The maker of Epidiolex, a prescription CBD drug, has sued in the United States for patent infringement.
GW Research, a subsidiary of Irish company Jazz Pharmaceuticals, says more than 15 drugmakers are infringing its patents by developing generic versions of Epidiolex, the only drug containing CBD approved by the Food and Drug Administration (FDA) of the United States.
These competitors would have submitted abbreviated new drug applications (ANDAs) to “market generic versions of GW’s pharmaceutical product, cannabidiol oral solution,” GW said, noting that some of their patents do not expire until September 2025. , while the others are still in effect until July 2027.
Epidiolex received authorization for use for the treatment of two rare forms of epilepsy in young children in 2018 and 2020 for the United States and in 2019 for Europe.
The 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, Lupine 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 lawsuit was filed in the United States District Court for the District of New Jersey.
“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 our scientific platform of industry-leading GW cannabinoids,” Andrew Civers-Davis of Jazz Pharmaceuticals told Marijuana Moment.
Larry Sandell, patent attorney at Mei & Mark LLP and head of the firm’s cannabis practice, told Marijuana Moment that ANDA patent cases of this type are relatively common in the pharmaceutical world, although they are somewhat unique here as they relate to cannabis products.