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.

Litigation 52

Litigation Litigating Manufacturing Contract 52

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.

Statute 114

Statute Manufacturing Contract Litigation 114

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.

Statute 52

Statute Contract Manufacturing Court 52

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

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.

Litigation 59

Litigation Litigating Government Court 59

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.

Statute 92

Statute Manufacturing Construction Laws 92

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. §

Laws 95

Laws Court Litigation Litigating 95

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

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.

Statute 95

Statute Manufacturing Court Decisions Court 95

SCOTUSBlog

OCTOBER 4, 2024

gun manufacturers. Three courts of appeals have adopted a literal interpretation of the law, he said, “to criminalize only the making of statements that are false,” while four others (including the one in which he was convicted) “interpret the statute more broadly” to apply also to misleading statements. Reynolds Vapor Co.

Manufacturing 120

Manufacturing Court Government Depositions 120

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.

Manufacturing 63

Manufacturing Statute Litigation Litigating 63

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.

Calendaring 123

Calendaring Court Statute Court Rules 123

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.

Litigation 59

Litigation Litigating Statute Manufacturing 59

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 105

Statute Stare Decisis Court Manufacturing 105

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.

Manufacturing 105

Manufacturing Statute Healthcare Litigation 105

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 103

Stare Decisis Court Rules Court Manufacturing 103

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.

Statute 59

Statute Cause of Action Court Rules Litigation 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.

Manufacturing 52

Manufacturing Litigation Litigating Statute 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.

Tort 48

Tort Litigation Litigating Construction 48

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.

Tort 46

Tort Litigation Litigating Construction 46

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.

Manufacturing 60

Manufacturing Healthcare Court Statute 60

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.

Manufacturing 59

Manufacturing Litigation Litigating Court 59

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.

Tort 41

Tort Litigation Litigating Manufacturing 41

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). ”

Court 63

Court Cause of Action Manufacturing Litigation 63

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.

Statute 52

Statute Manufacturing Court Litigation 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.

Laws 83

Laws Court Technology Construction 83

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.

Court 40

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.

Court 40

Court Statute Manufacturing Litigation 40

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.

Virtual Assistant 105

Virtual Assistant Healthcare Entertainment Education 105

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.

Litigation 53

Litigation Litigating Statute Court 53

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 64

Manufacturing Technology Statute Laws 64

FDA Law Blog

AUGUST 7, 2024

Koblitz — Increasingly the subject of induced infringement litigation, the viability of the carve-out has been questioned for several years now. Novartis further claims that the MSN labeling is unlawful because it violates the statutory requirement that the indications be “the same.”

Manufacturing 59

Manufacturing Statute Court Litigation 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.

Laws 59

Laws Contract Statute Construction 59

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.

Statute 103

Statute Court Education Administrative Law 103

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

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.

Statute 52

Statute Court Manufacturing Court Rules 52