CRA consultants supported Endo International plc (Endo) in its successful challenge of products that infringed on its patents covering Opana® Extended Release (ER). Dr. Gregory K. Bell assessed the commercial success of Opana ER. He testified with respect to the issue of non-obviousness regarding the patents-in-suit, as the patents-in-suit enabled a long-lasting controlled release formulation of the painkiller. The District Court relied on secondary considerations of nonobviousness, including Dr. Bell’s testimony demonstrating the commercial success of Opana ER and the nexus of the patent claims and market success. Dr. Bell was supported by a team including Dr. Andrew Tepperman and Dr. Justin Ho.
Potential MFN impact
Reference country selection HHS provided guidance on setting benchmark pricing by considering the lowest price among a set of reference countries, defined by...