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...
Renewed Efforts in Congress for Pharmaceutical Patent Reform
With the recent convocation of the 119th Congress, a change in administration, and resignation of USPTO Director Vidal, pharmaceutical patent reform is likely on the minds of many in Washington....
Heading Towards an Optimistic Initial Public Offerings (IPOs) Resurgence in 2025?
On January 16th, 2025, GT Medical Technologies, announced that it has raised $37 million in Series D financing round. The financing round was led by Evidity Health Capital and joined...
Edwards v. Meril at the Supreme Court: Testing the Scope of Hatch-Waxman’s Safe Harbor
On October 11, 2024, Edwards[1] filed a petition for a writ of certiorari with the U.S. Supreme Court.[2] The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe...
End of an Era: The After Final Consideration Pilot Program 2.0 Concludes
The sun is officially setting on the United States Patent and Trademark Office’s (USPTO) After Final Consideration Pilot Program 2.0 (AFCP 2.0)[1]. This program, which has been instrumental in facilitating...
Novo Nordisk Seeks to Block Compounded Versions of Diabetes / Weight Loss Drug
On October 22, 2024, Novo Nordisk made a submission to the U.S. Food and Drug Administration (FDA) nominating Novo Nordisk’s semaglutide products (WEGOVY, OZEMPIC and RYBELUS) to be included in...
CDRH Announces Pilot Program to Improve Recall Communication
On November 21, 2024, the FDA’s Center for Devices and Radiological Health (CDRH) announced a pilot communications program for improving the timeliness for communicating high-risk recalls.[1] The CDRH intends for...
