FDA Law Blog

NOVEMBER 30, 2022

Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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Patently O

NOVEMBER 8, 2021

The 2017 Supreme Court decision in TC Heartland gave renewed teeth to the venue statute governing litigation. Although the notice letter is a critical aspect of the Hatch-Waxman process, the Federal Circuit found that the letter was not an “act of infringement” as required by the venue statute. Celgene Corp.

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FDA Law Blog

SEPTEMBER 30, 2022

As we reported, on November 5, 2020, the District Court held that the relator could not plausibly plead the requisite scienter because Forest’s interpretation of the ambiguous statute was objectively reasonable and CMS did not warn Forest away from that interpretation through authoritative guidance. Burr , 551 U.S.

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FDA Law Blog

SEPTEMBER 29, 2021

The 340B program, authorized under Section 340B of the Public Health Services Act and administered by HRSA, imposes a ceiling price on pharmaceutical manufacturer sales to “covered entities,” which are certain health clinics that receive federal funding and certain types of safety net hospitals to provide them drugs at lower prices.

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Patently O

FEBRUARY 10, 2022

The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. Thus, the court has held that an offer-to-manufacture doesn’t count. In reviewing the letter, the court noted that the terms appeared quite complete.

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SCOTUSBlog

APRIL 20, 2022

Two pending petitions raise the question of the constitutionality of state statutes providing that corporations are deemed to have consented to “general” personal jurisdiction by virtue of having registered to do business in a state. Some older Supreme Court decisions support that theory of consent. Returning Relists.

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Patently O

FEBRUARY 24, 2022

Eligibility under Section 101 : American Axle & Manufacturing, Inc. 20-1394 (CVSG requested October 4, 2021); Undermining Jury Decisions : Olaf Sööt Design, LLC v. Qualcomm , a case focusing on appellate standing following an IPR final written decision favoring the patentee. Neapco Holdings LLC, et al. , Patreon, Inc.,

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Patently O

APRIL 12, 2023

The statute isclear that patents should be awarded to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” so long as the other requirements of patentability are met. One difficulty with the law here is that it is entirely judge made. SG Brief.

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FDA Law Blog

APRIL 19, 2021

The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products. As most readers of our blog are aware, the regulatory costs to manufacturers of medical products are much lower if FDA regulates a product as a medical device rather than a drug requiring FDA marketing approval.

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FDA Law Blog

JANUARY 11, 2024

Important to note here is that each interchangeable biosimilar was first approved as a biosimilar and each biosimilar manufacturer had been sued under the so-called “patent dance” procedure prior to seeking licensure of the biosimilar products as interchangeable. This all sounds complicated, I know.

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FDA Law Blog

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. In this case, the Supreme Court provided greater clarity on how to interpret that requirement.

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At the Lectern

MAY 30, 2024

.’ ” The appellate court also found inapplicable the Legislature’s intent statement in newly enacted Assembly Bill 600 that, in resentencing proceedings under section 1172.1 , which the bill amended, “courts have full discretion. ” The urging went unheeded, except for Justice Evans.

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Constitutional Law Reporter

APRIL 8, 2025

The decision allows the ATF to regulate so-called ghost guns by requiring serial numbers, sales receipts, and background checks. Supreme Courts Decision The Supreme Court reversed by a vote of 7-2. Instead, [the plaintiffs] burden is to show that the Rule itself is inconsistent with the statute on its face.’

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SCOTUSBlog

NOVEMBER 12, 2024

Share NVIDIA, the world’s most valuable company, sells computer graphics processing chips designed primarily for use in video games, which it sells to manufacturers of game devices. Court of Appeals for the 9th Circuit allowed the action to proceed, and the Supreme Court agreed to review the matter.

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ClimateChange-ClimateLaw

OCTOBER 20, 2020

1442, or the civil-rights removal statute, 28 U.S.C. The district court rejected eight grounds for removal, but the Fourth Circuit concluded its appellate jurisdiction was limited to determining whether the companies properly removed the case under the federal-officer removal statute. Mayor & City Council of Baltimore , No.

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ClimateChange-ClimateLaw

OCTOBER 7, 2019

The court upheld other aspects of the 2018 standards, including the applicable volumes, restrictions on the use of Renewable Identification Numbers for fuel that is exported, and EPA’s accounting for small refinery exemptions. American Fuel & Petrochemical Manufacturers v. EPA remanded the standards but did not vacate the rule.

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FDA Law Blog

MARCH 31, 2025

Supreme Courts decision in SEC v. 1096 contradicts longstanding statutory authority on the statute of limitations for civil monetary penalties. 2462, the statute of limitations for civil monetary penalties is five years from the occurrence of the penalized conduct. The latest iteration of proposed Section 27 in S.

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FDA Law Blog

APRIL 2, 2025

Supreme Courts decision in SEC v. Under current law, the FTC Commissioners and its ALJs are insulated by statute from presidential removal, raising separation of powers concerns that are currently being litigated in the courts. 1096 imposes a new and longer statute of limitations for patent settlements. Fourth , S.

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ClimateChange-ClimateLaw

SEPTEMBER 10, 2021

The New Jersey court also found no basis for Grable jurisdiction, rejecting the companies’ arguments that the City’s claims necessarily raised substantial and actually disputed issues of federal law such as First Amendment issues or issues addressed by federal environmental statutes. Northern Plains Resource Council v. BP p.l.c. ,

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Above The Law

APRIL 7, 2025

EPA (2024), she criticized the Courts decision to block an EPA rule without fully engaging with legal and procedural requirements, stating, The Court today enjoins the enforcement of a major Environmental Protection Agency rule without fully engaging with both the relevant law and the voluminous record. Luxshare, Ltd.

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Above The Law

MARCH 7, 2025

Jackson also inquired about the potential impact of a ruling on the statute of limitations and how courts should approach medical expertise when evaluating agency decisions, especially regarding the safety and efficacy of drugs. No decision yet Food and Drug Administration v. Reynolds Vapor Co.

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ClimateChange-ClimateLaw

DECEMBER 11, 2023

Agency Deference A doctrine established in the Supreme Court’s 1984 Chevron case is up for review this year in a pair of cases, Loper Bright v. Chevron established a framework for courts to analyze agency action. Raimondo and Relentless v. Department of Commerce. If the intent is clear, the agency must conform to Congressional intent.

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ClimateChange-ClimateLaw

MARCH 6, 2018

DECISIONS AND SETTLEMENTS. The Ninth Circuit Court of Appeals reversed a district court decision that vacated the listing of the Arctic ringed seal as threatened under the Endangered Species Act (ESA). order setting schedule Mar. 1, 2018; order denying remand and notice re tutorial Feb.

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ClimateChange-ClimateLaw

OCTOBER 25, 2024

The injunction was granted based on the law’s vagueness, just as in the SIFMA decision, and on the constitutional requirement that plans focus on providing benefits to plan members, not on benefiting industries operating within the state.

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ClimateChange-ClimateLaw

APRIL 9, 2021

In Minnesota, the district court granted the State of Minnesota’s motion to remand its case, which asserts state law claims under common law and consumer protection statutes. s consumer protection statute. On March 26, 2021, the court denied Exxon’s emergency motion for a temporary stay of the remand order.

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