On 25 October 2018, the Court of Justice of the EU (CJEU) held in Case C-527/17 Boston Scientific that, where a medical device incorporates an ancillary drug substance, that substance will not be entitled to supplementary protection certificate (SPC) protection. That is the case even if the drug substance has been subjected to an evaluation of its safety, quality and efficacy that is analogous to the authorisation procedure for medicinal products, which are entitled to SPC protection.
Factual and legal background
The grant of SPCs is governed by Regulation 469/2009 (the SPC Regulation) which provides (among other conditions) that an SPC will only be available for a product if “a valid authorisation to place the product on the market as a medicinal product has been granted in accordance with Directive [2001/83/EC]”.
The case relates to Boston Scientific’s TAXUS paclitaxel-eluting coronary stent. The stent provides an immediate therapeutic effect by mechanically dilating the constricted blood vessel, and paclitaxel inhibits further narrowing of the blood vessel (known as restenosis). Boston Scientific holds a patent covering the use of paclitaxel to inhibit restenosis, and sought an SPC to extend protection under this patent on the basis of the CE certificate for its paclitaxel-eluting stent (i.e., the medical device).
Medicinal products and general medical devices are regulated by Directive 2001/83/EC and Directive 93/42/EC respectively. In the case of combination drug/device products, the decision as to which of these two regulatory regimes applies is made by reference to the function and the principle therapeutic effect of the drug and device components. Most relevant in this case, if the device incorporates, as an integral part, a substance which has an action ancillary to that of the device, the device as a whole will be regulated as a medical device under Directive 93/42/EC. However, the quality, safety and efficacy of the ancillary drug substance must be verified “by analogy” with the requirements for medicinal products set out in Directive 2001/83/EC.
Boston Scientific argued that, although its TAXUS stent had been authorised as a device under Directive 93/42/EC, the drug element had been subject to an equivalent procedure to that set out in Directive 2001/83/EC, and so should be entitled to SPC protection.
The CJEU’s decision
The CJEU held that Boston Scientific’s TAXUS stent was not entitled to an SPC for the following reasons:
- A product may only benefit from SPC protection if it has been subject, as a medicinal product, to the authorisation procedure laid out in Directive 2001/83/EC.
- The terms “medicinal product” and “medical device” are mutually exclusive.
- A substance that forms an integral part of a medical device, and performs an action ancillary to that of the device, cannot be classified as a medicinal product, even if it could be classified as such if it were used separately.
- While a drug substance that is integral but ancillary to a device must be assessed by analogy with the procedure for the authorisation of medicinal products in Directive 2001/83/EC, that assessment is carried out in relation to its use as part of the device, not in relation to its use as a medicinal product. The assessment of the drug element of a combined device is therefore not equivalent or comparable to the procedure in Directive 2001/83/EC.The CJEU held that this strict interpretation of the SPC Regulation was in line with the objectives of the Regulation: “it is apparent from the title of [the SPC Regulation] and from recitals 3, 4 and 8 to 10 thereof that the EU legislature intended to reserve the grant of SPCs to medicinal products alone, to the exclusion of both medical devices and substances used as adjuvant products of a medical device.”
Impact of the decision
The judgment of the Court is on the basis that SPCs are only available for “medicinal products”, and as the definitions of “medical device” and “medicinal product” are mutually exclusive, it will not be possible to obtain SPC protection for a drug/device combination product that is classified and regulated as a medical device. However, it is clear from the decision that a uniform position does not currently exist across the EU, and that SPCs have been granted for products authorised as medical devices. Whether this judgment will have an impact on these decisions, remains to be seen.
The decision is instructive in the sense that whether a combination drug/device product is eligible for SPC protection will turn on its classification, which determines the regulatory regime that applies in order to place that product on the market. For the purpose of product classification, it is critical to assess in respect of the drug/device combination product:
- the product characteristics;
- the underlying functionality of the individual components; and
- the contribution of the respective components towards the claimed therapeutic effect.