Novartis wins patent protection for Gilenya

The U.S. District Court for the District of Delaware has upheld the validity of Novartis’ Gilenya (fingolimod) dosage regimen patent. 

Novartis welcomed the decision saying that it was based on the idea that the company’s intellectual property reflects the innovation and investment needed to invent and develop treatments that improve and extend people’s lives.

The decision also holds that the generic fingolimod product proposed by HEC Pharm in its ANDA will infringe the dosage regimen patent (U.S. Patent No. 9,187,405). The decision is appealable to the U.S. Court of Appeals for the Federal Circuit.

This decision continues the injunction against the marketing and sale of this and other generics that was granted to Novartis in June 2019. The dosage regimen patent with the associated pediatric exclusivity expires on Dec. 25, 2027; however, Novartis has previously entered into settlement agreements with a number of manufacturers which had filed ANDAs to market a generic version of Gilenya and who were active in this litigation. Under the confidential terms of these settlements, these ANDA filers will be able to launch a generic version of Gilenya on an agreed-upon date that is prior to the expiration of the dosage regimen patent.

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