Pharma Company Behind FDA-Approved CBD Drug Sues A Dozen Competitors Over Alleged Patent Infringement

Pharma Company Behind FDA-Approved CBD Drug Sues A Dozen Competitors Over Alleged Patent Infringement
MJ moment

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 Civers-Davis, a spokesperson for GW parent company Jazz Pharmaceuticals, told Marijuana Moment. “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.” FDA’s website shows that Epidiolex received authorization for use in the treatment of two sets of conditions in 2018 and 2020. The exclusivity period…

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Source : Pharma Company Behind FDA-Approved CBD Drug Sues A Dozen Competitors Over Alleged Patent Infringement

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