A federal judge found that the producer of the only medical-grade CBD product approved by the U.S. Food & Drug Administration (FDA) did not lie to the U.S. Patent and Trademark Office to avoid high filing fees.
U.S. District Judge Michael E. Farbiarz last week dismissed allegations that 19 patents held by producer Jazz Pharmaceuticals covering epilepsy treatment Epidiolex aren’t enforceable. Farbiarz ruled that there was no evidence that the company lied to the patent office to dodge higher fees. The judge said InvaGen Pharmaceuticals, which brought the case, failed to show Jazz’s statements to the U.S. Patent and Trademark Office were “unmistakably” false.
The allegation by InvaGen against Jazz came in a countersuit after Jazz sued InvaGen and its parent company Cipla, Mumbai, India, and more than other 15 drugmakers, in January 2023 for allegedly infringing patents covering Epidiolex, which won FDA approval in 2018.
How big?
InvaGen alleged to patent officials that Jazz Pharmaceuticals was not a small entity under patent office classifications that let companies with fewer than 500 employees get fee breaks. However, the court found that Jazz had only about 490 employees a month, on average, during the time frame relevant to the allegations.
In its original patent infringement filing, Jazz claimed that a total of 15 drugmakers were violating the company’s patents after they submitted Abbreviated New Drug Applications to commercially market generic versions of Epidiolex. Some of the Epidiolex patents do not expire until September 2025, while the others are still in force until July 2027.
60 counterclaims
After the patent infringement filing by Jazz, InvaGen alleged “inequitable conduct,” and lodged more than 60 counterclaims, including that the Epidiolex patents, first obtained by Jazz predecessor company, GW Research Ltd., were invalid and unenforceable. The patents were transferred to Jazz when the company bought GW Research in 2021 and turned it into a subsidiary.
GW held 57 U.S. patents and more than 750 patents internationally when it was purchased by Dublin, Ireland-based Jazz. Most cover cannabinoid product candidates including nabiximols, which are being trialed as a treatment for multiple sclerosis and spinal cord injury. The company also is researching cannabinoid treatments to address autism and schizophrenia.
Epidiolex was approved by the FDA in 2020 as a treatment for Lennox-Gastaut Syndrome (LGS) and Dravet Syndrome, severe forms of early-onset epilepsy affecting children. Both maladies are known for the severity of the seizures they cause, and both are characterized by their drug-resistant nature. LGS treatment is often associated with a broad regimen of several anti-epileptic drugs. Until the approval of Epidiolex, there had been no FDA-approved treatment for Dravet Syndrome. Known by the slightly different name “Epydiolex” in the United Kingdom, it was first approved by the UK Medicines and Healthcare Products Regulatory Agency in 2019.
Fiercely protective
Jazz, which has a reputation for delaying tactics aimed at limiting competition and maximizing short-term gains, has been criticized in the Federal Trade Commission and lost other cases in court over its strategy in the U.S. A federal court in Delaware ruled in 2022 that the company had attempted to block the introduction of a competing narcolepsy drug from a rival, Avadel Pharmaceuticals. Jazz Pharmaceuticals appealed the case, and a federal circuit court later upheld the lower court’s ruling.
“Jazz Pharmaceuticals has figured out a way to push the boundaries even further — a feat that demonstrates the lengths to which drug makers go to eke out extra profits and that two federal courts have now ruled was improper,” the New York Times wrote in the wake of the court rulings. For every month that Jazz could delay the arrival of competition, the company and its shareholders stood to benefit financially, the Times noted.
Jazz has taken an aggressive approach to lobbying in markets where it operates around the world, getting into the discussion as rules are being shaped. The company is registered to lobby on CBD policy with the U.S. Congress, and is a member of a CBD working group in France launched by the General Directorate of Health. The company has also lobbied aggressively in Brazil and other countries.
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