The drug company behind the CBD-based medication Epidiolex has filed a lawsuit against more than a dozen competitors that are seeking to create generic versions, alleging patent infringement.
GW Research Ltd, which along with GW Pharmaceuticals is a subsidiary of Jazz Pharmaceuticals, filed the suit. GW, one of the only companies to secure Food and Drug Administration (FDA) approval for a cannabis-derived medication, says that the various competitors have submitted what are known as Abbreviated New Drug Applications (ANDAs) in order to “commercially market generic versions of GW’s cannabidiol oral solution drug product.”
The lawsuit, filed in the U.S. District Court for the District of New Jersey on Tuesday, says that the attempts to develop and market those generics is happening “prior to the expiration of one or more” of GW’s patents. It then listed 25 U.S. patents it owns.
The 322-page filing contains many pages of technical descriptions and claims about jurisdiction, but it eventually gets into its main arguments against each of the competing companies’ ANDAs. It asserts that the patents affiliated with its epilepsy medication Epidiolex that are listed in what’s known as FDA’s “Orange Book” for authorized drugs have not yet expired, so any companies that seek to market generics would be in violation of patent infringement laws.
“We believe Epidiolex is an important life-improving medicine for patients with rare epilepsies,” Andrew…