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?
Read MoreAcadia 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?
Read MoreAcadia 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®?
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