Market exclusivity rights afforded by intellectual property such as patents, copyrights and trademarks can provide a crucial advantage to cannabis businesses. In addition to providing a valuable market advantage, intellectual property is extremely advantageous to cannabis companies seeking funding from sources such as venture capital that often look for companies with patent applications on file. Although cannabis-related patenting is still in its infancy, over 2,000 active cannabis-centric patents/applications have already been issued or published, and as evidenced by the last few months in 2019, the number is skyrocketing. Most of these patents are for technologies such as cultivation, processing and extraction techniques, cannabis-derived products, and medical treatments.
The U. S. Patent & Trademark Office’s (USPTO) willingness to grant cannabis patents, copyrights and trademarks may or may not translate to a willingness on the part of the USPTO Patent Trial and Appeal Board (PTAB) and Federal Courts to enforce them. Since cannabis remains a Schedule I drug under the Controlled Substances Act (CSA), some have opined that the so-called “illegality doctrine” may preclude cannabis-related patent infringement cases as well as other cannabis-related commercial disputes. Pursuant to the illegality doctrine, judges could potentially decline to entertain a lawsuit, hold that the USPTO exceeded its authority, or decide that there is no entitlement to damages with regard to intellectual property related to illegal activity.
Although possible, we believe the “illegality doctrine” should not be applied to cannabis-related patents for several reasons. Most notably, cannabis-related patent enforcement cannot be hindered by the government or federal courts when the federal government itself created the patent. That is, these patents cannot be considered the result of illegal activity when the patent rights are conveyed by the federal government under patent statutes. Nor do patents convey any right to engage in activity illegal under the CSA. Additionally, it is worth noting that patents related to cannabidiol (CBD) which contains less than 0.3% THC on a dry weight basis would clearly relate to a legal product pursuant to the Agricultural Improvement Act of 2018 (P.L. 115-334) “Farm Bill” which legalized such products on the federal level.
Thus far, both the PTAB and the Federal Courts have NOT treated cannabis patents differently than other patents. On January 3, 2019, the USPTO PTAB issued a Final Written Decision in the case Insys Development v GW Pharma Ltd (IPR 2017-00503) upholding 11 claims relating to U.S. Patent No. 9,066,920 which addresses the use of phyto-cannabinoids in the treatment of epilepsy. Notably, the PTAB did not raise the issue of the legality of a cannabis patent and treated the cannabis patent as it would any other patent, focusing on typical issues that relate to all patent challenges such as patentability, scope, claim construction, infringement, ownership and enforceability.
Despite the Growth of the Cannabis Industry, Uncertainty and Limited Legal Guidance Exist
The USPTO’s experience with cannabis patents is evolving as is the universe of prior art used to challenge the validity of patent claims based on novelty or obviousness. Regardless of the IP strategy chosen, IP protection should be a primary consideration for cannabis companies.
How Frier Levitt Can Help
Frier Levitt offers a full range of Intellectual Property services including patent, trademark and copyright procurement, trade secret and confidentiality agreements, infringement and Freedom-to-Operate Opinions and due diligence. Our pharmacist attorneys provide a nuance understanding of the science, chemistry as well as related Life Sciences and FDA issues. Please contact our Intellectual Property attorneys if you require advice or have questions.