Epidiolex maker files suit in U.S. to protect its patents

The maker of CBD prescription drug Epidiolex has filed a lawsuit in the USA alleging patent infringement.

GW Research Ltd, a subsidiary of Ireland-based Jazz Pharmaceuticals, claims that more than 15 drugmakers are violating its patents as they develop generic versions of Epidiolex, the only pharmaceutical containing CBD that is approved by the U.S. Food and Drug Administration (FDA).

Generic versions

Those competitors have submitted Abbreviated New Drug Applications (ANDAs) in order to “commercially market generic versions of GW’s cannabidiol oral solution drug product,” GW said in the lawsuit, noting some of the patents do not expire until September 2025, while the others are still in force until July 2027.

Epidiolex received authorization for use in the treatment of two rare forms of epilepsy in young children in 2018 and 2020.

Companies named

Defendants in the lawsuit brought by GW Research Ltd are: Teva Pharmaceuticals, Inc. Apotex Inc., Padagis US LLC, InvaGen Pharmaceuticals, Inc., Cipla Ltd., Cipla USA, Inc., API Pharma Tech LLC, Lupin Ltd., Alkem Laboratories Ltd., Taro Pharmaceutical Industries Ltd. , Ascent Pharmaceuticals, Inc., MSN Laboratories Private Ltd., MSN Pharmaceuticals, Inc., Zenara Pharma Private Ltd. and Biophore Pharma, Inc.

The suit was filed in the U.S. District Court for the District of New Jersey.

‘Vigorous’ defense

“We will vigorously defend our intellectual property rights, as this is an important part of what enables us to continue to innovate and develop new medicines for patients, including our pioneering work and industry-leading GW cannabinoid scientific platform,” Andrew Civers-Davis of Jazz Pharmaceuticals told Marijuana Moment.

GW is one of the biggest medical cannabinoid companies in the world, having developed its products under strict regulations for medicine in the markets where it is present.