FDA Litigation

Regulatory decisions made by the US Food and Drug Administration on matters such as regulatory exclusivities shape market opportunities for life sciences companies. Those companies need counsel who are able not only to provide strategic advice and guidance through the FDA process, but also to pursue high-stakes litigation challenging or defending FDA rules and decisions. Goodwin works with life sciences companies on pre-litigation strategy before the FDA and leads subsequent litigation efforts with a team that combines deep subject-matter knowledge with general experience litigating challenges under the Administrative Procedure Act.

Representative Experience

• Represented Alkermes in the successful defense of a challenge to FDA 505(b)(2) approval of the ARISTADA® product (aripiprazole lauroxil) in both the District Court for the District of Columbia (DDC) and D.C. Circuit against a competitor’s exclusivity challenge.
• Represented Braeburn in the DDC in a successful challenge to an FDA decision denying 505(b)(2) approval of the BRIXADI™ product (a buprenorphine depot product) based on a competitor’s exclusivity claim under the three-year exclusivity provision for new clinical investigations.
• Represented Lupin in the DDC in the successful defense of a challenge to FDA approval of a generic version of Namenda XR® based on a 180-day exclusivity provision for the first Paragraph IV ANDA filer.
• Represented Teva in the District Court for the District of Maryland in the successful defense of a challenge to FDA approval of a generic version of aripiprazole premised on an exclusivity claim under the Orphan Drug Act.
• Represented Ivy Sports Medicine in a successful appeal in the D.C. Circuit of the FDA’s decision to withdraw approval of a medical device used in knee-repair surgeries.