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

Friday, 3 November 2017

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:
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!

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