As a kid, I was frequently warned not to believe everything I see on television. My television screen time has dropped significantly since I was a kid, but I still maintain a healthy amount of skepticism when reading or listening to the media.
A few of my clients and contacts in the medical cannabis field have reached out to me about a recent article that has made its rounds on the internet in various forms. One of the articles’ headlines reads as follows: “GW Suffers Major Blow as U.S. Sinks Bid to Patent Cannabinoids for Epilepsy.” Another headline reads, “GW Pharma Denied Blanket Patent on Treating Epilepsy with Cannabinoids.” In the body of the second article, it even states, “U.S. Patent 9,066,920 B2 has been in the works since 2010, but on January 3rd of this year, the application was officially, and in no uncertain terms, denied.” The headline caused people to worry about the impact of this ruling on other medical cannabis-related IP.
Is this what really happened? Looking into the matter a bit more, it appears that headline wasn’t exactly accurate.
GW Pharmaceuticals, one of the leaders in medical cannabis- based drug development, is the manufacturer of Sativex® and Epidiolex®, two of the approved cannabis-based drugs. Epidiolex® has been approved in the US for is indicated for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome. GW is an aggressive patentee behind some of the recent growth in cannabis IP which I have previously addressed here.
GW’s United States Patent 9,066,920, relates to treatment of partial seizure using cannabidiol (CBD). Its broadest claim, claim 1, relates to treatment of partial seizure with a daily dose of at least 400 mg of CBD. The second claim introduces an upper daily dose limit of 800 mg. The patent was granted in June of 2015 with a total of 13 claims.
After grant, the patent was challenged by Insys Development Company, Inc. in an Inter Partes Review proceeding at the US Patent and Trademark Office (USPTO). In its decision of January 3, 2019, the Patent Trial and Appeal Board (PTAB) of the USPTO decided that claims 1 and 2 of the patent were unpatentable as obvious in view of cited prior art. However, despite this decision, the patent still remains valid and in force, as the PTAB did not invalidate claims 3-13. Of the claims which remain in force, some relate to use of combinations of CBD with other cannabinoids, origin of the CBD and amounts of tetrahydrocannabinol (THC) in the plant extract used for treatment.
Without going into a detailed analysis of the PTAB decision or the relevance of the remaining claims to GW’s product, there are a few important lessons here for readers interested in patents in the medical cannabis field:
- Potentially misleading headline: Legal proceedings regarding patents can be complex. Sometimes the press is not qualified to cover such topics. Articles in the popular or business press may not accurately describe the legal reality.
- Medical cannabis patents were not treated differently: The PTAB, in its decision, related to the obviousness of the claimed invention in light of the prior art. The patent was not treated any differently than other non-cannabis-related patents would be treated, despite the tight regulations associated with cannabis manufacture and use in the US, on the federal level.
- Multiple layers of coverage: The GW patent which was reviewed in the PTAB proceeding had multiple dependent claims to cover various levels of protection. This allowed them to maintain over 80% of their patent claims after review. Patentees should make sure that their patent applications contain varying levels of claims scope: from broad to intermediate to narrow, to ensure that if their broad claims are invalidated, the intermediate or narrow claims may still be upheld.
In summary, while it is important for companies in the medical cannabis field to stay abreast of news in the field, it is critical that the news reports they are reading are further investigated and verified.
Since 1995, JMB Davis Ben-David has been offering emerging startups and established companies with IP services to both protect their ideas and inventions and to stay ahead of their competition. For questions, comments and for more information on relating to patents, particularly in the medical cannabis, pharmaceutical and biotech fields, please contact the author at email@example.com.
[Photo Credit: Marijuana grower in Denver, Colorado by My 420 Tours, licensed under CC BY-SA 4.0.]