Intellectual Property Considerations for Cannabis Research and Innovation

By: Michael Shmilovich, Esq., M.S., CLP
Acting Director of the Office of Technology Transfer and Development at the National Heart, Lung, and Blood Institute

Cannabis and cannabinoid research now spans academic, clinical, public sector, and commercial settings. This growth has increased interest in how intellectual property (IP) may apply to new formulations, chemical entities, plant varieties, therapeutic uses, and research methods. Federal restrictions on cannabis can complicate research and commercialization, but they do not, by themselves, eliminate the possibility of patent protection. The more useful question is therefore not simply whether an innovation can be protected, but which form of IP protection is appropriate for the specific subject matter and intended use.

Patent Eligibility and Products of Nature

Botanical materials raise a threshold question under 35 U.S.C. § 101: when does a claimed invention differ sufficiently from a naturally occurring product to qualify as patent-eligible subject matter? A naturally occurring material is not made patent-eligible merely by being identified or isolated. By contrast, a human-made composition, modification, or application may be eligible when the claimed invention is meaningfully different from what occurs in nature. Eligibility is only one part of the analysis; a claim must also satisfy requirements such as novelty, non-obviousness, and adequate disclosure. [1,2] A human intervention and manipulation of a natural product may make it patent-eligible unless doing so is merely the isolation of a natural product using known methods (Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576 (2013)). For example, the patents covering Epidiolex, the CBD medicament indicated for Dravet and Lennox-Gastaut syndromes, cover methods and formulations of CBD not purified or isolated from CBD per se.

Cannabinoid-related patents may focus on a formulation or use, rather than on a naturally occurring cannabinoid alone. Formulation claims can address the specific combination and delivery of active and inactive ingredients, including oral solutions, emulsions, encapsulated preparations, sublingual films, transdermal patches, or controlled-release systems. Such claims can be important when formulation characteristics affect stability, delivery, bioavailability, or pharmacokinetics. Because formulation drives bioavailability and pharmacokinetics, these patents can be commercially valuable even when the underlying cannabinoid is well known. For example, U.S. Patent No. 11,291,631 includes claims directed to a cannabinoid-containing oral solution [3]:

A cannabinoid-containing oral solution comprises a cannabinoid, a lipid solvent, a sweetener and ethanol, characterized in that the sweetener is an ultrahigh potency sweetener.

The patent claim itself should be consulted for its precise scope and limitations.

Composition-of-matter claims may cover new synthetic or semisynthetic molecules, derivatives of naturally occurring compounds, salts, crystalline forms, or other defined compositions. Their scope and practical value depend on the claim language, the supporting disclosure, the prior art, and the ability to distinguish the claimed composition from naturally occurring materials.

An example is U.S. Patent No. 12,403,136, titled “Cannabinoid Derivatives as Pharmaceutically Active Compounds and Methods of Preparation Thereof.” [4]

where X is CH2, O, NBoc, NFMoc, NZ, NTs, NAc, NC (O)iPr, NBz or NH and Y is either H or OH. The structure shown above shares the same general structure as cannabidiol. However, those moieties indicated with “X” and “Y” in the body of the above figure taken from the patent application claim organic side chains that chemists substitute for their naturally occurring counterparts (in the case of X or Y) thus generating derivatives and analogues of the molecule. Such derivatives and analogues are made improve solubility, stability, bioavailability, or to attenuate adverse effects. Here, the main point is that incorporating such molecular substitutions changes the molecular structure away from its natural form thus making it novel in view of patent laws.

Plant patents and varieties protection: Under 35 U.S.C. § 161, applicants may protect a distinct and new plant variety that has been asexually reproduced, subject to the statutory requirements. This form of protection may be relevant to clonally propagated cannabis cultivars; plants reproduced by seed are outside the plant-patent framework. U.S. Plant Patent No. 27,475, “Cannabis Plant Named ‘Ecuadorian Sativa,’” provides one published example. [5,6] Under the Plant Variety Protection Act [7], the USDA grants breeders of new seed-propagated (sexually reproduced) plant varieties “patent-like certificates” that provide 20 years of exclusivity. Because the 2018 Farm Bill removed hemp from Schedule I, the USDA announced in April 2019 that it would begin accepting such applications.

Method-of-use claims: These may address a defined use of a cannabinoid or formulation (see above Epidiolex claims), such as administering a specified composition, dose, or regimen for a particular indication. Applicants may pursue different claim categories when supported by the application, but the appropriate strategy is fact-specific and should not be treated as a universal approach.

Trade Secrets and Confidential Know-How

Patent protection is not the only option. Information such as proprietary genetics, cultivation parameters, extraction conditions, analytical workflows, or manufacturing know-how may qualify for trade secret protection when it derives economic value from not being generally known and is subject to reasonable measures to maintain secrecy. Unlike a patent, a trade secret does not require public disclosure, but protection can be lost if the information becomes public or is independently developed. Trade secret protection is available under state law, and the Defend Trade Secrets Act of 2016 also established a federal civil cause of action for certain misappropriation claims. [8]

A Coordinated IP Strategy

A coordinated strategy may involve more than one form of IP protection. Depending on the facts, patents may address compositions, formulations, or methods of use; trade secrets may protect confidential processes or know-how; and trademarks may identify the source of lawful goods or services. The appropriate combination depends on the innovation, applicable law, disclosure needs, research goals, and plans for translation or commercialization.

Genetic Resources and Associated Traditional Knowledge

Research and patenting involving genetic resources or associated traditional knowledge can also raise questions about attribution, consent, access, and benefit-sharing. The Convention on Biological Diversity and the Nagoya Protocol provide international frameworks relevant to access and benefit-sharing, although implementation varies by jurisdiction. In May 2024, the World Intellectual Property Organization member states adopted a treaty establishing a patent disclosure requirement for certain inventions based on genetic resources or associated traditional knowledge. The treaty’s requirements apply through contracting parties after the treaty enters into force; adoption alone did not make the requirement universally applicable. [9,10,11]

For cannabis, these considerations may arise when research or patent claims rely on plant varieties, cultivation practices, extraction methods, or other knowledge associated with Indigenous Peoples or local communities. Researchers and applicants should evaluate the provenance of materials and knowledge, the law of the relevant jurisdiction, applicable institutional requirements, and whether consultation or benefit-sharing obligations apply.

Documentation initiatives and community-led governance approaches may also help preserve evidence of existing knowledge and support appropriate recognition. Because the relevant legal and ethical frameworks vary, these issues should be addressed early in research planning and IP strategy rather than after a project has advanced.

This article is provided for general informational purposes and does not constitute legal advice. Cannabis and intellectual-property laws continue to evolve; readers should consult qualified counsel regarding specific circumstances.