News & Analysis as of

Vacated Life Sciences

Baker Donelson

Federal Court Vacates LDT Final Rule

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The U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration's (FDA) final rule on March 31, 2025, under which the FDA would have started regulating most laboratory-developed tests (LDTs)...more

McDermott Will & Schulte

Specially Convened Rehearing Panel Vacates IPR Institution Denial

In a rehearing decision issued by a Delegated Rehearing Panel specially convened by the US Patent & Trademark Office (PTO) Director, the Patent Trial & Appeal Board vacated a prior panel decision denying institution, modified...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2023 #3

In this week’s Case of Week, the Federal Circuit affirmed inter partes review decisions upholding as patentable Teleflex’s challenged patent claims directed to a method for use of a guide extension catheter in arteries. This...more

Knobbe Martens

Federal Circuit Vacates PTAB’s Decisions in Axonics, Inc. v. Medtronic, Inc.

Knobbe Martens on

Sacral neuromodulation stimulates nerves above the tailbone to treat fetal incontinence and related bowel and bladder control issues. After California-based Axonics Inc. (“Axonics”) entered the sacral neuromodulation market...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - June 2022 #3

Novartis Pharms. Corp. v. Accord Healthcare, Inc., Appeal No. 2021-1070 (Fed. Cir. June 21, 2022) - In this week’s Case of the Week, the Federal Circuit granted panel rehearing of and vacated its prior decision in Novartis...more

Sterne, Kessler, Goldstein & Fox P.L.L.C.

2021 PTAB Year in Review: Analysis & Trends

[co-author: Jamie Dohopolski] Love it or hate it, ignore the USPTO Patent Trial and Appeal Board (PTAB) at your peril. The introduction of the PTAB as part of the America Invents Act over ten years ago has forever changed...more

Hogan Lovells

Eleventh Circuit Confirms: Mere Difference of Opinion Between Physicians Does Not Establish Falsity Under the False Claims Act

Hogan Lovells on

More than two years after the Northern District of Alabama granted summary judgment in a False Claims Act (FCA) case in favor of AseraCare Inc., holding that “contradiction based on clinical judgment or opinion alone cannot...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - July 2019 #2

PATENT CASE OF THE WEEK - In re: Global IP Holdings LLC, Appeal No. 2018-1426 (Fed. Cir. July 5, 2019) - The Federal Circuit vacated and remanded a decision of the Patent Trial and Appeal Board (“PTAB”) upholding an...more

Foley & Lardner LLP

Federal Circuit Questions Written Description For Antibody Claims

Foley & Lardner LLP on

The October 5, 2017 Federal Circuit decision in Amgen Inc. v. Sanofi is getting a lot of attention for its commercial impact, because the court vacated the permanent injunction that prevented Sanofi and Regeneron from...more

Knobbe Martens

Federal Circuit Finds Life Sciences Subject Matter Patent Eligible

Knobbe Martens on

On July 5, 2016, the U.S. Court of Appeals for the Federal Circuit issued an opinion vacating the summary judgment of invalidity of U.S. Patent No. 7,604,929 (“the ’929 Patent”) and sent the case back to the District Court...more

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