[1]   On November 28, 2025, the United States Patent and Trademark Office (“USPTO”) issued revised examination guidance regarding how patent law applies to inventions created with the assistance of AI, specifically regarding inventorship. [2]  The USPTO’s new guidance rescinds the February 2024 guidance in its entirety and replaces it with a revised framework. [3]  The new guidance clarifies how inventorship is determined in patent applications for inventions created with th

[1] Semaglutide drugs, sold under the brand names Ozempic and Wegovy, saw a substantial increase in use for treating diabetes and obesity, driving nationwide shortages. [2]  During the shortage, the FDA’s drug-shortage-list policies allowed compounding to expand as a practical substitute for the approved products.  [3]   Background Pharmacies compound patient-specific drugs when a suitable commercial product is unavailable. [4]  Under § 503A of the Food, Drug, and Cosmetic Ac

[1] I. Background on the Orange Book A.    Origin and Role of the Orange Book On October 31, 1980, the FDA’s released its first edition of the Approved Drug Products with Therapeutic Equivalence Evaluations (playfully named the “Orange Book”), which identifies drugs that are approved based on safety and effectiveness. [2]  This database is monitored by the FDA and provides a list of patents and the market exclusivities that protect brand-name drugs. [3]  The Orange Book play

[1] Overview On September 5, 2025, U.S. Circuit Judge William Bryson handed down a decision on a patent infringement suit brought by ConGlobal Technologies against Roboflow Inc. [2] ConGlobal held three patents for systems where they utilize machine learning to manage the position of railcars on railways, U.S. Patent numbers 12,217,183 (‘183), 12,020,148 (‘148), and 12,254,439 (‘439), which they alleged were infringed upon by Roboflow. [3] Roboflow made a motion to dismiss

Photograph of a courthouse, in iStock (last visited Nov. 16, 2024). Amazon’s APEX Program and Traditional Patent Claims In 2022, Amazon launched the APEX program, a tool designed to help patent owners safeguard their intellectual property by preventing the sale of infringing products on Amazon’s website. [1]  For a fee of $ 4,000, a utility patent owner can submit a claim of infringement against up to twenty sellers on Amazon. [2]  The accused seller has three options: (1)

Photo by Louis Reed, downloaded from and available on Unsplash Biosimilars versus Biologics Biosimilars are a class of medications that provide safe and effective treatment for a wide range of illnesses includingchronic skin and bowel diseases, arthritis, and certain cancers. [1]   Unlike traditional “small molecule” drugs, biologics are typically derived from living organisms like yeast and bacteria and are much more complex in terms of structure, composition, and manufactur

[1] The patent system in the United States is intended to promote innovation and serve as the catalyst for creative inventions. [2] Specifically, patent rights have a substantial impact on the prescription drug industry; this impact is on both the development of new drugs as well as the pricing of such drugs. [3] Patents are desired by innovators because they give the patent holder “exclusivity” of their work. [4] This creates a “temporary monopoly” on the invention, wh