ECJ Decision on the Protectability of Pharmaceuticals in Medical Devices: Legal Implications for the Pharmaceutical Industry
The decision of the European Court of Justice (ECJ) of 25 October 2018 (Case C-527/17) set key parameters for claiming supplementary protection certificates (SPC) in relation to pharmaceuticals that are an integral part of a medical device. For companies in the pharmaceutical and medical technology sectors aiming to secure their investments in research and development, the impact of this decision is considerable.
Basis of the Supplementary Protection Certificate (SPC)
Protection Mechanism and Objective
The supplementary protection certificate is a form of protection established under EU law, which may grant holders of a pharmaceutical patent an additional exclusive period of use upon expiry of the basic protection. The aim of this instrument is to provide incentives for the development of innovative therapies by compensating for lengthy approval periods.
Scope of Regulation (EC) No. 469/2009
According to the relevant regulation, a prerequisite for granting an SPC is that the product has been authorized as a human or veterinary medicinal product under European regulatory provisions. The purpose of protection is thereby limited to products that have been subject to an independent pharmaceutical regulatory review and authorization process.
Scenarios Involving Medical Devices
Combination of Pharmaceutical and Medical Device
In practice, there are many products on the market where a pharmaceutical is an integral part of a medical device – typically, for instance, a medical apparatus coated with a pharmaceutical substance. For these combination products, EU regulation generally provides for approval under medical device law and not under pharmaceutical law, even if the substance contained has a pharmacological effect.
Legal Assessment by the ECJ
Against this background, the ECJ clarified that an SPC can only be granted for such a pharmaceutical if it has received independent authorization as a medicinal product under the Regulation. The mere incorporation of an active substance in a medical device, approved according to medical device regulations, is not sufficient for the application of the SPC Regulation.
Implications for Industrial Property Protection
Limited Possibility of Extension
Companies relying on innovative combinations of pharmaceuticals and medical devices must increasingly resort to strategies outside the SPC regime to secure their intellectual property rights. The demarcation set by the ECJ means that patent protection for the pharmaceutical component of these medical devices cannot be extended by means of a supplementary protection certificate unless there is an independent pharmaceutical regulatory authorization.
Significance for Protection Rights Strategy
For commercial practice, this means a significant limitation regarding the planning and calculation of research expenses. Companies should carefully consider the regulatory framework at both the European and national level, as the choice of approval path essentially determines the subsequent scope of protection.
Conclusion and Outlook
The ECJ decision strikingly highlights the limits of the supplementary protection certificate with regard to pharmaceuticals used in medical devices. Compliance with strict authorization requirements is the decisive factor for protectability. In light of the ongoing convergence of pharmaceutical and medical device law as well as new forms of innovation, further developments in case law should be closely monitored.
For companies, investors, and other parties dealing with the business law aspects of protection rights in the healthcare sector, this leads to various questions relating to authorization, protection rights, and marketing strategies. In complex legal matters concerning patent protection and market access, the lawyers of MTR Legal can provide structured support and advise with consideration of the latest legal developments.
