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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Litigation Litigating Statute Manufacturing 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

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Manufacturing Statute Litigation Litigating 75

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 92

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 63

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

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

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

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

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

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 60

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 95

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

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 112

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.

Manufacturing 62

Manufacturing Technology Statute Laws 62

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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Manufacturing Court Depositions Statute 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 57

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 126

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

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

SCOTUSBlog

DECEMBER 3, 2023

Share Purdue Pharma’s bankruptcy deal, which will reach the Supreme Court for oral argument on Monday , is just one of many examples of recent unorthodox civil procedure maneuvers in public harms litigation. Although the statute formally allows for only pre-trial consolidation, 99% of cases consolidated into MDL settle.

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Litigation Litigating Tort Statute 85

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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Manufacturing Statute Litigation Litigating 59

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

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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Virtual Assistant Healthcare Entertainment Education 105

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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Litigation Litigating Manufacturing Contract 52

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.

Laws 52

Laws Manufacturing Litigation Litigating 52

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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Laws Court Technology Manufacturing 83

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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Statute Manufacturing Laws Court 47

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

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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Manufacturing Construction Legal Legal 52

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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Manufacturing Statute Law Firm Law Firms 52

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

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 59

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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Government Court Contract Cause of Action 49

SCOTUSBlog

JANUARY 20, 2022

In 1981, Congress passed a statute requiring that reimbursement rates paid to organizations for managing state Medicaid plans must be “actuarially sound.” The case has already been rescheduled three times, clearly indicating it’s on at least one of the justices’ radar. Next up is Texas v. Axon Enterprise, Inc.

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Court Statute Education Administrative Law 95

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 91