Key Takeaways: Patenting Personalized Medicine: One Size Does Not Fit All

Personalized medicine continues to reshape life sciences innovation, but it also introduces unique challenges in today’s evolving legal landscape.

In the webinar, “Patenting Personalized Medicine: One Size Does Not Fit All,” Sterne Kessler’s Paul Calvo, Ph.D. and Emily Tkac discussed how innovators can navigate patent subject matter eligibility, prior art risks, and global claim strategies when protecting personalized medicine inventions. Highlights include key business and legal insights focused on practical considerations for patent drafting and prosecution not only in the United States but across major jurisdictions.

1. Specific treatment claims are critical for U.S. eligibility: Claims tied to a specific drug, patient population, dose, and outcome are more likely to survive subject matter eligibility challenges.
2. Patents should be drafted with divided infringement in mind: Personalized medicine workflows include several different actors, such as the patient, the lab, the physician, and the pharmacist. Structuring claims so that one actor performs the active step can strengthen both enforcement and eligibility positions.
3. Global differences must be addressed early: Jurisdictions such as Europe, China, and India impose distinct claim format and evidence requirements that cannot easily be fixed later.
4. Clinical trial disclosures can become prior art: Even registrations without data may be used against later‑filed claims, so timing strategy for filings should be a strategic priority.
5. AI‑based personalized medicine claims require practical application: Claims must go beyond data processing steps and include concrete treatment steps or technological improvements.

Patenting personalized medicine requires a proactive, globally informed strategy that integrates eligibility, enforcement, and timing considerations. Watch the on demand webinar for further analysis.