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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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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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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FDA Law Blog

OCTOBER 1, 2024

Karst — If you monitor Regulations.gov dockets and litigation dockets on PACER like we do, then you know that one company name—more than any other over the past several years—pops up: Vanda Pharmaceuticals, Inc. Court of Federal Claims allowed Vanda’s Fifth Amendment takings claim to move forward in litigation.

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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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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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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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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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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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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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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. ,

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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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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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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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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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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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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.

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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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Patently O

APRIL 15, 2021

An inferior officer decision will interpret the statute as providing the PTO director with substantial authority; a principal officer decision will downplay the role of the PTO director. Patent Eligibility : Of the pending eligibility cases, I find American Axle and Ariosa the most interesting: American Axle & Manufacturing, Inc.

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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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The Process Street

NOVEMBER 28, 2023

Applications of AI manufacturing AI has various applications in manufacturing that are revolutionizing the traditional methods and streamlining the processes. Enhanced safety AI-powered systems can identify and prevent potential hazards in the manufacturing environment.

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Patently O

JUNE 12, 2024

Note: I was involved in litigating patents from this patent family when owned by the predecessor-in-interest. I am no longer involved the litigation. The district court concluded that the patentee Eazy-PZ had engaged in litigation misconduct—all of which was associated with the asserted utility patent. Luv N’ Care, Ltd.

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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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The IP Law Blog

JUNE 16, 2022

One rarely litigated aspect of trademark law is that the use of the trademark must be for a lawful purpose. However, the FDA notes that delta-8 THC does not appear “in significant amounts in cannabis plants so it is often manufactured from hemp-derived cannabidiol.”. The Ninth Circuit recently tackled this issue in AK Futures LLC v.

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FDA Law Blog

OCTOBER 4, 2021

In yet another decision based on statutory interpretation, an appellate court has decided that FDA’s interpretation of the Federal Food, Drug, and Cosmetic Act (FDCA) is contrary to the plain text of the statute. It may lead to new litigation or call into question previous FDA awards of orphan drug exclusivity.

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The Fashion Law

SEPTEMBER 14, 2021

Hardly a stranger to litigation, the Philipp Plein brand and its eponymous founder landed on the receiving end of a strongly-worded lawsuit early this year accusing them of discriminating against an employee on the basis of his sexual orientation. Another Suit Underway.

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FDA Law Blog

DECEMBER 20, 2021

NPA asks the court to declare that the exclusionary clause does not retroactively apply to the dietary supplement NAC and seeks a preliminary and permanent injunction prohibiting FDA from taking any regulatory action against manufacturers, sellers or distributors of NAC based on the claim that the drug exclusion prohibition is retroactive.

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Constitutional Law Reporter

JANUARY 25, 2024

Individuals are sometimes removed from the No Fly List during ongoing litigation about their placement on that list. ” Paragraph (1) of section 1229(a) requires a single notice document that contains all the information specified in the statute, including the “time and place” of proceedings.

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Conflict of Laws

SEPTEMBER 15, 2024

The inaugural lecture was presented by Lord Lawrence Collins of Mapesbury (Former Justice at the United Kingdom Supreme Court) on the “Use and Abuse of Comity in International Litigation”. 4] Collins referred to the Laker Airways litigation, inter alia, Laker Airways Ltd v Sabena Belgian World Airways, 731 F. 2d 909 (DC Cir 1984). [5]

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FDA Law Blog

FEBRUARY 1, 2022

One comment took a different approach and requested that FDA address the conundrum that arises when the current Orange Book listings are manipulated such that listing of ineligible patents prolongs generic approval while omission of eligible patents, and subsequent litigation on those patents, prolongs launch.

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FDA Law Blog

MARCH 12, 2024

Koblitz — After years of silence from FDA on whether certain patents could be listed in the Orange Book, some manufacturers of drug and device combination products have had a rude awakening lately. FTC’s and Congress’s activities seem to have triggered litigation.

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JonathanTurley

MARCH 20, 2021

It is clearly not a “lie” unless Sharma manufactured the screenshot, which is not alleged. While this is clearly not a penal statute, the concern is equally present that the standards do not allow people of common intelligence to clearly discern where the line is drawn between prohibited and permissible conduct.

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At the Lectern

JULY 28, 2022

The opinion acknowledged, “under our interpretation of the relevant statutes a provider has greater remedies against a private health care service plan than it does against a public entity health care service plan.” ” Horvitz & Levy filed the successful petition for review. Inevitable discovery.

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Conflict of Laws

MAY 17, 2022

Hübner: Climate change litigation at the interface of private and public law – the foreign permit. Lieberknecht: Transatlantic tug-of-war – The EU Blocking Statute’s prohibition to comply with US economic sanctions and its implications for the termination of contracts. economic sanctions with extraterritorial reach. Bandemer (2021).

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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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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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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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