessment criteria going beyond the principles established by the CJEU in Medeva (C-322/10) and Eli Lilly (C-493/12) regarding the application of Art. 3 (a) of Regulation (EC) No. 469/2009. The Federal Patent Court highlighted that the circumstances of Actavis/Sanofi, Georgetown II and Actavis/Boehringer required an assessment as to whether the combination of active ingredients A+B has to be regarded as the “same innovation” as compared to the individual active ingredient A (for which the patent proprietor had already obtained an SPC), and therefore no further SPC should have been granted for the combination of active ingredients A + B under Art. 3(c) of the Regulation.  
Only for the purpose of examining under Art. 3(c), whether the combination of A + B embodies the inventive advance of the patent, it is therefore of relevance whether the individual actives (A and/or B) are protected as such by the basic patent.  
The Federal Patent Court acknowledges with this decision that formulation patents are eligible for an SPC extension to the same extent as other patent types such as use or process patents. This decision is of fundamental importance since the approach taken by the GPTO in the contested decision would have rendered it impossible to extend the vast majority of formulation patents. The reason being that, as a rule, formulation patents do not protect the product, i.e. the active ingredient or the combination of active ingredients in the sense of Article 1(b) of the Regulation, “as such”. It is rather the formulation of known actives by means of specific auxiliary substances, such as adjuvants (as in the case of vaccines) or excipients, that renders the claimed subject matter patentable and embodies the inventive advance of the patent.  
The decision of the Federal Patent Court appears to put into question as to whether the interpretation of Art. 3(a) of the Regulation proposed by J. Arnold would also be applicable in the event that the basic patent is not a product patent but rather a formulation, process or use patent. J. Arnold repeatedly suggested to the CJEU in proceedings before the UK High Court of Justice that Article 3(a) should be interpreted as meaning that the product is "protected" by the basic patent if (i) the product falls within the scope of the claim when interpreted in accordance with the Extent of Protection Rules and (ii) the product does so because it contains an active ingredient, or a combination of active ingredients, which embodies the inventive advance (or technical contribution) of the patent (cf. par. 97 of Teva UK Ltd & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) (13 January 2017) and par. 11 of Sandoz Ltd & Anor v G.D. Searle LLC & Anor [2017] EWHC 987 (Pat) (3 May 2017). It would appear that this test is not suitable for determining if a given formulation, use or process patent protects the product in the sense of Article 3(a). By contrast, the test developed by J. Warren seems to have a broader applicability and would, in our view, also lead to the correct result in the case of formulation, use or process patents (cf. par. 65 to 71 of Eli Lilly v Human Genome Sciences [2014] EWHC 2404 (Pat) (18 July 2014)). J. Warren suggested that a given product will be protected within Article 3(a), if it falls within the claims, subject to one proviso relating to circumstances where the claims contain some general word or words extending their extent beyond the principal scope of the claims, typically by the use of a word such as "comprises". 
Meanwhile, three referral proceedings are pending before the CJEU all of which concern the interpretation of Article 3(a) of the Regulation and the criteria for determining whether a given product is protected by the basic patent or not (Reference for a preliminary ruling from the High Court of Justice (Chancery Division) (United Kingdom) made on 8 March 2017 – Teva UK Ltd, Accord Healthcare Ltd, Lupin Ltd, Lupin (Europe) Ltd, Generics (UK) trading as "Mylan" v Gilead Sciences Inc. (Case C-121/17); Request for a preliminary ruling from the Bundespatentgericht (Germany) lodged on 21 November 2017 (Case C-650/17); and Sandoz et al. v. G.D. Searle et. al [2018] EWCA Civ 49, UK Court of Appeal, Judgment of 25 January 2018). It would be desirable if the CJEU does not limit the forthcoming judgements to the concrete facts of the respective referral decision but rather develops a generally applicable test which allows to ascertain whether a given product is protected in the sense of Article 3(a) in all possible circumstances including those addressed by the Federal Patent Court in the recently issued decision.