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Troutman Pepper Locke

Federal Circuit Ruling Broadens Reach of Prosecution History Estoppel to Include Canceled Claims

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Prosecution history estoppel typically arises when a claim is rejected during prosecution and is then amended (narrowed) to overcome the rejection. However, in Colibri Heart Valve LLC v. Medtronic CoreValve, LLC, No....more

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

Jones Day on

On March 31, 2025, a judge in the Eastern District of Texas struck down a 2024 Final Rule (the "Final Rule") by the Food and Drug Administration ("FDA") that exerted jurisdiction over the regulation of laboratory-developed...more

McDermott Will & Schulte

Inventor’s Motivation to Combine Does Not Control Obviousness

McDermott Will & Schulte on

The US Court of Appeals for the Federal Circuit affirmed a district court decision rejecting claims of a patent application directed to a dosing regimen for a cancer treatment, finding the claims to be obvious where the...more

Robins Kaplan LLP

Silvergate Pharms., Inc. v. Bionpharma Inc.

Robins Kaplan LLP on

Epaned® (enalapril maleate) - Case Name: Silvergate Pharms., Inc. v. Bionpharma Inc., Civ. Nos. 18-cv-1962, 19-cv-1067, 2024 WL 4417104 (D. Del. Oct. 4, 2024) (Goldberg, J.)  Drug Product and Patent(s)-in-Suit: Epaned®...more

Robins Kaplan LLP

Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC

Robins Kaplan LLP on

ProAir® HFA (albuterol sulfate) - Case Name: Teva Branded Pharm. Products R&D, Inc. v. Amneal Pharms. of NY, LLC, No. 2024-1936, 2024 WL 5176737 (Fed. Cir. Dec. 20, 2024) (Circuit Judges Prost, Taranto, and Hughes...more

Foley Hoag LLP

D.C. Circuit Holds 340B Program Does Not Prohibit Drug Manufacturers from Imposing Contract Pharmacy Restrictions

Foley Hoag LLP on

On May 21, 2024, the United States Court of Appeals for the District of Columbia Circuit (“D.C. Circuit”) issued its decision in United Therapeutics Corporation v. Carole Johnson, et al./Novartis Pharmaceuticals v. Carole...more

Bass, Berry & Sims PLC

D.C. Circuit Becomes Second Federal Appeals Court to Allow Restrictions on 340B Contract Pharmacies

Bass, Berry & Sims PLC on

On May 21, the U.S. Court of Appeals for the D.C. Circuit issued a unanimous decision in favor of drug manufacturers, finding that certain manufacturer restrictions on the use of contract pharmacies under the 340B drug...more

Sullivan & Worcester

LePage v. Mobile Infirmary Association: Alabama Wrongful Death of a Minor Statute Applies to Cryogenically Preserved Embryos

Sullivan & Worcester on

Carole M. Bass and Cara Koss co-authored this article. The authors have long raised as an issue the impact personhood legislation could have on assisted reproduction and, by extension, on estate and trust administration...more

Mintz

EnforceMintz — Practical Lessons Learned from FCA Litigation in 2023

Mintz on

In 2023, the Supreme Court and the United States Courts of Appeals published a number of significant decisions with implications for entities in the health care and life science industries facing False Claims Act (FCA)...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

A&O Shearman on

On May 15, 2023, the Supreme Court of the United States denied Teva Pharmaceuticals USA, Inc.’s (“Teva”) petition for certiorari in Teva Pharmaceuticals USA, Inc. v. GlaxoSmithKline, LLC, ending a nearly nine-year court...more

Skadden, Arps, Slate, Meagher & Flom LLP

Inside the Courts – An Update From Skadden Securities Litigators - May 2023

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Supreme Court Hears Argument on Traceability Requirement in Circuit-Split Slack v. Pirani - Key Points - - Before the end of June, the U.S. Supreme Court is expected to issue a decision in a high-profile securities case...more

Bradley Arant Boult Cummings LLP

30(b)(6) vs. 702 – Is Your Witness a Party or an Expert?

Bradley Arant Boult Cummings LLP on

Earnest v. Sanofi U.S. Services et al, U.S. Circuit Court of Appeals for the Fifth Circuit, No. 20-30184 (Feb. 10, 2022) - The plaintiff sued Sanofi U.S. Services, Inc. and Sanofi-Aventis U.S., LLC in the Eastern District...more

Hogan Lovells

FDA proposes streamlining combination product regulations

Hogan Lovells on

On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

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