SCOTUS deals fresh blow to Novartis’ MS drug patent
Petition to review invalidation of Gilenya patent denied | Novartis challenged decision resulting from a change in judicial panel.
The US Supreme Court has rejected a petition from Novartis to review a decision that invalidated a patent for its blockbuster multiple sclerosis drug Gilenya.
The court’s decision, delivered on April 17, is the latest blow to Novartis in its bid to revive the patent and prove it had been infringed by Chinese generics maker HEC Pharm. It also potentially paves the way for more competitors’ versions of the drug.
Novartis sued a number of generic manufacturers including HEC Pharm over alleged infringement of its patent, US number 9,187,405, which expires in 2027.
In January 2022, a three-judge panel of the US Court of Appeals for the Federal Circuit upheld the validity of the dosing regimen patent—a decision that was reversed by a modified panel of judges in June the same year, after one judge retired.
The Swiss pharma giant argued that “allowing panel changes to overturn already-entered decisions undermines confidence in the judiciary” and that the outcome wrongly denied the company of its patent covering a “groundbreaking new method for treating multiple sclerosis”.
‘Heightened burden’
In its petition for writ of certiorari, Novartis asked the Supreme Court to review the outcome in light of the change to the panel of judges. It also called into question the Federal Circuit’s conclusion regarding the patent, arguing that “rather than the statute’s flexible case-by-case approach, the Federal Circuit’s new decision demands that a patent explicitly or necessarily describe the elements of a patent’s claims”.
The company added: “That heightened burden prevents factfinders from relying on descriptions that are implicit to skilled artisans in the relevant field based on their common knowledge. And it allows courts to invalidate patents even if skilled artisans would understand the description of the invention without such a disclosure.”
The Supreme Court’s refusal to hear the case follows its rejection in October of Novartis' emergency motion to halt the Federal Circuit’s mandate.
Novartis argued it would suffer “immediate and irreparable harm that could not be reversed by an award of damages”.
Previously, the firm had said that its 2022 financial year sales of Gilenya could be hit by $300 million if generic versions were to launch in the US.
In a statement on Monday, Novartis said it acknowledged the decision of the Supreme Court not to hear the appeal and remained “deeply committed to the MS community”, Reuters reported.
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