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Novartis : U.S. Court Upholds Validity Of Gilenya Dosage Regimen Patent

(RTTNews) – Novartis (NVS) said Monday that it welcomed the decision by the US District Court for the District of Delaware to uphold the validity of the Gilenya or fingolimod dosage regimen patent.

The ruling also holds that the generic fingolimod product proposed by HEC Pharm Co. Ltd. and HEC Pharm USA in its Abbreviated New Drug Application will infringe the dosage regimen patent.

The ruling 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 December 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 the settlements, the 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 US Court of Appeals for the Federal Circuit dismissed an appeal of the Inter Partes Review decision from the US Patent and Trademark Office upholding the validity of the dosage regimen patent.

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