An SPC may be applied for on the basis of a basic patent and a marketing authorisation (‘MA’). Article 6 of the SPC regulation requires that the SPC must, however, be granted to the holder of the basic patent (rather than the MA holder). This is not problematic where a single entity is both patentee and MA holder, and is also not problematic when a separate MA holder consents to an SPC application by the patent holder (e.g. where the MA holder is a licensee). However, issues may arise when an SPC is applied for by a patent holder without the consent of the MA holder – a so-called ‘third party SPC’. Under such circumstances, MA holders may be required either to take a licence under the third party SPC or to attempt to have the third party SPC revoked, if they are to commercialise their approved product. Given these issues, some have questioned the legality of third party SPCs.
As previously reported, such a dispute between a patent holder and MA holder has led to a referral to the CJEU from the UK High Court in Eli Lilly v Genentech, [2019] EWHC 388 (Pat). Genentech had secured a basic patent relating to antibodies that bind a specific epitope, and applied for an SPC. At the time of referral, Genentech did not have an approved product covered by the basic patent. Genentech’s SPC application was instead based on an MA held by Eli Lilly, concerning Lilly’s antibody ixekizumab (Taltz®).
The case was designated as C‑239/19, and in its recent order the CJEU held that a preliminary ruling was not necessary to resolve Lilly v Genentech, because the basic patent had already been held invalid by the referring court. The CJEU therefore described the referral as “manifestly inadmissible” and declined to give any preliminary ruling. While invalidity of the patent concerned had been anticipated by the referring court, and reasoning had been given in favour of a preliminary ruling in spite of this invalidity, the CJEU deemed that the reasoning was “purely hypothetical” in view of the prior resolution of Lilly v Genentech.
While the lack of clarification regarding third party SPC legality has been disappointing for some commentators, the high value of SPCs and the intricacies of regulatory law make an admissible referral in the near future likely.
