SPCs: a deep dive into CJEU case law
The European Supplementary Protection Certificate (SPC) Regulation incentivises pharmaceutical research and development by providing an extension to patent protection to compensate for time lost in obtaining a marketing authorisation (MA).
It has proved a challenge to interpret and has been responsible for a steady stream of referrals to the Court of Justice of the European Union (CJEU) since its inception. Although the CJEU has managed to settle some of the debates about SPCs, several remain live.
Protected by the basic patent in force
Article 3(a) of the SPC Regulation requires that, for an SPC to be granted, “the product is protected by a basic patent in force”.
Around ten years ago a series of references to the CJEU1 sought to settle the interpretation of this provision. These cases held that a product is “protected by a basic patent” if it is “specified” or “identified” in the wording of the claims of the patent.
Unfortunately for the CJEU, and those in the life sciences sector, this did not settle the matter. Particular areas of open interest were (i) combination products; and (ii) functional claims and Markush formulae. The CJEU has since given two further decisions, Teva (C-121/17) in 2018 and Royalty Pharma (C-650-17) in April 2020, which seek to provide more certainty in the interpretation of Art 3(a).
Combination products
The Teva referral stemmed from the UK and related to Gilead’s SPC for its Truvada combination product (tenofivir disoproxil/emtricitabine). Mr Justice Arnold (as he was then) heard the case and noted that Gilead’s SPC had been litigated around Europe with differing results, and concluded that article 3(a) was therefore not subject to a uniform test and required a further referral.
In its decision on that referral, the CJEU held that, for a combination product to be “protected” by the basic patent under article 3(a), the claims need not expressly mention the combination but must relate to it necessarily and specifically. To determine whether they do, the national court needs to make two cumulative findings:
