Generics Bulletin

US Court of Appeals Upholds Gilenya Compound Patent, Dealing A Blow To Ezra Ventures

11 Dec 2018

Upholding the validity of Novartis’ Gilenya compound patent, a US Court of Appeals ensures that US-based Ezra’s generic fingolimod hydrochloride product will stay off the market until at least 2019. Generics players challenging the blockbuster multiple-sclerosis brand's patents have had mixed fortunes thus far.

Courtroom — Gilenya compound patent is upheld as valid • Source: Shutterstock

Ezra Ventures remains barred from launching its generic of Novartis’ Gilenya (fingolimod hydrochloride) capsules until at least next year, after a US Court of Appeals affirmed that the originator’s key compound patent was valid through the end of its five-year patent extension.

Delaware District Judge Leonard Stark had in June last year held that US patent 5,604,229 was valid and infringed by...