We’ve written extensively on cannabis trademarks and the unique issues posed by the fact that cannabis remains a Schedule I controlled substance under federal law. Some of the highlights can be found here:
- Cannabis Trademarks: Back to the Basics
- Cannabis Franchising vs. Trademark Licensing: Get it Right or Face the Consequences
- Marijuana Trademarks
- Cannabis Trademark Basics: What Makes a Mark Weak?
- Trade Dress 101 for Cannabis Businesses
We also like to write about more forward-thinking issues that could affect the cannabis industry, like plain packaging regulations and counterfeit goods, in order to help our clients and business owners prepare for what may be coming down the pipeline. One such issue we’ve been considering is how the cannabis industry will be affected if the Drug Enforcement Administration (DEA) moves cannabis from Schedule I of the Controlled Substances Act, which is reserved for drugs that have a high potential for abuse, no currently accepted medical application, and a lack of acceptable safety standards for use under medical supervision, to Schedule II, allowing for more research and potentially making FDA-approved derivatives of cannabis available for prescription (with substantial restriction, natch).
Moving cannabis into the pharmaceutical realm would implicate a whole host of other federal laws and regulations, including rigorous Food and Drug Administration (FDA) review, and naming requirements that go beyond merely obtaining a federal trademark for your brand. Without venturing into the quagmire that is FDA review, the purpose of this post will be to give an overview of how the naming of cannabis “drugs” would change in the context of pharmaceuticals.
Marketed drugs have three different names: a chemical name, a generic name, and a brand name. The chemical name is the drug’s scientific name and, being generally unknown to the general population, is not used to identify the drug in clinical or marketing situations. The generic name is assigned by the United States Adopted Names (USAN) Council, and will be commonly used to identify a drug during its clinical lifespan. The brand name, which is always trademarked, is selected by the company that patents the drug and obtains 17 years to exclusively make, sell and use the drug pursuant to patent law.
A five-step process is undertaken in naming a marketable drug:
- New Chemical Entity (NCE) and patent application;
- Generic naming;
- Brand naming;
- FDA review; and
- Final approval.
Step one consists of submitting data on any newly discovered compound to the FDA for classification as an NCE to obtain authorization to begin animal testing to determine the effects of the compound. This step also includes beginning the patent application process, which can take multiple years to complete. After NCE classification, the USAN Council, which is composed of members of the United States Pharmacopeia, the American Medical Association, the American Pharmaceutical Association, and the FDA, creates and assigns a generic name to the chemical. The generic name is then sent to the World Health Organization for final approval. The USAN has certain criteria for naming, including that the name must be:
- Easy to pronounce;
- Suitable for use in both the U.S. and internationally;
- Not misleading nor confusing;
- Not implying efficacy; and
- Not implying application to particular anatomical parts.
The process and considerations for developing a brand name to trademark are nearly identical to that of any other industry, in that the name cannot be generic or descriptive, and cannot be the same as or confusingly similar to any existing marks. Just as with the generic drug name, brand names to be registered with the USPTO for federal trademark protection cannot be misleading or misdescriptive. Additionally, the Center for Drug Evaluation and Research (CDER) will evaluate, prior to the marketing of a drug, the “potential for a proposed proprietary name (i.e., ‘brand name’) to cause or contribute to medication errors as part of the Center’s focus on the safe use of drug and therapeutic biologic products.” The purpose of this review is to ensure accurate interpretation of the product’s name for product procurement, prescription, preparation, dispensing, and administration to patients. Healthcare practitioners rely on a drug’s name as a critical identifier of a product amongst thousands of other drugs. Confusing names can lead to administering the wrong product to patients or dispensing the product incorrectly.
While this is a very brief, high level overview of the pharmaceutical naming process, the takeaway is that if cannabis moves from Schedule I to Schedule II of the CSA, the complexities of branding and trademarking may change, but they certainly won’t disappear.