Third Party SPCs: referral to CJEU in Lilly v Genentech
The issue of so-called “Third Party SPCs” has vexed European biotech and pharma for some time: is it right that a Patentee can obtain a Supplementary Protection Certificate (“SPC”) on a product for which the Marketing Authorisation (“MA”) issued to an unrelated entity – typically a competitor?
The CJEU has now been asked this question in a recent referral from the High Court, in Lilly v Genentech ( EWHC 388 (Pat)).
Third Party SPCs are particularly relevant to antibody products (as in the case at issue), because in this technical area European patent claims can be obtained with a scope that protects a genus of antibodies that can cover a competitor’s product.
In the case at issue, Genentech applied for an SPC based on its own patent to anti-IL17A/F antibodies and Lilly’s MA for its product Taltz® (Ixekizumab), an antibody to IL-17A that also binds to IL-17A/F. Lilly then brought proceedings before the High Court seeking a declaration that Genentech’s SPC, if granted, would be invalid because the patent does not protect the product, and because of the lack of a relationship – or consent - between Lilly and Genentech.
Mr Justice Arnold’s judgment considers the two points at the heart of the issue: whether a claim to a genus of antibodies “protects” a given authorised product according to Article 3(a) of the SPC regulation, and whether an MA granted to a party unrelated to the patentee, is an acceptable authorisation according to Article 3(b) of the regulation.
When considering whether the requirements of Article 3(a) are met, it is of note that Arnold J comes to different conclusions for the product claim (yes) and second-medical use claim (no). This difference turns on the requirement for plausibility of the medical use claim, and knits together (i) recent UK Supreme Court case law (Warner Lambert v Generics) confirming the need for a plausible disclosure of a medical use claim, with (ii) recent CJEU SPC case law (Teva v Gilead) stating that information that became available after the patent was filed cannot be used to determine the content of the basic patent.
Regarding the Third Party issue, Arnold J considered that the law is not clear. The SPC Regulation only states that the holder of a basic patent is entitled to an SPC based on the basic patent when a medicinal product that is protected by the basic patent is authorised to be placed on the market. There is no requirement for the holder of the MA have a legal relationship with the holder of the basic patent, nor is there a requirement for the holder of the MA to consent to the grant of an SPC.
This can give rise to a situation in which an SPC is granted to the Patentee, and so the MA holder must take a licence under that SPC or seek to invalidate that SPC, to be able to market its own authorised product during the term of the SPC.
The dispute between Lilly and Genentech is not confined to the UK. Genentech has filed parallel applications in other EU Member States for SPCs based on its patent and Lilly’s MA. An EU-wide answer to the question of the allowability of Third Party SPCs is therefore desirable. Only the CJEU can provide an EU-wide answer. Therefore, Arnold J granted Lilly’s request for a reference to the CJEU on this point.
That a referral on this point has been made is not itself particularly surprising because the issue has arisen several times in recent years, only for those cases to be resolved for other reasons. It is interesting that the referral was made directly from the High Court, on a case where the patent (and so any SPC based on that patent) was found to be invalid in a separate judgment ( EWHC 387 (Pat)). In the usual way of things, this case would be appealed and a CJEU referral on the SPC issues, if needed (i.e. if the patent was subsequently found to be valid), would typically have been made from the Court of Appeal. However, Arnold J made the referral after noting that there is a very real possibility that the UK courts will lose their jurisdiction to make references to the CJEU on 29 March, and that the question of Third Party SPCs is of interest across Europe.
The question that has been proposed is along the following lines, to be refined by the parties as needed:
“Does the SPC Regulation preclude the grant of an SPC to the proprietor of a basic patent in respect of a product which is the subject of a marketing authorisation held by a third party without that party’s consent?”