A recent UK High Court Decision (2019 EWHC 388) has referred the following question to the CJEU (C-239/19):-

“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?”

This action concerns a claim brought by Eli Lilly regarding initial revocation of the UK designation of a European patent (EP1641822) owned by Genentech, whereby Genentech counterclaimed for infringement. The Genentech patent relates to anti-IL17A/F antibodies and their use in the treatment of inflammatory disorders. Genentech applied for an SPC based on this patent, for an antibody called ixekizumab which binds to IL-17A/F for use in the treatment of psoriasis and psoriatic arthritis. However, a marketing authorisation (MA) was successfully granted to Eli Lilly for the same product (tradename – TALTZ®) and same therapeutic use. Eli Lilly contested that if the SPC application was eventually granted to Genentech, it should be invalid because they are relying on a third party MA (i.e. that the MA does not belong to Genentech) without the consent of the third party (in this case, Eli Lilly) and the patent does not cover the product.

In this area, case law is conflicted regarding third party marketing authorisations. Both UK and CJEU decisions had to be considered in the UK High Court decision. Firstly, Eli Lilly contested that the base patent upon which an SPC is based cannot be held by a party different to the one holding an MA for the product covered by the base patent. It was stated that if a patent holder (in this case Genentech), who has not necessarily been involved in taking steps to achieve an MA should not deserve an SPC. For example, a patent holder may have knowledge that another party is expending time, costs and effort on achieving an MA and they would essentially “piggy-back” on the MA once granted. In response, Genentech argued that the base patent and the MA can be held by completely separate parties. Genentech cited Biogen v SKB (C-181/95) which held that a patent and an MA on the product covered by the patent may be held by different and unconnected parties and the owner of the MA is not obliged to provide the patent holder with a copy. Thus, the patent holder without the MA is not able to market the product in competition.

It is hoped that the CJEU will be able to provide some clarity on the rights of patent holders when applying for an SPC based on a third-party MA. Please contact us if you would like to discuss this matter further.