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
Below is Alston & Bird’s Health Care Week in Review, which provides a synopsis of the latest news in health care regulations, notices, and guidance; federal legislation and congressional committee action; reports, studies,...more
In a 5-4 ruling this month, the U.S. Supreme Court’s decision in Medical Marijuana, Inc. v. Horn significantly expanded a plaintiff’s ability to sue under the Racketeer Influence and Corrupt Organizations Act (RICO) for...more
Resolving a deep split among federal circuit courts, the U.S. Supreme Court has broadened plaintiffs’ ability to sue under the Racketeer Influenced and Corrupt Organizations Act (RICO) for economic loss stemming from personal...more
Welcome to your monthly rundown of all things administrative law, where we highlight all the happenings you may have missed. ...more
Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...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
On October 11, 2024, Edwards filed a petition for a writ of certiorari with the U.S. Supreme Court. The question presented, as framed by Edwards, is: “Whether, under Hatch-Waxman’s safe harbor, an infringing act is “solely...more
Whistleblower Watch is a critical resource for in-house counsel and compliance professionals. Each quarter, Cozen O’Connor summarizes the most notable False Claims Act (FCA) enforcement actions, settlements, and legal trends,...more
On August 7, 2024, the Centers for Medicare & Medicaid Services (“CMS” or the “Agency”) issued a final procedural notice (“Notice”) outlining a new Medicare coverage pathway, aimed at achieving timelier and predictable access...more
The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more
On December 1, 2023, amendments to Federal Rule of Evidence (FRE) 702 geared toward emphasizing and explaining the responsibility of the judge as a “gatekeeper” for expert testimony took effect. On December 18, 2023, one of...more
The US Supreme Court rules that, under the Federal False Claims Act (FCA), the knowledge and subjective beliefs of a defendant at the time a false claim was submitted are determinative, and post hoc objectively reasonable...more
Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more
US and EU Life Sciences Law firms Fieldfisher & Gardner Law recently held a CLE event in Silicon Valley covering Healthcare Compliance, Data Privacy and Regulatory hot topics for MedTech and Pharma companies. Discussion...more
For most of us, we’re stuck in the August heat, on delayed European vacations, or hopefully just hanging out at the beach. But for the Court it still was work as usual, including a return trip to the Federal Circuit for the...more
For sale, or not for sale- That is the question in Larry G. Junker v. Medical Components Inc. et al., case that started in the U.S. District Court for the Eastern District of Pennsylvania and which has now been appealed to...more
A medical device patentee has asked the U.S. Supreme Court to save his design patent, related to an introducer sheath handle, from invalidity based on application of the “on-sale” bar, which prohibits patenting an invention...more
The U.S. Supreme Court recently decided a case resolving a patent dispute between two medical device companies, Hologic, Inc. and Minerva Surgical. The opinion was closely watched because it raised the question of whether an...more
The Supreme Court’s recent decision in Minerva Surgical Inc. v. Hologic, Inc. has drastically limited the doctrine of assignor estoppel, requiring patent practitioners to reconsider assignment and other contractual provisions...more
The doctrine of assignor estoppel bars an inventor who assigns a patent to a third party from later arguing that the assigned patent is invalid. The Supreme Court has now upheld this doctrine but has limited its scope,...more
The Supreme Court clarified the doctrine of assignor estoppel in its June 29th Minerva v. Hologic opinion. In doing so, the Court vacated the Federal Circuit’s opinion estopping Minerva from arguing that Hologic’s patent is...more
On June 29, 2021, the Supreme Court published its divisive opinion in Minerva Surgical, Inc. v. Hologic, Inc., Et. Al. The 5-4 decision penned by Justice Kagan upheld the centuries-old doctrine of Assignor Estoppel, while...more
The U.S. Supreme Court’s June 29 decision in Minerva Surgical, Inc. v. Hologic, Inc. has important implications for inventors who assign patent rights, employers to whom employees assign patent rights, other assignees, and...more
In a decision reaching all corners of the technology sector, the U.S. Supreme Court on June 29, 2021 held that, when fairness requires, a patent inventor can contest a patent's validity after assigning it to a third party....more
Rooted in the principle of fairness, the doctrine of assignor estoppel generally prevents an inventor, who had previously assigned their patent rights to another for value, from later contesting the validity of the assigned...more