Novartis has officially petitioned the Supreme Court in a continued effort to protect Gilenya from generic rivals for at least several more years.
The Swiss pharma giant filed the 55-page document on Wednesday, after announcing in September that it would file a petition with the court. The case dates back to 2016, when HEC Pharm filed for generic approval of its own version of Gilenya, Novartis’ blockbuster multiple sclerosis drug. The generic was approved in 2019, but Novartis fought back with lawsuits claiming that several patents do not expire until 2027.
A federal court in Delaware previously granted a permanent injunction against HEC’s generic until a patent for 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 previous member retired – agreed to allow a rehearing and the panel reversed the ruling in June, making it ‘405 Novartis patent became invalid.
Novartis argued in its Supreme Court petition last week that the Supreme Court must “bring the Federal and Ninth Circuits into compliance with the law and good practice.”
“Allowing panel changes to overturn decisions already in place undermines trust in the judiciary. It gives the impression that circuit courts are administering judge-specific justice, where the outcome depends not on merit, but on which judges are assigned to the panel,” the petition reads.
Novartis had requested that the lower court’s mandate be suspended while it prepared its petition, which the Supreme Court rejected in October. According to court documents, the version of HEC launched in October. Last year, Novartis said it expected it would lose about a quarter of a billion dollars in sales by 2022 if generics hit the market.
On Jan. 11, Novartis filed another complaint against HEC in federal court in Delaware, alleging that the generic drug’s labeling — including instructions to first test patients for the virus that causes chickenpox — infringes patent ‘179, which also expires in 2027.
“If Defendants do not permanently enforce infringement of the ‘179 patent, Novartis will suffer substantial and irreparable damages for which no remedy exists,” the company said.
Gilenya earned nearly $2.8 billion in 2021, making it Novartis’ third highest seller in the Innovative Medicines segment. HEC has previously accused Novartis of making $3.8 million a day on Gilenya in the US, “charging at least 10 to 20 times than its generic competitors.”
“Novartis continues to vigorously defend the validity of U.S. Patent No. 9,187,405, which covers a 0.5 mg dosing regimen,” Novartis said in an email to Endpoints News on Tuesday. “The process could take several months to determine whether the petition will be granted.”
HEC Pharm was not immediately available for comment.