In my webinar a couple of weeks ago (SPCs part 1), I mentioned that I hoped the judgement on the Santen case at the CJEU (C-673/18) would be out soon. Well, the CJEU must have been listening because exactly two weeks later it’s now out.
At first reading, the judgement revolves around the term “product”, which we discussed in the first webinar and the interaction of this term with limitations written into the rules on SPCs. The SPC regulation defines the “product” as the active agent or combination of actives and the SPC application must be relying on its first Marketing Authorisation (MA) for this “product” as a pharmaceutical agent. The earlier judgement in Neurim (C-130/11) had suggested that this limitation might not apply where the old MA was for a use which did not fall within the new patent. The Santen judgement rejects this concept and puts us squarely back on a strict and literal interpretation of the rules.
We’ll be taking a closer look at this and several other judgements from the CJEU in part two of the SPC webinar, which will take place on 13 August.
Part one of the the SPC webinar is available for viewing here, if you need a refresher before part two.