"Although the Advocate General seems to be ruling out an infringement test to establish whether a product is protected by a basic patent under Article 3(a), the precise test to be used remains unclear. At least some form of disclosure of each active ingredient of a product appears to be necessary, but how specific this must be is not known.You can read this article in full here.
What is clear from the opinion, however, is the proposal for SPCs to be obtained for a patented part of authorised products containing a combination of active ingredients. In reaching this conclusion, the advocate general has obviously recognised the importance of providing SPC protection for active ingredients which are first authorised in combination with other active ingredients.
If the CJEU follows the opinion, the narrow interpretation of what is “protected” by a basic patent may mean that some granted SPCs are invalid. On the other hand, the more permissive interpretation of what represents a valid authorisation could provide new opportunities for obtaining useful (and very broad) SPC protection.
Overall, the above-mentioned aspects of the A-G’s opinion provide what seems to be a workable approach for obtaining SPC protection for combination products.
While the facts of the Medeva and Georgetown et al cases relate to combination vaccines, the issues apply equally to other areas of human and veterinary medicine and also in agriculture. Indeed, an increasing trend to authorise medicines and plant protection products in combination suggests that the Court’s decision may have far-reaching consequences. The final judgement will therefore be eagerly anticipated".
A niche blog dedicated to the issues that arise when supplementary protection certificates (SPCs) extend patents beyond their normal life -- and to the respective positions of patent owners, investors, competitors and consumers. The blog also addresses wider issues that may be of interest or use to those involved in the extension of patent rights. You can email The SPC Blog here