Written By: Caldwell
In recent years, many US states have decriminalized possession and use of products containing or derived from the cannabis plant, particularly where there is a medical benefit. One might therefore expect that obtaining a federal trademark registration for such products would now be easier than in former years, but for many such products this remains untrue.
Under the federal constitution, authority to regulate foods, drugs and cosmetics is divided between the federal government and the states. Generally, whenever there is a conflict between federal law and local law, federal law controls per the Supremacy Clause[1]. For decades, the US Controlled Substances Act of 1970[2] tightly controlled distribution of both marijuana and hemp products. Trademark examiners in the US are instructed by Section 907 of the Trademark Manual of Examining Procedure (TMEP)[3] to check whether shipment of a product is in compliance with other statutes. If shipment of a product is illegal, for instance under the Controlled Substances Act, there is no valid “use in commerce” and therefore no valid “basis” for the trademark application. When describing a product in a trademark application, to get the application through, the applicant must state that the product has a concentration of Tetra Hydro Cannabidiol (THC), the psychoactive element in cannabis, of “not more than 0.3 percent by dry-weight basis.”[4]
The carve-out for hemp based on THC concentration came into existence when farmers in Kentucky grew restive with the prohibition against growing hemp, which contains cannabidiol (CBD), a non-narcotic chemical with medical properties, but little or no THC. It so happens that Kentucky had 2 influential senators: Mitch McConnell, the current Republican Senate minority leader, and Dr. Rand Paul, an ophthalmologist, in whom the proponents of hemp and CBD found unlikely champions. They convinced their US Senate colleagues to include, in the 2018 Farm Bill, a provision that took “industrial hemp” out of the Controlled Substances Act. Farmers happily resumed growing hemp, and there was a proliferation of hemp-derived products containing CBD.
Did the loosened restrictions on hemp mean “open season” for CBD trademarks? Not so fast!
In deciding what goods are permissible subjects for trademark protection, the United States Patent and Trademark Office (USPTO) takes its cue from the US Food & Drug Administration (FDA) as to whether or not a product is on something called the Generally Recognized as Safe (GRAS) list.[5] The FDA takes the position, at present, that CBD products which are “topical,” i.e. rubbed on like a lotion, are safe but CBD products which are “ingestible,” i.e. which you eat, drink, or inhale, are not yet considered safe, because there have not been enough studies yet to prove that they are safe. Thus, if a party wishes to register a trademark for a CBD product, they should describe the product as being for topical use. Later, studies may satisfy the FDA that CBD products for ingestible use are safe, providing the option to “laterally expand your field of trademark use” to get registration for additional products.
The reasons for the FDA’s cautious approach to approvals are historical. In about 1960, an American drug company applied to the FDA for the OK to market a drug called KEVADON, with the generic name “thalidomide,” for use as a tranquilizer and to combat “morning sickness” in pregnant women. The drug already had approval in Canada and about 20 European and African countries. The application was reviewed at the FDA by a Canadian-American female pharmacologist named Dr. Frances Kelsey, who concluded that there was insufficient evidence of safety to warrant approval. Dr. Kelsey’s superiors backed her up despite pressure from the drug company. KEVADON was administered to pregnant women in Europe and Africa, and caused tens of thousands of children to be born with limb deformities in what became known as the “thalidomide tragedy.” Dr. Kelsey was recognized by President Kennedy with the President’s Award for Distinguished Federal Civilian Service, and her actions led to the 1962 changes in the federal Food Drug & Cosmetic Act, which requires evidence, prior to marketing, that a drug is not only safe, but also effective[6].
What are the take-aways about the marketing of cannabis-derived products?
Topical CBD products can be the subject of a trademark registration today. However, it remains impermissible to register a mark for a product with a significant quantity of THC or for an ingestible CBD product.[7]
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Read more articles on cannabis here: Cannabis Patent Infringement Case Extinguished by Bankruptcy Proceeding, Developments and Trends in Cannabis Intellectual Property Rights
[1] Article VI, Paragraph 2.
[2] 21 U.S.C. Chapter 13.
[3] www.bitlaw.com/source/tmep/907.html; 37 Code of Fed. Regulations, sec. 2.69
[4] 21 C.F.R. section 1308.11
[5] FDA.gov/food/generally-recognized-as-safe-gras/gras-substances-scogas-database
[6] En/Wikipedia.org/wiki/Frances_Oldham_Kelsey
[7] uspto.gov/sites/default/files/documents/Exam%Guide%201-19.pdf