Genentech is the proprietor of European patent (UK) No. 1 641 822 entitled "Il-17A/F heterologous peptides and therapeutic uses thereof". Genentech does not at present have a product covered by the patent but Lilly market an antibody under the trade mark "Taltz" as a treatment for moderate to severe plaque psoriasis and psoriatic arthritis in adults. Taltz is an antibody to IL-17A which also binds to IL-17A/F.
Genentech applied for an SPC based on their European patent (UK) No. 1 641 822 and Lilly's MA for Taltz.
Lilly initiated proceedings against Genentech seeking a declaration that any SPC granted on Genentech's application would be invalid on the grounds that (1) the application does not comply with Article 3(a) of the SPC Regulation because Taltz is not protected by Genentech's patent and (2) the application does not comply with Articles 2, 3(b) and/or 3(d) of the SPC Regulation because the Taltz MA is a third party MA being relied upon without the owner's content i.e. without Lilly's consent.
With regards to Lilly's first argument, Arnold J found that an SPC application based on the product claim would meet Article 3(a) because Teva v Gilead made it clear that a product may be specified in the claims in functional terms, whereas an SPC application based on the second medical use claim would not satisfy Article 3(a) - the difference here is based on Arnold's finding that the second medical use claim lacks sufficiency.
With regards to Lilly's second argument, Arnold J held that the law is not clear with regards to whether or not the MA being relied upon has to be owned by the Proprietor of the basic patent or whether they can be owned by different parties.
As the dispute between Genentech and Lilly is not confined to solely the UK, Arnold J held that an EU wide answer to the question of the allowability of SPC applications based on third party MAs is desirable. As only the CJEU can provide an EU-wide answer, and on account of Brexit looming, Arnold J made a referral to the EU asking the following question:
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 an MA held by a third party without that party's consent?
On the same day that the present decision was issued, Arnold J also handed down a second judgement in relation to the validity of Genentech's European patent (UK) No. 1 641 822 and Lilly's infringement thereof - read article here.