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.
CRA's RADAR Insights: Impact of US pricing strategies on orphan drug pricing in Germany - Part 3
In Part 3 of this series, RADAR data on orphan-drug pricing in Germany revealed a significant increase in manufacturer-set list prices for new orphan drugs...