The SPC blog

A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here

Wednesday, 25 April 2018

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

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

As a recap, the referring court asked the following question:
What are the criteria for deciding whether "the product is protected by a basic patent in force" in Article 3(a) of Regulation No. 469/20091 ?
The Advocate General has advised the Court to rule as follows (thanks to Google translate):
"Article 3 (a) of Regulation (EC) No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products, precludes the issue of a certificate supplementary protection relating to active ingredients which do not appear in the wording of the claims of the basic patent. The fact that a substance or composition falls within the scope of the protection of the basic patent is a necessary, but not sufficient, condition for constituting a product protected by a patent within the meaning of Article 3 (a) of Regulation No 469/2009. 
A product is protected by a patent within the meaning of Article 3 (a) of that Regulation if, on the priority date of the patent, it would have been obvious to a person skilled in the art that the active ingredient in question was specifically and specifically identifiable in the wording of the claims of the basic patent. In the case of a combination of active ingredients, each active ingredient in that combination must be specifically and precisely as well as individually identifiable in the wording of the claims of the basic patent."

Friday, 6 April 2018

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

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

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

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

Thursday, 29 March 2018

Denmark - Gilead successfully enforces its SPC for Truvada

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

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

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

Friday, 23 March 2018

Forum Institut SPC Seminar 2018

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

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

Thursday, 22 March 2018

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

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

Thursday, 8 March 2018

Sweden, Incyte and the correction of the duration of SPCs

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

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

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

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

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


Friday, 2 March 2018

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

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

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

Friday, 8 December 2017

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



Saturday, 11 November 2017

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'.


Thursday, 9 November 2017

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!