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ARTICLE · 11 MAY 2017

Federal Circuit Holds Objective Indicia Must Be Linked To Novel Features

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The 283 patent is one of four Orange Book-listed patents for GILENYA™, which is used in the treatment of multiple sclerosis.

United StatesIntellectual Property
J. Jason Williams
J. Jason Williams
J. Patrick Elsevier
J. Patrick Elsevier
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In Novartis AG v. Torrent Pharms. Ltd. (2016-1352), the Federal Circuit affirmed the PTAB's decision in consolidated IPR proceedings (IPR2014-00784, IPR2015-00518) invalidating all claims of U.S. Patent 8,324,283. In doing so, the court affirmed the PTAB's finding that Novartis' evidence on the objective indicia of nonobviousness lacked sufficient nexus to the claimed invention to warrant a different outcome.

The '283 patent is one of four Orange Book-listed patents for GILENYA" (fingolimod), which is used in the treatment of multiple sclerosis. The claims of the '283 patent are directed to solid oral dose forms of the drug in combination with a sugar alcohol, specifically mannitol. During the IPR, the petitioners established that the prior art taught solid oral dosage forms of fingolimod for treating MS, and that two references in particular "strongly suggested" that mannitol would be examined as an excipient in the formulation.

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