Sterne, Kessler, Goldstein & Fox P.L.L.C.
Innovation in cannabis- and psychedelic-based products is accelerating, but the intellectual property landscape is becoming more strategic and complex. As clinical research expands and regulatory frameworks evolve, companies require an intellectual property strategy that considers patent eligibility issues and the interplay between patent and regulatory exclusivity. Success requires technical precision, lifecycle thinking, and close alignment with your company’s regulatory and commercial developments.
In the webinar “State of Play in the Cannabis and Psychedelic Patent Landscape: What You Need to Know,” Sterne Kessler’s David Holman, Ph.D. and Deborah Sterling, Ph.D. discuss the latest developments shaping IP in the cannabis and psychedelics sectors for legal and business leaders.
- Market Growth Is Reshaping Patent Strategy: Commercial growth in both cannabis and psychedelics is driving a corresponding rise in patent activity. As markets scale, companies need earlier and more deliberate exclusivity planning across products, formulations, delivery systems, and methods of use.
- Clinical Research Creates Both Value and Risk: Expanding clinical trial activity supports future product approvals and can strengthen patent filings, particularly for treatment claims. At the same time, more published research means more prior art, which raises the bar for novelty and nonobviousness challenges.
- Natural Products Require Careful Claim Drafting: Because naturally occurring materials are not themselves patentable, successful claims often depend on non-natural formulations, specific concentrations, defined combinations, or technically distinct applications. Precise drafting is essential for addressing subject matter eligibility concerns.
- Layered Portfolios Outperform One-Off Filings: The most resilient strategies combine multiple types of protection and multiple generations of patents. Broad claims, narrower fallback claims, follow-on indications, dosing refinements, and delivery innovations can all strengthen a portfolio as development progresses.
- Patent and Regulatory Exclusivity Should Work Together: The Epidiolex case study showed how patents, PTAB proceedings, district court litigation, and FDA exclusivity can all interact for a single product. The strongest market positions come from coordinating patent prosecution with regulatory milestones and lifecycle management.
