Compounding Pharmacies: Examining Recent Litigation and Commercial Concerns from a Global Lens

Rob Rodrigues
Partner
RNA Law

Marta E. Wosińska, PhD
Senior Fellow, Center on Health Policy
The Brookings Institution

Shashank Upadhye
Partner
Upadhye Tang LLP
Compounding pharmacies are increasingly being viewed as a threat to IP. Innovator concerns have snowballed over the past year, resulting in claims of patent infringement and calls for regulatory action over the compounded versions of blockbuster drugs known as GLP-1s.
This session will examine key questions that have arisen in the U.S. legal and regulatory landscape including, the FDA’s role in the absence of an approval process for these drugs, and whether there is an exemption from infringement. Panel leads will also explore global considerations, and how the prevalence of these practices will impact brand and generic manufacturers moving forward.