Jazz Pharmaceuticals has rebuffed attempts by rival Teva Pharmaceuticals to legally disqualify its patent for Epidyolex, a cannabis-based drug worth hundreds of millions of dollars a year.
The legal dispute between the two pharmaceutical heavyweights began when several companies, including Teva, sought permission from the US Food and Drug Administration in 2022 to manufacture and market a generic version of Epidyolex.
In 2023, Jazz successfully thwarted these companies from producing Epidyolex by filing a lawsuit asserting that the applications alone infringed on its intellectual property, and that the approval of the applications would lead to further infringement.
Teva responded by filing counterclaims against Jazz, alleging that it falsely portrayed itself as a ‘small entity’ to the United States Patent and Trademark Office (PTO) during the Epidyolex patent application.
This misrepresentation, according to Teva, would constitute ‘inequitable conduct’ and, if proven, could legally prevent Jazz from enforcing its patent.
After a thorough analysis, the court ruled that Teva failed to establish that Jazz’s representation as a ‘small entity’ was ‘unmistakably false,’ specifically noting inadequate pleading regarding the average number of employees when applying for the patent.
According to US patent law, a company can be considered a small entity if it has fewer than 500 employees. Jazz, at the time of writing, has over 3000 employees.
Furthermore, the court highlighted Teva’s failure to sufficiently plead intent, as they did not identify specific individuals associated with filing the patent applications who were aware of these alleged misrepresentations. Consequently, the counterclaims were dismissed, enabling Jazz to continue enforcing its patent over Epidyolex.
According to Jazz’s latest financial figures, published in November 2023, Epidyolex generated revenues of $213.7 million in the three months to September 30, 2023, marking an increase from $196.2 million in the same period a year earlier.