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
The Federal Circuit recently issued a precedential decision in Shockwave Med., Inc. v. Cardiovascular Sys., Inc. (CSI), affirming-in-part and reversing-in-part the Patent Trial and Appeal Board’s (PTAB) decision, and...more
Received wisdom is that inter partes review proceedings are limited to prior art as defined by patents and printed publications. But in recently decided Shockwave Medical, Inc. v. Cardiovascular Systems, Inc., another prior...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
The US Court of Appeals for the Federal Circuit found that a district court misconstrued claim terms based on a misapplication of the clear and unequivocal disavowal standard and vacated its noninfringement decision. Maquet...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
As the FTC continues to crack down on pharmaceutical manufacturers’ allegedly improper listing of patents in the FDA Orange Book, counsel for Teva and Amneal presented oral arguments in the Court of Appeals for the Federal...more
If you’ve ever wondered how they keep implanted medical devices from becoming dead weight when the batteries run out, this recent Federal Circuit decision addresses one solution—wireless charging through the skin! It also...more
On April 11, 2022, Niazi Licensing Corporation (“Niazi”) succeeded in part in its appeal at the Federal Circuit in Niazi Licensing Corporation v. St. Jude Medical S.C. Inc. Niazi’s lawsuit alleged that St. Jude Medical S.C....more
NIAZI LICENSING CORPORATION v. ST. JUDE MEDICAL S.C., INC. Before Taranto, Bryson, and Stoll. Appeal from the U.S. District Court for the District of Minnesota. Summary: Providing examples in the claim language and...more
By Memorandum Opinion entered in Conformis, Inc. v. Medacta USA, Inc., Civil Action No. 19-1528-RGA (D.Del. March 4, 2021), The Honorable Richard G. Andrews construed the remaining terms in dispute in the four (4)...more
The US Court of Appeals for the Federal Circuit affirmed in part and reversed in part two Patent Trial and Appeal Board (Board) decisions, finding that the Board erred in its construction of certain claim terms relating to an...more
Immunex Corp. v. Sanofi-Aventis U.S. LLC, Appeal Nos. 2019-1749, -1777 (Fed. Cir. Oct. 13, 2020) - In our Case of the Week, the Federal Circuit addressed the construction of the term “human antibodies.” In doing so, the...more
This month we highlight two reversals by the Federal Circuit and a summary judgment of indefiniteness from New Jersey. CASES - Federal Circuit - Grant of Preliminary Injunction Reversed - Indivior Inc. v. Dr....more
Under the U.S. Patent laws, claims must particularly point out and distinctly claim what the inventor understands her invention to be. Up until three years ago, the inquiry for determining indefiniteness was to ask whether...more
Andrews, J. Claim construction opinion issues regarding two terms from one patent. A Markman hearing took place on November 17, 2016. The disputed technology relates to biometric belt connectors....more
Addressing claim construction issues, the US Court of Appeals for the Federal Circuit reiterated the necessity of reading claims in the context of the written description when they are not clear on their face. Howmedica...more
Decision Date: August 7, 2015 - Court: U.S. Court of Appeals for the Federal Circuit - Patent: D661,801; D661,802; D661,803; D661,804 - Holding: Summary judgment of invalidity REVERSED; claim construction...more
Globus Medical, Inc. v. Depuy Synthes Products, LLC., et al., C.A. No. 13-854-LPS, August 14, 2015 - Stark, C.J. Claim construction opinion regarding 10 terms from 2 patents-in-suit...more
Andrews, J. The court construes terms relating to a patent for a device used to stabilize a human spine. The case was filed in January 2014. Oral argument was held on May 14, 2015 regarding 8 terms of one patent-in-suit....more
Applying the Supreme Court’s new “reasonable certainty” standard for patent definiteness in Biosig Instruments, Inc. v. Nautilus, Inc. (2015) (Nautilus III), the Federal Circuit again held that Biosig’s patent for a heart...more
In Biosig Instruments, Inc. v. Nautilus Inc., the Federal Circuit reversed the district court’s finding that the claims at issue were invalid as indefinite, because the claims were not “insolubly ambiguous.” This case...more
On April 26, 2013, in Biosig Instruments, Inc. v. Nautilus, Inc., the U.S. Court of Appeals for the Federal Circuit (Newman, Schall, Wallach*) reversed and remanded the district court's summary judgment that U.S. Patent No....more