Bloomberg Law
Free Newsletter Sign Up
Bloomberg Law
Advanced Search Go
Free Newsletter Sign Up

Novartis Gets Justice Roberts to Pause Gilenya Patent Loss (1)

Sept. 29, 2022, 5:03 PMUpdated: Sept. 29, 2022, 7:53 PM

The US Supreme Court paused the cancellation of some of Novartis Pharmaceuticals Corp.'s patent on the dosage regimen for its blockbuster multiple sclerosis drug Gilenya.

Chief Justice John Roberts accepted Novartis’ request for a stay of a mandate from the US Court of Appeals for the Federal Circuit, which ruled that several of the patent’s claims were invalid and opened the door for generic drug makers like HEC Pharm Co. to sell copycats.

Issuing the mandate now would lead to a flood of generics into the market and permanently erode Gilenya’s price, Novartis argued in the application.

“And following a generic entry of that magnitude, Novartis would no longer be able to sustain the patient-service program that it maintains for patients taking Gilenya,” Novartis argued. “The irreparable harm to Novartis and to the public interest outweigh the impact of a stay on HEC’s plans to launch its admittedly infringing product.”

A response to Novartis’s emergency application is due Oct. 5. HEC representatives weren’t immediately available for comment.

Rare Federal Circuit Redo

The nation’s top patent court had first ruled in favor of Novartis, but reversed itself on panel rehearing after a rare set of circumstances. Judge Kathleen M. O’Malley, the original author of the opinion that upheld Novartis’s patent in a 2-1 ruling, retired and was replaced with Judge Todd M. Hughes. Hughes joined Chief Judge Kimberly A. Moore, the original dissenter, and the result flipped.

Novartis asked for the stay to remain in place pending the high court’s consideration of its petition for review of the case.

It urged the justices to review either its petition or a similar one from Bristol-Myers Squibb Co.'s Juno Thereaputics asking the court to reinstate its $1.2 billion patent infringement award.

The fact that the decision was reversed with the addition of one judge shows the division in the Federal Circuit on the issue, Novartis argued.

In its case and Juno’s, Novartis says the Federal Circuit erred in its interpretation of a provision of the Patent Act that requires a “written description” of an invention. Both companies argued that the Federal Circuit imposed a “heightened” standard for how much description is necessary to satisfy the requirement.

Novartis’s US Patent No. 9,187,405 doesn’t disclose whether patients should be given a higher dosage when they start the medication, called a loading dose. Not mentioning a loading dose isn’t enough for a skilled expert in the field to understand that one isn’t needed, the Federal Circuit had ruled. Originally, O’Malley and Judge Richard Linn found that Novartis’s description was adequate.

“The new decision prompted a wave of criticism, in part because it is exceptionally rare for a court of appeals to reverse itself only because one member of the panel left the court and was replaced by a new judge who would have decided the case differently,” Novartis wrote.

Gibson, Dunn & Crutcher LLP, Goodwin Procter LLP, and Morrison & Foerster LLP represent Novartis. Skiermont Derby LLP represents HEC.

The case is Novartis Pharmaceuticals Corp. v. HEC Pharm Co. Ltd., U.S., stay granted 9/29/22.

(Updated with additional reporting throughout.)

To contact the reporter on this story: Samantha Handler in Washington at

To contact the editor responsible for this story: Jay-Anne B. Casuga at