GW Research last Tuesday filed a lawsuit against a handful of competitors for allegedly infringing on the company’s patent for Epidiolex by seeking to create generic versions of the patented drug. In 2018, GW Research, which together with GW pharmaceutical are subsidiaries of Jazz pharmaceuticals, became the first company to get FDA approval for a cannabis-based drug (Epidiolex). Currently, several companies have submitted abbreviated new drug applications (ANDA) to manufacture and market generic versions of Epidiolex.
According to GW Research, one or more patents on the drug that are listed in the FDA’s “Orange Book” are yet to expire and hence the company continues to enjoy market exclusivity. Going by information on the FDA’s official website, that seems to be the case. Epidiolex, which is a CBD isolate, received FDA authorization for use in treating two severe forms of childhood seizures in 2018 and 2020. It enjoys market exclusivity up to September 2025 for the first set and up to July 2027 for the second set. Hence, companies seeking to make generics are violating patent infringement laws.
GW Research has filed a 322- page lawsuit at the New Jersey District Court making arguments against the ANDAs that have been submitted to the FDA by competing companies. The company is asking the court to enjoin the companies and bar them from proceeding with their FDA applications to prevent a case of patent infringement which can be costly. With this view in mind, it seems like the case has been filed “with the best interest of all parties at heart.”