Dr. Gregory K. Bell recently testified in three successful challenges to abbreviated new drug applications (ANDA) on behalf of pharmaceutical manufacturers seeking to protect patents covering their products. A key factor in each challenge was how to demonstrate commercial success of the product and the nexus between that success and the patents-in-suit with respect to the issue of non-obviousness of the patents-in-suit.
Dr. Bell was supported in these cases by CRA consultants including Andrew Tepperman, Justin Ho, Cavay Ip, Archan Ruparel, and Natalie Nah.
Biosimilars: Economic Issues for IP Litigation
In July 2021, the U.S. Food and Drug Administration granted a determination of interchangeability to a biosimilar drug for the first time. This approval has...