FDA Law Blog

NOVEMBER 7, 2021

Kirschenbaum — On September 30, we blogged about the ongoing dispute and litigation around the use of contract pharmacies under the 340B Drug Discount Program (click here ). A key issue before the court was whether, despite the relevant statute’s silence on the issue, Congress intended to allow the use of contract pharmacies.

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Statute Contract Manufacturing Court 52

JURIST

NOVEMBER 8, 2021

This doctrine allows the government to potentially dismiss litigation that would require disclosure of information damaging to national security. involves a complicated copyright dispute between two clothing manufactures. A lawsuit was filed in 2011 but was dismissed based on state secrets privilege. H&M Hennese & Mauritz, L.P

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Court Manufacturing Statute Litigation 197

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

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. manufacturing capability. patent law.

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Manufacturing Litigation Litigating Statute 122

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 Court 96

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 75

JonathanTurley

OCTOBER 30, 2022

See Pennsylvania General Assembly Statute §7102. OUTCOME: Reversed dismissal on the basis of tolling of statute of limitations. Mrs. Ferlito had constructed a lamb costume for her husband by gluing cotton batting manufactured by defendant Johnson & Johnson Products (“JJP”) to a suit of long underwear. 32; 285 S.W.

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Tort Litigation Litigating Manufacturing 35

Patently O

MARCH 18, 2024

Tube-Mac, is the plaintiff in this case and is looking to manufacture its own version of the container systems. 256. . = = = One interesting aspect of this decision relates to absence of a statute of limitations. ”) Patent law does not have a specific statute of limitations associated with claims to correct inventorship.

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Statute Cause of Action Court Rules Court 58

JonathanTurley

OCTOBER 31, 2021

See Pennsylvania General Assembly Statute §7102. OUTCOME: Reversed dismissal on the basis of tolling of statute of limitations. Mrs. Ferlito had constructed a lamb costume for her husband by gluing cotton batting manufactured by defendant Johnson & Johnson Products (“JJP”) to a suit of long underwear. 32; 285 S.W.

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Tort Litigation Litigating Manufacturing 36

SCOTUSBlog

JULY 5, 2023

that the Lanham Act, the federal trademark statute, reaches only conduct “where the claimed infringing use in commerce is domestic” and that confusion to consumers in the United States is not relevant to the analysis. The key is the “conduct relevant to the statute’s focus,” and that conduct must occur in the United States.

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Statute Manufacturing Court Laws 90

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 parties settled the litigation before the IPRs were complete, but agreed that the IPRs could continue. Neapco Holdings LLC, et al. , Patreon, Inc., 35 U.S.C. §

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Laws Court Litigation Litigating 95

FDA Law Blog

OCTOBER 4, 2023

As such, that statute was unjust, confiscatory and violated their constitutional due process rights. The court did not make much of Plaintiff’s argument that a manufacturer cannot terminate its participation in Medicare for close to two years, see Motion at 8; Complaint at 27-28, potentially dismissing it as a mere administrative matter.

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Manufacturing Litigation Litigating Court 59

FDA Law Blog

JULY 13, 2022

If a drug that has been approved for 12 years—but less than 16 years—is selected for the Drug Price Negotiation Program, a biosimilar manufacturer can request a one-year moratorium on negotiations for that product so that the biosimilar manufacturer has time to secure licensure and begin marketing of the biosimilar version.

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Manufacturing Litigation Litigating Statute 52

SCOTUSBlog

APRIL 19, 2024

VanDerStok , involving the Biden administration’s efforts to regulate firearm parts kits (colloquially known as “ghost guns”) under the Gun Control Act of 1968, which imposes licensing, background-check, recordkeeping, and serialization requirements on persons engaged in the business of importing, manufacturing, or dealing in “firearms.”

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Felony Immigration Court Statute 128

JonathanTurley

NOVEMBER 21, 2021

Below is my column in the Wall Street Journal on the ongoing opioid litigation and an important ruling out of the Oklahoma Supreme Court. Companies can be held strictly liable for products that are defective in design, manufacture or warnings. In the opioid litigation, the companies were producing a lawful, nondefective product.

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Tort Litigation Litigating Manufacturing 34

Patently O

MAY 6, 2022

The statute does not create any express ‘safe harbor’ for the generic manufacturer against liability for patent infringement. Certainly, the manufacturer would be liable for inducement if it encouraged off-label infringing use of its product. This situation was litigated most recently in GlaxoSmithKline LLC v.

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Manufacturing Statute Litigation Litigating 62

SCOTUSBlog

NOVEMBER 17, 2023

Natural Resources Defense Council , in which the court held that when a federal statute is ambiguous, courts should defer to an agency’s interpretation of that law as long as it is reasonable. But at the arguments on Jan. On the first day of the session, Jan. The question before the court in FBI v. County of El Dorado (Jan.

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Immigration Calendaring Government Manufacturing 110

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). . Instead of deriving peace, honour, and affluence from their incessant labour and incomparable skill, they have sunk under vexation and the pressure of litigation. Van Ness argues that the U.S.

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Statute Manufacturing Construction Laws 91

FDA Law Blog

SEPTEMBER 13, 2021

A final OIG rule to change the structure of manufacturer rebates to Medicare Part D and Medicaid Managed Care plans and their PBMs is enmeshed in litigation and is likely to be at least postponed until 2026 (see our post ), and perhaps prevented from implementation altogether, by Congressional mandate.

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Manufacturing Litigation Litigating Government 98

The IP Law Blog

MARCH 2, 2021

es the threat posed to companies that rely on third-party manufacturers. Considering the importance of Chinese manufacturing to global trade, the Chinese legal system and its evolving trademark enforcement system will likely cause companies to get creative. 7 While the statute makes willfulness a prerequisite to a pro?ts

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Manufacturing Mens Rea Contract Tort 52

FDA Law Blog

DECEMBER 21, 2021

In other words, the California law assumes that every potential Paragraph IV patent settlement is anticompetitive, and the pharmaceutical manufacturers must show that the settlement is not anticompetitive to avoid upwards of $20 million in fines. The case was dismissed without prejudice.

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Court Statute Manufacturing Litigation 40

FDA Law Blog

DECEMBER 21, 2021

In other words, the California law assumes that every potential Paragraph IV patent settlement is anticompetitive, and the pharmaceutical manufacturers must show that the settlement is not anticompetitive to avoid upwards of $20 million in fines. The case was dismissed without prejudice.

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Court Statute Manufacturing Litigation 40

FDA Law Blog

SEPTEMBER 19, 2023

On the heels of its powerful (and unprecedented) amicus brief in Paragraph IV litigation between Jazz and Avadel concerning a patent covering a Risk Evaluation and Mitigation Strategy (“REMS”) listed in the Orange Book, the Federal Trade Commission (“FTC”) is gearing up to tackle anticompetitive Orange Book listing practices.

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Manufacturing Statute Healthcare Litigation 105

Patently O

NOVEMBER 8, 2021

The 2017 Supreme Court decision in TC Heartland gave renewed teeth to the venue statute governing litigation. Although the notice letter is a critical aspect of the Hatch-Waxman process, the Federal Circuit found that the letter was not an “act of infringement” as required by the venue statute. Celgene Corp.

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Statute Manufacturing Court Decisions Court 94

Patently O

JULY 17, 2022

Instead, a generic manufacturer can sell its product with a “skinny label” that “carves out” any patented uses found in the brand drug’s labeling—and thereby avoid inducing infringement of the brand manufacturer’s patent rights. The petition was filed by highly regarded Supreme Court litigator William Jay (Goodwin) on July 11, 2022.

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Manufacturing Healthcare Court Statute 59

SCOTUSBlog

SEPTEMBER 29, 2023

The question comes to the court in the case of George Sheetz , who in 2016 applied for a permit to build a 1,854-square-foot manufactured home on land that he owns in Placerville, California. To receive the permit, Sheetz was required to pay El Dorado County $23,420 in traffic-mitigation fees. The plaintiff in the case, Yonas Fikre, is a U.S.

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Calendaring Court Statute Court Rules 113

ClimateChange-ClimateLaw

DECEMBER 11, 2023

This blog post explores how the litigation landscape has developed since the SEC proposed the rule, and discusses the implications of several developing cases and doctrines. Together, these matters suggest a volatile litigation landscape that the SEC will have to navigate thoughtfully as it finalizes and defends the climate disclosure rule.

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Legal Legal Court Statute 61

SCOTUSBlog

MARCH 20, 2023

The facts Hetronic, based in Oklahoma, manufactures and sells radio remote controls that operate heavy-duty construction equipment. The court asks if there is a “clear, affirmative indication” from the face of the statute that Congress intended the law to apply extraterritorially. It owns U.S. Has Congress directly spoken here?

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Stare Decisis Laws Statute Construction 79

Day on Torts

MARCH 16, 2022

Where there were genuine issues of material fact in a products liability case filed against the manufacturer and seller of an ATV, summary judgment for defendants was reversed. Defendant manufacturer asserted that any evidence that the winch might have reverse-spooled was speculative, but the Court of Appeals disagreed. In Vaulton v.

Manufacturing 59

Manufacturing Court Depositions Statute 59

Trademark & Copyright Law

APRIL 24, 2020

For decades, a trademark owner’s chances of recovering an infringer’s profits in litigation varied depending on where the case was pending. But Fossil’s manufacturers in China began using counterfeit Romag fasteners, and Fossil did not take appropriate steps to keep them from doing so. The Background. Willfulness No Longer Required.

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Statute Manufacturing Court Litigation 52

Patently O

MARCH 25, 2021

Although Ford sells Explorers in Montana, the particular Ford Explorer here was not designed, manufactured, or sold in Montana. None of our precedents has suggested that only a strict causal relationship between the defendant’s in-state activity and the litigation will do. ” Quoting Reiter (1979). ”

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Court Cause of Action Manufacturing Litigation 63

Conflict of Laws

NOVEMBER 23, 2023

Apart from customary international law, it is also doubtful that Meng’s conduct in Hong Kong fell within the scope of the federal bank and wire fraud statutes. conduct is required under the federal bank and wire fraud statutes, Meng engaged in no U.S. The machines to make these chips are manufactured in the Netherlands.

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Manufacturing Technology Statute Laws 63

Patently O

DECEMBER 22, 2022

Question presented: If a generic drug’s FDA-approved label carves out all of the language that the brand manufacturer has identified as covering its patented uses, can the generic manufacturer be held liable on a theory that its label still intentionally encourages infringement of those carved-out uses? Teva petition.

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Court Laws Manufacturing Technology 59

Conflict of Laws

OCTOBER 23, 2023

Statute has left little of the common law untouched. US customers also waived their rights to litigate in representative proceedings against Carnival (the ‘class action waiver’) ( PJ, [27] ). First, a statute may impose a choice of law rule directing the application of the lex fori where a connecting factor is established.

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Laws Contract Statute Construction 58

SCOTUSBlog

APRIL 20, 2022

Two pending petitions raise the question of the constitutionality of state statutes providing that corporations are deemed to have consented to “general” personal jurisdiction by virtue of having registered to do business in a state. was filed by a plaintiff seeking to enforce a similar registration statute. Returning Relists.

Statute 101

Statute Stare Decisis Court Manufacturing 101

SCOTUSBlog

JULY 1, 2021

Share The Supreme Court on Tuesday narrowed the doctrine of patent assignor estoppel, which prohibits an inventor from assigning a patent to someone and then later contending in litigation that the patent is invalid. By a vote of 5-4, the court rejected calls to completely abandon the doctrine. Formica Insulation Co. ,

Stare Decisis 101

Stare Decisis Court Rules Court Manufacturing 101

Patently O

SEPTEMBER 26, 2022

The most anticipated case last year was the 101 eligibility petition regarding automobile drive shaft manufacturing process. One way to think about this case is the level of responsibility that the generic manufacturer has to make sure that its drug is not used in an infringing way. American Axle (cert denied). USPTO , No.

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Court Laws Manufacturing Statute 125