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Appeals Food and Drug Administration (FDA)

A&O Shearman

New Jersey District Court Orders Delisting Of Teva Inhaler Patents From The Orange Book

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On June 10, 2024, Judge Stanley R. Chesler of the United States District Court for the District of New Jersey granted the Amneal defendants’ motion for partial judgment on their counterclaims in a Hatch-Waxman dispute, and...more

Knobbe Martens

Federal Circuit Review | June 2024

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Reliably Determining Reasonable Royalty Rates from Lump Sum Licenses - In Ecofactor, Inc. V. Google LLC, Appeal No. 23-1101, The Federal Circuit held that license agreements containing a lump sum payment “based on” a royalty...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Reverses Motion to Dismiss—Generic Manufacturer’s Label Combined with its Expansive Public Statements Plausibly...

The Federal Circuit reversed a decision from the District of Delaware dismissing a case for failing to plead induced infringement because the totality of the evidence raised fact questions that could not be resolved on a...more

McDonnell Boehnen Hulbert & Berghoff LLP

CVS Pharmacy Inc. v. Forest Laboratories Inc. (2d Cir. 2024)

In a decision characterized (somewhat remarkably) by the Circuit Court as being one of first impression, the Second Circuit affirmed dismissal with prejudice of an antitrust allegation by a class of plaintiffs* against Forest...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Upholds Rifaximin Patent Rulings, Affirms ANDA Approval Restrictions

In Salix Pharmaceuticals, Ltd. v. Norwich Pharmaceuticals, Inc. 2023-1952 (Fed. Cir. April 11, 2024), this case involves appellate review of a district court’s findings regarding patent obviousness and infringement in...more

Dechert LLP

Dechert Re:Torts - Issue 14

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A Prescription for Liability: Michigan Repeals Flagship Drug Immunity Law - Michigan’s recent repeal of immunity provisions under its Product Liability Act has potentially significant implications for pharmaceutical...more

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

2023 ITC Section 337 Year in Review: Analysis & Trends: The Public Interest Impact – Considerations from AliveCor and Masimo

The year 2023 was marked by two landmark Commission determinations resulting in exclusion orders and cease and desist orders against a popular consumer wearable—the Apple Watch. both investigations focused on health...more

Gardner Law

Court Affirms Criminal Convictions for Device Execs Under the FDCA

Gardner Law on

The U.S. Court of Appeals for the First Circuit recently upheld multiple misdemeanor convictions for two former medical device company executives under the Food, Drug and Cosmetic Act (FDCA). While the former executives...more

WilmerHale

The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences - January 2024

WilmerHale on

Illumina Agrees to Unwind Acquisition of Grail Following Fifth Circuit Decision.  On December 15, 2023, the Fifth Circuit vacated the FTC’s order that Illumina unwind its acquisition of Grail—a developer of a multi-cancer...more

Sheppard Mullin Richter & Hampton LLP

Federal Circuit Evaluates Impact of the Final Written Decision (FWD) in a Parallel Inter-Partes Review (IPR) on District Court’s...

In United Therapeutics Corp. v Liquidia Tech Inc., the Federal Circuit reviewed the district court’s decision on invalidity and infringement of two pharmaceutical patents and the impact of the Final Written Decision (FWD) in...more

McDermott Will & Emery

See Here: No Standing Based on Vague Future Plans or Adverse Priority Findings

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The US Court of Appeals for the Federal Circuit dismissed an appeal from a final written decision in an inter partes review (IPR) proceeding, finding that the petitioner lacked standing because it suffered no injury in fact....more

Fitch, Even, Tabin & Flannery LLP

Calculating Patent Term Extension for FDA Delay: Original Patent or Reissue Patent Issue Date?

The Federal Circuit appeal in Merck Sharp & Dohme B.V., Merck Sharp & Dohme, LLC v. Aurobindo Pharma USA, Inc. et al., concerns whether patent term extension (PTE) for regulatory delay, in particular delay for FDA drug...more

Cozen O'Connor

Notice of Appeal - A quarterly newsletter reviewing Third Circuit opinions impacting white collar defense lawyers - Fall 2023

Cozen O'Connor on

BACKGROUND- A sugar distributor sought to acquire a sugar producer. The district court determined that the relevant product market included distributors as sources of refined sugar, in addition to sugar producers. The...more

Dechert LLP

Dechert Re:Torts - Issue 9

Dechert LLP on

Delaware Supreme Court Rejects No-Injury Medical Monitoring Claims - As part of our ongoing coverage of issues in Medical Monitoring, we noted that the Delaware Supreme Court received a certified question from the U.S....more

Haug Partners LLP

D.C. Circuit Dismisses FTC Antitrust Suit: Exclusive Pharma Patent Licenses Remain Permissible Under The Patent Act

Haug Partners LLP on

On Friday, August 25, 2023, the U.S. Court of Appeals For The District Of Columbia Circuit affirmed dismissal of an antitrust action brought by the Federal Trade Commission regarding Endo Pharmaceuticals’s grant of an...more

Akin Gump Strauss Hauer & Feld LLP

Federal Circuit: Patent Term Adjustment Results in Invalidity on Obviousness-Type Double Patenting Grounds

The Federal Circuit recently affirmed a United States Patent and Trademark Office (PTO) decision to invalidate four related patents on obviousness-type double patenting grounds (OTDP), holding that any analysis of OTDP for...more

Harris Beach PLLC

Claims Specifying a “Therapeutically Effective” Dose Have No Additional Efficacy or Safety Limitations

Harris Beach PLLC on

In United Therapeutics Corporation v. Liquidia Technologies, Inc., the U.S. Court of Appeals for the Federal Circuit held that a claim to a method of treatment for pulmonary hypertension was not invalid for lack of enablement...more

A&O Shearman

SCOTUS denies cert in skinny label appeal from the Federal Circuit

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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

(ACOEL) | American College of Environmental...

Bounty Laws and Citizen Suits

In a jurisprudential pile-up, the Fifth Circuit has become the arena for two simultaneous legal battles that may shape the law of standing and realign federal environmental law. While all eyes are on the U.S. Supreme Court...more

Epstein Becker & Green

Podcast: The Legal Battle Over Mifepristone - Diagnosing Health Care

On April 21, 2023, the U.S. Supreme Court ruled to preserve access to the prescription abortion drug mifepristone. However, while the case continues in the U.S. Court of Appeals for the Fifth Circuit, the future of...more

Proskauer - Employee Benefits & Executive...

Understanding Recent Litigation on Medication Abortion: A Guide for Health Plan Sponsors

Last Friday, the United States Supreme Court stayed a federal district court order that suspended the U.S. Food and Drug Administration’s approval of the drug mifepristone, which is used as part of a two-drug regimen to...more

ArentFox Schiff

ESG Litigation Update: States’ Challenge to Department of Labor Investment Duties Rule Will Remain in Amarillo

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The past year has seen a new star become fixed in the judicial firmament. The US District Court for the Northern District of Texas, Amarillo Division, has found new prominence, most recently retaining a challenge 26 states...more

McDermott Will & Emery

Patent Law Principles Apply to Claim Scope: Orange Book Delisting and Listing and Regulations

The US Court of Appeals for the Federal Circuit ordered that the only Orange Book patent asserted in a lawsuit must be delisted since its claims were directed to the computer-implemented distribution system and not a method...more

Mintz - Intellectual Property Viewpoints

Federal Circuit Affirms Delisting of REMS System Patent from FDA Orange Book

On February 24, 2023, the U.S. Court of Appeals for the Federal Circuit, in Jazz Pharmaceuticals, Inc., v. Avadel CNS Pharmaceuticals, LLC, Case No. 23-1186, affirmed a decision from the District Court of Delaware directing...more

Perkins Coie

Cannabis Legal Report - March 2023

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Cannabis: In Focus - - DEA Classifies Two Lab-Derived Cannabinoids as Schedule I - Washington Federal Judge Dismisses Suit Challenging Residency Requirements...more

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