Novartis to Petition U.S. Supreme Court to Uphold Gilenya Patent

Novartis said it will petition the U.S. Supreme Court to uphold a patent that protects the dosing regimen of Gilenya (fingolimod) that’s approved for relapsing forms of multiple sclerosis (MS).

The original patent was not set to expire until the end of 2027, which meant generic versions wouldn’t be able to reach the market until that date. But a recent court ruling deemed the patent invalid, which would allow generics to be immediately launched.

The patent has been previously challenged by companies wishing to market Gilenya generics, most recently by HEC Pharma in 2020. In a hearing, the U.S. District Court for the District of Delaware ruled in Novartis’s favor to uphold the patent’s validity.

It was again upheld in a three-judge panel from the U.S. Court of Appeals for the Federal Circuit (CAFC) in January and an injunction was imposed on HEC, preventing it from mounting more legal challenges until the patent expired.

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However, a modified CAFC panel reversed that original decision in June and found the patent to be invalid following HEC’s request for another hearing.

Now, Novartis will ask the Supreme Court to review that decision.

“Novartis intends to vigorously defend the validity of the patent and is considering all available options, including current plans to seek review of this decision by petition to the US Supreme Court, a process which may take several months to determine if the petition will be granted,” the company said in a press release.

Gilenya was approved in the U.S. in 2010 for treating adults with relapsing forms of MS, including clinically isolated syndrome, relapsing-remitting MS, and active secondary progressive MS. The approval was expanded in 2018 to include children and adolescents ages 10 and older.

The approved dosing regimen, protected under the patent, is a 0.5 mg dose taken orally once a day.

Generic medications contain the same active ingredients and have the same effects on the body as their brand name reference product. Introducing generics into the market generally drives drug prices down by generating competition.

Generics are approved based on abbreviated new drug applications wherein proof must be provided that the therapy is equivalent to the reference medication, but preclinical and clinical data to establish its safety and effectiveness are generally not required.

The U.S. Food and Drug Administration has approved several generic versions of Gilenya since 2019, including one from HEC Pharma, but these couldn’t be marketed until Novartis’ patent expired.

Novartis entered into settlement agreements with some companies applying for Gilenya generics, allowing the launch of approved generic products on an agreed upon date ahead of the patent’s expiration.

If the Supreme Court maintains the patent’s invalidity, HEC and other companies will be able to launch their generics imminently. Novartis estimates this could impact their 2022 sales by $300 million.