Patent litigation under the Hatch-Waxman Act


Shana K. Cyr, Finnegan, Reston, VA


257th ACS National Meeting - Orlando
Tuesday, April 2, 2019, 10:00am-10:30am
Orange County Convention Center Room W308D
”Patent litigation under the Hatch-Waxman Act”


Whoever without authority makes, uses, offers to sell, sells, or imports into the United States any patented invention infringes the corresponding patent. Pharmaceutical companies generally enforce their patents by filing suit against competitors attempting to copy the innovator’s drug product in federal district court under the provisions of the Hatch-Waxman Act. This presentation will discuss the framework of pharmaceutical patent litigation under the Hatch-Waxman Act, including the patent listing requirements, FDA’s Orange Book, paragraph IV certifications, and the availability of a 30-month regulatory stay.