On 25 October 2018 the CJEU issued its decision C-527/17 concerning a supplementary protection certificate (SPC) for a combination of a medical device and a pharmaceutical drug. In short, the CJEU ruled that a CE-mark approval for a medical device incorporating a substance as an integral part of said device cannot be considered a marketing approval in accordance with the Medicinal Product Directive 2001/83, even if the substance was subject to the CE mark assessment.
In Europe, regulation No. 469/2009 forms the legal basis for supplementary protection certificates for medicinal products. Article 2 of the regulation defines the scope and provides that any product protected by a patent in the territory of a Member State, and prior to being placed on the market as a medicinal product, is subject to an administrative authorisation procedure according to Medicinal Products Directive 2001/83.
The present case related to a stent coated with the drug paclitaxel (hereinafter “the TAXUS medical device”), i.e. paclitaxel was incorporated as integral part of the stent, to prevent and treat restenosis. Restenosis is a common adverse advent of endovascular procedures. Paclitaxel is a cancer drug approved by the European Medicines Agency (EMA).
The referral to the CJEU by the Federal Patents Court, Germany, concerned an SPC application for the TAXUS medical device and was based on the European patent 0681 475 regarding the medical use of paclitaxel for the treatment of restenosis, and on a CE conformity certificate for the TAXUS medical device.
In its decision, the CJEU states that the terms “medicinal product” and “medical device” are mutually exclusive in such a way that a product that falls within the definition of a “medicinal product” within the meaning of Medicinal Product Directive 2001/83 may not be classified as a medical device within the meaning of the Medical Device Directive 93/42. The CJEU goes on to say that in this regard, the principal mode of action of the product should be taken into account. A product which does not achieve its principal mode of action by pharmacological, immunological or metabolic means falls under the definition of a ‘medical device’. Conversely, a product which achieves its principal intended action in the human body by such means may be classified as a medicinal product within the meaning of the Medicinal Product Directive 2001/83. When the substance that is incorporated in the medical device only has ancillary action in addition to the action of the medical device it may not be classified as a medicinal product according to the Medicinal Product Directive 2001/83, even if it could be classified as such if it were used separately.
