FDA Law Blog

MAY 30, 2024

Kirschenbaum — Last week, the United States Court of Appeals for the District of Columbia ruled that Section 340B of the Public Health Service Act does not prohibit pharmaceutical manufacturers from imposing conditions on the distribution of discounted drugs to covered entities in the program. By Sophia R. Gaulkin & Alan M.

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Manufacturing Contract Statute Court 59

Constitutional Law Reporter

DECEMBER 11, 2024

Supreme Court has agreed to consider whether Mexican government may continue its lawsuit against U.S. gun manufacturers. Estados Unidos Mexicanos , alleges the manufacturers aided and abetted the illegal sales of guns to traffickers for cartels in Mexico. gun manufacturers and one gun distributor. In appealing to the U.S.

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Manufacturing Government Constitutional Law Court 98

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."

Manufacturing 52

Manufacturing Court Court Decisions Litigation 52

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

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 101

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. But the courts have taken the general provision and given it substantial meaning beyond the text.

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Manufacturing Technology Statute Court Decisions 97

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.

Manufacturing 52

Manufacturing Court Court Decisions Laws 52

Patently O

FEBRUARY 24, 2022

The Supreme Court has not yet granted writ of certiorari in any patent cases this term. Rather, any new grant this term will very likely be pushed back to the October 2022 Term for hearing and decision. Still, there are a number of important patent cases pending before the court. by Dennis Crouch. Lets talk them through.

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Laws Court Litigation Litigating 95

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.

Manufacturing 52

Manufacturing Court Decisions Court 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 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

Manufacturing 72

Manufacturing Healthcare Contract Government 72

FDA Law Blog

SEPTEMBER 30, 2022

Kirschenbaum — In November 2020, we blogged about a decision by the Federal District Court of Maryland dismissing a Federal False Claims Act (FCA) qui tam suit alleging that Forest Laboratories knowingly reported inflated best prices under the Medicaid Drug Rebate Program (MDRP), resulting in underpayment of rebates. of America v.

Court Decisions 40

Court Decisions Statute Court Manufacturing 40

Conflict of Laws

APRIL 27, 2025

student, Galatasaray University, Turkey A Maltese court has refused to enforce a $740 million default judgment issued by the 15th Judicial Circuit Court of Florida (Palm Beach County) in a defamation suit brought by Applicant Mehmet Tatlici against his half-brother, Defendant Ugur Tatlici. [1] Ugur Tatlici , Case No. 9] Defendant U?

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Real Estate Legal Legal Court 49

LexForti

APRIL 22, 2021

Shrinivas Sugandhalaya LLP , the court denied the motion to compel the arbitrations proceeding under federal equitable estoppel law. 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.

Laws 52

Laws Manufacturing Court Contract 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

Patently O

APRIL 26, 2024

by Dennis Crouch I was rereading the Supreme Court’s recent enablement decision of Amgen Inc. 594 (2023) and was struck by the Supreme Court’s statement that its 19th Century decision of Wood v. ” The Lower Court Decision In 1842, Wood sued William Underhill and Aschel Gerow for infringement.

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Manufacturing Court Court Decisions Legal 115

Patently O

FEBRUARY 17, 2021

Supreme Court 2021). The Supreme Court’s doctrine in Graham v. Of course, in deciding Graham , the Supreme Court wrote that the new Section 103 ““was intended to codify judicial precedents” such as ” Hotchkiss v. by Dennis Crouch. Amarin Pharma, Inc., Hikma Pharmaceuticals USA Inc. John Deere (1966) and KSR v.

Manufacturing 94

Manufacturing Court Court Decisions Laws 94

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 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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Litigating Litigation Manufacturing Contract 52

Patently O

FEBRUARY 10, 2022

The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. The district court says sided with the patentee and a jury awarded $1.2 Thus, the court has held that an offer-to-manufacture doesn’t count. Section 102(b).

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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. This argument was quickly rejected by the court. (2) Thus, the district court properly dismissed the claims against Mylan N.V. Celgene Corp. Mylan Pharma ( Fed. and therefore venue in that state is improper.

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Statute Manufacturing Court Decisions Court 95

FDA Law Blog

JUNE 15, 2022

In 2019, we blogged that the District Court found for the plaintiffs, holding that CMS did not have the statutory authority to make such a change without first conducting a hospital acquisition cost survey data. The District Court opinion was subsequently reversed by the D.C. See 42 U.S.C. Becerra, No. 20-1114, 596 U. S. _ (2022).

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Statute Court Court Decisions Healthcare 52

Patently O

APRIL 12, 2023

by Dennis Crouch A decade ago, the US Supreme Court issued a pair of decisions that upended substantial aspects of patent practice. In court, these cases are often decided at pleading-stage, before any evidence is introduced or considered. Mayo Collaborative Servs. Prometheus Labs., 66 (2012); and Alice Corp. 208 (2014).

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Technology Manufacturing Court Statute 64

FDA Law Blog

APRIL 19, 2021

We have blogged recently about several FDA setbacks in court ( here , for example). Circuit Court of Appeals on Friday. FDA , the Court of Appeals ruled that FDA cannot regulate a medical product – in this case, the radiographic contrast agent barium sulfate – as a drug when the product meets the definition of a device.

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Court Manufacturing Statute Technology 40

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

FDA Law Blog

JUNE 7, 2023

Claud & Faraz Siddiqui — As we move into the heat of the summer, we can look forward to the annual June deluge of opinions coming from the Supreme Court. In this case, the Supreme Court provided greater clarity on how to interpret that requirement. The Supreme Court Decision The unanimous Supreme Court was having none of it.

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Court Statute Government Court Rules 40

FDA Law Blog

SEPTEMBER 24, 2023

Circuit Court of Appeals described in a recent opinion as an “aggressive timeline for industry compliance.” Within two days of the final rule, the Window Covering Manufacturers Association filed suit at the D.C. The court heard the case on an expedited basis and, last week, vacated the final rule. See 15 U.S.C.

Manufacturing 59

Manufacturing Court Court Decisions 59

SCOTUSBlog

MARCH 26, 2025

Share The Supreme Court on Wednesday upheld a Biden-era rule regulating so-called ghost guns untraceable weapons without serial numbers, assembled from components or kits that can be bought online. Justice Clarence Thomas dissented from the courts decision, complaining that it had agreed to rewrite statutory text.

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Court Manufacturing Court Decisions Technology 143

Patently O

JANUARY 11, 2024

Sanofi : In its unanimous opinion, the Supreme Court affirmed that Amgen’s broad functional claim was invalid having failed the requirements that claims must be enabled to their full scope, allowing for “a reasonable amount of experimentation.” Background on Amgen v. ” Amgen. Hyde , 242 U.S. 261 (1916). 2d 731 (Fed.

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Technology Court Manufacturing Court Decisions 53

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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Litigating Litigation Diligence Manufacturing 52

Patently O

DECEMBER 14, 2023

In its decision , the court offered two alternative justifications for siding with the patentee, which I’ll discuss in reverse order: No Patricide : First, the court held that the ‘271 patent does not qualify as a proper OTDP reference against the earlier-filed and earlier-issued ‘740 patent. 3d 1208 (Fed.

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Court Manufacturing Court Decisions 64

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

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

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). DECISIONS AND SETTLEMENTS. Climate Litigation Chart (Update #92): FEATURED CASE.

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Litigating Litigation 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. SB8, signed by Texas Governor Greg Abbott in May, bans abortion when an ultrasound can detect a “heartbeat,” which is often before a woman even knows she is pregnant.

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Court Manufacturing Attorney Court Decisions 208

JURIST

NOVEMBER 1, 2021

A Second Circuit decision vacated two lower court rulings which allowed healthcare workers to claim religious exemptions to New York’s COVID-19 vaccine mandate. 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.

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Healthcare Court Manufacturing Court Decisions 197

SCOTUSBlog

OCTOBER 2, 2024

Share The Supreme Court will hear oral argument next week in a challenge to a 2022 federal rule that seeks to regulate “ghost guns” – firearms without serial numbers that, the Bureau of Alcohol, Tobacco, Firearms, and Explosives says, almost anyone can quickly assemble with parts that they purchase, often in a kit online or through the mail.

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Manufacturing Laws Court Decisions Court 111

SCOTUSBlog

APRIL 20, 2022

Share The Relist Watch column examines cert petitions that the Supreme Court has “relisted” for its upcoming conference. The court denied cert on Monday. Justice Sonia Sotomayor, joined by Justices Stephen Breyer and Elena Kagan, filed an opinion dissenting from the court’s denial of summary vacatur.

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Statute Stare Decisis Court Manufacturing 101