Biomarin’s campaign to block Ascendis from importing its new TransCon CNP drug is getting into the thick of it.  The Markman hearing is scheduled for February, and the evidentiary hearing is scheduled for late April.  In a prior post, I discussed the upcoming Markman hearing, which both parties are likely to rely upon to tee up arguments on infringement and invalidity.  Yet, even if Ascendis fails to prove that it does not infringe the patent, and also fails to invalidate the patent, there are two additional defenses that Ascendis could rely upon—public interest and intervening rights.  What are these defenses, and how strong are they? 

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?