By Thomas J. Kowalski, Vicki G. Norton, Ph.D., Jarrad M. Gunther and Brandon A. Chan, Ph.D. In defending against allegations of patent infringement, there are numerous avenues to invalidating an asserted patent or rendering it unenforceable. Invalidity contentions can include asserting that the claims are
Duane Morris Life Sciences Law
Duane Morris Life Sciences Law, published by Duane Morris LLP, focuses on legal issues affecting the life sciences sector. The blog covers topics such as patent eligibility and intellectual property protection for emerging technologies like AI and diagnostics, regulatory compliance in financing and exit strategies, product liability concerns, and health economics related to personalized medicine. It also addresses legal challenges in wearable technology and provides insights on navigating complex intersections of scientific innovation, investment, and legal frameworks within the life sciences industry.
Latest from Duane Morris Life Sciences Law - Page 2
U.S. Supreme Court Grants Certiorari in Hikma v. Amarin, Placing “Skinny Label” Inducement in Focus
On January 16, 2026, the Supreme Court of the United States granted certiorari in Hikma Pharmaceuticals USA Inc. v. Amarin Pharma, Inc. (No. 24-889) to address when induced-infringement liability can attach to a generic drug launched under a “skinny label.” The grant…
FDA Launches the TEMPO Pilot for Digital Health Devices to Improve Patient Access to Technologies
By Duane Morris
By Vicki G. Norton, Ph.d., Frederick R. Ball and Victoria (Tori) Hawekotte The U.S. Food and Drug Administration has announced the Technology-Enabled Meaningful Patient Outcomes (TEMPO) for Digital Health Devices Pilot, through which FDA would exercise enforcement discretion over participant…
USPTO Signals Strong Support for Patent Eligibility in Cutting-Edge Technologies
By Duane Morris
The USPTO’s new director has singled out AI, distributed ledger technologies and diagnostics as prime areas of innovation that merit patent protection. Companies, investors and other stakeholders are closely watching how the USPTO’s active guidance may better align patent practice…
Financing and Exit Strategies in Life Sciences: Aligning Capital with Compliance and IP Value
By Duane Morris
By Driscoll R. Urgate, P.A. Financing and exit transactions in the life sciences industry differ fundamentally from those in traditional technology or manufacturing sectors. Scientific risk, regulatory oversight, and intellectual property rights intersect at every stage of a company’s growth,…
Vicki Norton to Speak at Personalized Cancer Vaccine Summit
By Duane Morris
Duane Morris Partner Vicki G. Norton, Ph.D., will be speaking at the Personalized Cancer Vaccine Summit in Boston on Thursday, November 20. She will be on the panel “Health Economics, IP & Early Access: Navigating Legal Grey Zones in the…
Replay: Wearables Webinar Series, Part 3: Product Liability and IP Strategies for Wearables
By Duane Morris
A replay of “Wearables Webinar Series, Part 3: Product Liability and IP Strategies for Wearables” is now available for viewing.
Wearables Webinar Series, Part 3: Product Liability and IP Strategies for Wearables
By Duane Morris
Duane Morris will host the third session of its Wearable Webinars Series, Product Liability and IP Strategies for Wearables, on Tuesday, November 4, 2025, 12:00 p.m. to 12:30 p.m. Eastern. REGISTER About the Program As wearables continue to reshape industries—from…
Replay: Wearables Webinar Series, Part 2: Cybersecurity and Data Privacy Concerns for Wearables
By Duane Morris
A replay of “Wearables Webinar Series, Part 2: Cybersecurity and Data Privacy Concerns for Wearables” is now available for viewing.
Replay: Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables
By Duane Morris
A replay of “Wearables Webinar Series, Part 1: Update on FDA Regulation on Wearables” is now available for viewing.