News & Analysis as of

Appeals Supreme Court of the United States Pharmaceutical Industry

A&O Shearman

Pharma company challenges the US False Claims Act: what’s at stake for whistleblowers and government enforcement?

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A pharmaceutical company is currently appealing a record USD1.6 billion judgment in the US, arguing that a key part of the US False Claims Act (FCA) is unconstitutional. This case, now before the Court of Appeals for the...more

A&O Shearman

Pharma Company Brings Latest Constitutional Challenge To False Claims Act In Third Circuit

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On April 29, 2025, a pharmaceutical company filed the latest constitutional challenge to the qui tam provision of the False Claims Act (“FCA”) when it appealed in the United States Court of Appeals for the Third Circuit a...more

Greenbaum, Rowe, Smith & Davis LLP

First Circuit Decision Regarding Anti-Kickback Statute Standard Widens Circuit Split and Creates Potential for Supreme Court...

The U.S. Court of Appeals for the First Circuit, in United States v. Regeneron, has joined the Sixth and Eighth Circuits in adopting the “but-for” standard to find that a violation of the Anti-Kickback Statute (AKS) triggers...more

Jones Day

U.S. Supreme Court Invites Solicitor General to Submit Briefing on "Skinny Labels"

Jones Day on

On June 23, 2025, the Supreme Court invited the Solicitor General to submit a brief expressing the views of the United States—dramatically increasing the likelihood that the Court will eventually grant review—in Hikma...more

Cranfill Sumner LLP

Kickbacks and Causation: Supreme Court Could Soon Settle the Question of Anti-Kickback Statute and False Claims Act Causation...

Cranfill Sumner LLP on

A decision by the First Circuit Court of Appeals has deepened the legal debate surrounding False Claims Act (FCA) actions based on violations of the Anti-Kickback Statute (AKS). This decision has increased speculation that...more

Perkins Coie

First Circuit Imposes Higher “But-for” Causation Standard for False Claims Act Liability Based on Alleged Anti-Kickback Statute...

Perkins Coie on

On February 18, 2025, the U.S. Court of Appeals for the First Circuit added its voice to a growing chorus of appellate courts to elevate the standard of proof required to show a violation of the federal False Claims Act in...more

ArentFox Schiff

Investigations Newsletter: Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions

ArentFox Schiff on

Federal Government Urges Court of Appeals to Uphold Constitutionality of FCA Qui Tam Provisions - In a brief filed earlier this week, the US federal government has urged the Eleventh Circuit Court of Appeals to uphold the...more

McDermott Will & Schulte

Pay for Delay Is Sometimes Okay

The US Court of Appeals for the Second Circuit affirmed the dismissal of a lawsuit against pharmaceutical companies accused of violating antitrust laws by using reverse payments to delay entry of a generic version of a...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 & Schulte

New Technology Does Not Alter Enablement Rules

Exploring the applicability of its enablement law to life sciences, the Supreme Court of the United States issued a unanimous opinion, concluding that patent claims covering a genus of antibodies defined in part by functional...more

Foley & Lardner LLP

The Future of the 340B Program: 2023 Key Decisions

Foley & Lardner LLP on

Critical decisions are pending before courts and legislators in 2023 that promise to shape the future of the 340B Drug Pricing Program (340B Program), which provides discounts on outpatient drugs for certain health care...more

McDermott Will & Schulte

Hold That Generic, Please: Supreme Court Grants Emergency Request to Stay Federal Circuit’s Mandate

In a rare action by the Supreme Court of the United States, Chief Justice Roberts granted Novartis’s emergency request for a stay of a mandate from the US Court of Appeals for the Federal Circuit, which had found a Novartis...more

McDermott Will & Schulte

Genesis Opinion Provides Opportunity for District Court to Determine Definition of “Patient” for 340B Covered Entities

A federal district court likely will determine the 340B program definition of “patient” following a decision by the US Court of Appeals for the Fourth Circuit in Genesis Healthcare v. Becerra. The issue was whether the...more

McDermott Will & Schulte

July Surprise - Supreme Court Agrees to Review Medicare Payment Cuts to 340B Drugs

The US Supreme Court has announced that it will take up review of the decision by the US Court of Appeals for the District of Columbia Circuit upholding Medicare’s 2018 payment cuts to 340B drugs. The case will be closely...more

Schwabe, Williamson & Wyatt PC

Latest Federal Court Cases - November 2020 #2

Valeant Pharmaceuticals North America LLC v. Mylan Pharmaceuticals Inc., Appeal No. 2019-2402 (Fed. Cir. Nov. 5, 2020) - In our Case of the Week, the Federal Circuit addressed a lingering question about venue following the...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2020 Insights

Despite political and economic uncertainties, markets and deal activity were resilient in 2019, and strong fundamentals remain in place heading into 2020. Companies continue to face a challenging litigation and enforcement...more

WilmerHale

False Claims Act: 2019 Year-in-Review

WilmerHale on

The Supreme Court held that the FCA’s extended limitations period is available to relators in qui tam cases even when the government declines to intervene. Lower courts continued to divide over the first-to-file bar,...more

Robins Kaplan LLP

Financial Daily Dose 11.19.2019 | Top Story: T-Mobile Chief John Legere to Leave Company in April

Robins Kaplan LLP on

T-Mobile chief and fan-of-magenta John Legere has announced that he’ll be stepping down in April at the end of his current contract. Legere will be succeeded by Mike Sievert, the carrier’s current president and COO....more

Skadden, Arps, Slate, Meagher & Flom LLP

Cross-Border Investigations Update - September 2019

This issue of Skadden’s semiannual Cross-Border Investigations Update takes a close look at recent cases, regulatory activity and other key developments, including a review of the first year of GDPR enforcement, analysis of...more

Shook, Hardy & Bacon L.L.P.

"Secret Sale" of Drug Counts as Prior Art in Patent Battle

On January 22, 2019, the U.S. Supreme Court affirmed the U.S. Court of Appeals for the Federal Circuit’s decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., No. 17-1229 (Jan. 22, 2019)....more

McDermott Will & Schulte

Secret Sales Still Qualify as Prior Art Under AIA

Addressing whether the on-sale bar of America Invents Act (AIA) 35 USC § 102(a)(1) applies to confidential sales where specific details are not made public, the Supreme Court of the United States found that the post-AIA...more

Ward and Smith, P.A.

On-Sale Bar: Less clever way of saying, Happy Hour? Maybe. Important for Patent Protection? Yes.

Ward and Smith, P.A. on

If the term "happy hour" in this article's title caught your attention, you may be disappointed by what comes next. This article is actually about limitations on patent protection, which I would argue is just as...more

McAfee & Taft

Gavel to Gavel: Supreme Court provides clarity

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Originally published in The Journal Record | January 31, 2019. This month, the U.S. Supreme Court issued its opinion in Helsinn Healthcare v. Teva Pharmaceuticals, confirming that private sales of an invention may preclude...more

Polsinelli

Supreme Court Confirms the AIA On-Sale Bar Covers Secret Sales—But Invites Controversy over What Is “Otherwise Available to the...

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The Supreme Court recently issued its closely-watched decision in Helsinn Healthcare S.A. v. Teva Pharmaceuticals USA, Inc., which has direct implications regarding the scope of § 102 prior art under the America Invents Act...more

Weintraub Tobin

Can Secret Sales Prohibit Patenting Your Invention?

Weintraub Tobin on

Prior to the Leahy-Smith America Invents Act (“AIA”), the patent statute (35 U.S.C. § 102(b)) prohibited patenting an invention that was “on sale in this country, more than one year prior to the date of the application for...more

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