District Court issues ruling in Hatch Waxman Case regarding Shire’s Lialda
Shire to consider appeal.
Shire has been informed that the United States District Court for the District of Delaware has ruled that Cadilla Healthcare Ltd/Zydus Pharmaceuticals (USA) Inc.’s (“Zydus”) proposed generic version of Lialda (mesalamine) does not infringe US Patent No. 6,773,720 (“the ’720 patent”).
Despite this ruling, Shire believes that the proposed Zydus product infringes the ‘720 patent and will continue to vigorously defend its intellectual property rights. Shire has thirty days in which to file an appeal to the Court of Appeals to the Federal Circuit.
Notwithstanding the judge’s ruling in the trial, Zydus does not have a tentative or final approval of their abbreviated new drug application which is a prerequisite for Zydus’ commercial introduction of a generic product.
Lialda is a prescription medication approved for the induction of remission in patients with active, mild to moderate ulcerative colitis (UC) and for the maintenance of remission of UC.
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