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'.

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!

Extending Patents to Medical Devices - an article

There isn't so much out there when it comes to an overview on SPCs and medical devices. However, the February 2011 issue of Intellectual Property and Technology Law Journal does contain an article by Sinan Uktu (Covington & Burling LLP) on that topic entitled "Extending Patents to Medical Devices in Europe".

A copy of the article can be obtained here.

SPCs, actives and medical devices

Recently, we posted a German Federal Patent Court decision which overruled a decision of the German Patent and Trademark Office, and granted an SPC to an implantable medicinal device (see link - Yttrium-90 Glass Microspheres). In light of questions we have received on this issue the SPC Blog asks whether any of its readers is aware of further decisions on SPCs involving medicinal devices.

By way of background, the issue is as follows.

Article 2 of SPC Regulation EC 469/2009 stipulates that:

"Any product protected by a patent in the territory of a Member State and subject, prior to being placed on the market as a medicinal product, to an administrative authorisation procedure as laid down in 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 or Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products may, under the terms and conditions provided for in this Regulation, be the subject of a certificate."

[A product according to Article 1 of the SPC regulation is any active ingredient or combination of active ingredients of a medicinal product].

What does the underlined text mean? Does it mean that only a product specifically approved under Directive 2001/83/EC or 2001/82/EC may be subject of an SPC, or does it allow for an SPC to be granted for an active approved under some other EC legislation, and where the active component has undergone the same level of scrutiny as required by in Directive 2001/83/EC or 2001/82/EC.

The latter situation may arise in the medicinal devices Directives 93/42/EC (for Medicinal Devices) and 90/385/EEC (for implantable medicinal devices).

For example, Article 1(3) of Directive 93/42/EC indicates that medical devices containing actives are generally covered by the medicinal device directive and would not be authorised under Directive 2001/83/EC or 2001/82/EC. [The exception is where the device and the medicinal product form a single integral product which is intended exclusively for use in the given combination and which is not reusable, in which case Directives 2001/83/EC or 2001/82/EC apply].

Directive 93/42/EC specifies, in paragraph 7.4 of Annex 1,that:
"Where a device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product as defined in Article 1 of Directive 65/65/EEC and which is liable to act upon the body with action ancillary to that of the device, the safety, quality and usefulness of the substance must be verified, taking account of the intended purpose of the device, by analogy with the appropriate methods specified in Directive 75/318/EEC [now Directive 2001/83/EC]. Similar language is found in Article 1(3) and paragraph 10 of Annex 1 of Directive 93/385/EEC.

Thus it would appear that an active component of a medicinal product whose approval is governed by the medicinal devices Directives should to be assessed at the same level of rigour as an active agent covered by Directives 2001/83/EC or 2001/82/EC. The need for equally stringent testing of active ingredients approved under different directives makes perfect sense, but does that fact alone open the door to SPC protection for the product?

Arguably it should. It appears to be unfair that SPC protection would only be available to actives that have been approved under Directives 2001/82/EC or 2001/83/EC, and that a new active specifically delivered by a device but approved under the medicinal devices Directive 93/42/EC (for example), could not take advantage of the SPC provisions.

The German Federal Patent Court in the Yttrium-90 Glass Microspheres case considered the level of testing required by the medicinal devices Directives allowed the product to conform to the administrative authorisation requirement of Article 2 of SPC Regulation EC 469/2009.

A similar conclusion was arrived at by the Court of The Hague in 2004 in Genzyme Biosurgery v. BIE (if anyone has an English translation of this decision we'd love to see it).

However, a court might consider that it was not able to interpret Article 2 of the SPC regulation more broadly than approval under Directives 2001/82/EC and 2001/83/EC per se. It might also be argued – at a stretch - that assessment of safety "by analogy" with Directive 2001/83/EC is not necessarily assessment at the same standard as under by Directive 2001/83/EC.

If you have other examples in the device area we would be interested to find out.

You can post any thought as a Comment below.

SPC on the basis of an MA for active implantable medical devices

Thanks to Matthias Kindler and Bianca-Lucia Vos (Hoffmann Eitle) for providing the following summary of a recent decision on SPCs for medical devices:

"The German FPC has issued a decision on SPC application 12 2005 000 052 in the name of the Curators of the University of Missouri. The SPC is for “yttrium-90 glass microspheres” and the application had been rejected by the GPTO because the application referred to EC Certificates CE 500 749 and CE 501 532 for the product “TheraSphere(R) yttrium-90 glass microspheres” as relevant MAs. The EC certificates were issued by BSI Product Services according to Council Directive 90/385/EEC relating to active implantable medical devices. The GPTO based the rejection on the ground that only medicinal products and not medical devices were authorized by the legislators as the basis for an SPC.

The German FPC overturned the decision of the GPTO. They found that under the specific circumstances of the present case the certificates CE 500 749 and CE 501 532 are to be considered as certificates granted analogously to Directive 65/65/EEC (now replaced by 2001/83/EC in the version of Directive 2004/27/EC). "

A copy of the German decision can be obtained here, and an english translation here.

Two quick questions

The SPC Blog has received two questions from readers. Can you help them?

1. "Are the travaux préparatoires for the SPC Regulation available online -- I've tried finding them on the European Commission's website but have had no luck so far".

2. "Does anyone know whether patent extensions were ever considered for medical devices? And why were they not included within the SPC provisions?"

If you have anything to offer, can you please post your information as a Comment below.