Novartis AG v. Ezra Ventures LLC

Ezra filed an Abbreviated New Drug Application (ANDA) for a generic version of Novartis’s multiple sclerosis drug, Gilenya®. Novartis sued for infringement, asserting the 229 patent. Because the 229 patent was filed before the 1994 Uruguay Round Agreements Act (URAA), its patent term was 17 years. It was set to expire in 2014. Novartis secured a patent term extension (PTE) of five years, 35 U.S.C. 156. Section 156 was enacted to restore the value of the patent term that an owner loses because the product cannot be commercially marketed without regulatory, e.g., FDA, approval. Multiple patents may cover the same product, but only one patent’s term can be extended. Novartis also owned the 565 patent covering Gilenya® and sought PTE on the 229 patent, which now expires in February 2019. Because the 565 patent issued from an application filed after the URAA, its 20-year term expired in 2017. The court denied Ezra’s motion for judgment on the pleadings, where Ezra argued that the extension of the 229 patent’s term beyond the life of the 565 patent de facto extended the life of the 565 patent and rendered the 229 patent invalid for double patenting; the two patents' claims are not patentably distinct. Ezra stipulated that its ANDA product infringes and dropped the double patenting issues. The court found the 229 patent valid, unexpired, enforceable, and infringed, and enjoined Ezra’s ANDA product until the 2019 expiration. The Federal Circuit affirmed. Obviousness-type double patenting does not invalidate an otherwise valid PTE. View "Novartis AG v. Ezra Ventures LLC" on Justia Law