Novartis takes Gilenya Patent Case to US Supreme Court

Novartis takes Gilenya Patent Case to US Supreme Court

Novartis - the Global healthcare company has officially petitioned the US Supreme Court in an ongoing effort to protect Gilenya from generic rivals for at least another several years.

The Switzerland based pharma giant filed a petition before the High Court to review a September decision by the U.S. Court of Appeals for the Federal Circuit that was passed against it.

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.

Novartis contended that the High Court should, "bring the Federal and Ninth Circuits in line with the law and sound judicial practice."

In its petition it asserted that, "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 US Supreme Court denied Novartis' request for a stay on the lower court's mandate in October while it prepared its petition for review.

The company estimated that Generics would cause a quarter billion-dollar loss in sales by 2022 if they were to be introduced in the market.

Novartis on 11th January, 2023 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 which 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 argued.

A revenue of nearly $2.8 billion was earned by Gilenya in 2021, making it Novartis' third-largest seller in its Innovative Medicines division. Previously, HEC has alleged 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."

At this juncture, Novartis is taking issue with the sequence of events that led to the decision.

After Novartis appeared set for a win in appeals court, a judge's retirement derailed its case, the company claimed in its Supreme Court filing. Originally, a panel of three judges supported the company's side of the case, but after HEC Pharm filed for a petition for rehearing, eventually one judge retired.

Thereafter it resulted in the new panel finding for invalid patent, the company said.