SCOTUSBlog

JANUARY 24, 2025

In 2009, Congress passed the Family Smoking Prevention and Tobacco Control Act, which gives the FDA the power to regulate tobacco products and requires manufacturers to obtain the FDAs permission before putting a new tobacco product on the market. What arguments could you raise, she queried, that would be different than the manufacturer?

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Court Manufacturing Government Litigating 98

JURIST

JUNE 15, 2022

AHS argued that, under 42 USC § 1395l(t)(14)(A)(iii)(II) , HHS was required to set reimbursement rates at the average price hospitals at which bought each drug from the manufacturer for all hospitals. HHS did not conduct a survey that would have allowed them to vary rates between hospitals.

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Court Rules Court Manufacturing Statute 195

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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Manufacturing Contract Laws Statute 59

JURIST

NOVEMBER 8, 2021

involves a complicated copyright dispute between two clothing manufactures. The statute requires that district courts ask the Register of Copyrights to assess whether the copyright would have been granted if the Register was aware the information was inaccurate. H&M Hennese & Mauritz, L.P

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Court Manufacturing Statute Litigation 197

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 104

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. Of the $138.7

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Manufacturing Laws Litigation Litigating 58

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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Statute Tort Manufacturing Court 59

The Crime Report

AUGUST 2, 2022

Shooting victim Ilene Steur accused Glock of selling more firearms than a legitimate market could handle, feeding a secondary market and attracting customers who intended to use the guns with “criminal intent.”

Manufacturing 52

Manufacturing Statute Contract Attorney 52

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. The statute’s patent specific.” But, as relevant for this case, 35 U.S.C. §

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Manufacturing Statute Court Construction 126

FDA Law Blog

JANUARY 4, 2022

Many of the updates relate to drug manufacturer practices with regard to speaker events, including meals, choice of venue, and attendance. Although the PhRMA Code is a voluntary code of conduct, drug manufacturers should consider updating their marketing policies and practices to align with the new Code. (We

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Manufacturing Statute Litigation Litigating 98

Patently O

JANUARY 17, 2022

This was a very technical decision and we can manufacture the entire machine without any complication in the United States, with the exception that there are two parts that must not be assembled in the United States, but assembled after the machine arrives in Brazil. .” manufacturing capability. Deepsouth Packing Co.

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Manufacturing Litigation Litigating Statute 122

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.

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Statute Contract Manufacturing Court 52

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. and Apple Inc.,

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Manufacturing Contract Statute Technology 126

SCOTUSBlog

FEBRUARY 16, 2024

brings the justices yet another case under a statute with which they are all too familiar – the Federal Arbitration Act. The workers in this particular case (including Neil Bissonnette) are commercial truck drivers, who transport packaged goods manufactured by Flowers Foods, best known for its production of Wonder Bread.

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Statute Manufacturing Contract Litigating 114

Patently O

APRIL 16, 2024

However, in a quirk of history, Congress created a patent-law specific venue statute in the 1800s that severely limits where a patent case can be filed. The Supreme Court’s decision in TC Heartland clarified that a domestic corporation “resides” only in its state of incorporation for purposes of the patent venue statute.

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Statute Manufacturing Law School Court 45

Patently O

JUNE 28, 2022

When the Patent Act of 1790 refers to inventors, it lists gender inclusive forms of “he, she, or they:” [The inventor(s) must] set[] forth, that he, she, or they , hath or have invented or discovered any useful art, manufacture, engine, machine, or device, or any improvement therein… Patent Act of 1790. See, Kara W.

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Laws Manufacturing Statute Legal Documents 103

FDA Law Blog

JUNE 15, 2022

Writing for a unanimous court, Justice Kavanaugh explained that the Medicare statute provides CMS a choice between two options on how to set reimbursement rates for drugs provided in the hospital outpatient setting. The statute sets this “average price” as ASP plus 6%. Becerra, No. 20-1114, 596 U. S. _ (2022). See 42 U.S.C.

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Statute Court Court Decisions Healthcare 52

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. That statute has an exception that protects competing uses if their use of the mark is “noncommercial.” Share Thursday’s decision in Jack Daniel’s Properties v.

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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. process that the machine or manufacture perform. ‘(B) B) HUMAN GENES AND NATURAL MATERIALS.

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Manufacturing Technology Statute Court Decisions 97

SCOTUSBlog

JUNE 15, 2023

Jackson’s opinion starts by restating the long-standing rule that a congressional statute “abrogates” sovereign immunity only if Congress uses language that is “unmistakably clear.” Therefore, [the statute] unmistakably abrogates their sovereign immunity too.” Tribes are indisputably governments.

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Statute Government Manufacturing Court 116

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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Manufacturing Statute Healthcare Court 40

The Crime Report

OCTOBER 18, 2021

Federal gun laws regulate receipt and possession of firearms as well as their manufacture, importation, distribution, and transfer. Most of the defendants prosecuted under federal statutes were charged with unlawful possession of a firearm. The report did not speculate on the reasons for the 2004 surge and its subsequent decline.

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Felony Manufacturing Statute Attorney 119

Conflict of Laws

DECEMBER 19, 2023

The Court held that local consumer legislation – in the form of the Consumer Guarantees Act 1993 (CGA) – applies to foreign manufacturers. The decision is of particular interest to New Zealand consumers and manufacturers of goods that are supplied in New Zealand, as well as traders advertising their products to New Zealanders.

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Manufacturing Court Statute Laws 69

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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Manufacturing Statute Laws Court 52

FDA Law Blog

MAY 8, 2023

Once FDA has cleared or approved a PCCP, that statute states that a supplemental application “shall not be required” to make a change consistent with such PCCP. Manufacturers should be able to verify and validate the proposed modifications within their existing quality system.

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Drafting Manufacturing Data Management Technology 98

SCOTUSBlog

MARCH 23, 2023

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. Kagan’s questioning of Bennett Cooper, representing the toy manufacturer, shows just how settled she was in her position by the end of the morning.

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Statute Manufacturing Court Lawyer 104

Mondaq

AUGUST 16, 2021

Sale of goods statutes afford consumers a set of protections, which are fairly uniform across jurisdictions. Product liability claims are often rooted in provincial sale of goods legislation.

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Manufacturing Statute 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

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. Under 35 U.S.C. §

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Manufacturing Laws Statute Technology 113

FDA Law Blog

FEBRUARY 26, 2025

Trusting suppliers is still fundamental to any drug or device manufacturer. And the Department of Justice will still pursue viable civil and criminal cases , if not under the FCPA then under other statutes like the False Claims Act, Title 18 fraud and conspiracy, and even RICO. So, yes, compliance and quality still matter, a lot.

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Diligence Manufacturing Statute Government 66

FDA Law Blog

OCTOBER 3, 2022

As many of our readers know, the federal antikickback statute prohibits offering or paying healthcare professionals (HCPs) anything of value as an inducement or reward for ordering or prescribing an item or service reimbursable by federal health care programs.

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Healthcare Statute Manufacturing Government 105

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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Manufacturing Statute Contract Court 40

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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Court Contract Statute Manufacturing 118

Patently O

APRIL 25, 2022

The case claims a particular “nitride crystal substrate” used in semiconductor manufacturing. In particular, the claims required “precise” positioning but the specification did not include “standard for measuring” the degree of precision. Finally, in Ex parte Kim (Fed.

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Manufacturing Statute 133

FDA Law Blog

NOVEMBER 30, 2022

According to the allegations in the complaint, approval of the new Los Angeles manufacturing facility required a Prior Approval Supplement (PAS) and a Pre-Approval Inspection (PAI) of the facility. 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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Manufacturing Healthcare Contract Government 72

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. By Sophia R. Background.

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Mens Rea Statute Healthcare Manufacturing 83

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