Lowenstein Sandler partner and Chair of the firm’s Life Sciences & Chemical Patent practice Robert J. Paradiso has contributed a chapter on patentability to the academic publication Kratom: History Science and Potential, edited by Jack E. Henningfield, Chad E. Beyer, and Robert B. Raffa for Academic Press.
The book is the first to address the unregulated, widespread availability of kratom, with its weak opioid and stimulant effects, coupled with limited awareness of it by healthcare professionals. Kratom has great therapeutic utility and medicinal potential, but more study, caution, and possible regulation are needed. The book discusses geographical sourcing, historical uses, current worldwide uses, and potential for treatment of other medical conditions. Most exciting for healthcare professionals will be the implications of this substance's potential for treatment of diseases like depression, ADHD, PTSD, and substance-use disorder, particularly opioid use disorder (OUD).
Paradiso writes on the patentability and exclusivity of kratom-based natural products, explaining the process required for U.S. regulatory approval and patent protections for new drugs and offering some product life cycle management strategies.
Paradiso observes that while the development and commercialization of kratom-based pharmaceutical products may face significant regulatory-related challenges, “kratom's potential therapeutic benefits warrant further scientific investigation.” He advises that a “robust patent strategy, including the identification of novel formulations and uses, is essential to secure intellectual property protection and recoup the substantial investments required for drug development.” He adds: “With the proper strategy and implementation of a holistic approach, a valuable kratom patent portfolio can be created for a product developer—one that will both advance human health and wellness and prove commercially viable.”
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