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Constitutional Challenges Life Sciences

McDermott Will & Emery

No Supremacy Clause Preemption Where State Statute Doesn’t Conflict With Federal

The US Court of Appeals for the Fifth Circuit explained that ordinarily, when state law contradicts with federal law, the state law may be preempted by the federal law under the US Constitution’s Supremacy Clause. However,...more

Jones Day

Judge Blocks FDA Regulation of Laboratory-Developed Tests

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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

Mayer Brown

Brasília em Pauta – Edição Nº 187

Mayer Brown on

Prezados e prezadas, O “Brasília em Pauta” é um boletim semanal preparado pela equipe de Contencioso de Brasília, contendo os principais casos a serem julgados pelo Supremo Tribunal Federal (STF), Superior Tribunal de...more

Ropes & Gray LLP

2024 FDA Enforcement Review: Quality and Transparency Remain Critical Concerns

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The U.S. Food and Drug Administration (“FDA”), in partnership with the Department of Justice (“DOJ”), pursued significant and, in some cases, precedent-setting enforcement actions in 2024. The government continued to...more

Mintz - Health Care Viewpoints

EnforceMintz — Scienter, Causation, and Constitutional Questions: 2024’s Three Key FCA Litigation Issues

In 2024, federal courts issued a number of important decisions in False Claims Act (FCA) cases that are particularly noteworthy for the health care and life sciences industries. We focus here on decisions that further develop...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

Robins Kaplan LLP

Financial Daily Dose 1.12.2021 | Top Story: New PPP Round Kicks Off with Focus on Community Lenders

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Version 3.0 of the PPP kicked off yesterday, with community lenders leading the way by focusing on “underserved borrowers—including women-led businesses and those run by Black, Latino and Asian owners and other minorities” in...more

Hogan Lovells

Trump administration reversal would take away FDA’s authority to approve biosimilars

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On June 25, 2020, the Department of Justice (DOJ) filed a brief in the United States Supreme Court that reverses the government’s prior position by arguing that none of the provisions of the Patient Protection and Affordable...more

Kramer Levin Naftalis & Frankel LLP

In Two Life Sciences Cases, the Supreme Court Declines to Address the Constitutionality of IPRs of Pre-AIA Patents

Last week, the U.S. Supreme Court declined to review the constitutionality of inter partes review proceedings (IPRs) challenging patents issued before the Leahy-Smith America Invents Act (AIA). ...more

McDonnell Boehnen Hulbert & Berghoff LLP

Supreme Court Takes Pass on Considering IPR Constitutionality

There is little rhyme nor reason in the cases the Supreme Court decides to review. But the Court has patterns in its case selection that do (to some degree) probe what the Justices think are important questions. One pattern...more

Seyfarth Shaw LLP

Fifth Circuit Affirms Striking Down Individual Mandate of Affordable Care Act and Remands on Issue of Severability

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In a bold but conservative 2-1 decision Wednesday, The United States Court of Appeals for the Fifth Circuit affirmed the ruling of a federal district judge in Texas striking down the individual mandate of the Affordable Care...more

Skadden, Arps, Slate, Meagher & Flom LLP

Skadden's 2019 Insights: Trump Policy Actions Could Reshape Health Care and Life Sciences Landscape

In 2018, President Donald Trump and numerous executive branch agencies announced proposals that, if implemented, will reshape the landscape for virtually every sector of the health care industry. Many of these proposals are...more

Knobbe Martens

Patent Law Update for Medical Device Companies 2018 (Presentation)

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Knobbe Martens Partners Paul Conover, Irfan Lateef, and Curtis Huffmire presented "Patent Law Update for Medical Device Companies 2018" at the MedTech Innovation Summit in San Francisco, CA on November 28, 2018. This session...more

Troutman Pepper Locke

Attorney General’s Office May Weigh In on Constitutionality of IPRs involving Pre-AIA Patents

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The 2011 America Invents Act (AIA) provided a variety of new ways to administratively challenge patents, including the now widely used inter partes review (“IPR”) procedure. In two recent appeals of IPR decisions, Genentech...more

Morrison & Foerster LLP

Hatch-Waxman and BPCIA Developments in June 2018

This month, we highlight significant developments in June 2018, including a Supreme Court decision regarding the PTAB, a federal court affirmation in Impax Laboratories Inc. v. Lannett Holdings Inc., and new legislation...more

Smart & Biggar

Rx IP Update - 2017 Highlights in Canadian Life Sciences IP

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The year 2017 was one of the most significant years for Canadian Life Sciences IP and Regulatory Law in Canada’s history. The year saw major developments in patent linkage, patent term, and substantive patent issues. As we...more

Smart & Biggar

RxIP Update - 2016 Year in Review

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The following are highlights of developments in Canadian life sciences intellectual property and regulatory law in 2016, updating our 2016 mid-year highlights. 1. Substantive patent law developments - Utility and...more

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