Zydus Wins Appeal in Shire’s Patent Case Over Generic Lialda for UC

Zydus Wins Appeal in Shire’s Patent Case Over Generic Lialda for UC
Zydus Pharmaceuticals won a patent battle over Shire’s ulcerative colitis drug Lialda (mesalamine), with the U.S. Court of Appeals for the Federal Circuit ruling that Zydus' proposed generic version of Lialda does not infringe upon Shire's patent covering the drug. “We welcome this decision, which is a positive step and will help us further our mission of making available high-quality, affordable generic products to our customers and their patients,” Pankaj R. Patel, chairman and managing director at Zydus Cadila, said in a press release. Mesalamine is a compound that has been around for years and is not patent protected. Shire’s patent covers the release mechanism, allowing the drug to travel through the intestines untouched until it reaches the colon. U.S. Patent No. 6,773,720 protects this delayed release mechanism. The patent feud has been going on for seven years now. Zydus, owned by India's Cadila Healthcare, was the first company that questioned Shire’s rights to Lialda when they filed an Abbreviated New Drug Application with the U.S. Food and Drug Administration (FDA) for a generic version of Lialda in 2010, according to reporting by Law360. In 2016, the U.S. District Court for the District of Delaware ruled in favor of Zydus, claiming the proposed generic did not infringe on the patent, as the expert testimony did not indic
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