It may seem like déjà vu, but the Court of Justice of the European Union (CJEU) has this week handed down a judgment (C-121/17) addressing the question of what constitutes a “product protected by a basic patent in force” in accordance with Article 3(a) of the SPC Regulation. This question has of course been referred to the CJEU on multiple previous occasions. However, as noted by the UK High Court in Teva (UK) Ltd v Gilead Sciences Inc  EWHC 13 (Pat) (the UK case giving rise to this CJEU referral), there is still divergence across Europe relating to the grant of supplementary protection certificates (SPCs). This follows from the fact that the guidance previously given is not at all clear.
One of the difficulties in the SPC field has cropped up in relation to “combination products”. The judgment handed down this week stems from a referral from the UK in a case relating to Gilead’s SPC for its anti-retroviral drug Truvada. Truvada is a combination product containing tenofovir disoproxil and emtricitabine. The basic patent relied upon by Gilead in order to obtain their SPC contains a claim reciting a pharmaceutical composition comprising tenofovir and optionally other therapeutic ingredients. Before the UK court, the validity of Gilead’s SPC was contested on the basis that the “inventive advance” of the patent was not the combination product. Thus, it was argued that the product was not “protected by a basic patent in force”. The judge considered it appropriate to refer the question to the CJEU to, once again, seek clarification on this issue.
The CJEU has now ruled that for a combination product, the combination must necessarily “fall under the invention covered by the patent” and that each of the active ingredients must be “specifically identifiable”. Whether this guidance will be enough to harmonize interpretation of the SPC Regulation, particularly with respect to combination products, remains to be seen. However, I for one, very much doubt that this is the final word on this topic.
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.