Federal Circuit denies Novartis’ bid to halt generics
Bid to stay invalidity decision pending a SCOTUS appeal fails | Patent covers a multiple sclerosis drug | Company could take $300m hit if generics are launched.
The US Court of Appeals for the Federal Circuit has rejected Novartis’ attempt to stay the mandate that a patent covering multiple sclerosis drug Gilenya (fingolimod) is invalid while the company appeals.
On Tuesday, 27 September, the Federal Circuit declined to order a stay while Novartis appeals against the invalidation decision to the US Supreme Court. The court did, however, grant Novartis’ motion to seal its motion to stay mandate.
In June this year, the Federal Circuit held that the Gilenya dosing regiment patent was invalid, potentially opening the floodgates for the introduction of generic versions of the drug.
The June ruling had reversed a prior Federal Circuit ruling, which had held that the patent was valid, concluding that the patent’s written description of the dosage regimen was sufficient.
Then, earlier this month, Switzerland-based Novartis announced that it planned to appeal against the “negative decision” to the US Supreme Court. At the time, the Federal Circuit had denied Novartis’ petition to rehear the dispute.
Novartis filed a motion to stay the mandate while it appealed on 23 September, arguing that there is fair prospect that the Supreme Court would reverse the Federal Circuit’s decision.
“This question is indisputably important. Each panel opinion in this case drew a dissent, the new panel confirmed the importance of the question by granting rehearing, and the judges of this court that have addressed the question are equally divided,” said Novartis’ motion.
It added: “That disagreement exemplifies longstanding divisions on this court over written description law more generally. And because this Court denied en banc review, only the Supreme Court can clarify the written description standard and bring uniformity and certainty to this unsettled area of law.”
Novartis added that if the mandate issues, it would suffer “immediate and irreparable harm that could not be reversed by an award of damages”. Previously, the drugmaker said that if generic versions of Gilenya were to launch in the US, it expects financial year 2022 sales to be negatively impacted by $300 million.
“This court has consistently upheld district court findings that the introduction of a generic drug during the pendency of an infringement suit would cause irreparable harm to the patent owner by permanently eroding the price and shrinking the market,” said the motion.
But, just four days later, the Federal Circuit denied the motion to stay the mandate. However, Circuit Judge Linn dissented from the denial of the motion to stay the mandate and would have granted the alternative request to extend the mandate deadline by an additional three days.
As LSIPR was going to press, it was reported that Novartis has submitted an emergency motion with the Supreme Court to halt the Federal Circuit's mandate.
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