JURIST

DECEMBER 31, 2023

The Supreme Court of Korea found on Thursday that shipbuilder Hitachi Zosen Corp. and heavy equipment manufacturer Mitsubishi Heavy Industries owe 50 million won (approx. The court’s Thursday ruling upheld two lower court decisions. The same court then found the same for Mitsubishi Heavy in June 2019.

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Court Court Decisions Manufacturing Government 129

Patently O

AUGUST 8, 2022

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. process that the machine or manufacture perform. ‘(B) B) HUMAN GENES AND NATURAL MATERIALS.

Manufacturing 97

Manufacturing Technology Statute Court Decisions 97

SCOTUSBlog

MARCH 20, 2023

The case involves a dispute between Jack Daniel’s (the largest American whiskey manufacturer) and VIP Products (the second-largest American dog toy manufacturer). 7 Tennessee Sour Mash Whiskey” manufactured by “Jack Daniel’s,” the toy refers to a “Bad Spaniel” that makes “Old No. 2 on your Tennessee carpet.”

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Statute Manufacturing Court Decisions Court 105

FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.

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Manufacturing Administrative Law Court Court Decisions 115

ClimateChange-ClimateLaw

MARCH 27, 2025

The Court viewed this structure as evidence that Congress intended to preempt state regulations that bear on the performance of a [covered] product as manufactured. District Court for the Northern District of California, which ruled that EPCA did not preempt Berkleys ordinance. A trade group first challenged the law in the U.S.

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Laws Court Construction Government 59

Law 360

AUGUST 27, 2024

A San Francisco federal judge mulling tracking device manufacturer Tile Inc.'s s bid to arbitrate some claims that its Bluetooth trackers are dangerous because they empower stalkers asked the parties at a hearing Tuesday to brief her on the effect of a recent California appellate court decision regarding arbitrability.

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Manufacturing Court Decisions Court 52

Law 360

AUGUST 13, 2024

Chip manufacturer Nvidia Corp. Supreme Court victory over investors who accuse the company of downplaying its reliance on the crypto mining market, arguing that a lower court decision allowing the case to move forward "eviscerates the guardrails that Congress erected to protect the public from abusive securities litigation."

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Manufacturing Court Court Decisions Litigation 52

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.,

Manufacturing 72

Manufacturing Healthcare Contract Government 72

Law 360

JUNE 29, 2021

Having received guidance from the Texas Supreme Court that Amazon cannot be held liable for third-party products that are shipped and fulfilled by Amazon, but not manufactured by the company under its brand, the Fifth Circuit on Tuesday reversed a lower court's decision that Amazon is a "seller" under the state's law.

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Manufacturing Court Court Decisions Laws 52

Mondaq

APRIL 12, 2022

Court of Appeals for the Eleventh Circuit, in Brown v. Nexus Business Solutions, LLC affirmed a district court's decision that business development managers who solicited and sold General Motors. On April 1, 2022, the U.S.

Manufacturing 40

Manufacturing Court Decisions Court 40

FDA Law Blog

APRIL 16, 2024

Gaulkin — On April 10, the Fourth Circuit unanimously affirmed a summary judgment ruling for the Centers for Medicare & Medicaid Services (CMS) regarding the agency’s definitions of “line-extension drug” and “new formulation” for purposes of determining rebates that drug manufacturers may owe the Medicaid Drug Rebate Program (MDRP).

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Manufacturing Statute Court Decisions Court 59

FDA Law Blog

SEPTEMBER 30, 2022

CMS itself has recognized this by repeatedly inviting manufacturers to use reasonable assumptions where a question is not addressed in the statute, regulations, or CMS guidance. The AMP, best price, and ASP statute and regulations are complex and full of gaps and ambiguities. We are closely following the SuperValu cert.

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Court Decisions Statute Court Manufacturing 40

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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Litigation Litigating Manufacturing Contract 52

Patently O

FEBRUARY 17, 2021

.” But, the court looked also to the long-felt unmet need before negating patentability: During a period of half a century, in which the use of flash light batteries increased enormously, and the manufacturers of flash light cells were conscious of the defects in them, no one devised a method of curing such defects. ” A.

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Manufacturing Court Court Decisions Laws 94

LexForti

APRIL 22, 2021

According to the facts, the brothers Balkrishna and Nagaraj Setty signed an agreement for partnership where they became the joint owner of the incense manufacturing company. Later, the brothers started their own competing manufacturing companies in separate Indian Cities i.e., Bangalore and Mumbai.

Laws 52

Laws Manufacturing Court Contract 52

Patently O

APRIL 26, 2024

” The Lower Court Decision In 1842, Wood sued William Underhill and Aschel Gerow for infringement. ” The circuit court agreed with the defendants and instructed the jury that the specification was too vague and uncertain to support the patent. .”

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Manufacturing Court Court Decisions Legal 115

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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Contract Manufacturing Statute Contract Law 78

Patently O

NOVEMBER 8, 2021

The 2017 Supreme Court decision in TC Heartland gave renewed teeth to the venue statute governing litigation. Celgene Corp. Mylan Pharma ( Fed. There are two different ways to show proper venue: Venue by Residence : Venue is proper if the defendant(s) reside in the district where the case is filed.

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Statute Manufacturing Court Decisions Court 95

Intelligize Blog

MAY 21, 2024

Historically, voting on executive compensation packages has been a pro forma exercise at the annual meetings of technology manufacturer 3M Co., A January court decision necessitated a new vote on Musk’s compensation, which has left Tesla insiders lobbying major investors and proxy advisers to give the plan a thumbs up.

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Manufacturing Court Decisions Technology Court 57

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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Technology Manufacturing Court Statute 64

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. The asserted patent covers a new method of manufacturing an automobile drive-shaft with reduced vibration. Neapco Holdings LLC, et al. , Patreon, Inc.,

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Laws Court Litigation Litigating 95

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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Court Manufacturing Statute Technology 40

FDA Law Blog

SEPTEMBER 24, 2023

Within two days of the final rule, the Window Covering Manufacturers Association filed suit at the D.C. This decision from three Democrat-appointed judges can be seen as a traditional pullback of a procedurally deficient agency rule. But there may be more for us to learn from this decision. See 15 U.S.C.

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Manufacturing Court Court Decisions 59

FDA Law Blog

DECEMBER 7, 2023

A regulatory consultant on the panel made a recommendation to FDA that it lean more heavily on Remote Interactive Evaluations (“REIs”) to help alleviate its backlog—of which HPM recently learned the Agency had only conducted 10 in the last 30 months for purposes of drug manufacturing compliance.

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Litigation Litigating Diligence Manufacturing 52

FDA Law Blog

JUNE 15, 2022

In this case, the agency must set reimbursement rates using each drug’s “average price” charged by the manufacturers for the drug, as “calculated and adjusted by the Secretary as necessary for purposes of” this statutory provision. Option 2 applies only if HHS has not conducted such a survey. citing §1395 l (t)(14)(A)(iii)(II)).

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Statute Court Court Decisions Healthcare 52

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.

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Litigation Litigating Statute Manufacturing 59

SCOTUSBlog

MARCH 26, 2025

Justice Clarence Thomas dissented from the courts decision, complaining that it had agreed to rewrite statutory text. Justice Samuel Alito wrote his own dissent in which he contended that his colleagues had resolved the dispute based on an issue that the lower court had not reached and the parties had not really addressed.

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Court Manufacturing Court Decisions Technology 145

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. The Supreme Court Decision The unanimous Supreme Court was having none of it.

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Court Statute Government Court Rules 40

Patently O

JANUARY 11, 2024

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc.

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Technology Court Manufacturing Court Decisions 53

Patently O

APRIL 23, 2024

Teva has traditionally been a generic manufacturer, but in this case sued Eli Lilly for infringing its patents covering methods of treating headache disorders like migraine using humanized antibodies that bind to and antagonize calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. Lilly for a few years.

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Court Manufacturing Court Decisions Laws 45

Patently O

DECEMBER 14, 2023

In that situation, the patent applicant might maintain the compound claims in the original application and then file a “divisional application” to protect the methods of manufacture. ” Based upon the peculiar facts of this case, MSN argued that neither of these requirements had been met.

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Court Manufacturing Court Decisions 64

SCOTUSBlog

OCTOBER 2, 2024

But the gun owners and gun manufacturers challenging the rule counter that the federal government has not previously required a license to build a gun for private use. Manufacturers must also put a serial number on guns. They were later joined by several manufacturers and another advocacy group.

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Manufacturing Laws Court Court Decisions 120

ClimateChange-ClimateLaw

NOVEMBER 1, 2016

The Ninth Circuit Court of Appeals reversed a district court decision that vacated the listing of the Beringia distinct population segment (DPS) of the Pacific bearded seal subspecies as “threatened” under the Endangered Species Act (ESA). Climate Litigation Chart (Update #92): FEATURED CASE. Alaska Oil & Gas Association v.

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Litigation Litigating Attorney Court 40

JURIST

DECEMBER 16, 2021

This tit-for-tat directive against Texas SB8 is the latest of the bold moves Newsom has taken and responds directly to the Supreme Court decision last week. Newsom has been a roll since convincingly surviving a recall effort against him in September.

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Court Manufacturing Attorney Court Decisions 208

JURIST

NOVEMBER 1, 2021

The decision also vacated an injunction from the Northern District of New York and a prior Second Circuit ruling on an Eastern District of New York case. While the two lower court decisions originate from different jurisdictions, both pertain to healthcare workers’ concerns over the COVID-19 vaccine.

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Healthcare Court Manufacturing Court Decisions 197

SCOTUSBlog

APRIL 20, 2022

Some older Supreme Court decisions support that theory of consent. Some courts read [Supreme Court precedent] as effectively foreclosing [this consent-by-registration theory of jurisdiction], while others insist it remains viable.”. In Cooper Tire & Rubber Company v.

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Statute Stare Decisis Court Manufacturing 105

SCOTUSBlog

NOVEMBER 21, 2024

A federal district court in Arizona rejected the group’s request to stop the land exchange, and the full U.S. Court of Appeals for the 9th Circuit affirmed that ruling. Pharmaceutical Research and Manufacturers of America v. McClain 24-118 Issue : Whether the U.S.

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Court Depositions Manufacturing Government 81