When “About” Becomes Indefinite: Federal Circuit Provides Guidance for Life Science Patent Applications Regarding Limits of Approximation in Enviro Tech v. Safe Foods
Key Takeaway: The term “about” remains useful in biotech and pharmaceutical claims, but only if the patent provides objective guidance about what the term means. Absent that guidance, “about” may...
Changes to Mexican Patent Law May Impact Life Science Patent Prosecution
Key Takeaway: While recent amendments to Mexico’s patent laws promote faster prosecution and earlier decisions on patents, concerns abound as to the feasibility and integrity of the prosecution process. On...
Amendments to Mexico’s Federal Law for Protection of Industrial Property Inform More Flexible International IP Strategy for Biotech Companies
Key Takeaway: Amendments to Mexico’s Federal Law for Protection of Industrial Property align more with U.S. Patent and Trademark Office standards for restoring priority and application revival, increasing international patent...
Federal Circuit Confirms Patent Eligibility of Gene Therapy Patent in Regenexbio Inc. v. Sarepta Therapeutics
Key Takeaway: Genetically engineered cultured host cells containing recombinant nucleic acids useful for gene therapy are patent-eligible for being markedly different from anything occurring in nature. In REGENXBIO Inc. v....
AI Risks With the Patent Office: What Life Science Companies Should Be Asking Now
Key Takeaway(s): AI tools are reshaping patent preparation and prosecution, but statements made to the USPTO are permanent, and AI-generated inaccuracies don’t come with warning labels. Efficiency gains are real, but...
Well-Known Genus, Novel Method: A Post-Amgen Framework for Written Description & Enablement
Key Takeaways: Recent Federal Circuit decision draws a meaningful distinction between patents that claim a broad genus as the invention itself and those that claim a novel therapeutic method using...
FDA Issues Recommendations for the Development of Individualized Therapies for Patients With Ultra-Rare Diseases
Key Takeaway: The FDA is developing a “plausible mechanism framework” to facilitate approval of individualized therapies for the treatment of rare genetic diseases that currently face approval challenges. As discussed previously...
One Battle After Another: Broad Institute Wins at PTAB in CRISPR Dispute
Key Takeaways: Interference proceedings, though increasingly rare, are heavily evidence-based and determine which party is the first inventor when two or more applicants claim the same patentable invention. Sometimes, an...
IP Considerations Following FDA Announcement on Flexibility for Cell and Gene Therapies
Key Takeaways: Manufacturing processes of cell and gene therapies (CGTs) may remain fluid well into development and even after FDA approval, and therefore sponsors of CGTs may benefit from patent...
New FDA Guidance Allows Biosimilar Applicants to Use Data From Outside the U.S. To Accelerate Their Approval in the U.S.
Key Takeaway: New FDA guidance released on February 23, 2026, and March 9, 2026, signals a continued shift toward regulatory flexibility aimed at accelerating approval of biosimilar treatments for rare...
AI and Genomics: A New Era of Personalized Medicine
Key Takeaway: Advances in AI and genomic analysis will allow medical providers to tailor treatment for individual patients at the genome level, but challenges exist for protecting AI-assisted inventions. Genomic...
Practical Application and Particular Treatment: What the USPTO’s December 4 Memorandum Means for Life Sciences §101 Eligibility
The USPTO’s December 4, 2025 memorandum on Subject Matter Eligibility Declarations (SMEDs) seeks to raise awareness of the “underutilized path” of submitting Rule 132 declarations, referred to as “SMEDs”, for...
Proposed Legislation to Codify “Skinny Label” Safe Harbor
On December 5, 2025, the Skinny Labels, Big Savings Act (H.R. 6485) was introduced in the House of Representatives. The bill, if enacted, would shield certain drug manufacturers who have...
Life Science Considerations on the USPTO’s New Guidelines for AI-Assisted Inventorship
On November 26, 2025, the United States Patent and Trademark Office (USPTO) issued revised guidelines for determining inventorship of AI-assisted inventions,[1] which is a significant development in life science innovations,...
USPTO’s Automated Search Pilot: Through a Biotech Lens
In October 2025, the U.S. Patent and Trademark Office (USPTO) launched the “Artificial Intelligence Search Automated Pilot Program,” or ASAP!, an initiative to identify potential prior art using artificial intelligence...
Patent Exclusivity and Price Controls: Teva v. Kennedy
On November 20, 2025, the D.C. District Court issued its opinion [1] in a lawsuit where Teva Pharmaceuticals USA, Inc. challenged the validity of the Medicare Drug Price Negotiation Program...
Purdue Pharma’s $7.4 Billion Chapter 11 Plan Formally Approved
A federal bankruptcy court on November 18 formally approved Purdue’s $7.4 billion Chapter 11 plan to settle thousands of opioid-related lawsuits. The plan requires (1) a $6.5 billion contribution from...
USPTO, JPO, and EPO Meet to Discuss Global IP Challenges
Beginning on October 20, 2025, recently confirmed United States Patent and Trademark Office (USPTO) Director John A. Squires met with European Patent Office (EPO) Vice-President Steve Rowan and Japanese Patent...
AI and the Fight Against Antimicrobial Resistance
Antimicrobial resistance has become a major concern in recent years. According to studies, approximately 1.1 million deaths each year are linked to bacterial resistance to antimicrobial drugs.[1] The fear of...
New FDA Program Prioritizes Review of Certain ANDAs
On October 3, 2025, the U.S. Food and Drug Administration (FDA) unveiled a pilot prioritization program that provides for accelerated review of abbreviated new drug applications (ANDAs) for generic companies...
Eyeing the Prize of the U.S. Patent System, the Trump Administration Proposes Patent Maintenance Fee Overhaul
The Trump administration is considering changing the U.S. patent maintenance fee structure from the existing three fixed flat fees to an annual, value‑based “tax” model where patent holders would pay...
