Canopy sues GW Pharma over cannabis patent
Canadian medical cannabis company Canopy Growth has accused GW Pharma of using a patented technological process to produce its flagship epilepsy treatment, Epidiolex, without authorisation.
According to the lawsuit filed on Tuesday, December 22, at the US District Court Court for the Western District of Texas, GW Pharma infringed Canopy’s patent, US patent number 10,870,632 (the “’632 patent”).
The disputed patent covers a process for extracting cannabidiol (CBD) from cannabis plant material, and according to Canopy, anticipates the use of CBD as an anti-epileptic treatment.
In the complaint, Canopy said: “The processes described in the ’632 patent significantly improved upon other approaches to enriching, isolating, and/or synthesising cannabinoids, and in particular those that relied on hexane and ethanol extracts. The extract produced from the patented processes can be used as an active principle for the production of a medication... including as an anti-epileptic.”
The Canadian company alleged that GW used this process, without its permission, to produce Epidolex—an anti-epileptic medication comprising a pharmaceutical formulation of highly purified CBD.
The US Food and Drug Administration approved Epidiolex in June 2018 for the treatment of seizures, and it became commercially available in the US on November 1, 2018.
GW went on to report approximately $366 million in net product sales of Epidiolex in the US in the first nine months of 2020. The complaint holds that “the success of GW’s Epidiolex is based, at least in part, on GW’s use, without authority, of the CO2 extraction process described and claimed in the ’632 patent, which enables the production of a CBD-rich extract from cannabis material”.
Canopy argued that it gained the rights to the ’632 patent when it acquired Germany’s C3 Cannabinoid Compound Company in 2019, and that the patent is part of a family dating back to October 2000.
It also stated that GW was aware, or should have been aware, that the extraction process it uses to manufacture Epidiolex infringes the ’632 patent because GW has been monitoring the ’632 patent family for more than 14 years.
Canopy pointed out in its complaint that GW challenged the issuance of a European counterpart application, patent number EP 1 326 598 in May 2006, by filing an opposition before the European Patent Office. However, by the time GW filed its opposition, the parent application of the ’632 patent—US number 8,895,078 (the “078 patent”)—had already been filed, said Canopy.
“In light of its monitoring and proactive steps to invalidate a European counterpart, GW knew, or should have known, of the existence of the US counterpart applications in the ’632 patent family,” it added.
Canopy further held that GW declined a licence to the ’078 patent in 2017, and that its infringement of the ’632 patent has been and continues to be “willful and deliberate”.
It also argued that its suit was “not about restricting patient access to Epidiolex” but rather about putting a stop to GW's “knowing and unauthorised use of Canopy’s IP”.
