Cell and gene therapies represent a transformative frontier in modern medicine, offering potential cures for previously untreatable conditions. However, securing intellectual property (IP) protection for these innovations...more
7/8/2025
/ Biotechnology ,
Clinical Trials ,
Intellectual Property Protection ,
Inventions ,
Life Sciences ,
Patent Applications ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Prior Art ,
Regulatory Requirements ,
USPTO
Those hoping the Court of Appeals for the Federal Circuit would finally resolve priority in the long-pending dispute between the University of California and the Broad Institute will have to wait a little longer. Oral...more
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....more
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....more
2/11/2025
/ Artificial Intelligence ,
Data Privacy ,
Enforcement ,
Healthcare ,
Innovation ,
Intellectual Property Litigation ,
Intellectual Property Protection ,
IP License ,
Life Sciences ,
Patent Applications ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Regulatory Requirements ,
Trade Secrets
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
11/15/2024
/ Biologics ,
Business Model ,
Damages ,
Discovery ,
Food and Drug Administration (FDA) ,
Healthcare ,
Injunctive Relief ,
Life Sciences ,
Non-Disclosure Agreement ,
Patent Infringement ,
Patent-Eligible Subject Matter ,
Patents ,
Reverse Engineering ,
Trade Secrets
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
On January 10, 2024, the USPTO released new Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc. et al. v. Sanofi et al.
The guidelines clarify that the...more
Standards for patenting antibodies have substantially tightened over the last few years restricting scope of antibody claims—or, in some cases, undermining the validity of granted patents. Most recently, Singapore updated...more
The Supreme Court’s recent decision in Amgen v. Sanofi puts a spotlight on enablement of functionally defined claims. Future developments may shed light on a number of remaining questions for patent applicants. Here are five...more
In ChromaDex Inc. v. Elysium Health Inc., the Federal Circuit found U.S. Patent No. 8,197,807 (the “’807 patent”), which is directed to a dietary supplement comprising an isolated vitamin, invalid for lack of subject matter...more
The standard for written description in the life sciences seems to have tightened lately, leading patent applicants to wonder what level of written support and working example data is necessary to support genus claims....more
The Federal Circuit continues to tighten the standards for written description of functional claims, particularly in the biologics realm, which is putting patent applicants in the position of having to pursue narrow claims...more
The United States Patent and Trademark Office (USPTO) published the latest revision to its Manual of Patent Examining Procedure (MPEP) on June 30, 2020. According to the Executive Summary, in this revision, nearly all of the...more