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. In United Therapeutics Corporation v.

Manufacturing 59

Manufacturing Contract Statute Court 59

JURIST

FEBRUARY 20, 2021

The North Dakota House of Representatives approved legislation Wednesday that would exempt some locally made guns from federal regulations and laws. ” This new legislation would still require gun-owners to act in accordance with North Dakota laws, regulations, and registration. .”

Manufacturing 146

Manufacturing Statute Legal Legal 146

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).

Manufacturing 59

Manufacturing Contract Laws Statute 59

JURIST

NOVEMBER 8, 2021

While neither case is particularly high profile, both involve subtle interpretations of surveillance and copyright law, respectively. involves a complicated copyright dispute between two clothing manufactures. Fazaga and Unicolors, Inc. H&M Hennese & Mauritz. Unicolors, Inc. H&M Hennese & Mauritz, L.P

Court 197

Court Manufacturing Statute Litigation 197

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. It is doubtful that Cuomo truly believes that the law will make a significant, if any, impact on gun violence. The new law is written to get around a federal ban on such lawsuits. Of the $138.7

Manufacturing 58

Manufacturing Laws Litigating Litigation 58

Patently O

JUNE 28, 2022

The following year, Congress passed the first patent act that was then signed-into law by President George Washington. Three years later, Congress substantially rewrote the statute and, at that time changed the pronouns. The new law eliminated the female pronoun “she.” patent system. 307, 308 (2018); B. LEGAL HIST.

Laws 103

Laws Manufacturing Statute Legal Documents 103

The Crime Report

JUNE 18, 2021

6 Capitol breach with violating a federal law that makes it a crime to transport a firearm or explosive for unlawful use in a riot, reports the Washington Post. Prosecutors in Oregon, and a few other states and the District of Columbia, applied the law as a lead charge in more than two dozen cases as then-Attorney General William P.

Laws 105

Laws Manufacturing Statute Attorney 105

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.

Manufacturing 52

Manufacturing Statute Contract Attorney 52

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.

Statute 59

Statute Tort Manufacturing Court 59

Day on Torts

JANUARY 25, 2021

Plaintiff brought this products liability claim against numerous defendants, including several industrial equipment manufacturers who made and sold equipment used by the deceased husband at his job. The husband died after being diagnosed with mesothelioma due to asbestos exposure at work. Code Ann. § 29-28-102(6).

Manufacturing 59

Manufacturing Court Statute Court Rules 59

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

Manufacturing 98

Manufacturing Statute Litigation Litigating 98

Patently O

JANUARY 17, 2022

patent law. 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. .” Patent Law Amendments Act of 1984, Pub.

Manufacturing 122

Manufacturing Litigation Litigating Statute 122

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. §

Manufacturing 126

Manufacturing Statute Court Construction 126

SCOTUSBlog

JUNE 27, 2023

Share The justices narrowly rejected a challenge to the constitutionality of a Pennsylvania law that allows any company doing business in the state to be sued there – even if the corporation is not headquartered in Pennsylvania and the conduct at the center of the lawsuit occurred somewhere else. of Philadelphia v. of Ireland v.

Laws 117

Laws Court Manufacturing Statute 117

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. In its appeal, Broadcom also argued that the jury should have receive instructions on the presumption against extraterritorial application of US law. Broadcom Ltd. 2129 (2018).

Manufacturing 126

Manufacturing Contract Statute Technology 126

Patently O

FEBRUARY 24, 2022

Eligibility under Section 101 : American Axle & Manufacturing, Inc. The statute indicates that any party to an IPR final-written-decision has a right to appeal. The asserted patent covers a new method of manufacturing an automobile drive-shaft with reduced vibration. Neapco Holdings LLC, et al. , Patreon, Inc., 35 U.S.C. §

Laws 95

Laws Court Litigation Litigating 95

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.

Manufacturing 52

Manufacturing Statute Laws Court 52

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.

Statute 52

Statute Contract Manufacturing Court 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. Kagan rests her analysis on two basic points of trademark law, summarized emphatically at the beginning and reiterated at the end of her opinion.

Manufacturing 115

Manufacturing Statute Cause of Action Court 115

Patently O

JUNE 15, 2021

Although it required invention in name, it was really just becoming a replacement to monopolies barred by the Statute of Monopolies (1624). . Not only are the questions now before me novel, but the whole law relating to patents may still, in this country, be regarded in that light. Van Ness argues that the U.S.

Statute 92

Statute Manufacturing Construction Laws 92

FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? Congress has given FDA the authority to require device manufacturers to provide cybersecurity information in their premarket submissions for a “cyber device.” Please refer to the help text in this section for the content that is required according to this statute.”

Laws 105

Laws Manufacturing Drafting Technology 105

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.

Manufacturing 69

Manufacturing Court Statute Laws 69

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

Manufacturing 75

Manufacturing Statute Litigation Litigating 75

The Crime Report

OCTOBER 18, 2021

Federal gun laws regulate receipt and possession of firearms as well as their manufacture, importation, distribution, and transfer. Federal law also penalizes the criminal use of firearms. Most of the defendants prosecuted under federal statutes were charged with unlawful possession of a firearm.

Felony 119

Felony Manufacturing Statute Attorney 119

Patently O

AUGUST 8, 2022

The short provision has remained essentially unchanged since it was originally handwritten in the 1700s and signed into law by President George Washington. ” Unfortunately, due to a series of Supreme Court decisions, patent eligibility law in the United States has become confused, constricted, and unclear in recent years.

Manufacturing 97

Manufacturing Technology Statute Court Decisions 97

The IP Law Blog

JANUARY 18, 2024

While there are certain rights in common law trademarks, greater protection is afforded by registering the mark with the USPTO. But there are exceptions and exclusions under patent law. For example, courts have found that abstract ideas, natural phenomena, and laws of nature are not patentable. A patent protects an invention.

Manufacturing 113

Manufacturing Laws Statute Technology 113

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.

Statute 52

Statute Court Court Decisions Healthcare 52

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.

Manufacturing 40

Manufacturing Statute Healthcare 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).

Manufacturing 59

Manufacturing Statute Court Decisions Court 59

Patently O

APRIL 15, 2021

The case does not expressly decide any patent law issues, but does provide some guidance as to how courts should approach mixed questions of law and fact (such as claim construction) and the right to a jury trial. The court made no determination as to whether the API was actually copyrightable in the first place. Hirshfeld , No.

Laws 83

Laws Court Technology Construction 83

SCOTUSBlog

JUNE 24, 2021

When Patel later sought to adjust his status to lawful permanent resident and obtain a green card, a divided panel of the Board of Immigration Appeals denied him relief, holding that he is inadmissible because he “falsely represented” himself as a U.S. citizen for a benefit under state law. Becerra and with consecutive numbers.

Administrative Law 99

Administrative Law Immigration Laws Government 99

At the Lectern

MARCH 4, 2024

FCA US LLC , the Supreme Court today holds that restitution a manufacturer owes under the Song-Beverly Act (Civ. That rule applies “at least where, as here, a consumer has been forced to trade in or sell a defective vehicle due to the manufacturer’s failure to comply with the Act.” In Niedermeier v. Code, § 1790 et seq.)

Manufacturing 45

Manufacturing Laws Statute Court 45

SCOTUSBlog

DECEMBER 10, 2022

The move came in response to a tide of lawsuits brought against manufacturers of the technology by women who alleged serious complications from its use in surgery. But in any event, the company contends, it suffered the real injury from insufficient warning of possible risks, due to the laws’ vague language regarding “violation[s].”.

Manufacturing 79

Manufacturing Statute Attorney Court 79

Hoban Law Group

JUNE 8, 2021

If you manufacture, distribute, or sell hemp products in the U.S., These requirements are mandated by various laws and regulations and can be challenging to navigate. First, ensure your product label adheres to federal labeling regulations governing the type of product you are manufacturing, distributing, or selling.

Manufacturing 132

Manufacturing Government Laws Statute 132

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.

Court 122

Court Contract Statute Manufacturing 122

SquirePattonBoggs

JANUARY 13, 2021

Whitmer , which upheld the State of Michigan’s alcohol delivery laws in the face of a dormant Commerce Clause challenge. State-licensed alcohol producers and manufacturers (first tier) sell their products to licensed wholesalers (second tier), who in turn distribute the product to licensed retailers (third tier).

Laws 55

Laws Court Statute Manufacturing 55

FDA Law Blog

SEPTEMBER 30, 2024

CMS did not finalize the price verification survey, which would have required manufacturers of 10 costly drugs selected annually to provide clinical information as well as information on production, distribution, research, and marketing costs, revenue and profit, and ex-U.S. that is not supported by the statute and applicable regulations.”

Manufacturing 59

Manufacturing Calendaring Statute Laws 59