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Supreme Court of the United States › Pharmaceutical Industry

The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary... more +
The United States Supreme Court is the highest court of the United States and is charged with interpreting federal law, including the United States Constitution. The Court's docket is largely discretionary with only a limited number of cases granted review each term.  The Court is comprised of one chief justice and eight associate justices, who are nominated by the President and confirmed by the Senate to hold lifetime positions. less -
McDonnell Boehnen Hulbert & Berghoff LLP

Astellas Pharma, Inc. v. Sandoz Inc. (Fed. Cir. 2024)

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One of the anticipated consequences of the Supreme Court's Loper decision is that it will unleash judges to impose their statutory interpretations of administrative agencies' applications of the law within their areas of...more

McDermott+

M+ Check-Up: September 6, 2024

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Congress Returns. The House and Senate will be back in session on September 9, 2024, with a joint focus on completing consideration of a continuing resolution (CR) to maintain government funding beyond the end of fiscal year...more

Proskauer - Minding Your Business

The Broad Impact of Edwards v. Meril on the Safe Harbor Provision

Proskauer - Minding Your Business on

The Federal Circuit’s decision in Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., has garnered significant attention, especially concerning the application of the “safe harbor” provision under 35 U.S.C. §...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 4, August 2024

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Welcome to our fourth issue of The Health Record - our healthcare law insights e-newsletter. In this edition, we address a variety of topics including a recent SCOTUS ruling and the potential impact on CMS, issues of patient...more

Spilman Thomas & Battle, PLLC

The Health Record - Healthcare Law Insights, Issue 3, July 2024

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Welcome to our third issue of The Health Record - our healthcare law insights e-newsletter! We are winding down the summer with our talented group of law students and they have continued to research and write, shadow...more

McDermott Will & Emery

Loper Bright and the 340B Statute

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In its Loper Bright decision last week, the Supreme Court of the United States likely opened opportunities for further legal challenges to the Health Resources and Services Administration’s (HRSA’s) interpretation and...more

Epstein Becker & Green

Another Leak Confirmed and Other Important Decisions and Divisions Issued, but Not Loper or Trump - SCOTUS Today

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The Supreme Court’s day started with the specter of yet another leak of a reproductive rights decision having occurred....more

Lathrop GPM

Broad Biotech Patent Claims-the Saga Continues

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There now is increased interest about the written description and enablement requirements for patent applications claiming antibodies. This may stem from the recent U.S. Supreme Court decision in Amgen v. Sanofi, finding lack...more

Spilman Thomas & Battle, PLLC

The Health Record - Health Law Insights, Issue 2, June 2024

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Welcome to our second issue of The Health Record - our healthcare law insights e-newsletter! SCOTUS Agrees to Review Medicare DSH Payments Case - “The suit, Advocate Christ Medical Center v. Becerra, was originally filed in...more

Jenner & Block

Client Alert: Access to Mifepristone Still Standing for Now, but Questions Remain

Jenner & Block on

On Thursday morning, the Supreme Court issued its decision in FDA v. Alliance for Hippocratic Medicine. Justice Kavanaugh wrote for a unanimous Court dismissing the Alliance for Hippocratic Medicine from the case for lack of...more

Dinsmore & Shohl LLP

Supreme Court Rejects Challenge to FDA Regulation of Abortion Medication

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In a unanimous decision today, the Supreme Court rejected efforts to limit access to the abortion pill mifepristone, overturning an earlier decision by the 5th Circuit Court of Appeals. The Supreme Court ruled that the...more

Wiley Rein LLP

Wiley Consumer Protection Download (June 4, 2024)

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Welcome to Wiley’s update on recent developments and what’s next in consumer protection at the Consumer Financial Protection Bureau (CFPB) and Federal Trade Commission (FTC). In this newsletter, we analyze recent regulatory...more

McDermott Will & Emery

Pay for Delay Is Sometimes Okay

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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

Manatt, Phelps & Phillips, LLP

Supreme Court Holds Invalid Cholesterol Drug Patent That Covered Millions of Undisclosed Antibodies

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In Amgen Inc. v. Sanofi, the Supreme Court unanimously held that “[i]f a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent specification must enable a person skilled in...more

Axinn, Veltrop & Harkrider LLP

Large and Unjustified: Second Circuit Clarifies Pleading Requirements in Reverse Payments Cases

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On May 13—and more than ten years after Federal Trade Commission v. Actavis, the leading U.S. Supreme Court case on reverse payment settlements—the Second Circuit for the first time weighed in on whether (and how) antitrust...more

BakerHostetler

[Podcast] Biotechnology, Chemical and Pharmaceutical: Supreme Showdown

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In 2023, a lawsuit that had wound its way through the judicial system for nearly 10 years finally had its day in the U.S. Supreme Court – and made waves in the biotechnology, chemical and pharmaceutical communities. Our...more

Foley & Lardner LLP

Cancer Drugs: Strategies For Patenting Antibody-Drug Conjugate Inventions

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Antibody-drug conjugate (ADC) is a promising class of cancer treatments with accelerating U.S. Food and Drug Administration (FDA) approval and rapidly growing market size as discussed in previous articles in this series. This...more

Axinn, Veltrop & Harkrider LLP

Vanda Strikes Out at the Supreme Court

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Two weeks ago we discussed Vanda Pharmaceuticals’ ambitious cert petition asking the Supreme Court to discontinue the “reasonable expectation of success” standard for patent obviousness that for decades has been a mainstay of...more

Foley Hoag LLP

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

Foley Hoag LLP on

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

Haug Partners LLP

Written Description for Genus Claims Following Juno Therapeutics v. Kite Pharmaceuticals

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Section 112 of the Patent Act contains multiple requirements that relate to the adequacy of an inventor’s disclosure within a patent application.  The Supreme Court has offered some clarity to inventors seeking to patent...more

Foley Hoag LLP - State AG Insights

State Attorneys General Weigh in Amidst Supreme Court Case That Could Restrict Access to Abortion Drug Mifepristone

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Attorneys general across the country have joined in litigation related to mifepristone, a drug used for medication abortions. A case currently before the Supreme Court, FDA v. Alliance for Hippocratic Medicine, could affect...more

Kramer Levin Naftalis & Frankel LLP

Law360: Supreme Court Amgen Ruling's Major Effect On Enablement

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Eight months ago, the U.S. Supreme Court interpreted the enablement requirement in the May 18, 2023, Amgen Inc. v. Sanofi decision.[1] Although the court did not change the law, affirming the U.S. Court of Appeals for the...more

Axinn, Veltrop & Harkrider LLP

Clarity May Be Around the Corner for Antitrust Scrutiny of Reverse Payment Settlements

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In the ten years since the Supreme Court ruled in Federal Trade Commission v. Actavis that reverse payment settlements—or settlements where a patent holder pays an accused patent infringer cash or other consideration to end...more

Haug Partners LLP

10 Years after Actavis, the Cases that Follow Tell a Story

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I. Introduction - No pharmaceutical antitrust decision has had more impact than the Supreme Court’s 2013 decision in Federal Trade Commission v. Actavis, a decision which officially defined the term “reverse payment...more

Morrison & Foerster LLP

True Facts About False Claims: MoFo's FCA Newsletter - October 2023

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Designed for busy in-house counsel and compliance professionals, this newsletter seeks to bring you up to speed on key federal and state False Claims Act (FCA) developments, with links to primary resources. Each quarter, we...more

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