Novartis Wins Patent Battle for its Blockbuster MS Drug Gilenya

Novartis is breathing a sigh of relief after a U.S. federal judge upheld Novartis’ dosage regiment patents for its multiple sclerosis drug, Gilenya. The legal ruling, subject to appeal, protects the Swiss pharma giant’s revenue stream from the blockbuster drug for a little bit longer.

On Monday, a ruling made by the U.S. District Court for the District of Delaware was unsealed that upheld the validity of the Gilenya (fingolimod) dosage regimen patent. The decision in favor of Novartis will prevent generic drug makers from challenging the revenue stream of Gilenya through 2027, which is when the current patents are set to expire. The decision holds that the generic fingolimod product proposed will infringe on the dosage regimen patent currently held by Novartis. The decision is appealable to the U.S. Court of Appeals.

The lawsuit was prompted after generic drug maker HEC Pharm Co., Ltd. and HEC Pharm USA Inc. (HEC) filed an Abbreviated New Drug Application to the U.S. Food and Drug Administration in hopes of having a generic version of Gilenya available before the patent expires. HEC Pharm Co. Limited, along with Biocon Limited and Sun Pharmaceutical Industries Limited won approval for generic versions of Gilenya from the U.S. Food and Drug Administration in December 2019 ahead of that patent expiration date.

In a brief statement, Novartis said it welcomes the decision made by the federal court.

“…as our intellectual property reflects the innovation and investment needed to invent and develop treatments that improve and extend people’s lives,” Novartis said.

Per previous deals Novartis made with other generic drug companies, some generic versions of Gilenya will be available to the public prior to that 2027 sunset of patents. Details of those agreements have not been made public.

Gilenya generated $738 million in the second quarter.

The dosage regimen patent with the associated pediatric exclusivity expires on Dec. 25, 2027. In 2018, Novartis won a lawsuit that extended its patent protection for Gilenya. Then last year, Novartis won another legal battle preventing generic drug companies from marketing their fingolimod products in the United States. In June 2019, the Swiss company won a preliminary injunction against the generics manufacturers until this latest patent decision could be made.

In separate proceedings, the U.S. Court of Appeals for the Federal Circuit dismissed an appeal of the Inter Partes Review (IPR) decision from the U.S. Patent and Trademark Office upholding the validity of the dosage regimen patent. That decision is subject to further appeal, Novartis announced.