Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 236: Advocating for Accessible Diagnoses with Sydney Severance of Operation Upright
Federal Court Strikes Down FDA Rule on LDTs - Thought Leaders in Health Law®
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 233: Prioritizing Women’s Health Through Innovation with Lindsey Calcutt of Incora Health
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 228: Designing & Manufacturing Auto-Injectors with Kimberlee Steele of SHL Medical
Building a Business at the Intersection of Neurodata and Innovation With Rob Cooley
AGG Talks: Cross-Border Business Podcast - Episode 26: U.S. Enforcement Trends Targeting Foreign Pharmaceutical and Medical Device Manufacturers
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 209: North Carolina’s Life Sciences Industry with Laura Gunter of NCLifeSci
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 208: Extended Reality Technology and the ThinkReality Headset with Mattney Beck of Lenovo
AI in the Operating Room: Liability Issues for Device Makers — The Good Bot Podcast
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 201: SHL Medical’s Investment in the Carolinas with Kimberlee Steele of SHL Medical
The FDA's Response to AI Medical Innovation — The Good Bot Podcast
Meet Meaghan Luster: Patent Litigation Associate at Wolf Greenfield
FDA Releases Laboratory-Developed Tests Final Rule – Thought Leaders in Health Law
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 177: Brain Health and Research with Dr. Fridriksson, Neuroscientist, Professor, & Vice President of Research at the Universit
Transparency and the Open Payments Program
Medical Device Legal News with Sam Bernstein: Episode 19
Medical Device Legal News with Sam Bernstein: Episode 18
Medical Device Legal News with Sam Bernstein: Episode 17
Health + Tech - Improving Cancer Care With Digital Health Tools
Medical Device Legal News with Sam Bernstein: Episode 14
For the past decade, controversy regarding the laws of patent eligibility has created uncertainty in the minds of inventors and investors, especially in the biotechnology, medical diagnostics, and software industries adjacent...more
Join medical device and digital health entrepreneurs, CEOs of venture-backed companies, and business development executives from large Medtech and digital health companies, as well as angels, venture capitalists, and...more
United States Magistrate Judge James M. Wicks (E.D.N.Y.) recommended that Defendant Apple Inc.’s (“Apple”) motion to dismiss Plaintiff Joseph Wiesel’s (“Wiesel”) action for infringement of U.S. Patent No. 7,020,514 (the “’514...more
Connected technology products are a part of daily life. Connectivity standards – such as 5G and Wi-Fi – provide a common language that allows products from different manufacturers to communicate with each other. ...more
The inter partes review provisions of the Leahy-Smith America Invents Act have been criticized for the propensity of the Patent Trial and Appeal Board (PTAB) to find invalid all or at least some of the challenged claims,...more
In this edition of The Precedent, we outline the decision in Trudell Medical International Inc. v. D R Burton Healthcare LLC. The U.S. Court of Appeals for the Federal Circuit recently affirmed in part, reversed in part and...more
Late last year we reported on the United States Court of Appeals for the Federal Circuit decision holding that certain device patents should not have been listed in the FDA’s Orange Book since the claims of the patents in...more
In recent years, the rapid advancement of artificial intelligence (AI) and machine learning (ML) technologies has sparked a wave of innovation across various sectors, particularly in life sciences. ML technologies have...more
This month the Supreme Court denied certiorari on Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., and in doing so, seemingly indicated its support for a broad interpretation of the Hatch-Waxman safe harbor...more
This is the third post in a 3-part series. Below, we describe Example 49 which focuses on using AI to assist with a medical treatment....more
This case examines the application of trademark functionality doctrine in the medical device industry, specifically addressing whether the pink color of ceramic hip components can be protected as a trademark. The case...more
Welcome to Venable’s BiologicsHQ Monthly Injection - December 2024....more
This latest edition features an interview with retiring longtime Wilson Sonsini IP partner Vern Norviel and articles on MedTech and pharma trends for 2025, the eligibility of life sciences companies for qualified small...more
Surgimatix, our client spotlight this month, developed what can only be called a novel solution. Surgimatix is an early-stage medical device company pioneering the first proprietary laparoscopic device that delivers...more
On December 20th, 2024, the Court of Appeals for the Federal Circuit issued an important decision in Teva Branded Pharmaceutical Products R&D v. Amneal Pharmaceuticals that impacts Orange Book (OB) listings for patents...more
Earlier this year we reported on the Federal Trade Commission’s efforts taken against certain drug manufacturers when listing device patents in the FDA’s Orange Book. We concluded that the efforts to date by the FTC had a...more
The listing of patents in the Orange Book has an important role in intellectual property protection for pharmaceuticals. Patents listed in the Orange Book can include, without question, patents covering compositions or...more
Patent term extension (PTE) under 35 U.S.C. § 156 is a statutory program that restores to a patent at least a portion of the term that was effectively lost while the covered product was undergoing regulatory review and could...more
In a landmark decision (UPC_CFI_15/2023) delivered on November 15, 2024, the Unified Patent Court's Local Division in Munich (UPC, LDM) ruled in favor of Edwards Lifesciences Corporation in a patent infringement case against...more
Investment in artificial intelligence (AI) is rising fast. The International Data Corporation projects global spending on AI R&D will reach $632 billion by 2028, more than twice the expected total for 2024....more
Author’s Note: This is an updated version of the post to our blog dated October 30, 2024. Later that day, FDA announced the resolution of Novo Nordisk’s semaglutide shortage, which altered the conclusion of our original post...more
On September 23, 2024, Judge Kleeh of the Northern District of West Virginia denied Regeneron Pharmaceuticals, Inc.’s (“Regeneron”) motion for a preliminary injunction against Amgen Inc. (“Amgen”) related to Amgen’s filing of...more
In Teva Branded Pharm. Prods. R&D v. Amneal Pharms. of N.Y., LLC, the US District Court for the District of New Jersey ordered Teva to delist five patents from the Food and Drug Administration (FDA)’s Approved Drug Products...more
Recently, the Delaware Chancery Court and the Third Circuit issued three significant decisions on key issues affecting licensing and M&A transactions in the life sciences industry....more
We have been monitoring the dispute between Edwards Lifesciences Corp. (“Edwards”) and Meril Life Sciences Pvt., Ltd. (“Meril”) before and after the initial Federal Circuit decision. The dispute focused on whether Meril’s...more