A Supplementary Protection Certificate (SPC) extends protection of a patented product past the 20 year term (for a maximum further term of 5 years) if that product is also protected by a marketing authorisation. However, whether a product covered by a marketing authorisation is “protected” by a patent has been the subject of various referrals to the Court of Justice of the European Union (CJEU).
In Teva v Gilead (C-121/17 here), the CJEU has today given its ruling on the criteria for deciding whether “the product is protected by a basic patent in force” in Article 3(a) of Regulation No. 469/2009.
The Court (Grand Chamber) ruled:
Article 3(a) of Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009, concerning the supplementary protection certificate for medicinal products, must be interpreted as meaning that a product composed of several active ingredients with a combined effect is ‘protected by a basic patent in force’ within the meaning of that provision where, even if the combination of active ingredients of which that product is composed is not expressly mentioned in the claims of the basic patent, those claims relate necessarily and specifically to that combination. For that purpose, from the point of view of a person skilled in the art and on the basis of the prior art at the filing date or priority date of the basic patent:
- the combination of those active ingredients must necessarily, in the light of the description and drawings of that patent, fall under the invention covered by that patent, and
- each of those active ingredients must be specifically identifiable, in the light of all the information disclosed by that patent.
There are still several referrals to the CJEU pending on other controversial areas of the law concerning SPCs but the above should help to give some certainty.