Argentum can't bring Gilenya patent challenge
Argentum Pharmaceuticals can’t have a Novartis patent for a multiple sclerosis drug invalidated because it doesn’t have standing to bring the challenge, the US Court of Appeals for the Federal Circuit has ruled.
In a precedential decision issued last Thursday, April 24, the Federal Circuit said that Argentum had failed to prove that it has concrete evidence of plans to develop a generic version of Gilenya (fingolimod).
Argentum was just one of a group of generics makers, including Teva and Actavis, who brought actions looking to have Novartis’ Gilenya patent invalidated.
The joint request was rejected by the US Patent Trial and Appeal Board. While all the other companies settled their appeal with Novartis, Argentum challenged the PTAB’s decision at the Federal Circuit.
According to Argentum, it and its manufacturing partner KVK-Tech risked being sued by Novartis over their planned abbreviated new drug application (ANDA) for a generic version of Gilenya, which they planned to file with the US Food and Drug Administration.
But Novartis argued that Argentum’s request should be thrown out for lack of standing since it was KVK-Tech, not Argentum, that was in danger of being sued.
In any case, Argentum’s plans for a Gilenya generic were “merely conjectural”, Novartis alleged, since it had not provided any concrete evidence in support of its claims.
The Federal Circuit agreed, citing Novartis’ argument that it would be KVK-Tech folding the ANDA: “Argentum has not provided evidence showing that it would bear the risk of any infringement suit or anything related to its involvement in the ANDA process beyond generic statements.”
Argentum’s estimates that it would suffer at least $10-50 million in lost profits once the FDA approves were “both conclusory and speculative,” the court added.
In January, Novartis filed for an injunction against numerous other generics makers who had filed ANDAs for their own versions of Gilenya, at the US District Court for the District of Delaware.
The drug is among Novartis’ best performers, with estimated sales of more than $3 billion per year.
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