The US Federal Trade Commission is keeping the spotlight on Orange Book patent listings with a court filing challenging Sanofi’s listing of patents for its insulin glargine product. The action expands the list of patents the agency is targeting and puts additional pressure on industry to avoid listings that could trigger enforcement action.
The agency submitted an amicus brief in Mylan Pharmaceuticals Inc.’s suit against Sanofi claiming Sanofi improperly listed patents in the US Food and Drug Administration’s Orange Book that pertain to injector pens but do not claim insulin glargine or Sanofi’s SoloSTAR product