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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FDA Law Blog

MARCH 24, 2024

By Faraz Siddiqui — As drug manufacturers battle the Health Resources and Services Administration (“HRSA”) in federal courts over the role of 340B contract pharmacies, an Eighth Circuit decision to uphold a 2021 Arkansas law may render those cases inconsequential in that state. Code Ann. § 23-92-604(c)(1), (2) (Act 1103).

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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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Patently O

DECEMBER 7, 2023

The Federal Circuit recently affirmed a district court judgment finding that Abbreviated New Drug Applications (“ANDAs”) submitted by generic drug manufacturers did not infringe patents rights held by H. Lundbeck A/S and its licensee Takeda relating to the antidepressant drug Trintellix (vortioxetine).

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JonathanTurley

JULY 12, 2021

The centerpiece of Cuomo’s plan is a new law to allow victims of gun violence to sue gun manufacturers under a nuisance theory. Indeed, its main component — a law allowing citizens to sue gun manufacturers — will be as productive as trying to win the New York Marathon by running furiously in place. Andrew Cuomo.

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Patently O

JANUARY 17, 2022

Deepsouth litigated its case to the Supreme Court, and the Court eventually allowed the company to escape some portion of its adjudged liability based upon the territorial limits of U.S. ” However on certiorari, the Supreme Court felt itself bound by the statute and precedent. patent law. We know that U.S.

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Day on Torts

MARCH 24, 2022

Where plaintiff filed a products liability claim based on a hip replacement device she had received, but her hip replacement occurred more than ten years before her suit was filed, dismissal based on the statute of repose was affirmed. The statute of repose for products liability cases is a hard line with very limited exceptions.

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SCOTUSBlog

SEPTEMBER 29, 2023

Share The Supreme Court on Friday issued orders from its so-called “long conference” – the justices’ private conference in the last week of September, at which they met for the first time since the end of June to add new cases to their docket. The trial court rejected that argument, and the California Court of Appeals agreed.

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The Crime Report

AUGUST 2, 2022

In a court filing last month, Glock claimed it has immunity from the suit under the federal Protection of Lawful Commerce in Arms Act and that the state law it is accused of violating is unconstitutional since it attempts to override the federal law.

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SCOTUSBlog

MARCH 15, 2024

In this case, Truck Insurance Exchange wants to object to the plan proposed by the bankrupt asbestos company Kaiser Gypsum because the plan does not require the disclosure of parallel claims to other asbestos manufacturers that would allow the insurer to make sure the claims it must pay are not fraudulent.

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Conflict of Laws

DECEMBER 19, 2023

The New Zealand Court of Appeal has just released a judgment on the cross-border application of New Zealand consumer and fair trading legislation ( Body Corporate Number DPS 91535 v 3A Composites GmbH [2023] NZCA 647 ). In response, 3AC protested the New Zealand court’s jurisdiction.

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Patently O

FEBRUARY 10, 2022

2015) in finding that manufacture and delivery of a product in a foreign country can infringe a US patent if sufficient sales-activity occurred within the US. The Federal Circuit rejected this appeal — holding that the presumption is applied when courts interpret the law or construe a statute. Broadcom Ltd.

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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. The statute sets this “average price” as ASP plus 6%.

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SCOTUSBlog

FEBRUARY 16, 2024

brings the justices yet another case under a statute with which they are all too familiar – the Federal Arbitration Act. As regular readers will know, the court in the last few decades has heard numerous cases under the FAA. LePage Bakeries Park St.

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FDA Law Blog

NOVEMBER 7, 2021

We reported that HRSA was proceeding with enforcement actions against drug manufacturers that have declined to sell to 340B covered entities that use multiple contract pharmacies to dispense 340B drugs to their patients, despite the pendency of several lawsuits challenging such enforcement. Last week, the U.S.

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The Fashion Law

JULY 13, 2021

A federal court has handed down a bit of a mixed ruling in a lawsuit accusing Canada Goose of misleading consumers about the nature of the trapping methods used to source the fur for its buzzy jackets by claiming that it is dedicated to “the ethical, responsible, and sustainable sourcing and use of real fur.” Motion to Dismiss.

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SCOTUSBlog

JUNE 27, 2023

After Mallory was diagnosed with colon cancer, he went to court in Pennsylvania and argued that he had been exposed to asbestos and other toxic chemicals while working for Norfolk Southern. Norfolk Southern urged the state court to throw out Mallory’s lawsuit. The lower courts agreed, but on Tuesday the Supreme Court reversed.

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Laws Court Manufacturing Statute 110

Patently O

FEBRUARY 24, 2022

The Supreme Court has not yet granted writ of certiorari in any patent cases this term. Still, there are a number of important patent cases pending before the court. Still, there are a number of important patent cases pending before the court. Eligibility under Section 101 : American Axle & Manufacturing, Inc.

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SCOTUSBlog

JUNE 9, 2023

VIP Products firmly rejected the use of the Jack Daniel’s trademarks by a manufacturer selling a line of dog toys that mock various beverage manufacturers. All members of the court joined Kagan’s opinion finding that toy a condemnable infringement of the Jack Daniel’s marks. 2 On Your Tennessee Carpet” replaces “Old No.

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SCOTUSBlog

APRIL 20, 2021

Share This Wednesday, the Supreme Court will hear oral argument in Minerva Surgical Inc. Federal courts have applied this doctrine since 1880, and the Supreme Court implicitly approved of the doctrine in 1924 in Westinghouse Electric. Manufacturing Co. The court could maintain the doctrine but limit its scope.

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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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Law 360

JULY 24, 2024

A Kentucky federal judge has ruled that digital information isn't covered by the federal smuggling statute and dismissed a charge against a magnetics manufacturer and two executives accused of emailing magnet schematics to Chinese companies.

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FDA Law Blog

APRIL 3, 2023

Kirschenbaum — On March 31, the Federal District Court for the District of Maryland upheld CMS’s definition of a “new formulation” under the Medicaid Drug Rebate Program (MDRP). By way of background, manufacturers are subject to an additional per-unit Medicaid rebate if they increase their prices greater than the rate of inflation.

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Patently O

APRIL 16, 2024

by Dennis Crouch Law school civil procedure courses spend very little time on proper venue because, in most cases venue is proper so long as the district court has personal jurisdiction over the defendant. ” This provision ensures the venue statutes do not limit the ability to sue foreign defendants U.S. See 28 U.S.C.

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SCOTUSBlog

JUNE 15, 2023

Coughlin , the Supreme Court held that Native American tribes are not immune from the automatic stay of the Bankruptcy Code. The lower courts rejected that idea, and on Thursday Justice Ketanji Brown Jackson’s opinion for an 8-1 majority affirmed those rulings. Tribes are indisputably governments.

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SCOTUSBlog

MARCH 23, 2023

The case comes to the court from the U.S. Court of Appeals for the 9th Circuit, which held that the toy was protected under the reasoning of Rogers v. Specifically, the 9th Circuit reasoned that Rogers requires an exception to the trademark statute for expressive speech and that the “Bad Spaniels” dog toy fell within the exception.

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Statute Manufacturing Court Lawyer 101

Mondaq

AUGUST 2, 2022

District Court for the District of Puerto Rico has recently ruled on a case dealing with Puerto Rico's Dealer's Contracts Act, also known as Law 75.

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Patently O

MARCH 4, 2024

For several years, Celanese kept its Ace-K manufacturing process a trade secret while selling the Ace-K product it produced. Historically, an inventor could choose to protect a new manufacturing process either by patenting it or by keeping it as a trade secret – but not both. Celanese appealed. Compare D.L. Auld Company v.

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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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Patently O

APRIL 15, 2021

Here is a rundown of what’s happening with US Supreme Court cases: Decided : The court recently decided Google LLC v. The court made no determination as to whether the API was actually copyrightable in the first place. ” Argued : On March 1, 2021, the court heard oral arguments in US v. by Dennis Crouch.

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FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. Background. Greber, 760 F.2d 2d 68, 71 (3d Cir.), denied, 474 U.S.

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The IP Law Blog

JANUARY 18, 2024

For example, a trade secret can be a manufacturing process, recipe, distribution method for products, research and development information, software algorithm, list of ingredients, list of suppliers, list of customers, pricing strategy, business plan, or advertising strategy. . § then it is no longer a trade secret. See 35 U.S.C. §

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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

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Gravel2Gavel

NOVEMBER 22, 2021

The courts have issued several new and significant rulings on environmental and administrative law the past few weeks. COURT OF APPEALS FOR THE DISTRICT OF COLUMBIA CIRCUIT. Truck Trailer Manufacturers Association, Inc. by Anthony B. See 81 FR 73478.)

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SquirePattonBoggs

JANUARY 13, 2021

On Monday the Supreme Court addressed—or, perhaps more to the point, chose not to address—an issue close to the hearts of many in the midst of a pandemic: home delivery of fine wine and spirits. The Court declined to review the Sixth Circuit’s decision in Lebamoff v.

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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. This argument was quickly rejected by the court. (2) Celgene Corp. Mylan Pharma ( Fed. If a non-human person, this requires being incorporated within the state (or the like).

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FDA Law Blog

OCTOBER 3, 2022

district court of Massachusetts by former employee and whistleblower Michael Bawduniak in April 2012 as a qui tam action. The Alert described several factors that could potentially violate the antikickback statute. Wasserstein — On September 26, 2022, Biogen Inc. This lawsuit was brought to the U.S. See United States ex rel.

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