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...
FDA Announces Review of New Clinical Trials That Export Americans’ Biological Samples to Hostile Countries
On June 18, 2025, the U.S. Food and Drug Administration (FDA) announced that it will review new clinical trials that involve sending biological samples to “hostile countries,” to prevent exploitation...
CRISPR Dispute Heats Up With Recent Federal Court Decision
On May 12, 2025, the U.S. Court of Appeals for the Federal Circuit (CAFC) revived the Regents of the University of California’s (Regents) challenge to the Broad Institute’s CRISPR-Cas9 patents,...
Rare Disease Therapies Gain Momentum With Regulatory Support and Continued Market Growth
The landscape for rare disease treatments appears to be evolving rapidly, thanks to a confluence of regulatory momentum and a booming market forecast. Statements from key federal figures in recent...
Johnson & Johnson Study Shows Promise for the Treatment and Potential Cure of Multiple Myeloma
On June 3, 2025, the Journal of Clinical Oncology published a study funded by Johnson & Johnson, which showed that one-third of patients with relapsed/refractory multiple myeloma who were treated...
Executive Order 14297 and the Global Drug Market: Policy, Pricing, and Uncertainty
On May 12, 2025, President Trump issued Executive Order 14297[1] targeting prescription drug prices in America. The stated purpose of this order is to combat high drug prices in the...
U.S. Supreme Court Defers to Agency Decision-Making in FDA’s Denial of Premarket Approval of Flavored E-Cigarette Products
We previously reported a decision by the U.S. Food and Drug Administration (FDA), denying the premarketing authorization of several flavored e-cigarette product.[1] On April 2, 2025, the Supreme Court of...
FDA Publishes Case Studies and User Guide for Rare Disease Drug Developers
Drug development programs face unique challenges in demonstrating the safety and effectiveness of drugs for treating rare diseases. The FDA’s Accelerating Rare disease Cures (ARC) Program started the Learning and...
Two Bills Introduced to Target “Patent Thickets” and “Product Hopping”
On March 17, 2025, a bipartisan group of senators introduced two bills intended to decrease the cost of prescription drugs. The sponsors include Chuck Grassley (R-Iowa), John Cornyn (R-Texas), Richard...
National Institutes of Health (NIH) Announces Plan to Centralize Peer Review Process
On March 6, 2025, the National Institutes of Health (NIH) announced plans to centralize peer review of all applications for grants, cooperative agreements and research and development contracts within its...
District Court Finds the FDA Reasonably De-listed Eli Lilly’s Weight Loss Drug From Drug Shortage List
Congress authorized the FDA to determine whether a drug is “in shortage in the United States.” The FDA’s determination of a drug shortage triggers mechanisms designed to alleviate the shortage....
Suspension of the Climate Change Mitigation Pilot Program: What Happens Now?
Effective January 28, 2025, the new administration suspended the Climate Change Mitigation Pilot Program (CCMPP) at the United States Patent and Trademark Office (USPTO).[1] The USPTO had instituted this program...
Knobbe Martens Advises Pacira BioSciences in Acquisition of Remaining Equity Stake of GQ Bio
SAN DIEGO, Calif., February 28, 2025 – Pacira BioSciences, Inc., the industry leader in its commitment to deliver innovative, non-opioid pain therapies to transform the lives of patients, today announced...
