In January 2020, the Advocate General (AG) provided his opinion in Santen v INPI relating to how Article 3(d) of the SPC regulation should be interpreted. This opinion from the AG is interesting and important for two reasons. Firstly, it is trying to clear up almost 10 years of confusion that was caused by the Neurim judgement, and secondly the recommendation provided is very clear.
Insights: pharmaceutical industry
When it comes to exclusivity in the pharmaceutical and biopharmaceutical fields, patents and supplementary protection certificates (SPCs) are not the only games in town. In Europe, it is important to consider another layer of exclusivity, associated with regulatory data.
Second medical use claims are designed to protect substances or compositions for use in new medical treatments. Numerous decisions of the Technical Boards of Appeal of the EPO have confirmed that second medical use claims cannot be used to protect medical devices. However, as is so often the case in patent law, scientific advancements are beginning to blur the technical difference on which the legal distinction between medical devices and substances is based.