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Oral Argument Pharmaceutical Industry

McDonnell Boehnen Hulbert & Berghoff LLP

Aurobindo v. Merck Sharp and Dohme -- Oral Argument

The Federal Circuit heard oral argument in Auribundo's appeal of the district court's decision in favor of plaintiff Merck, in a case captioned In re Sugammadex (alternatively, Aurobindo v. Merck Sharp and Dohme). The issue...more

Foley Hoag LLP

Oral Arguments in FDA v. Alliance for Hippocratic Medicine: Mifepristone Case Likely to Turn on Article III Standing Requirements

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Nearly two years after the Court overturned Roe v. Wade in June 2022, additional challenges are being brought that may limit access to abortion in the U.S. Mifepristone was originally approved in 2000 by the U.S. Food and...more

Foley Hoag LLP - White Collar Law &...

Supreme Court Rejects “Objectively Reasonable” Defense to False Claims Act Liability

The SuperValu case arose from separate lawsuits against two companies that operate retail drug pharmacies across the country: SuperValu Inc. and Safeway, Inc. In each case, a whistleblower – on behalf of the federal...more

Perkins Coie

US Supreme Court Clarifies Knowledge Requirement in False Claims Act Cases—Raising New Interpretive Issues

Perkins Coie on

A defendant’s knowledge of and subjective beliefs about the meaning of legal requirements—not what an objectively reasonable person may have believed—are what matters when determining whether a defendant “knowingly” submitted...more

Zuckerman Spaeder LLP

Part III | SCOTUS Ruling: “Knowing” Violations of Unknowable Rules: Is the Supreme Court Poised to Alter the FCA Enforcement...

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For background on this case, please refer to Part I. For updates from the Supreme Court oral arguments on April 18, please refer to Part II. On Thursday, June 1, the Supreme Court issued its opinion in United States et al....more

ArentFox Schiff

Supreme Court FCA Scienter Ruling Revives Fraud Lawsuits Against Safeway and SuperValu

ArentFox Schiff on

Supreme Court FCA Scienter Ruling Revives Fraud Lawsuits Against Safeway and SuperValu On Thursday, the US Supreme Court issued its highly anticipated ruling regarding the threshold of liability under the False Claims Act...more

Sheppard Mullin Richter & Hampton LLP

Supreme Court Clarifies that Subjective (Not Objective) Knowledge of Falsity of Claim Dictates False Claims Act Liability

On June 1, 2023, the Supreme Court issued a unanimous decision holding that the scienter element of the False Claims Act (“FCA”) is met if a defendant subjectively knew his or her claims were false and submitted them anyway....more

Skadden, Arps, Slate, Meagher & Flom LLP

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

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

McDermott Will & Emery

This Week in 340B: May 2023 #3

McDermott Will & Emery on

This weekly series provides brief summaries to help you stay in the know on how 340B cases are developing across the country. Each week we comb through the dockets on more than 40 340B cases to provide you with a quick...more

Zuckerman Spaeder LLP

Part II - April 18 Oral Argument: “Knowing” Violations of Unknowable Rules: Is the Supreme Court Poised to Alter the FCA...

Zuckerman Spaeder LLP on

On April 18, 2023, the Supreme Court heard oral arguments in United States ex rel. Schutte v. Supervalu Inc., 9 F.4th 455, 459 (7th Cir. 2021) and United States ex rel. Proctor v. Safeway, Inc., 30 F.4th 649 (7th Cir. 2022)...more

Polsinelli

SCOTUS Appears Poised To Reject Defense-Friendly Safeco Scienter Standard In FCA Cases

Polsinelli on

On April 18, 2023, the Supreme Court of the United States (SCOTUS) heard oral arguments in a pair of monumental False Claims Act (FCA) cases to decide whether and when a defendant’s subjective understanding of an objectively...more

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

4 Potential Paths For High Court In Amgen Patent Case

On March 27, the U.S. Supreme Court heard oral argument in Amgen v. Sanofi, a closely watched case concerning the appropriate legal standard for patent law's enablement requirement. That requirement is found in Title 35...more

Axinn, Veltrop & Harkrider LLP

The Supreme Court Hears Arguments About the Enablement Standard in Amgen v. Sanofi

The Supreme Court heard arguments this week in Amgen v. Sanofi, the closely-watched case involving the enablement standard for patent claims, particularly as applied to functionally-defined genus claims. The question raised...more

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

Amgen Inc. v. Sanofi Live Coverage

On Monday, March 27, 2023, at 10:00 a.m. EDT, the Supreme Court of the United States will hear oral arguments in Amgen Inc. v. Sanofi, No. 21-757. William H. Milliken, a director in Sterne Kessler’s Trial & Appellate Practice...more

Latham & Watkins LLP

Healthcare & Life Sciences: Drug Pricing Digest - December 2021

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Drug Pricing Initiatives: Discussion continues of H.R. 5376 (the Build Back Better Act, or BBBA), the approximately $2.2 trillion social safety net, climate, and tax bill that includes measures related to drug pricing and...more

Rothwell, Figg, Ernst & Manbeck, P.C.

7th Circuit Hears Oral Arguments in Humira “Patent Thicket” Antitrust Case

On February 25, 2021, the U.S. Court of Appeals for the Seventh Circuit heard oral arguments in UFCW Local 1500 Welfare Fund v. AbbVie Inc. (Case No. 20-2402), a case appealed from the U.S. District Court for the Northern...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Amgen Faces “Uphill Battle” in Defending Antibody Genus Patentability

On December 9, 2020, the Federal Circuit heard oral arguments on the validity of Amgen’s patents (U.S. Patent Nos. 8,829,165 and 8,859,741) on cholesterol-lowering drug Repatha. Specifically, the question came down to whether...more

Rothwell, Figg, Ernst & Manbeck, P.C.

Big Pharma to Face Off at Federal Circuit Oral Arguments Over Antibody Genus Patentability

Mark your calendars – on December 9th, the Federal Circuit is slated to hear oral arguments as to whether two Amgen patents claiming a genus of antibodies meet the enablement requirement of 35 U.S.C. § 112. The court’s...more

K&L Gates LLP

K&L Gates Triage: Rutledge v. Pharmaceutical Care Management Association

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In this episode of Triage, Leah D’Aurora Richardson and Victoria Hamscho discuss next month’s Supreme Court oral arguments in Rutledge v. Pharmaceutical Care Management Association, including its potential impact on nearly...more

Goodwin

Oral Argument Scheduled for June 3 in Bevacizumab Preliminary Injunction Appeal

Goodwin on

We previously reported on the bevacizumab preliminary injunction appeal in Genentech v. Immunex Rhode Island Corp., Fed. Cir. Case No. 19-2155. The notice of oral argument was posted today and is scheduled for June 3, 2020....more

Robins Kaplan LLP

Financial Daily Dose 3.3.2020 | Top Story: Promised Central Bank Action Halts Market Slide (for now)

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Despite news of additional COVID-19-related deaths and infections in America, central bankers appear to have bought at least one day of peace for US markets, which posted strong gains on a late surge on Monday, breaking a...more

Goodwin

Biosimilar Appellate Roundup: Upcoming Oral Arguments and Decisions

Goodwin on

On December 6, 2019, the Federal Circuit will hear oral argument in a rituximab-related appeal by Biogen.  The appeal stems from a final written decision of the Patent Trial and Appeal Board (PTAB) in an inter partes review...more

Baker Donelson

Oral Arguments Scheduled in Challenge to 340B Payment Cuts While HHS Solicits Comments on Potential Remedy for 340B Hospitals

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The D.C. Circuit Court of Appeals has scheduled oral arguments for November 8, 2019 in the ongoing lawsuit challenging Medicare payment cuts to hospitals in the 340B drug pricing program. The court is considering an appeal by...more

Akin Gump Strauss Hauer & Feld LLP

District Court Affirms FDA Policy on Compounding with Bulk Drug Substances—Bringing Much Needed Clarity for the Outsourcing...

On August 1, 2019, the U.S. District Court for the District of Columbia affirmed the U.S. Food and Drug Administration’s (FDA’s) decision to exclude the bulk drug substance vasopressin from the agency’s List of Bulk Drug...more

Searcy Denney Scarola Barnhart & Shipley

United States Judicial Panel on Multidistrict Litigation – January 2019 Hearing Session Preview

The next hearing session of the United States Judicial Panel on Multidistrict Litigation (“JPML”) is scheduled for January 31, 2019 in Miami, Florida. Six matters are set for oral argument to consider motions to transfer each...more

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