Court denies Lilly’s application to block GSK SPC

The English High Court has dismissed an application by Eli Lilly to stop Human Genome Sciences (HGS) from receiving a supplementary protection certificate (SPC) based on a marketing authorisation Lilly may receive for a new drug.

HGS, now owned by GlaxoSmithKline (GSK), holds European Patent 0 939 804, which covers the protein neutrokine-α and the antibodies that bind to it. According to the judgment, many thousands of antibodies bind to neutrokine-α.

GSK’s lupus drug Benlysta is formulated with neutrokine-α antibody belimumab. Lilly sought to make a new drug with another antibody that binds to the protein, called tabalumab.

In 2012, Lilly asked the English High Court for a declaration that any SPC that might be granted to HGS in respect of its ‘804 patent based on Lilly’s marketing authorisation would be invalid.

The case was referred to the Court of Justice of the European Union, which in December last year issued an opinion on how to define antibodies in patent claims, and came back to Justice Warren for hearings in May and June.

Warren said in the opinion that there is no doubt that tabalumab is an antibody that binds to neutrokine-α, and that claim 13 in HGS’s patent relates to Lilly’s antibody “implicitly but necessarily and specifically”.

Therefore, Lilly’s application for a declaration fails, he said.

Edward Oates, a partner at Carpmaels & Ransford LLP in London, said: “If a company is early in developing a new technology, in this case antibodies against neutrokine-α, it will often claim that technology broadly, which means that subsequent developments by other companies may fall within the scope of the broad claims given to the first company.

“Lilly was developing tabalumab which, along with HGS’s antibody, belimumab, was within the scope of the patent.”

Lilly has several options following the case outcome, he said: “It could decide to suspend the project, or at least delay marketing until the relevant IP has expired. Or it could go ahead and maybe negotiate a licence from GSK. It may also appeal, and of course might eventually prevail.”

He added: “This is a more liberal application of SPC law, in terms of being generous to the SPC holder, than we’ve seen recently from some offices in other countries.”

A spokesperson for Lilly said that it was disappointed with the judgment and that it is seeking to appeal against the decision.

GSK told LSIPR that as the decision is under appeal, it could not comment further.