As part of Hatch-Waxman litigation, CRA was asked to assess commercial success of Ofirmev, an injectable acetaminophen product for peri-operative use. The CRA team assessed the success of Ofirmev in the United States and another embodiment of the patents in the Big 5 European countries. CRA’s expert, Dr. Gregory Bell, opined on commercial success as a secondary indicia of non-obviousness and opined that there was a nexus to the patents. Ultimately, the court agreed with Dr. Bell’s assessment and found for commercial success.
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...