The Risk of Pervasive Trade Secret Practices Within the Life Sciences
Trade secrets offer a number of benefits for life sciences companies compared to patents, such as theoretical indefinite intellectual property protection.

Trade secrets offer a number of benefits for life sciences companies compared to patents, such as theoretical indefinite intellectual property protection.
Three developments may have effects on the use of patents to fend off competition for therapeutic monoclonal antibodies.
Are manufacturing method patents warranted intellectual property protections, or groundless obstacles to competition?
In this post, I explore several problematic aspects of the court’s reasoning for rejecting the claims of pay-for-delay and market allocation.
In November 2020, the FDA released its most recent draft guidance for industry on biosimilarity and interchangeability
By Ameet Sarpatwari, Charlie Lee, Frazer Tessema, and Aaron S. Kesselheim Each month, members of the Program On Regulation, Therapeutics, And Law (PORTAL) review the peer-reviewed medical literature to identify interesting empirical studies, policy analyses, and editorials on health law and policy issues relevant to current or potential future work in the Division. Below are the abstracts/summaries…