Patent eligibility under 35 U.S.C. § 101 should be a straightforward threshold question: any “new and useful process, machine, manufacture, or composition of matter” is eligible for protection. Yet over time, this once-clear principle has become anything but.
Although the statute itself has remained unchanged for two centuries, its interpretation has evolved dramatically through judicial
Since the year began, we have attempted to divine the new administration’s approach to regulating human cell and tissue products (“HCT/Ps”).[1] What we have found is a collection of seemingly contradictory signals, keeping us guessing as to whether we will see an increase or decrease in HCT/P regulation – either by written regulation or
To all in-house counsel working in the pharmaceutical, medical device, biotech, and digital health industries: if you’re looking to complete a few final CLE hours before the end of 2025, we invite you to attend Reed Smith’s annual Virtual Life Sciences CLE Week, taking place from November 3 through November 7, 2025.
This week-long event
The Alliance to Stop Foodborne Illness, a program of the nonprofit consumer advocacy group Stop Foodborne Illness, proudly announces its annual list of 40 Under 40 Food Safety Professionals, Class of 2025.
This group represents innovative minds dedicated to advancing food safety and protecting public health worldwide. The up-and-coming professionals demonstrate exceptional leadership, groundbreaking
As we’ve discussed earlier several times, there is a lot of lawyer advertising on television and in other media, and it can have adverse effects. A lot of it also is of questionable accuracy, giving “the false impression that they reflect medical or governmental advice,” using phrases such as “consumer medical alert,” “health alert,”
Courses rarely live in one place. A video on your platform, slides in a folder, worksheets in a download, templates you keep improving. If you create a course, you own the rights to the words, images, and structure you made. Registering those rights creates a public record and unlocks stronger remedies if someone reuses your
On September 9, 2025, the U.S. Food and Drug Administration (“FDA”) Office of Prescription Drug Promotion (“OPDP”) issued a torrent of untitled letters, 40 in total, just days after rumblings that FDA would be cracking down on direct to consumer (“DTC”) advertising of pharmaceuticals.[1] This enforcement flurry—which we will digest in a later blog post,
The U.S. gave crypto one of its biggest regulatory jolts in years. With the signing of the Guiding and Establishing National Innovation for U.S. Stablecoins (“GENIUS”) Act stablecoins now have a legal framework. The GENIUS Act is part of a broader push to accelerate the development of emerging technologies in the U.S., from artificial intelligence
The rush to integrate AI is understandable. New tools promise faster drafting, richer research, and smoother operations. Adoption alone, however, is not enough. When powerful systems land in people’s hands without a shared understanding of how to use them well, the risks expand as quickly as the possibilities. A parallel track in AI literacy changes
At OG+S, we’re committed to staying ahead of the curve as technologies evolve — not for the sake of change itself, but because smarter tools help us serve clients better and create a more effective work environment for our team.
In today’s rapidly shifting legal landscape – efficiency, security, and flexibility are critical. That’s why