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Lawsuit: Generic drugmakers infringed on Epidiolex cannabis drug patents
Global pharma giant Jazz Pharmaceuticals filed a lawsuit alleging that a list of generic drug companies infringed on its patents for Epidiolex, a cannabis-derived drug used to treat seizures from Dravet syndrome, tuberous sclerosis complex and Lennox-Gastaut syndrome.
The lawsuit, filed in a federal court in New Jersey, alleges that Alkem, Apotex, Teva Pharmaceuticals and other generic drugmakers submitted plans to market generic variations of Epidiolex to the U.S. Food and Drug Administration, according to financial media outlet Benzinga.
Ireland-based Jazz alleges its patents, registered by its GW Pharmaceuticals subsidiary, protect the “composition and method of use of Epidiolex, and methods of treatment using Epidiolex” until 2035 and after.
The company also says said its exclusive FDA approval protects the drug for certain uses until 2025 and 2027.
According to pharmaceutical blog Fierce Pharma, the generic drug makers say the generic versions don’t infringe on the patents and that the patents aren’t valid.
Jazz acquired the patents when it bought U.K.-based GW Pharmaceuticals in 2021 in a deal valued at $7.2 billion.
Epidiolex made headlines in 2018 when it won FDA approval – the first drug with a cannabis-derived active ingredient to do so.