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.

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.

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.

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.

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.