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. A CRA’s expert 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 the CRA expert assessment and found for commercial success.
Recent federal circuit opinions address the economic domestic industry requirement
Under Section 337, a complainant must demonstrate that a domestic industry relating to each asserted patent either exists or is in the process of being...