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PTAB rules Gilenya dosing patent is valid

Attempts to bring generics of Novartis’ Gilenya (fingolimod) blockbuster to the US market eight years ahead of schedule have failed for now, with the US Patent Trial and Appeal (PTAB) ruling that a dosing patent shielding the multiple sclerosis drug should stand, rejecting challenges from Apotex, Argentum, Sun Pharma and Teva.

Attempts to bring generics of Novartis’ Gilenya (fingolimod) blockbuster to the US market eight years ahead of schedule have failed for now, with the US Patent Trial and Appeal (PTAB) ruling that a dosing patent shielding the multiple sclerosis drug should stand, rejecting challenges from Apotex, Argentum, Sun Pharma and Teva.

The four generics players “failed to show, by a preponderance of the evidence”, that claims 1-6 of US patent 9,187,405 – which expires on 25 December 2027, including six months...

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