FDA Law Blog

SEPTEMBER 30, 2022

CMS itself has recognized this by repeatedly inviting manufacturers to use reasonable assumptions where a question is not addressed in the statute, regulations, or CMS guidance. The AMP, best price, and ASP statute and regulations are complex and full of gaps and ambiguities. We are closely following the SuperValu cert.

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JURIST

DECEMBER 16, 2021

This tit-for-tat directive against Texas SB8 is the latest of the bold moves Newsom has taken and responds directly to the Supreme Court decision last week. Newsom has been a roll since convincingly surviving a recall effort against him in September.

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FDA Law Blog

JANUARY 15, 2024

Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.

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Law 360

JUNE 29, 2021

Having received guidance from the Texas Supreme Court that Amazon cannot be held liable for third-party products that are shipped and fulfilled by Amazon, but not manufactured by the company under its brand, the Fifth Circuit on Tuesday reversed a lower court's decision that Amazon is a "seller" under the state's law.

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SCOTUSBlog

MARCH 20, 2023

The case involves a dispute between Jack Daniel’s (the largest American whiskey manufacturer) and VIP Products (the second-largest American dog toy manufacturer). 7 Tennessee Sour Mash Whiskey” manufactured by “Jack Daniel’s,” the toy refers to a “Bad Spaniel” that makes “Old No. 2 on your Tennessee carpet.”

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FDA Law Blog

JUNE 2, 2023

Most are new or revised definitions and administrative changes, but several proposals represent new policies that should be of concern to drug manufacturers. Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices.

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JURIST

NOVEMBER 1, 2021

The decision also vacated an injunction from the Northern District of New York and a prior Second Circuit ruling on an Eastern District of New York case. While the two lower court decisions originate from different jurisdictions, both pertain to healthcare workers’ concerns over the COVID-19 vaccine.

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Patently O

AUGUST 8, 2022

Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title. process that the machine or manufacture perform. ‘(B) B) HUMAN GENES AND NATURAL MATERIALS.

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Manufacturing Technology Statute Court Decisions 96

FDA Law Blog

NOVEMBER 30, 2022

Last month the United States Court of Appeals for the Second Circuit affirmed the district court’s decision to dismiss a False Claims Act (FCA) ( 21 U.S.C 3729) quit tam suit, alleging that Grifols USA, Grifols Biologicals, Grifols, S.A.,

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Intelligize Blog

MAY 21, 2024

Historically, voting on executive compensation packages has been a pro forma exercise at the annual meetings of technology manufacturer 3M Co., A January court decision necessitated a new vote on Musk’s compensation, which has left Tesla insiders lobbying major investors and proxy advisers to give the plan a thumbs up.

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Manufacturing Court Decisions Technology Court 57

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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LexForti

APRIL 22, 2021

According to the facts, the brothers Balkrishna and Nagaraj Setty signed an agreement for partnership where they became the joint owner of the incense manufacturing company. Later, the brothers started their own competing manufacturing companies in separate Indian Cities i.e., Bangalore and Mumbai.

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Laws Manufacturing Court Contract 52

Patently O

APRIL 26, 2024

” The Lower Court Decision In 1842, Wood sued William Underhill and Aschel Gerow for infringement. ” The circuit court agreed with the defendants and instructed the jury that the specification was too vague and uncertain to support the patent. .”

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Manufacturing Court Court Decisions Legal 114

At the Lectern

MAY 30, 2024

Supreme Court decisions that “ ‘erode the analytical foundations’ of Hatch ,” and the justice “respectfully urge[d] the California Supreme Court to reexamine the continuing vitality of Hatch ’s narrow definition of an acquittal under federal double jeopardy principles.”

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FDA Law Blog

DECEMBER 7, 2023

A regulatory consultant on the panel made a recommendation to FDA that it lean more heavily on Remote Interactive Evaluations (“REIs”) to help alleviate its backlog—of which HPM recently learned the Agency had only conducted 10 in the last 30 months for purposes of drug manufacturing compliance.

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Patently O

FEBRUARY 10, 2022

The collaborative idea was that Eddings would manufacture the sheaths because Junker did not have that capability. Thus, the court has held that an offer-to-manufacture doesn’t count. In reviewing the letter, the court noted that the terms appeared quite complete.

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Patently O

APRIL 12, 2023

The statute isclear that patents should be awarded to “any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof” so long as the other requirements of patentability are met. One difficulty with the law here is that it is entirely judge made. SG Brief.

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JURIST

MARCH 26, 2024

The court heard arguments from the Food and Drug Administration (FDA), Danco (a drug manufacturer that only makes mifepristone) and the Alliance for Hippocratic Medicine (AHM). The questions focused on whether the AHM had standing to bring the case to court.

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FDA Law Blog

SEPTEMBER 24, 2023

Within two days of the final rule, the Window Covering Manufacturers Association filed suit at the D.C. This decision from three Democrat-appointed judges can be seen as a traditional pullback of a procedurally deficient agency rule. But there may be more for us to learn from this decision. See 15 U.S.C.

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Manufacturing Court Court Decisions 59

FDA Law Blog

APRIL 19, 2021

The decision has wide-ranging implications for FDA’s assertion of discretion in classifying and regulating medical products. As most readers of our blog are aware, the regulatory costs to manufacturers of medical products are much lower if FDA regulates a product as a medical device rather than a drug requiring FDA marketing approval.

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Patently O

FEBRUARY 17, 2021

.” But, the court looked also to the long-felt unmet need before negating patentability: During a period of half a century, in which the use of flash light batteries increased enormously, and the manufacturers of flash light cells were conscious of the defects in them, no one devised a method of curing such defects. ” A.

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FDA Law Blog

AUGUST 21, 2023

Specifically, the Court explained, because “[t]he Pregnancy Warning Regulation simply does not speak to whether a further warning related to a drug’s use during pregnancy can be added to the general Pregnancy Warning on a drug label, whether added by the FDA or added by a manufacturer,” the ”regulation does not, therefore, preempt state law.”

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FDA Law Blog

JUNE 7, 2023

Last week, the Court ruled on a pair of combined cases that potentially impacts many of our blog readers in the pharmaceutical, device, and biologics space that benefit from reimbursements from Federal health care programs. The Supreme Court Decision The unanimous Supreme Court was having none of it.

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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. Celgene Corp. Mylan Pharma ( Fed. There are two different ways to show proper venue: Venue by Residence : Venue is proper if the defendant(s) reside in the district where the case is filed.

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Statute Manufacturing Court Decisions Court 94

FDA Law Blog

JUNE 15, 2022

In this case, the agency must set reimbursement rates using each drug’s “average price” charged by the manufacturers for the drug, as “calculated and adjusted by the Secretary as necessary for purposes of” this statutory provision. Option 2 applies only if HHS has not conducted such a survey. citing §1395 l (t)(14)(A)(iii)(II)).

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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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Patently O

JANUARY 11, 2024

If a patent claims an entire class of processes, machines, manufactures, or compositions of matter, the patent’s specification must enable a person skilled in the art to make and use the entire class. Guidelines for Assessing Enablement in Utility Applications and Patents in View of the Supreme Court Decision in Amgen Inc.

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Technology Court Manufacturing Court Decisions 52

JonathanTurley

DECEMBER 12, 2021

Supreme Court decision allowing Texas’s ban on most abortion services to remain in place. But if states can now shield their laws from review by the federal courts that compare assault weapons to Swiss Army knives, then California will use that authority to protect people’s lives, where Texas used it to put women in harm’s way.”.

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Patently O

FEBRUARY 24, 2022

Eligibility under Section 101 : American Axle & Manufacturing, Inc. 20-1394 (CVSG requested October 4, 2021); Undermining Jury Decisions : Olaf Sööt Design, LLC v. The asserted patent covers a new method of manufacturing an automobile drive-shaft with reduced vibration. Neapco Holdings LLC, et al. , Patreon, Inc.,

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Patently O

APRIL 23, 2024

Teva has traditionally been a generic manufacturer, but in this case sued Eli Lilly for infringing its patents covering methods of treating headache disorders like migraine using humanized antibodies that bind to and antagonize calcitonin gene-related peptide (CGRP), a protein associated with migraine pain. Lilly for a few years.

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Court Manufacturing Court Decisions Laws 58

SCOTUSBlog

APRIL 20, 2022

Some older Supreme Court decisions support that theory of consent. Some courts read [Supreme Court precedent] as effectively foreclosing [this consent-by-registration theory of jurisdiction], while others insist it remains viable.”. In Cooper Tire & Rubber Company v.

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Patently O

DECEMBER 14, 2023

In that situation, the patent applicant might maintain the compound claims in the original application and then file a “divisional application” to protect the methods of manufacture. ” Based upon the peculiar facts of this case, MSN argued that neither of these requirements had been met.

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FDA Law Blog

JANUARY 11, 2022

The Federal Circuit twice reversed the District Court decision at issue in GSK v. Hikma was filed in November 2020 after the Court’s first decision issued in October 2020.) Teva , but Amarin v.

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Court Manufacturing Court Decisions Litigation 52

FDA Law Blog

JANUARY 11, 2022

The Federal Circuit twice reversed the District Court decision at issue in GSK v. Hikma was filed in November 2020 after the Court’s first decision issued in October 2020.) Teva , but Amarin v.

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Court Manufacturing Court Decisions Litigation 52

ClimateChange-ClimateLaw

DECEMBER 11, 2023

The Fifth Circuit summarily discredited two past court decisions from sister circuits that accepted the NRC’s ability to regulate for temporary nuclear waste storage facilities that are not on the site of a nuclear reactor. This is the background against which First Amendment challenges to disclosure requirements are situated.

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SCOTUSBlog

APRIL 13, 2022

Having lived through Dred Scott , he was deeply conscious of how mistakes by the court could lead to terrible outcomes. Comparing court decisions with which he disagreed to Dred Scott was almost a reflexive tactic of his. Farmers’ Loan & Trust Co.

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ClimateChange-ClimateLaw

OCTOBER 20, 2020

In its stay motion, the Truck Trailer Manufacturers Association (TTMA) argued that the court had already determined that its challenge to the EPA standards was likely to be successful and that the NHTSA standards could not function without the EPA standards. Truck Trailer Manufacturers Association, Inc. 16-1430 (D.C.

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