Soleno Therapeutics is anxiously awaiting FDA approval on its extended-release formulation of diazoxide choline (DCCR), which is indicated for treating Prader-Willis syndrome (PWS). Soleno’s drug has already received breakthroughdesignation status from FDA, as well as orphan drug designation.  Together, that suggests that if Soleno’s drug is approved this month, it will receive FDA-approved exclusivity for seven years.  Yet, after that, which patents does Soleno have that it can use to delay entry of generics?

Acadia has been embroiled in a patent dispute with MSN Pharmaceuticals over a generic version of Acadia’s Parkinson’s Disease drug Nuplazid® (pimavanserin).  The lawsuit boiled down to a single dispute over a single legal issue concerning a single patent.  In December 2023, the district court ruled in favor of Acadia.  The case is now on appeal before the Federal Circuit. What are the chances of MSN prevailing on appeal? 

Acadia Pharmaceutical has been litigating to keep out generics for its Parkinson’s Disease drug Nuplazid®.  Although Acadia initially sued five separate generics for infringement of multiple patents, all the generics settled-out except one, MSN Pharmaceuticals.  And in the case against MSN, only a single patent remains at issue (U.S. Patent No. 7,601,740).  MSN recently moved for summary judgment on the ground that the ‘740 patent is invalid for obviousness-type double patenting (ODP).  A recent precedential Federal Circuit decision, In Re: Cellect, LLC, addressed the ODP doctrine in detail.  How will Cellect affect Acadia’s defense against the last generic holdout for Nuplazid®?