Introduction – Is Patenting Cannabis Legal?
Early protection of intellectual property is a critical component in any business’s efforts to secure a competitive advantage in the marketplace. In the cannabis space, efforts to secure IP rights may be influenced by conflicting federal and state regulations. Despite increasing state regulation and legalization, cannabis remains a Schedule I drug under the Controlled Substances Act, and possession of cannabis is prohibited by federal law. However, this is not an express impediment to patenting cannabis-related inventions. Indeed, the U.S. Patent and Trademark Office (“USPTO”) has been issuing cannabis-related patents since as early 1942, including U.S. Patent No. 6,630,507, which is owned by the federal government, and relates to the use of cannabinoids as antioxidants and neuroprotective agents.
When considering filing a patent application for a cannabis-related invention, it is important to note that the USPTO applies the same legal standards to cannabis-related applications that are applied to all other categories of patent applications. That is, the invention must be new, useful, nonobvious and the application must teach a person skilled in the art how to make the invention and how to use the invention. Cannabis patents and applications are not solely directed to compositions that include tetrahydrocannabinol (“THC”) and/or cannabidiol (“CBD”), two compounds of interest found in cannabis. Rather, cannabis-related innovation includes a broad range of technologies, including, for example:
1. Plants – new strains of cannabis and genetically modified cannabis;
2. Detection and analysis –physical and chemical techniques for identifying and characterizing that various cannabinoid and terpenoid constituents present in cannabis;
3. Extraction and processing – methods of removing the desired compounds from cannabis and/or processing plants or extracts to achieve a desired chemical profile;
4. Compositions – essential oils, topical or cosmetic creams, and smoking or ingestible products;
5. Consumption devices – inhalers, nebulizers, applicators, or vaporizers;
6. Methods of treatment – methods of treating anorexia, epilepsy, and chronic pain; and
7. Other cannabis-related products – methods of cultivation and specialized agricultural implements.
Thus, whether you are a grower, engineer, chemist, physician, or related in some other way to the cannabis industry, it is important to consider your options for protecting your innovation.
Utility, Plant, and Design Patents
As noted above, the USPTO applies the same standard to reviewing cannabis-related patent applications as other patent application. Likewise, companies in the cannabis industry may apply for the same types of patent protection as companies in other industries. Specifically, plant patents, design patents, and utility patents.
The vast majority of U.S. patents are utility patents, which protect a new (or improved) product, process, or machine. Utility patents can be used to protect any of the classes of cannabis products described above. For example, U.S. Patent No. 8,910,630, directed to a cannabis drug delivery and monitoring system; and U.S. Patent No. 4,189,491, directed to methods of treating glaucoma with THC. However, an important consideration, particularly for method of treatment applications of cannabis, is the increasing importance of data. U.S. patent examiners reviewing such claims are increasingly requiring at least some data to show proof of concept. However, obtaining such data in the U.S. can be substantially more challenging than in jurisdictions where cannabis is legal.
Utility patents can also protect cannabis strains, for example, by claiming a cannabis plant having a range of chemical parameters, such as particular levels of THC, CBD, and/or particular terpenoids. See, e.g., U.S. Patent No. 9,370,164. This provides broader coverage than a plant patent (discussed below), and also allows for more variation in chemical profile of the plants during the various stages of growth and harvesting.
To date, there are relatively few plant patents covering cannabis strains. Plant patents may be used to protect specific plants that are not found in the wild and that are asexually reproduced. The ratios of various desired cannabinoids and terpenoids can be used to differentiate strains of cannabis, as well. However, plant patents are limited to a single claim directed to the particular strain of interest. This may not stop a competitor from developing and using a close, but non-infringing, cannabis strain.
Design patents protect the ornamental appearance of an item, but not its function or utility. The particular external appearance of an analytical instrument, the shape of a vaporizer, and the appearance of a pipe may all be protected by a design patent. Moreover, while design patents may only contain a single claim and do not protect an item’s function, they are typically obtained faster and at lower cost than a utility patent.
If your innovation is something that would not easily be reverse-engineered by another party (for example, a particular extraction/purification process), you may consider protecting it as a trade secret. Each of the types of patents described above provide the patent owner a limited time (20 years from filing date for utility and plant patents, and 15 years from grant for design patents) in exchange for disclosing the invention to the public.
In contrast, trade secrets derive value from being secret, and accordingly, in order to qualify as a trade secret you must make reasonable efforts to keep the invention secret. This could include, for example, limiting the number of individuals with access to the secret information, limiting access to the physical location where the invention is practiced, and requiring employees to sign confidentiality and non-disclosure agreements. However, unlike a patent, if another company independently arrives at the same invention, you cannot use your trade secret to stop them from practicing the invention. Thus, absent your disclosure of the trade secret or independent invention, the information will not become public, and the trade secret can be protected for an unlimited period of time.
In sum, there are many options for protecting your innovation in the cannabis industry. Carefully evaluating the possible avenues for IP protection are particularly important in this relatively new, highly competitive, and fast-paced field.