Cannabis – From Mystery to Medical IP
Cannabis still maintains much of its mystery, thousands of years after it was first used by humans. There is great uncertainty among modern medical practitioners and patients about the pros and cons, and whether or not to use it at all. The limited scientific information available to date has been largely drowned out by PR hype, regulators, and inaccurate anecdotal information from acquaintances. Even governments have appeared confused. The U.S. Drug Enforcement Agency (“DEA”) regulates marijuana as a Schedule I substance, meaning it has high potential for abuse, but no accepted medical use. In the meantime, the U.S. Department of Health and Human Services procured a U.S. patent no. 6,630,507 in 2003 for certain new medical uses. The State of California legalized medical marijuana way back in 1996.
Let’s break it down. Cannabis contains thousands of chemicals, and more than a few affect biological functions in humans. Compounds from the cannabis plant are called “cannabinoids.” Two examples of cannabinoids THC and CBD. THC is best known for elevating mood (ie. the high), but it has other medical effects, such as reducing pain. CBD does not elevate mood, but is known to have anti-inflammatory effects and also treat pain. It is believed that multiple compounds in cannabis can act together to produce cumulative benefits for some medical purposes. This leads to a strong medical interest in i) whole cannabis, ii) extracts of cannabis and iii) isolated individual chemicals from cannabis (such as isolated THC or CBD). Some companies are trying to improve these isolated chemicals. As well, there is interest in refining different doses and the key modes of administration – oral, pulmonary (lung) and topical.
The research focus on individual components indicates that cannabis medical science is growing up. Many other modern drugs were originally isolated and purified from plants. This allowed focused study on the drug’s therapeutic effects in cell-based tests, ultimately progressing to large scale clinical trial testing in humans. For example, the anti-cancer drug, paclitaxel, was first isolated from parts of the yew tree. Isolation of the compound meant that it could be clinically tested and approved to treat cancer patients. Much more clinical research was then done on treating patients with different doses, treatment regimens, and combinations with other anticancer drugs. If you put yourself in the place of a physician, you would probably have more of a scientific comfort level with a patient taking a drug with a predictable, tested dosage, instead of the uncertain contents of smoking a burning herb.
In the face of this evidence-based approach to cannabis medicine, the U.S. DEA recently had to admit that cannabis has medical benefit. The U.S. Food and Drugs Administration (“FDA”) just approved a clinically-tested CBD composition for treatment of epilepsy (brand name Epidiolex, by GW Pharma), the DEA then classified the drug as a composition with proven medical use and low potential for abuse, permitting it to be sold (recall that CBD does not produce a high). The reclassification applies to CBD compositions containing less than 0.1% THC, not all cannabidiol products. The DEA and FDA may still take enforcement action against unapproved CBD-containing products.
Expect more acknowledgment of the medical benefits of cannabis. We are now entering a boom time for scientific research on cannabis. The U.S. National Institutes of Health recorded 98 clinical studies completed containing the term “cannabis” between 2000 to the end of 2009. There were 397 studies completed from 2010 to present. Research was stifled by the illegality of cannabis. Funding is now more readily available for evidence-based clinical and social research. Cannabis research will proceed under the watchful eye of research ethic boards rather than potential police prosecution.
IP rights in cannabis follow the medical R&D in extracts and isolated compounds. New formulations and uses for treatment may be patented. In the case of the U.S. government’s patent mentioned above, the patent is on treating oxidative stress. GW Pharma has patented its epilepsy treatments. There is also a highly-publicized patent infringement lawsuit pending in the U.S. involving a patent on allegedly new cannabis extracts (U.S. patent no. 9,730,911; United Cannabis Corporation v. Pure Hemp Collective, Inc., case no. 1:18-cv-01922-NYW. U.S.D.C., District of Colorado).
Awarding IP protection for medical advances should not alarm patients, despite the initial higher cost of a new drug formulation or medical treatment. A company cannot patent conventional cannabis per se, just the company’s specific inventions made using cannabis. If a company spends millions of dollars on R&D, they need to have strong IP to recoup that investment. IP allows reinvestment in future research, so that more patients benefit from proper, evidence based medical trials. Although cannabis is a pretty familiar plant in our culture, it has a very high tech medical future ahead of it.
A version of this article was first published in The Lawyer's Daily, © 2018 LexisNexis Canada.