The 95 clinical studies posted so far this year involving cannabis are indicative of the pharmaceutical industry’s interest in the drug, said Deborah Sterling, a director at Sterne, Kessler, Goldstein & Fox PLLC. The studies target conditions ranging from obesity to opioid use disorder. This year’s number of clinical trials outpaces each year of the last decade.
Pharmaceutical companies often seek extensive patent protection. Jazz Pharmaceuticals lists 33 patents in the Food and Drug Administration’s Orange Book covering Epidiolex, a prescription drug containing CBD used to treat severe seizure disorders.
Cannabis-related patent applications peaked in 2020 at around 500 and have slowly tapered off since, according to a report by Sterne Kessler. “One thing that may or may not be impacting IP around that time was of course COVID,” said Sterling. She noted the 18-month lag from filing to publication.
Last month, a patent holding company sued at least six cannabis growers. The suit accuses them of infringing two inventions covering methods of extracting chemical compounds from plants.
The US cannabis industry has blossomed into a $40 billion force, Bloomberg News reported in December. The drug’s status as a Schedule I controlled substance for recreational use and Schedule III for medically dispensed cannabis and FDA-approved drugs doesn’t limit its patentability. Such applications face the same scrutiny as others, requiring that the invention be new, nonobvious, and teach readers how to make and use it.
“Some of the breeders also feel that the plant itself shouldn’t be patented like that, it’s for everybody to share,” said Andrew Berman, CEO and co-founder of the Arcana Collective, a group of cannabis breeders that license their cultivars to retailers. Berman said companies rushing to patent cannabis risk being perceived like Monsanto, which gained notoriety for patenting genetically modified soybean seeds and suing farmers for infringement.
Alisha Holloway, chief science officer at Phylos Bioscience, said that as more cannabis technology becomes publicly known, it becomes more difficult to have something that is novel and patentable. Phylos holds issued US patents and pending applications ranging from cannabis plant species to ways to use genes to select cannabis plants with specific features.
“We feel pretty strongly that patents, because they require public disclosure, they do accelerate collective knowledge,” said Holloway. “The rising tide lifts all ships,” she added, noting that Phylos has licensed some of its technology for free to universities for research. Sterling said pharma companies usually pour millions into clinical trials, so IP protection is imperative for securing an exclusive market to recoup costs.
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