05/19/2009 On May 19, 2009, the U.S. Court of Appeals for the Federal Circuit issued a ruling affirming the U.S. District Court of the Eastern District of Virginia’s finding that Lupin’s generic cefdinir drug product does not infringe U.S. Patent No. 4,935,507. In the litigation, Astellas Pharma and Abbott Laboratories sought to prevent Lupin’s marketing of a generic equivalent to Omnicef® (cefdinir). After RMMS secured an early advantageous claim construction ruling, Lupin was able to secure a noninfringement victory on summary judgment on all claims. On appeal, the Federal Circuit affirmed the claim construction and noninfringement ruling. In that opinion, the Federal Circuit addressed en banc an issue that had been vexing prior district courts for nearly two decades: the appropriate way to construe claims known as ‘product by process’ claims. This decision is expected to have long-ranging impact in the pharmaceutical, chemical and biotechnology areas.
This victory enables Lupin to continue marketing its generic cefdinir product, and continues to place RMMS at the forefront of generic challenges to brand pharmaceutical patents.
Deanne Mazzochi argued the case before the Federal Circuit. Also involved in the underlying litigation and appeal were Paul Molino, William Rakoczy, Tara Raghavan and Eric Hunt.