Biomarin’s effort to block Yuviwel, Ascendis’ TransCon CNP drug, has reached a lull.  Last year, Biomarin brought a proceeding before the International Trade Commission (ITC) to block Ascendis from importing its drug.  The ITC held an evidentiary hearing in late April of this year, and the ALJ is scheduled to issue its “final initial” determination by the end of August.  In the meantime, the Commission Investigative Staff (Staff) filed its brief following the evidentiary hearing.  Does the Staff’s findings bode well or ill for Ascendis’ hopes of keeping its Yuviwel drug on the market?

Biomarin’s bid to block Ascendis from launching a competing drug for treating achondroplasia is nearing the merits.  Biomarin started its campaign in the International Trade Commission (ITC), and in response, Ascendis filed two district court declaratory judgment actions.  Ascendis withdrew the first DJ action, and the second one has been stayed.  The ITC case is now scheduled to hear the parties’ claim construction disputes later this month.  The outcome of that hearing, which will finally touch upon the merits of Biomarin’s infringement allegations, could prove to be a major inflection point in this dispute.  What’s at stake in the upcoming Markman hearing?     

Biomarin Pharmaceutical sells Voxzogo, which is indicated for treatment of a genetic condition known as achondroplasia, which is the leading cause of short-limbed dwarfism.  Ascendis Pharma has applied to the FDA for license to sell a competing drug, TransCon CNP. Hoping to stifle Ascendis’ path to the market, Biomarin has launched an ITC case seeking to block Ascendis from importing its drug into the US. For now, Ascendis is relying upon a safe harbor defense. Can Biomarin use its Orange Book patents to preemptively block a competing drug from Ascendis?