In an earlier post, we discussed the recent rise in Section 337 proceedings against pharmaceutical products and medical devices at the International Trade Commission. Last week, Bioverativ, which markets the recombinant Factor IX product, Alprolix®, filed a Section 337 complaint against importation of CSL’s Factor IX product, Idelvion®, alongside a patent infringement suit in the District of Delaware. Both complaints allege infringement of three patents covering methods of treating hemophilia B and controlling bleeding episodes using a chimeric Factor IX polypeptide. The Section 337 action may shed light on the ITC’s analysis of indirect infringement, including induced and contributory infringement, for method-of-treatment claims as well as the public interest considerations involved in assessing the availability and scope of an exclusion order in the context of a biologics patent dispute.
Stay tuned to Big Molecule Watch for further updates.