SPCs for drug/device combinations?
24 November 2017
Supplementary protection certificates (SPCs) (as provided under EU Regulation (EC) No. 469/2009) are intended to compensate patent proprietors for any potential loss of exclusivity due to the long regulatory approval procedures required to get new drugs onto the market. To this end SPCs can provide up to five years of patent term extension in relation to specific active ingredients that are the subject of a marketing authorisation. However, it is generally understood that SPCs are not available for medical devices as the regulatory hurdles to get these products onto the market is not considered to be high enough to justify compensation to the patent term. Consequently, the position for patent proprietors sitting squarely in either of these two camps has been fairly clear. But what about drug/device combinations?
SPCs are administered by the national patent offices of EU member states and, until now, there has been little common ground between member states as to whether such combination products are entitled to an SPC. However, the German Federal Court has now referred this question to the CJEU (case number C-527/17) and there is hope that this will finally provide some clarity for patent proprietors and applicants in this area.
As mentioned above, the current situation for drug/device combinations is complicated. For example, consider a drug device combination in which the drug is incorporated into the device and provides a supporting effect. This product must be authorised by a notified body according to the CE-marking procedure. However, the regulatory authority for medicinal products must be consulted as part of the CE-marking procedure in order to comment on the quality, safety and usefulness of the drug component. The drug is therefore assessed according to the standards for a medical product and, on the basis of this consultation, the notified body will issue or deny the CE-mark. As part of the consultation process the regulatory authority may require evidence in the form of clinical trials, which may be substantial if the drug itself is new. Consequently, the drug/device combination may have to go through the same regulatory hurdles (and consequent delays to market entry) as a new drug. Should it therefore be entitled to the same SPC rights as compensation for this delay?
The case referred to the CJEU relates to paclitaxel (approved as an anti-cancer drug since 1999) in the treatment of restenosis. An SPC was requested on the basis of a CE-mark authorising a stent which incorporated paclitaxel as an integral part. The regulatory authority advising the notified body in the consultation process required clinical trials to establish the therapeutic effectiveness of the stent incorporating paclitaxel as compared to a stent alone. The regulatory authority ultimately provided a positive report and the CE-mark was issued. However, the German Patent and Trademark Office rejected the SPC application and an appeal is pending before the 14th Senate of the Federal Patent Court (which has now been stayed until the CJEU has issued its decision).
An English translation of the question referred to the CJEU is 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?”
The Federal Patent Court has referred to a number of other CJEU decisions in which the question of the whether the drug product was subject to safety and efficacy testing during the authorisation procedure was decisive in determining whether or not such authorisations fall within the scope of the SPC regulations.
In this case the Court believes that the drug component went through testing that was equivalent to that required for marketing authorisation by a regulatory authority. The Court also considers that as the outcome of the CE-marking process was dependent on the consultation with the regulatory authority it should be considered to be equivalent to an administrative authorisation procedure. On this basis the Federal Court recommends considering an authorisation based on a CE-mark as being equivalent to a marketing authorisation issued by a regulatory authority, meaning that the drug/device combination should be eligible for an SPC.
This seems like a well-reasoned opinion from the Federal Court that would provide welcome clarity for patent applicants and proprietors in this field. We will await the decision from the CJEU with interest.
Helen Henderson
Life Sciences & Chemistry group
If you require further information on anything covered in this briefing, please contact Helen Henderson (hhenderson@withersrogers.com; 44 20 7940 3600) or your usual contact at the firm. This publication is a general summary of the law. It should not replace legal advice tailored to your specific circumstances.
© Withers & Rogers LLP, November 2017
