The Court of Justice of the European Union (CJEU) recently ruled that, unlike medicinal products, medical devices incorporating an ancillary drug substance cannot benefit from supplementary protection certificate (SPC) protection.
Facts and procedural background
SPCs are governed by Regulation No 469/2009 (the "SPC Regulation") and are intended to compensate the holders of pharmaceutical patents for the studies and authorisation procedures required to market their products. The SPC Regulation provides that only products protected by a patent and approved in accordance with the Medicinal Products Directive (2001/83/EC) are eligible for SPC protection.
Medical devices, on the other hand, are governed by the Medical Device Regulation (Council Regulation 2017/745) and are subject to the CE marking procedure. Medical devices that incorporate an ancillary active substance are subject to a more stringent procedure than other types of medical devices as the national medicines authority of an EU member state or the European Medicines Agency must establish the quality, safety and utility of the drug component found in the combination device.
The key question in the case at hand was whether the regulatory assessment of ancillary medicinal products renders combination medical devices eligible for SPC protection. The national patent offices had taken different approaches to this issue.
Boston Scientific held a second medical use patent covering the use of the molecule paclitaxel for the prevention of restenosis and commercialised a CE-marked combination medical device under this patent (a paclitaxel-eluting coronary stent).
Boston Scientific applied to the German Patent Office for an SPC, based on its paclitaxel patent and the CE certificate of conformity for the paclitaxel-eluting coronary stent. The patent office rejected the application on the ground that the product did not have a marketing authorization as required by the SPC Regulation (i.e. a marketing authorization for a medicinal product granted in accordance with Directive 2001/83/EC).
Boston Scientific appealed the German Patent Office's decision, arguing that the adjuvant (paclitaxel) had been subjected to a procedure analogous to that applicable to place a medicinal product on the market.
The CJEU’s decision (Case C-527/17)
The Court rejected Boston Scientific's argument.
It first recalled that the terms "medicinal product" and "medical device" are mutually exclusive in that a product that falls within the definition of a medicinal product, within the meaning of Directive 2001/83, may not be classified as a medical device, within the meaning of Directive 93/42. Therefore, 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.
The Court added that while an active ingredient that is integral but ancillary to a device must be assessed by analogy with the procedure for the authorization 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 active ingredient component of a combined device is therefore not equivalent or comparable to the procedure provided for by Directive 2001/83/EC.
In conclusion, it is not possible to obtain an SPC for a combination medical device incorporating an ancillary active ingredient, based on a CE certificate of conformity.
While this decision will not be welcomed by medical device manufacturers, it at least sheds light on a situation that was not always clear, given that the national patent offices tend to take different approaches to these types of products.