Novartis Is Losing Its Battle Against a Generic Drug for MS

On Thursday of last week, the US Supreme Court (SCOTUS) allowed the launch of generic versions of Novartis’s Gilenya, siding with China’s HEC Pharm Co and other pharmaceutical companies that plan to sell generics in the US.

The litigation between Novartis and HEC has been ongoing since 2015 when the former sued the latter for infringing on a patent and attempting to market a generic version of the drug Gilenya. In that case, HEC claimed the Novartis patent was incomplete because it lacked proper dosing information, rendering it invalid. Specifically, HEC found that Novartis neglected to include that Gilenya required a higher loading dose at the beginning of treatment.

In August 2020, the US District Court of Delaware upheld the patent’s validity and issued an injunction against HEC until the patent expired in 2027. Then in January 2022, a three-judge panel of the US Court of Appeals for the Federal Circuit (CAFC) again upheld the patent’s validity, quelling an HEC appeal to the initial ruling.

However, that decision was later reversed, and the patent was found invalid in June 2022 during a rehearing granted by the CAFC.

SCOTUS Chief Justice John Roberts temporarily blocked the Federal Circuit from issuing an October 4 mandate that would have allowed generic versions of Gilenya. But on October 13, SCOTUS denied Novartis’ attempt to block further the marketing and sale of generic versions of Gilenya.

The ruling will have significant financial implications for Novartis, which sold $2.8 billion of Geilenya last year. According to Drugs.com, Gilenya is covered for most patients with commercial or private insurance that qualify for Medicare. The drug costs between $2,100 and $9,000 for a supply of 30 single doses. HEC claims that its generic form of Gilenya will cost 10–20 times less than what Novartis charges now.

Novartis had already agreed to allow several smaller pharmaceutical companies to sell a generic form of Gilenya before the expiration of the patent in 2027. Aurobindo Pharma, Dr. Reddy’s Laboratories, Sun Pharmaceutical Industries, Viatris, Mylan Pharmaceuticals, and Apotex Inc have all been granted some exception to the patent, according to Reuters.

The SCOTUS ruling damages Novartis but represents a win for patients and generic drugs in general. Because patented drugs can monopolize the market, they tend to lead to higher drug costs paid by patients and their insurers.

In a prior statement, Novartis asserted that they weren’t backing down from the case: “Novartis intends to vigorously defend the validity of the patent and is considering all available options.”