Late Stage Drug Development

Strategic IP and Regulatory Counseling for Life Science Companies. When a life science company focuses on or advances to later-stage drug development, drug registration, and marketing for a therapeutic, its intellectual property strategy must also shift. Losses worth millions of dollars daily can occur once exclusivity and patent rights expire. Therefore, a lifecycle IP management strategy, usually starting at the latest by Phase III clinical trials, is paramount to maximizing the value of a drug product by extending exclusivities and enforcing rights against infringers.

Unique among leading global law firms, Goodwin’s Late Stage Drug Development practice focuses on obtaining and enforcing patent protection that extends patent term on late stage products. Whether positioning patent portfolios for late stage investors, or simply protecting a company’s revenue stream, our team comprised of life sciences patent lawyers, Hatch-Waxman and biologics litigators with decades of experience representing both brands and generics, and FDA regulatory experts craft late stage patent, regulatory, and exclusivity strategies for life science companies developing therapeutics. We also advise on commercial launch strategy, inspections and marketing campaigns. We know how patents and regulatory exclusivities operate, how to obtain additional patents that provide additional term, how to obtain patent term extensions, and how patent and generic challengers think. We have had significant successes for clients in helping them maximize and defend patent protection for therapeutics closer to approval, as well as at and after product launch.

Whether advising companies on pre-approval strategies, patent and regulatory procurement, patent office challenges, FDA challenges, litigation, regulatory compliance or IP matters relevant to exits via IPOs and acquisitions, our Late Stage Drug Development team seamlessly advises companies and investors on late stage IP and regulatory issues.