Novartis petitions Supreme Court in effort to 'vigorously defend' Gilenya patent
Novartis has officially petitioned the Supreme Court in an ongoing effort to protect Gilenya from generic rivals for at least another several years.
The Swiss pharma giant filed the 55-page document Wednesday, after announcing its intent to petition the court in September. The case dates back to 2016, when HEC Pharm filed for generic approval of its own version of Gilenya, Novartis’s blockbuster multiple sclerosis drug. The generic won approval in 2019, but Novartis fought back with lawsuits asserting that various patents don’t expire until 2027.
A federal court in Delaware previously granted a permanent injunction against HEC’s generic until a patent covering a 0.5 mg dosing regimen of Gilenya expires in 2027, and a three-judge appeals panel upheld the decision last January. However, a new judge — who joined the panel after a prior member retired — agreed to grant a rehearing and the panel reversed the ruling in June, invalidating Novartis’s ‘405 patent.
Novartis argued in its Supreme Court petition last week that the high court should “bring the Federal and Ninth Circuits in line with the law and sound judicial practice.”
“Allowing panel changes to overturn already-entered decisions undermines confidence in the judiciary. It creates an impression that circuit courts administer judge-specific justice, with outcomes depending not on the merits but on which judges are assigned to the panel,” the petition reads.
Novartis had requested a stay on the lower court’s mandate while it prepared its petition, which the Supreme Court denied in October. HEC’s version launched in October, according to court documents. Last year, Novartis said it expected to lose about a quarter billion dollars in 2022 sales if generics were to hit the market.
On Jan. 11, Novartis filed yet another complaint against HEC in Delaware federal court, alleging that the generic drug’s labeling — including instructions to first test patients for the virus that causes chickenpox — infringes on its patent ‘179, which also expires in 2027.
“If Defendants’ infringement of the ’179 patent is not permanently enjoined, Novartis will suffer substantial and irreparable harm for which there is no remedy at law,” the company said.
Gilenya earned nearly $2.8 billion in 2021, making it Novartis’ third-highest seller in its Innovative Medicines segment. HEC has previously accused Novartis of making $3.8 million per day on Gilenya in the US, “charging at least 10 to 20 times what its generic competitors would.”
“Novartis continues to vigorously defend the validity of US Patent No. 9,187,405, covering a dosing regimen for 0.5mg,” Novartis said in an email to Endpoints News on Tuesday. “The process may take several months to determine if the petition will be granted.”
HEC Pharm was not immediately available for comment.