MoFo Life Sciences

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Firm Profile: Morrison & Foerster LLP
425 Market Street
San Francisco, CA 94105-2482, United States
Phone: (415) 268-7000
Fax: (415) 268-7522
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FDA Releases Draft Guidance on Evaluating the Risk and Credibility of AI Used in Establishing Drug and Device Safety, Effectiveness, and Quality

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…more
 /  Administrative Law, Health, Science, Computers, & Technology

Front-of-pack, Front-of-mind

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…more
 /  Administrative Law, Consumer Protection, Health

What is “Healthy?” Are Fats In?

Yesterday, FDA released the final rule that updates the definition for “healthy” nutrient content claims. In an update that may be long overdue, manufacturers who use the term “healthy” (or derivative terms: “health,”…more
 /  Health, Science, Computers, & Technology

Stop-Gap Spending Bill Provision Takes Aim at Biologics Patent Litigation

UPDATE: The stop-gap spending bill has been revised to remove the provision discussed herein. However, life sciences companies should nonetheless take note of efforts by congress to enact patent-related reforms such as this…more
 /  Health, Intellectual Property, Science, Computers, & Technology

USPTO Fee Changes for 2025

In the November 20, 2024 Federal Register Notice, the United States Patent and Trademark Office (USPTO or the “Office”) released its final rule on patent fee adjustments (“Final Rule”). These fee adjustments, set to take effect…more
 /  Intellectual Property

An Insecure Future: Court Ruling Guts USDA Regs On Genetically Engineered Plants

In a decision that raises significant questions about the future oversight of genetically engineered (GE) plants in the United States, the U.S. District Court for the Northern District of California on Monday, December 2, 2024,…more
 /  Administrative Law, Agriculture, Health, Science, Computers, & Technology

USPTO Withdraws Consideration Of Controversial Change To Terminal Disclaimer Practice

On December 4, 2024, nearly seven months after issuing a Notice of Proposed Rulemaking that proposed major and controversial changes to terminal disclaimer practice, which we previously discussed in an earlier blog post, the…more
 /  Intellectual Property, Science, Computers, & Technology

Patent Term Extension For Medical Devices

Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could not…more
 /  Health, Intellectual Property, Science, Computers, & Technology

Patent Vs. Trade Secret Considerations For Cell And Gene Therapies

Understanding what to patent versus what to keep as a trade secret is an increasingly important and challenging decision facing companies developing biologics products, such as cell and gene therapies, where technologies are…more
 /  Health, Intellectual Property, Science, Computers, & Technology

Establishing Unexpected Results: PTAB Highlights Pitfalls For Rule 132 Declarations

A recent decision by the Patent Trial and Appeal Board (PTAB) sheds light on certain pitfalls patent applicants may encounter when submitting declarations under 37 C.F.R. § 1.132 (“Rule 132 Declarations”). Rule 132 Declarations…more
 /  Intellectual Property

Beyond Final Rejection: What’s Next For Patent Prosecution After USPTO Terminates Its After Final Consideration Program?

On October 1, 2024, the United States Patent and Trademark Office (USPTO) announced that it is terminating its After Final Consideration Pilot Program 2.0 (AFCP 2.0), which is set to expire on December 14, 2024. The expiration…more
 /  Intellectual Property

Under Lock And Key – Private Sales May Not Qualify As Public Disclosure

Recently, the Federal Circuit affirmed a PTAB decision finding that a private sale of a product did not constitute a public disclosure by the inventor of the product. The Leahy-Smith America Invents Act provides exceptions for…more
 /  Intellectual Property

Federal Circuit Clarifies Scope Of Obviousness-Type Double Patenting In Allergan USA V. MSN Laboratories

On August 13, 2024, the U.S. Court of Appeals for the Federal Circuit issued a welcomed decision to patentees in Allergan USA, Inc. v. MSN Laboratories Private Ltd., No. 24-1061 (Fed. Cir. 2024) clarifying the scope of…more
 /  Business Organizations, Intellectual Property, Science, Computers, & Technology

Senate Unanimously Passes Bill To Limit Patent Infringement Challenges By Drug Manufacturers

The Affordable Prescriptions for Patients Act (APPA) of 2023 unanimously passed the Senate on July 11, 2024. The APPA was first introduced to the House on January 30, 2023 by Representative John Cornyn (R-Tx), with the aim of…more
 /  Health, Intellectual Property, Science, Computers, & Technology

The PTAB Axes Skin Treatment Patent Under Amgen

The Patent Trial and Appeal Board (“PTAB”) recently invalidated a University of Massachusetts (“UMass”) patent related to the treatment of the skin disease vitiligo in a post-grant review. (See Forte Biosciences Inc v…more
 /  Health, Intellectual Property, Science, Computers, & Technology
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