Patenting Personalised Medicine – One Size Does Not Fit All

Sterne Kessler Director Paul A. Calvo, Ph.D., and Associate Emily S. Tkac authored the IAM article “Patenting Personalised Medicine – One Size Does Not Fit All,” highlighting intellectual property (IP) pitfalls of personalized medicine innovation and how to sidestep them. The article is featured in IAM’s Special Report 2024 Q4: New Dawn for Life Sciences IP Strategy.

Personalized medicine creates new opportunities for life sciences innovation. Calvo and Tkac discuss the complexities and challenges associated with securing patent protection in the field of personalized medicine, emphasizing that traditional patent frameworks may not adequately address the unique aspects of personalized treatments, which are tailored to individual genetic profiles.

The authors discuss global perspectives on patentability and provide an in-depth review of subject matter eligibility and USPTO guidance. The article emphasizes the need for a more nuanced approach to IP rights to foster innovation while ensuring accessibility. It also covers the ethical considerations and regulatory hurdles that accompany the patenting process in this sector.