The Supreme Court has granted a temporary emergency stay of a lower court order that Novartis Pharmaceuticals says would allow the development of as many as 20 generic versions of its commercially successful multiple-sclerosis drug, Gilenya.
The emergency application in Novartis Pharmaceuticals Corp. v. HEC Pharm Co. Ltd., court file 22A272, was filed with the court on Sept. 28 and granted Sept. 29 by Chief Justice John Roberts.
The applicant, Novartis, is headquartered in Basel, Switzerland; the respondent, HEC, a generic drug maker, is headquartered in Dongguan, China.
Novartis is known for developing a vaccine aimed at the virus that causes COVID-19, though that vaccine is not at issue in the current legal dispute.
In June, the U.S. Court of Appeals for the Federal Circuit reversed a lower court ruling that favored Novartis, agreeing with HEC that several of the patents on the MS drug were invalid. This created the possibility that rival companies like HEC could develop their own generic versions of Gilenya.
Novartis unsuccessfully urged the appeals court to rule in its favor, arguing that allowing the generics to proceed would put downward pressure on the drug’s price and cause the shriveling of the market in “ways that could be impossible to calculate at an after-the-fact damages trial.”
Gilenya is reportedly Novartis’ third biggest drug as measured by sales. If generics move forward, the company said over the summer it expected to miss out on $300 million in revenue in the near future.
Roberts did not provide reasons for his decision but directed HEC to respond to the application not later than Oct. 5.
Novartis has also asked the Supreme Court to formally consider its case by holding oral arguments at some point in the future.
HEC could not be reached for comment.
Meanwhile, the Supreme Court is preparing to begin hearing cases in its new term on Oct. 3.
The court announced on Sept. 28 that it will hear all scheduled oral arguments for the upcoming term in the courtroom. Some arguments had been conducted entirely over the telephone after pandemic-related restrictions were imposed in 2020.
Members of the public, attorneys, and the media will be allowed to attend the arguments in person. Masking will be optional. The court will also continue to livestream the audio feed for arguments, a practice that was implemented during the pandemic.
“The building will otherwise be closed to the public until further notice,” the announcement added.
