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

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

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