UK court overturns Genentech patent, cites Brexit in CJEU referral
The patents division of the English High Court has found that a patent owned by Genentech is invalid and denied the biotechnology company’s application for a supplementary protection certificate (SPC).
The judgments relate to Genentech’s patent (UK number 1,641,822) for an antibody (anti-IL17A/F) which is used in the treatment of psoriasis and rheumatoid arthritis (RA).
While Justice Arnold found the patent and SPC application to be invalid in his judgments today, March 1, he made a referral to the Court of Justice of the European Union on the question of whether an SPC could be granted to an owner of a drug patent when the marketing authorisation is held by a third party.
He noted that he was referring the question because of Brexit.
Arnold said it was likely that Genentech would appeal against his ruling, but that there was “a very real possibility” the English Court of Appeal would lose its jurisdiction to make references to the CJEU on March 29, 2019, and an EU-wide answer to the third-party marketing authorisation question was required.
Regarding Genentech’s patent, Arnold determined that the skilled person would “consider it reasonably likely that IL-17A/F existed in nature and would consider it a promising target for RA therapy”.
He concluded that the patents’ claims directed to the antibody were obvious in relation to RA.
Arnold also had to determine if the claims covered a second medical use, specifically for the use of the antibody in the treatment of psoriasis.
Eli Lilly markets an anti-IL17A/F antibody product, Taltz (ixekizumab). It is a prescription injection used to treat psoriatic arthritis and moderate to severe plaque psoriasis in adults.
Although Genentech does not currently sell a product relating to its patent, it filed an SPC based on its patent and Eli Lilly’s EU marketing authorisation for Taltz.
Eli Lilly sought to invalidate Genentech’s patent on the grounds of lack of novelty, obviousness and insufficiency. It also asked for a declaration that the SPC, if granted, would not be valid and that Taltz does not fall under the scope of Genentech’s patent.
Arnold determined that the second medical use claims of Genentech’s patent were insufficient for lack of plausibility.
“In my judgment the skilled person would not regard it as plausible that an anti-IL-17A/F antibody would have a discernible therapeutic effect on psoriasis,” Arnold said.
He added that there was “no emphasis on psoriasis in the specification”, and in short “the claim of efficacy against psoriasis is speculative”.
Regarding the SPC, Arnold determined that because of his conclusion that the claims of the patent are invalid, the SPC application must fail.
Eli Lilly had argued that the market authorisation for Taltz is a third party authorisation and therefore, the SPC application could not proceed.
Arnold said that the dispute between Eli Lilly and Genentech was not confined to the UK. This is because Genentech had filed parallel applications for SPCs based on the ‘822 patent and the Taltz marketing authorisation in other EU member states.
“Accordingly, an EU-wide answer to the question was required, which only the CJEU could provide,” Arnold said.
In his referral, Arnold asked the CJEU to determine if an SPC could be granted to Genentech in respect of Taltz, which is subject to marketing authorisation held by Eli Lilly, without Eli Lilly’s consent.
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