Our lawyers have significant courtroom experience with bench and jury trials, emergency hearings, and Markman hearings in federal district courts across the United States. We have represented clients in appeals before the United States Court of Appeals for the Federal Circuit. Many of our cases have resulted in landmark decisions from the Federal Circuit in the areas of pharmaceutical and biotechnology patent litigation, including decisions setting the standards for inherent anticipation of polymorph patents, confirming that the submission of an ANDA is not alone an act of willful infringement, and prohibiting the assertion under the Hatch-Waxman Act of patents claiming “off label” uses of a drug.
Locke Lord is among the most accomplished firms in Hatch-Waxman litigation. Our attorneys have vast experience at both the trial and appellate levels litigating patent infringement actions involving blockbuster prescription drugs. We routinely assist clients with issues concerning ANDA and §505(b)(2) drug applications, paragraph IV certifications, paragraph IV notice letters, exclusivity (NCE, pediatric, patent term extensions, 180-day first-to-file), forfeiture of exclusivity, at-risk launches and patent settlements. We advocate our clients’ interests before the FDA and, if necessary, litigate approval and exclusivity issues against the agency. Locke Lord has represented pharmaceutical industry clients in high stakes antitrust litigation as well as proceedings before the Federal Trade Commission.
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