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!