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Welcome to Mofo Life Sciences

MoFo Life Sciences shares timely legal and business insights and in-depth analyses on trends and the complex technologies at the heart of the global pharmaceutical, biotechnology, diagnostics, medical devices, digital health, and AgTech fields.

March 25, 2025 - AI, Healthcare
AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts
By: Matthew A. Ferry and Tricia Matibag
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of
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March 25, 2025 - FDA
HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway
By: Claudia M. Vetesi, Brigid DeCoursey Bondoc and Alex M. Schroth
On March 10, the U.S. Department of Health and Human Services (HHS) issued a press release emphasizing “radical transparency to make sure all Americans know what is in their food” and announcing that HHS Secretary Robert F. Kennedy Jr. directed the U.S. Food and
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March 24, 2025 - Intellectual Property, Medical Devices + Diagnostics, Pharma
Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents
By: Lisa N. Silverman Ph.D. and Emily Jane Roberts Ph.D.
On March 13, 2025, the Federal Circuit issued a decision in Merck Sharp & Dohme B.V. v. Aurobindo Pharma USA, Inc. , No. 23-2254 (Fed. Cir. 2025) that clarifies how patent term extension (PTE) is calculated for reissue patents. PTE was established under the
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March 10, 2025 - Intellectual Property
Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods
By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.
On March 6, 2025, the United States Court of Appeals for the Federal Circuit (“Federal Circuit”) issued a precedential decision in ImmunoGen, Inc. v. Stewart , in which the court clarified its standards for determining obviousness in the context of a claimed method of
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March 04, 2025 - AI, Intellectual Property
Navigating Inventorship in the Era of AI-Assisted Drug Discovery
By: Caressa Tsai Ph.D., Joshua A. Crawford and Meghan McLean Poon Ph.D.
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of
... ›
February 27, 2025 - Intellectual Property
Federal Circuit addresses subject matter eligibility for compositions of matter in US Synthetic v. ITC
By: Karen G Potter Ph.D. and Rebecca Weires
Earlier this month, the Federal Circuit decided a subject matter eligibility case closely watched in the pharmaceutical industry. The case involved composition-of-matter claims reciting measured results. Reversing the decision below, the court ruled that the claims were directed to concrete structures, not patent-ineligible abstract
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February 11, 2025 - AI, Intellectual Property
Patents and Trade Secrets in AI and Life Sciences
By: Briana Erin Mittleman Ph.D., Meghan McLean Poon Ph.D. and Joshua A. Crawford
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of
... ›
January 21, 2025 - AI, FDA, Regulatory
FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions
By: Ashley E. Quinn, Brigid DeCoursey Bondoc, Erin M. Bosman, Julie Y. Park and Elena Catherine Klonoski
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of
... ›
January 17, 2025 - FDA, Healthcare
Front-of-pack, Front-of-mind
By: Claudia M. Vetesi and Lauren N. Margolies
On Tuesday, FDA proposed a rule that would require a front-of-pack mini nutrition label on most packaged foods by 2028. This is yet another effort by FDA to make it easier for consumers to determine which foods are “healthy” at a quick glance. Last
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January 16, 2025 - FDA, AI, Regulatory
FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality
By: Ashley E. Quinn, Brigid DeCoursey Bondoc, Erin M. Bosman, Julie Y. Park and Elena Catherine Klonoski
This post is part of MoFo’s 2025 Intersection of AI and Life Sciences blog series. In this blog series, we explore how artificial intelligence is revolutionizing research, innovation, and patient care in the life sciences. Stay tuned for expert insights regarding the impact of
... ›

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Welcome to Mofo Life Sciences

AI Agent as a Service in Medtech: Key Considerations for Commercial Contracts

By: Matthew A. Ferry and Tricia Matibag

HHS Secretary to FDA: Consider Elimination of GRAS Self-affirmation Pathway

By: Claudia M. Vetesi, Brigid DeCoursey Bondoc and Alex M. Schroth

Federal Circuit Clarifies Patent Term Extension Calculation for Reissue Patents

By: Lisa N. Silverman Ph.D. and Emily Jane Roberts Ph.D.

Navigating Obviousness: Federal Circuit Addresses Patentability of Pharmaceutical Dosing Methods

By: Jeffrey W. Schmidt Ph.D. and Karen G Potter Ph.D.

Navigating Inventorship in the Era of AI-Assisted Drug Discovery

By: Caressa Tsai Ph.D., Joshua A. Crawford and Meghan McLean Poon Ph.D.

Federal Circuit addresses subject matter eligibility for compositions of matter in US Synthetic v. ITC

By: Karen G Potter Ph.D. and Rebecca Weires

Patents and Trade Secrets in AI and Life Sciences

By: Briana Erin Mittleman Ph.D., Meghan McLean Poon Ph.D. and Joshua A. Crawford

FDA Draft Guidance on Artificial Intelligence-Enabled Device Software Functions

By: Ashley E. Quinn, Brigid DeCoursey Bondoc, Erin M. Bosman, Julie Y. Park and Elena Catherine Klonoski

Front-of-pack, Front-of-mind

By: Claudia M. Vetesi and Lauren N. Margolies

FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality

By: Ashley E. Quinn, Brigid DeCoursey Bondoc, Erin M. Bosman, Julie Y. Park and Elena Catherine Klonoski