It's the end of the procedure for the end of procedure argument...

Fot those of you who love an "end of procedure notice" discussion, then this one is for you.  The decision in C-567-16 is now out, and the link is here. 

The spoiler is that an end of procedure notice is not equivalent to a marketing authorisation - see the answers from the CJEU below.  

1.      Article 3(b) 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 is to be interpreted as meaning that an end of procedure notice issued by the reference Member State in accordance with Article 28(4) of Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use, as amended, as regards pharmacovigilance, by Directive 2010/84/EU of the European Parliament and the Council of 15 December 2010, before the expiry of the basic patent, as defined in Article 1(c) of Regulation No 469/2009, may not be treated as equivalent to a marketing authorisation within the meaning of Article 3(b) of that regulation, with the result that a supplementary protection certificate may not be obtained on the basis of such a notice.

2.      Article 10(3) of Regulation No 469/2009 is to be interpreted as meaning that the fact that no marketing authorisation has been granted by the Member State concerned at the time the supplementary protection certificate application is lodged in that Member State does not constitute an irregularity that can be cured under that provision

Is there a future for medical devices? - an article

Many thanks to Nicholas Fischer and Andrew Hutchinson (Simmons & Simmons) for sharing their article (here) on SPCs for medical devices which was recently published in Bio-Science Law Review.  A summary of the article is set out below:

Supplementary Protection Certificates (SPCs) have on occasion been sought for medical devices, forcing granting authorities and courts across Europe to consider the question: are medical devices included within the scope of the SPC system? These cases have produced inconsistent outcomes. The European Commission's study into the SPC system and the new EU medical device regulations bring into the spotlight the scope of the SPC system and the regulatory regime relating to medical devices.  

This article reviews UK and European cases on the ability of the SPC system to be applied to medical devices and considers the main issues faced by such applications. It also considers whether now might be the time to introduce a new system for 'medical device SPCs'.

A new CJEU referral on claims with functional features

Last week, the 14th Senate of the German Federal Patent Court referred new questions to the CJEU on the criteria for Article 3(a) of Regulation (EC) No. 469/2009 (decision 14 W (pat) 12/17) in an attempt to clarify when a functional definition in a claim refers implicitly, but necessarily and specifically to the product in question, as stipulated by the CJEU in Eli Lilly (C-493/12).

Dirk Bühler (Maiwald), who acted for the patentee Royalty Pharma, has kindly provided a copy of the decision (here), an English translation of the decision (here) and a summary of the case (see below the questions).  For those who just want to read the questions, they are reproduced directly below:

1. Is a product protected by a basic patent in force according to Article 3 (a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment? 

2. Is it therefore not sufficient for the requirements of Article 3 (a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?

3. Is a product not protected according by Article 3 (a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?

Summary 

Background 

It seems fair to say that Medeva (C-322/10) and its progenies have rather complicated than clarified as to when a product is protected by a basic patent in accordance with Article 3 (a) of the Regulation (see e.g. latest referral of Judge Arnold ([2017] EWHC 13 (pat)).

Even though it is clear in view of the numerous decisions by the CJEU since Medeva that Article 3(a) precludes SPCs for products which would infringe the patent despite not being referred to in the claims at all, e.g. for the presence of the term “comprising, there has been a debate as to how specifically the product must be disclosed in individualized form in the claims. 

For claims with functional definitions this debate has focused on whether the requirement set by Eli Lilly that such claims must refer implicitly, but necessarily and specifically to the product allows for SPCs in situations where the product is not disclosed as an individualized embodiment. Whilst this position has been endorsed by the UK courts for generic antibody claims ([2014] EWHC 2404 (Pat)) and claims with Markush formulas ([2017] EWHC 987 (Pat)), patent offices in other jurisdictions have taken a more restrictive standpoint and interpret Eli Lilly to require an individualized disclosure of the specific compound at least in the specification or to refer to antibodies only.

The referred case
The claims of the basic patent EP 1 084 705 B1 are concerned with the treatment of Diabetes mellitus by administration of DPIV-inhibitors and are based on the inventors’ recognition that inhibition of the enzyme DPIV generally allows for lowering of blood glucose levels by preserving the endogenous incretin hormones. The patent discloses individual DPIV inhibitors and points out that other DPIV inhibitors may be used as well. The general nature of the invention has been recognized by the German Federal Court of Justice in its decision on the German patent DE 196 16 486  based on the priority filing which belongs to the leading case on enablement in Germany (BGH X ZB 8/12 – Dipeptidyl-Peptidase-Inhibitoren).

DPIV-inhibitors marketed for treatment of Diabetes mellitus include sitagliptin which is not disclosed individually in the basic patent and has been developed by a licensee of the patent. Sitagliptin is also protected by a later filed composition of matter patent. The situation is thus comparable with Eli Lilly where the claims were directed to the genus of Neutrokine-alpha antibodies, but the product in question, tabalumab which is a Neutrokine-alpha antibody, was not individually disclosed in the claims or the specification and had been developed after the filing date of the basic patents.
An SPC application for sitagliptin was rejected by the German Patent and Trademark Office because sitagliptin would not be disclosed individually in the patent. The rejection was appealed.

In its referring decision the Senate acknowledges that sitagliptin is a DPIV-inhibitor as demonstrated by the assessment report of the EMA and would thus be within the extent of protection conferred by Article 69 EPC. However, according to the Senate’s interpretation of Medeva and Eli Lilly it would not be sufficient for the purpose of Article 3 (a) that the product in question, namely sitagliptin, falls within the extent of protection (Schutzbereich )conferred by the claims. It would rather be required that the product is disclosed specifically enough to form the subject matter (Schutzgegenstand) of the claims which in the absence of an individualized disclosure of sitagliptin in the basic patent would not be the case. 

The Senate however acknowledges that a different position has been taken by e.g. UK courts on highly comparable case scenarios (see [2017] EWHC 987 (Pat) in view of Medeva and Eli Lilly. This divergent interpretation of the CJEU’s case law by the national courts and patent offices would not be acceptable to applicants and run counter to the overall objective of the Regulation, namely to provide a uniform solution for the common market. 

The Senate has therefore decided to stay the appeal proceedings and to refer the following questions:

1. Is a product protected by a basic patent in force according to Article 3 (a) of Regulation (EC) No 469/2009 only if it belongs to the protected subject-matter as defined by the claims and is thus provided to the person skilled in the art as a specific embodiment?

2. Is it therefore not sufficient for the requirements of Article 3 (a) of Regulation (EC) No 469/2009 that the product in question meets the general functional definition of an active substance class as mentioned in the claims, but apart from that is not individualized as a specific embodiment of the teaching protected by the basic patent?

3. Is a product not protected according by Article 3 (a) of Regulation (EC) No 469/2009 by a basic patent in force if it is covered by the functional definition contained in the claims, but was developed only after the filing date of the basic patent based on independent inventive activity?

Thanks Dirk!

New CJEU referral - C527/17 - Does Regulation (EC) No. 469/2009 apply to CE-marked drug/device combinations?

The 14th Senate of the German Federal Patent Court has referred the controversial question of whether Regulation (EC) No. 469/2009 applies to CE-marked drug/device combinations to the CJEU for further clarification (decision 14 W (pat) 13/16). A copy of the decision can be found here. The case is now pending before the CJEU with case number C-527/17.  Markus Coehn (Peterreins Schley), who acted for the applicant, has kindly provided the following background and summary of the case:

Background:
There is largely agreement that Regulation (EC) No. 469/2009 does not apply to medical devices. Besides the formal aspect that CE-marked medical devices are not authorized according to Directive 2001/83/EC, the regulatory hurdle for obtaining a CE-mark is generally considered as too low to justify compensation of the patent term. At the same time, there is also agreement that the Regulation (EC) No. 469/2009 should be applicable to all types of pharmaceutical research without discrimination. This legislative goal is expressly stated in the Proposal for a Council Regulation (EEC) concerning the creation of a supplementary protection certificate for medicinal products, COM(90) 101 final-SYN 225, margin number 25. 

These two positions clash in cases of drug/device combinations, in particular drug/device combinations in which the drug is incorporated in the medical device and provides an ancillary (i.e. supporting) effect. Such drug/device combinations can only be authorized by a notified body according to the CE-marking procedure (Directive 93/42/EEC) but not by a regulatory authority for medical products (according to Directive 2001/83/EC). Nevertheless, regulatory authorities are involved in the CE-marking procedure by means of the so-called consultation process: prior to approval, the notified body asks a regulatory authority for medical products to assess the quality, safety and usefulness of the drug component. The regulatory authority then carries out the assessment according to the standards of Directive 2001/83/EC. On basis of this advice, the notified body then issues or denies the CE-mark. Preparing for and conducting the consultation process can be lengthy and time-consuming, in particular since the regulatory authorities often require evidence on basis of clinical trials to demonstrate quality, safety and usefulness of the drug component. Thus, the main reason for granting SPCs – loss of commercially exploitable patent term due to long regulatory approval procedures according to directive 2001/83/EC – equally applies at least to some drug/device combinations. 

 The present situation is best exemplified with the following example: Consider a new and innovative drug that has to be administered as an integral part of a medical device. The EU legislator only allows authorizing of the drug/device combination according to the CE-marking procedure. Since the drug is new, the regulatory authority involved in the consultation process requires the manufacturer to carry out substantial clinical trials to be done in compliance with Directive 2001/83/EC. Is such a manufacturer entitled to a SPC? If not: Is this not a discrimination of a pharmaceutical research to deny a SPC, contrary to the legislator’s intentions?

There is presently no common ground between the courts of the EU member states on how to resolve this issue. The referral to the CJEU will hopefully provide much-needed further clarification.

The referred case:
The referral concerns a German SPC application on basis of European Patent EP 0 681 475 B1 relating to the 2nd medical use of the anti-proliferative paclitaxel for the treatment of restenosis. Restenosis is a common side-effect of angioplasty, a minimally invasive procedure in which blood vessel are dilated to remove a stenosis. Paclitaxel as such was already authorized as a cancer drug by the EMA (EMEA/H/C/000216) on July 19th 1999. For this reason, the SPC request was limited to paclitaxel for the local administration to dilated blood vessels for the prevention or treatment of restenosis, i.e. limited to a different purpose in the sense of the Neurim decision (C-130/11). 

The SPC request was based on a CE-mark authorizing a stent which incorporated paclitaxel as an integral part. The manufacturer indicated in the CE-marking procedure that paclitaxel is incorporated into the stent to prevent and treat restenosis. The regulatory authority advising the notified body in the consultation process required that the usefulness of paclitaxel for treating restenosis is established on basis of a clinical risk/benefit analysis, i.e. on basis of clinical trials establishing therapeutic efficacy for treating restenosis in comparison to placebo (stent only). After a positive advice from the regulatory authority, the notified body issued the CE-mark in 2003.

The SPC application was rejected by the German Patent and Trademark Office on Feb. 19th, 2016. An appeal was lodged against the decision. The appeal is pending before the 14th Senate of the Federal Patent Court and stayed until the CJEU has rendered its decision.

The referring decision:
The English translation of the referred question reads as follows:

 “Is Art. 2 of the Regulation (EC) No. 469/2009 of the European Parliament and the Council dated May 6th, 2009, concerning the supplementary protection certificate for medicinal products to be interpreted such that an authorization according to Directive 93/42/EEC for a drug-device-combination in the sense of Art. 1(4) of Directive 93/42/EEC has to be considered as equivalent to an marketing authorization according to Directive 2001/83/EC, if the drug component, in the course of the approval procedure according to Annex I, Section 7.4, Paragraph 1 of the Directive 93/42/EEC, was scrutinized for quality, safety and usefulness according to Directive 2001/83/EC by an authority for a medicinal product of an EU member state?”

In the Reasons of the decision, the Federal Patent Court discusses two main aspects, namely whether an authorization according to Directive 93/42/EEC can be considered as equivalent to an authorization according to Directive 2001/83/EC and whether an authorization according to Directive 93/42/EEC can be considered as an administrative authorization procedure. 

Turning to the first aspect, the Court notes that an analogy may be seen to the CJEU’s decisions Synthon (C-159/09), Generics (UK) (C-427/09), Hogan Lovells (C-229/09), and Sumitomo Chemical (C-210/12) in which the CJEU considered authorizations not explicitly mentioned in Art. 2 of Regulation (EC) No. 469/2009. In these cases, the question of whether the drug/plant protection product was subject to (equivalent) safety and efficacy testing during the authorization procedure was decisive in determining whether or not such authorizations fall into the ambit of the SPC regulations. The Court concludes that, in the present case, the drug component underwent testing of safety and efficacy/usefulness that was equivalent to the requirements of Directive 2001/83/EC.
 
Turning to the second aspect, the Court considers that notified bodies are not authorities, but notes that notified bodies are vested with public authority. Furthermore, the Court notes that the notified body has to duly consider the advice of the regulatory authority in the consultation process with the effect that the notified body is barred from issuing a CE-mark in case of a negative advice from the regulatory authority. Thus, the CE-marking process has, in this case, the same obligatory character as an administrative procedure.

Taking these two aspects and the legislative aim of Regulation (EC) No. 469/2009 into account, the Court recommends considering an authorization according to Directive 93/42/EEC for a drug-device-combination as being equivalent to a marketing authorization according to Directive 2001/83/EC for the purposes of Art. 2 of Regulation (EC) No. 469/2009.

Many thanks Markus!

EU Commission consultation on SPCs and pharmaceutical research exemptions

The EU commission has announced a consultation (available here) on improvements to the SPC system.  Possible improvements could include the creation of a European SPC title, the introduction of an SPC manufacturing waiver and an update on the scope of EU patent research exemptions.

Responses to the consultation must be submitted via an online questionnaire (available here).  The deadline for filing submissions is 4 January 2018.

Swedish Patent and Registration Office appeals to the Swedish Supreme Court on the correction of SPC terms

As previously reported on this blog (here), the Swedish Patent and Market Court of Appeal (PMCA) found that SPCs granted pre-Seattle could be corrected to have the duration calculated based on the notification date rather than the decision date, if applicable. The PMCA found that the Regulation 469/2009 itself did not provide for any legal remedies to correct the term (i.e. Article 17.2 of 1610/96 is not applicable), but that correction could be made under general principles of Swedish national administrative law.

This decision has now been appealed to the Supreme Court by the Swedish Patent and Registration Office. The questions discussed in the appeal relate only to Swedish administrative law and not to the Regulation or other EU law.

The Supreme Court must grant leave to appeal in order to hear the case on the merits. If they do, it will be most interesting to see how they deal with the pending referral in C-492/16 (Incyte).

Many thanks to Hampus Rystedt at Zacco for providing these new developments.

Tenofovir in Denmark - Accord Healthcare fends off Gilead's motion for a preliminary injunction

Nicolaj Lindgreen and Nicolaj Bording at Kromann Reumert report the following news on Gilead's SPC for the combination of tenofovir and emtricitabine in Denmark:

On 26 October 2017, the Danish Maritime and Commercial High Court issued a ground-breaking decision rejecting Gilead's motion for preliminary injunction against Accord Healthcare Limited based on Gilead's Danish SPC for the combination of tenofovir disoproxil (as fumarate) and emtricitabine. 

Accord had defended the motion for preliminary injunction by arguing non-infringement and invalidity of the asserted SPC.  

The Court supported Accord's argument that the SPC's combination of tenofovir disoproxil (as fumarate) and emtricitabine was not protected by the basic patent, and, accordingly, the SPC had been granted in contrary to Article 3(a) of the SPC Regulation.
The only claim in the basic patent that concerns the potential combination of tenofovir with another compound is claim 27, which claims an optional combination of tenofovir with "other therapeutic ingredients".  

Gilead had argued that the skilled person would understand the words "other therapeutic ingredients" in claim 27 as referring to emtricitabine. Hence, according to Gilead, the combination of tenofovir disoproxil (as fumarate) and emtricitabine was covered by the basic patent.  

Accord had argued, in particular, that case law from the CJEU dating from after the grant of the SPC makes it clear that a "product" according to the SPC Regulation has to be specified in the claims, either by reference to the compound's name, its chemical structure or by a functional definition, provided that the functional definition necessarily and specifically relates to the compound in question. Clearly, Accord argued, the words "other therapeutic ingredients" in claim 27 did not specify emtricitabine, neither by name/chemical structure nor by a functional definition, as the words "other therapeutic ingredients" say nothing about the specific function or nature of such "other therapeutic ingredients".  

As indicated, the Court agreed with Accord's invalidity arguments stating that Accord, on this basis, had "proved that the certificate-in-suit is invalid". Hence, the motion was rejected. 

The decision is ground-breaking as this is only the second time in 40 years that a motion for preliminary injunction in the patent area is rejected with reference to invalidity of the asserted right. Normally, it is considered close to impossible to fend off a motion for a preliminary injunction in a patent-related case, if invalidity arguments are the only defence. 

In terms of infringement, the Court found that, had the SPC been valid, Accord's combination product was covered by the SPC. Accord had argued non-infringement referring to the fact that the SPC was granted for tenofovir disoproxil in its fumarate salt form in combination with emtricitabine, whereas Accord's product contained tenofovir disoproxil in its free base form. The Court concluded that Gilead's marketing authorisation on which the SPC had been granted, which did not specify the fumarate salt form of tenofovir, covered tenofovir in all its forms, and, accordingly, so did the SPC. 

Nicolaj Lindgreen and Nicolaj Bording acted for Accord Healthcare Limited.

Tenofovir - the Swiss Bundespatentgericht goes for the infringement test

The SPC Blog is grateful to Siegfried Grimm at E. Blum & Co. for providing the following summary of a recent Tenofovir case in Switzerland:

The year is 2017 B.C. Europe is entirely governed by European Legislation. Well, not entirely... One small country of indomitable Swiss still holds out against the invaders. And life is not easy for the European judges who reside the fortified camps of Luxembourg ... 

In its decision of October 3, 2017 (here in German), the Swiss Federal Patent Court clarified what the criteria are for deciding “whether the product is protected by a basic patent in force”.  The Swiss court clearly refused to adopt the CJEU's “Medeva” line of decisions. As a consequence, Swiss SPCs will be assessed based on the infringement test.  No additional criteria, such as “specified in the wording of the claims” (Medeva), “the claims relate, implicitly but necessarily …” (Eli Lilly), “core inventive advance …” (Actavis) or the like are to be applied.  Accordingly, the Swiss court applied a more liberal approach compared to the CJEU, leaving room for Swiss SPCs where European SPCs are likely not available.  

The SPC in question relates to tenovofir disoproxil fumarate + emtricitabine.  Claim 1 of the basic patent covers tenovofir disoproxil fumarate and claim 27 mentions “optionally other active ingredients”, without mentioning of emtricitabine.  The Swiss court came to the conclusion that this SPC is protected by a basic patent in force and thus perfectly complies with Swiss practice.  The court also came to the conclusion, that the above CJEU decisions will not help deciding the case, as Eli Lilly might be in favor of such decision while Actavis would rule against it.  

The decision is open to appeal within 30 days. 

Interestingly, the same case is litigated before the High Court, [2017] EWHC 13 (Pat), now pending before the CJEU.

"SPC Law and Practice 2017: you can’t keep a good blog down": now open for registration

Anyone working with SPCs must have a very special sort of understanding...

This year's seminar run by The SPC Blog, "SPC Law and Practice 2017: you can’t keep a good blog down” is now open for registration. After a year with our SPC feet up, the new referrals have reopened some issues and we’ll be taking the usual punchy look at the evolving case law and practice with speakers from private practice and the IPO.  This year we have a new venue, the CMS office at 78 Cannon Street, and the date of the seminar is the afternoon of Friday 1 December 2017.

The link to the invite is here!

The planned agenda (subject to some evolution..) is:

A review of the recent case law – Catherine Katzka (Kilburn and Strode)
“The IPO examiners” – practice and case law update from around Europe
Inventive advance – [speaker to be confirmed]
The Max Plank review of SPCs – Roberto Romandini (MPI)
Q&A

Further speakers to be confirmed in due course.

We will try to accommodate all comers, but if demand for places outstrips the supply it may be necessary to limit the number of people attending per law firm to give as many firms as possible a chance of attending.  Preference will be given to anyone from industry, since they are kind enough to provide the patents, the SPCs, the litigation and the competitive edge that makes the whole seminar possible.

Swedish Appeal Court opens towards re-examination of Swedish SPC terms

Many thanks to Louise Jonshammar (Awapatent) for providing the following summary of recent decisions of the Swedish Patent and Market Appeal Court on SPC terms following the CJEU's Seattle Genetics case:

"On 4 October, 2017, the Swedish Patent and Market Appeal Court handed down eight decisions in appeal cases regarding re-examination of SPC term decisions. 

The background relates to the famous Seattle Genetics case (C-471/14) in which the CJEU gave a preliminary ruling on the interpretation of Article 13(1) 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. In the judgement, the CJEU held that the ‘date of the first authorisation to place the product on the market in the [European Union]’ within the meaning of Article 13(1) is the date on which notification of the decision granting marketing authorisation was given to the addressee of the decision. As many patent offices around the EU, if not most, calculated the SPC term on the date of grant of the marketing authorisation, the judgement started an avalanche of requests for changes to the already issued SPCs. The different EU countries have handled these requests differently, as re-examination is not provided for in the regulation. 

The Swedish Patent and Registration Office refused to change the term of already issued SPCs unless there was still time within the two months’ appeal limit to appeal the grant decisions – in which case the patentee was urged to file such appeal. The reason for refusal was mainly that new practice is not a basis for re-examination under the Swedish Administrative Law. 

The Patent and Market Court agreed with the patent office and did not change the decisions. Further, the court said that decisions to grant SPC effect not only the applicant but also an unknown number of other actors on the market, having contradictory interests. Therefore, decisions on grant of SPCs shall be considered similar to civil actions, despite the fact that third parties are not parties to these decisions. 

The Patent and Market Appeal Court decisions are long and include a lot of very useful reasoning for understanding the decision. The grand finale of the decisions is a reasoning on the balance of interest between the patentee and third parties. The Patent and Market Appeal Court finds that where the patent protection has ceased and the SPC has come into effect, companies marketing generic drugs may have customised their efforts on the market to fit the decision and prepared according to the final date of the SPC in the decision. If the SPC term has begun, the interest of foreseeability speaks against a change of the SPC term in such cases. Before the beginning of the SPC term, however, the patentees’ interest in a longer term shall prevail. Therefore, as a general rule, decisions on SPC term shall be changed in accordance with the principles set out in the Seattle Genetics judgement, provided that a request for changes has been filed before the beginning of the SPC term. 

The decisions then differ depending on when the patentee filed its request - in some cases the term is extended and the patent office is asked to put that decision into practice, in other cases the request for change of the term is denied because the SPC term has already begun. 

Also, as a point of interest, one may note that the Patent and Market Appeal Court disagrees with the Patent and Market Court with respect to SPC applications being considered similar to civil actions. The fact that a re-examination may have economic consequences for third parties is not a special circumstance which motivates a deviation from the general rule of administrative law. The third party interest shall therefore be considered within the re-examination, which is then what the Patent and Market Appeal Court does in its balancing of interests, as described above. 

Another interesting note is that the Patent and Market Appeal Court has allowed for the decisions to be appealed to the Supreme Court."

Switzerland and paediatric extensions - an update

Switzerland is slowly moving towards amending its patent legislation to allow for paediatric extensions in the context of a revision of the Swiss law on pharmaceutical and medicinal products.

The changes in the Swiss Patent Act to allow for pediatric extensions have already been approved by the Swiss parliament in 2016.  The changes allow for:

• Pediatric extensions to SPCs under conditions like in the EU; and
• Independent paediatric SPCs linked directly to the term of the patent, in cases where there is no regular SPC. 

According to the Swiss Federal Institute for Intellectual Property website (here), amendments proposed to the implementing regulations of the Swiss Patent Act are currently under a general consultation which will end on 20 October 2017. 

The aspired date for the entry into force of the amended Patent Act and the implementing regulations is January 1, 2019.  However, a more likely date is looking like mid-2019.

Many thanks to Claudia Bibus and Siegfried Grimm at E. Blum and Co. as well as Nick Bassil at Kilburn & Strode for providing this information!

Tenofovir - High Court Decision in France

Those following the tenofovir SPC litigation in Europe will be pleased to hear that the High Court of Paris has recently handed down a decision in relation to Gilead's SPC based on EP0915894.  Denis Schertenleib, who acted for Mylan in these proceedings, has kindly provided a short summary of the case, along with a copy of the decision and an English translation.

"Recently, the High Court of Paris had to opine on the validity of the Gilead SPC on Truvada covering tenofovir and emtricitabine. The SPC was based on the basic patent for tenofovir.  One of its claims covered a combination of tenofovir with another optional therapeutic ingredient.  

In the context of preliminary injunction proceedings, the Presiding judge of the Paris High Court had to decide whether this SPC was likely to be held invalid on the merits. The Court held in a ruling dated 5 September 2017, that the SPC was likely to be invalid.

The reasoning of the Court was based on the finding that the reference to another “therapeutic ingredient” could not be deemed to constitute a functional definition of any compound under the Eli Lilly v HGS doctrine of CJEU case C-493/12. In addition, the Court held that nothing in the description or the prior art could be held to point to Emtricitabine as being this optional therapeutic ingredient. Finally, the Court noted that the combination of tenofovir and emtricitabine could not constitute the core invention of the basic patent under the Actavis v Sanofi doctrine of CJEU case C-443/12. The Court thus held that the SPC was likely to be invalid and that no preliminary injunction could be granted.

The Judgment in French and translated in English can be downloaded here.

The ruling can be appealed and a case on the merits is ongoing.”

Many thanks to Denis for this!

Call for comments for C-443/17 (Abraxis Bioscience)

The UK IPO is seeking comments on CJEU case C-443/17 (Abraxis Bioscience) with a view to advising the UK government as to whether it wishes to make representations in this reference.  Comments should be sent by email to policy@ipo.gov.uk by 6 September 2017.

As a refresher, the question referred to the CJEU in this case is as follows:

Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?

Canadian Government proposes Certificate of Supplementary Protection Regulation

Canada appears to be moving closer towards having system for patent term extension. On 15 July 2017, the Government of Canada published a proposed Certificate of Supplementary Protection Regulations in the Canada Gazette (here).  In addition, the Government is seeking comments on the proposed Regulation by 30 July 2017.

The background section of the Regulatory Impact Analysis Statement is reproduced here:

"In order to meet Canada’s CETA obligations, the Patent Act (the Act) was amended to create a framework for the issuance and administration of certificates of supplementary protection (CSP), for which patentees with patents relating to human and veterinary drugs may apply. As set out in the Act, the new CSP regime, which will be administered by the Minister of Health (Minister), will provide additional protection from the date of the expiry of the eligible pharmaceutical patent based on the first authorization for sale of a drug containing a new medicinal ingredient or combination of medicinal ingredients in Canada. This new protection, which is intended to partly compensate for time spent in research and obtaining marketing authorization, provides patent-like rights in respect of drugs containing the same medicinal ingredient or combination. The scope of protection can be no broader than the scope of protection afforded by the patent set out in the CSP, and is subject to the same limitations and exceptions as the patent.

The term of a CSP is the difference between the date of the filing of the application for the patent and the date of issuance of the authorization for sale, reduced by five years, and capped at two years [i.e. CSP term = (Notice of Compliance date – Patent filing date) – five years, with a cap of two years].

The Act allows CSP applications to be submitted within a prescribed timeframe from (i) the authorization for sale of a drug, or (ii) the subsequent grant of an eligible patent that occurs after the authorization for sale of the drug. To be eligible, the application for authorization to sell a drug containing a medicinal ingredient or combination must be filed with the Minister before, or within a reasonable amount of time from, when the approval of a drug containing the same medicinal ingredient or combination was first sought in any comparable jurisdictions (the timely submission requirement). For a medicinal ingredient or combination to be eligible for a CSP, a drug containing it must not have been previously authorized for sale (as that phrase is defined) in Canada.

This regime is substantially defined in the amendments to the Act. The proposed Regulations specify the various timelines and requirements necessary for the purpose of the regime."

Paediatric Extensions in Norway

The SPC Blog is grateful to Arne Lund Kverneheim at Bryn Aaflot for the following news on paediatric extensions in Norway:

"Paediatric extensions in Norway will be implemented and available from 1 September 2017. This means that SPCs with expiry dates later than 1 March 2017 will be entitled to extensions provided that the application for the extension is submitted according to the requirement in the regulation or in the transitional regulations. 

The background for the amendments in the Norwegian Medicines Act and the Patent Law is in the EEA committee decision of 5 May 2017 (92/2017) adapting the SPC regulation 1768/92 - 469/2009 to include the EEA states. 

The implication is that any SPC in Norway with expiry date later than 1 March 2017 is entitled to paediatric extensions. The maximum duration of the protection will however be no longer than 6 months after the expiry of the SPC. 

RequirementsThe requirement in Norway will be the same as in EU member states.  Application forms in Norwegian and English will be provided by NIPO. 

NIPO will allow receipt of applications for paediatric extensions from 1 August 2017. The extension will be in force when the application is made public and after implementation of the regulation. 

DeadlinesThe normal deadline to apply for a paediatric extension is 2 years prior to expiry of the SPC. However, in a transition period of 5 years after implementation, which is until 1 September 2022, the deadline is 6 months prior to expiry of the SPC. 

Please note that an application for an extension will not prevent any third party who, between the expiry of the certificate and the publication of the application for an extension, in good faith has commercially used the invention or made serious preparation for such use, to continue such use. 

ExamplesThe transition regulations for SPC with an expiry close to the implementation can be interpreted with the following examples and timeline:

• SPC expiry 1 April 2017

entitled to a 1 month extension from 1 September 2017 (until 1 October 2017)
applicable from 1 August 2017

• SPC expiry 1 June 2017

entitled to a 3 months extension from 1 September 2017 (until 1 December 2017)
applicable from 1 August 2017

• SPC expiry 1 November 2017

entitled to a 6 months extension (until 1 May 2018)
apply by 1 October 2017

• SPC expiry 1 June 2018

entitled to a 6 months extension (until 1 December 2018)
apply by 1 December 2017"

Many thanks to Arne again!

Max Planck Institute SPC Survey - deadline for participating - 23 June 2017

As many readers of this Blog will be aware, the Max Planck Institute for Innovation and Competition is currently conducting a study on supplementary protection certificates in the European Union on behalf of the European Commission.  The study aims to include the views and opinions of a wide range of stakeholders including pharmaceutical companies, professional and industry associations as well lawyers, patent attorneys and other interest groups.

As part of the study, a survey is being conducted which includes questions on the past experience with the system, general policy considerations, assessment of the present legal rules, as well as some proposals on the potential amendment of the current SPC Regulations. The answers will be collected on an anonymous basis.  The deadline for participating in the survey is this Friday, 23 June 2017

If you are interested in participating in the survey, please contact Victoria Rivas at the Max Planck Institute at victoria.rivas@ip.mpg.de

Darunavir and the interpretation of Article 3(a) by Mr Justice Arnold

darunavir

Earlier this week, Mr Justice Arnold handed down a decision (here, [2017] EWHC 987 (Pat)) relating to the validity of Searle’s SPC to darunavir  in view of Article 3(a) of the SPC Regulation.

The facts of the case are as follows: G.D. Searle LLC hold SPC/GB07/038 (“the SPC”) to darunavir.  Janssen Sciences Ireland UC is the exclusive licensee. The SPC is based on EP 0 810 209, to which claim 1 is directed to a compound presented by Formula I

wherein the substituents P1, P2, R2, R3, and R4 are listed.

Sandoz and Hexal challenged the validity of the SPC on the basis that it does not comply with Article 3(a) of the SPC Regulation because darunavir is not specified or identified in any of the claims of the patent.  In particular, they argued that although darunavir falls within the scope of the claims, it is not specifically identified by name or structure in the claims or in the specification, nor is there any teaching in the patent which points to darunavir.

After briefly reviewing the CJEU’s  “guidance” in the Medeva and Lilly cases in relation to whether a product satisfies the requirement of Article 3(a) of the SPC regulation, Mr Justice Arnold came to the conclusion that it is sufficient for the claim to specify the product by means of a Markush formula which covers it.  Not entirely happy with the CJEU’s unclear tests, he also referred to what he considered as a better test, and as he advanced in Teva v Gilead, which would require that the product falls within the claim and that it embodies the inventive advance (or technical contribution) of the claim.

Kristina Cornish and Dayle Callaghan of Kilburn & Strode LLP were part of the team acting for the defendant in this successful matter.

Atripla - a combination of issues

Mr Justice Arnold gave his ruling earlier this week in Teva UK Limited & Ors v Merck Sharp & Dohme Corporation [2017] EWHC 539 (Pat).

In brief, Merck Sharp & Dohme (MSD) was granted an SPC for a combination product of  efavirenz, emtricitabine and tenofovir disoproxil fumarate based on EP (UK) 0 582 455 (the product is marketed as Atripla by Bristol-Myers Squibb Co. and Gilead Sciences Inc).  At trial, MSD relied on claim 16 as protecting the product.  Claim 16 reads:

“A combination of the compound of claim 12 or a pharmaceutically acceptable salt thereof with a nucleoside analog having biological activity against HIV reverse transcriptase.”

MSD also previously obtained an SPC for efavirenz based on the same patent.  Teva, Accord and Mylan challenged the validity of the SPC.

Mr Justice Arnold found that the SPC was invalid because it did not comply with either Article 3(a) or Article 3(c) of the SPC Regulation.  More specifically, he found that the scope of protection of claim 16 extended to a combination of efavirenz and tenofovir or a combination of efavirenz and emtricitabine, but not to a combination of all three actives.  He also found that the SPC does not comply with Article 3(c) because claim 16 does not represent a distinct invention from the invention protected by the claims for efavirenz.

Forum Institut SPC Seminar

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 2017 and on how to understand the decisions and which practical consequences we may expect for the future.  

Date: 31 May 2016; venue: Amsterdam.

More information is available here.  

To register, just forward this blogpost to Jean-Claude himself at jc.alexandreho@forum-institut.de or click here.

A new CJEU referral - C-681/16

In case C-681/16 (Pfizer Ireland Pharmaceuticals, Operations Support Group), the Landgericht Düsseldorf  has referred questions to the CJEU relating to SPCs and the specific mechanism.  According to the UKIPO's website, the questions are:

1.Can the holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany rely on the specific mechanism to prevent the importation of products into the Federal Republic of Germany from the accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania … and Croatia (Annex IV to the 2003 Act of Accession, OJ 2003 L 236, p. 797, as amended in OJ 2004 L 126, p. 4, for Estonia, Latvia, Lithuania, Poland, Slovenia, Hungary, Slovakia, the Czech Republic; Part I of Annex V to the 2005 Act of Accession, OJ 2005 L 157, p. 268, for Romania and Bulgaria; Annex IV to the 2011 Act of Accession, OJ 2012 L 112, p. 60, for Croatia) if the supplementary protection certificate was applied for in the Federal Republic of Germany at a point in time at which the laws for obtaining such a supplementary protection certificate already existed in the respective accession States but could not be applied for by, or issued to, the holder of the supplementary protection certificate issued for the Federal Republic of Germany because the basic patent required for the issuing of the supplementary protection certificate did not exist in the accession State?

2.Does it make any difference to the answer to Question 1 if it was merely at the time of the filing of the application for the basic patent issued for the Federal Republic of Germany that such protection through a basic patent could not be obtained in the accession State but, by the time of publication of the application on which the basic patent issued for the Federal Republic of Germany was based, it could be so obtained?

3.Can the holder of a supplementary protection certificate that was issued to it for the Federal Republic of Germany rely on the specific mechanism to prevent the importation of products into the Federal Republic of Germany from the accession States the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria, Romania… and Croatia if those products are imported after the expiry of the term of the supplementary protection certificate stipulated in the original decision to grant the patent but before the expiry of the six-month extension of the term of the supplementary protection certificate that was granted to it on the basis of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004?

4.Does it make any difference to the answer to Question 3, in the case of Croatia, that, on account of the accession of Croatia in 2013, the specific mechanism did not come into force until after the entry into force of Regulation (EC) No 1901/2006 of the European Parliament and of the Council of 12 December 2006 on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004 on 26 January 2007 – unlike in the other Member States which acceded prior to 26 January 2007, namely the Czech Republic, Estonia, Latvia, Lithuania, Hungary, Poland, Slovenia, Slovakia, Bulgaria [and] Romania …?

An update on the Pharmaq v Intervet case

In December 2016, the Borgarting Court of Appeal handed down its decision on the validity of Intervet's Norwegian SPC relating to a fish vaccine against pancreatic disease.

The SPC Blog is grateful to Lars Erik Steinkjer at Wikborg Rein for providing a copy of the Court of Appeal judgement (here), a translation of the decision (here) as well as a summary of the facts of this case and of the Court of Appeal decision for readers of the SPC Blog.  Lars Erik Steinkjer and Gunnar Meyer from Wikborg Rein and Ida Gjessing from Grette represented Pharmaq in these proceedings.

Lars writes:

"In the MA for Intervet's vaccine, Norvax Compact PD, the active ingredient is identified as “Inactivated Salmon Pancreatic Disease Virus Strain F93-125”. However, to the Norwegian Industrial Property Office Intervet applied for, and was granted, an SPC with a broader product definition, i.e. “Salmonid pancreatic disease virus that, when injected intraperitoneally at a titre of 103.5 TCID50 into Atlantic salmon post-smolts held in sea water at 14°C causes the fish to develop symptoms of pancreatic disease, wherein
                a) said virus is the virus strain as deposited at ECACC under Deposit number V94090731 or closely related strains which share similar genotypic and/or phenotypic characteristics to said deposited virus strain and
                b) said virus reacts serologically with convalescent anti-FPDV antiserum or antiserum raised against    the deposited virus strain V94090731 and
                c) said virus is in an inactive form.”

Before the Norwegian courts Pharmaq challenged the validity of Intervet’s SPC on the basis of Article 2, 3 and 4 of the SPC Regulation. The Oslo District Court decided to make a referral to the EFTA-court on the interpretation of said articles and the EFTA-court issued its advisory opinion on the 9th of April 2015 (reported earlier here). 

In its subsequent judgment, the Oslo District Court held the SPC valid and infringed by Pharmaq's vaccine (reported earlier on the Blog here). The Court of Appeal, however, overturned the District Court's decision and revoked the SPC as it was held invalid on the basis of article 4 of the SPC regulation. 

Although the Court of Appeal agreed with the District Court's opinion that if the SPC scheme shall fulfill its objectives for biological medicinal products, the scope of protection cannot be limited to a strict interpretation of the wording of the active ingredient in the marketing authorisation, the Court of Appeal also stressed that this consideration must be weighed against the other objectives of the SPC regulation and that SPCs should not be given a wide scope of protection such that improved medicinal products are kept off the market to the detriment of human or veterinary health. 

In the Court of Appeal's opinion it was not clear how the limits on the scope of protection from biological medicinal products ought to be established. The court assumed however that the difference between the products must at least be expressed in such a manner that it has a practical and appreciable effect on the quality, safety and efficacy for the products to constitute two different "active ingredients" according to the SPC regulation. 

On the evidence, the Court of Appeal held that Pharmaq's vaccine, which is based on a different strain than the strain used in Intervet's vaccine, is "systematically, consistently and significantly more efficient against SAV 3 infection than Intervet's vaccine". Thus, the two strains could not be considered the same active ingredient in the meaning of the SPC regulation.  In line with the guidance given by the EFTA-court, the consequence was that the SPC was found invalid.

The judgment is not final as the time limit for appeal to the Norwegian Supreme Court is still running."

Plant Protection Product SPCs - an article

News comes from Velautha-Cumaran Arunasalam and Filip de Corte who report the publication of their recent article "Supplementary protection certificates for plant protection products: the story of 'The Ugly Duckling'" in the Journal of Intellectual Property Law & Practice (JIPLP).  They write:

The paper was put forward to celebrate the upcoming 20th anniversary of the PPP (plant protection product) SPC Regulation coming into effect and to confirm the continued importance of the SPC Regulation for the plant protection sector.

Importantly, the paper considers briefly the social as well as economic factors behind the SPC Regulations and puts forward reasons why not all the case law on medicinal product SPCs, especially those concerning combination products, should be directly applicable to the plant protection sector.  The Regulations can be said to be sisters but not twins.

The article can be accessed here.

Another EC tender on SPCs - this time on the economic impact

Via this post on the IPKat comes news of a recently published tender entitled "Study on the economic impact of supplementary protection certificates, pharmaceutical incentives and rewards in Europe." This study will complement the ongoing legal study on SPCs (reported on the SPC Blog here).

According to the press release:

"The study will provide an economic evaluation of the incentives and rewards for pharmaceutical innovation in Europe, and its functioning within the Internal Market. 

The study will in particular analyse the effects of supplementary protection certificates (SPCs) for pharmaceutical uses (human and veterinary), and plant protection, data protection and market exclusivity for medicinal products for human use.

Evidence on the overall impact on availability and accessibility of pharmaceutical care for patients and the pressure on health systems across the European Union will be examined. The evidence and analysis provided by this study will hence support the policy making in those areas."

More detailed information on the tender can be obtained in the technical specifications, here. The deadline to apply is 8 February 2017.

The return of SPC referrals…

Following previous posts on this case (here, here and here), the UKIPO will now be preparing its submission in the recent CJEU referral in Merck (Case C-567/16).

Marking the return of SPC referrals, of which a number have now followed, Simmons & Simmons (Andrew Hutchinson, Machteld Hiemstra and Nicholas Fischer) has published an article on this case – kindly available here.

As well as considering the referral and issues raised by Arnold J’s decision in respect of Article 3(b), this article analyses the UK IPO’s original decision under Article 3(c) and reviews the parallel Dutch Patent Office decision, which interestingly comes to a contrasting outcome under both grounds.

More questions for the CJEU from the High Court

In two separate decisions handed down last Friday, Teva UK Limited & Ors v Gilead Sciences Inc [2017] EWHC 13 (Pat) and Abraxis Bioscience LLC v The Comptroller-General of Patents [2017] EWHC 14 (Pat), Mr Justice Arnold has decided to send more questions to the CJEU for a preliminary ruling.

In Teva UK Limited & Ors v Gilead Sciences Inc, at [95], Mr Justice Arnold repeats question 1 of the Actavis v Sanofi case:

"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?"

In Abraxis Bioscience LLC v The Comptroller-General of Patents, the question is (at [62]):

"Is Article 3(d) of the SPC Regulation to be interpreted as permitting the grant of an SPC where the marketing authorisation referred to in Article 3(b) is the first authorisation within the scope of the basic patent to place the product on the market as a medicinal product and where the product is a new formulation of an old active ingredient?"

Taxol eluting stent decision from the Swiss Federal Administrative Court

The SPC Blog has received news from Tarik Kapic of Bovard of a decision from the Swiss Federal Administrative Court that will force the Swiss Institute of Intellectual Property to decide whether an SPC can be granted on a stent eluting an active ingredient.  An application was filed in 2014 but the Institute refused completely to enter into the matter and the Court has now accepted the appeal based on a “denial of justice” (Rechtsverweigerung). 

A copy of the decision can be found here.  Unfortunately no English translation is available at the moment.

Many thanks to Tarik for passing this on!

New CJEU Reference and Comments for the UKIPO - C-492-16 - Incyte Corporation

Case C-492/16 (Incyte Corporation) appears to be the latest SPC dispute to be referred to the CJEU for a preliminary ruling.  According to the Curia website, the following questions have been referred:

1.  Must Article 17(2) of 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 ¹ be interpreted as meaning that ‘the date of the first authorization to place the product on the market in the Community’ is incorrect in an application for a supplementary protection certificate, within the meaning of that regulation and 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, ² where that date was determined without taking account of the Court of Justice’s interpretation of the law in the judgment in Seattle Genetics (Case C-471/14), with the result that it is appropriate to rectify the date of expiry of the supplementary protection certificate even if the decision to grant that certificate was made prior to that judgment and the time limit for appealing against that decision has already expired?

2.  Is the industrial property authority of a Member State which is entitled to grant a supplementary protection certificate required to rectify, of its own motion, the date of expiry of that certificate in order to ensure that that certificate complies with the interpretation of the law set out in Case C-471/14?
____________¹ OJ 1996, L 198, p. 30.
² OJ 2009, L 152, p. 1.

In addition, the UKIPO is seeking comments on this case.  Comments must be emailed to policy@ipo.gov.uk by 25 January 2017.

UKIPO seeks comments on C-567/16

The UKIPO is seeking comments on CJEU case C-567/16 (Merck Sharp and Dohme Corporation) with a view to advising the UK government as to whether it wishes to make representations in this reference.  The deadline for filing submissions is coming up very soon - 6 January 2017.

The questions referred to the CJEU are:

1. Is an End of Procedure Notice issued by the reference member state under Article 28(4) of European Parliament and Council Directive 2001l83/EC of 6 November 2001 on the Community code relating to medicinal products for human use before expiry of the basic patent to be treated as equivalent to a granted marketing authorisation for the purposes of Article 3(b) of European Parliament and Council Regulation 469/2009/EC of 6 May 2009 concerning the supplementary protection certificate for medicinal products (codified version) (the “SPC Regulation”), such that an applicant for an SPC in the Member State in question is entitled to apply for and be granted an SPC on the basis of the End of Procedure Notice?
2. If the answer to question (1) is no; in the circumstances in question 1, is the absence of a granted marketing authorisation in the Member State in question at the date of the application for an SPC in that member state an irregularity that can be cured under Article 10(3) of the SPC Regulation once the marketing authorisation has been granted?

Many thanks to Andrew Hutchinson (Simmons & Simmons) for pointing this out!