FDA Law Blog

FEBRUARY 5, 2023

Both courts found the statute to be ambiguous, but only the Delaware court vacated HRSA’s penalties; the New Jersey court remanded the issue to HRSA. Last week, a panel of three judges at the Third Circuit who reviewed these three cases decided in favor of the drug manufacturers. A lot is at stake here.

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SCOTUSBlog

MARCH 15, 2024

Share As a specific legal question, Tuesday’s bankruptcy case is simple, almost trivial: whether the Bankruptcy Code provisions that permit any “party in interest” to “be heard on any issue” in a Chapter 11 proceeding extend to an insurance company obligated on the claims against an asbestos company during the latter’s reorganization.

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The IP Law Blog

JANUARY 18, 2024

For example, a trade secret can be a manufacturing process, recipe, distribution method for products, research and development information, software algorithm, list of ingredients, list of suppliers, list of customers, pricing strategy, business plan, or advertising strategy. In most cases, reverse engineering is legal.

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Manufacturing Laws Statute Technology 113

FDA Law Blog

JUNE 16, 2023

Kirschenbaum — On May 24, Minnesota enacted the Commerce and Consumer Protection Omnibus Bill, Senate File 2744 ( SF 2744 ), which significantly expands the state’s existing drug pricing activities with serious implications for all drug manufacturers, and particularly generic drug manufacturers. We address each below.

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JURIST

FEBRUARY 22, 2021

The law, 13 VSA § 4021(a) , bans people from manufacturing, possessing, transferring, selling, purchasing, receiving or importing large-capacity magazines in the state of Vermont. ” The post Vermont Supreme Court upholds state’s first major gun-control law appeared first on JURIST - News - Legal News & Commentary.

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Patently O

FEBRUARY 10, 2022

2015) in finding that manufacture and delivery of a product in a foreign country can infringe a US patent if sufficient sales-activity occurred within the US. The Federal Circuit rejected this appeal — holding that the presumption is applied when courts interpret the law or construe a statute. Broadcom Ltd. and Apple Inc.,

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FDA Law Blog

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). CMS will send the final manufacturer invoice for discount liabilities accrued by then on April 30, 2028.

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FDA Law Blog

NOVEMBER 6, 2022

Gaulkin — We previously blogged about Pfizer’s copay assistance lawsuit, which sought to challenge HHS’s interpretation of the Federal health care program anti-kickback statute (AKS) and position that the company’s proposed copay assistance program would violate the AKS. By Sophia R. Background. Pfizer’s Petition to SCOTUS.

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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). . Exactions and frauds, in all the forms which rapacity can suggest, are daily imposed and practised under the pretence of some legal sanction. Van Ness argues that the U.S.

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FDA Law Blog

DECEMBER 12, 2022

How could the manufacturers even follow this guidance without illegally departing from their previously approved labeling? The Kentucky AG uniquely adds that FDA’s proposal improperly interferes with the Commonwealth’s exercise of supervisory authority over its physicians, including statutes addressed to obtaining informed consent.

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FDA Law Blog

OCTOBER 4, 2023

As such, that statute was unjust, confiscatory and violated their constitutional due process rights. Because Plaintiffs are not legally compelled to participate in the Program—or in Medicare generally—they have not shown a strong likelihood of success on the merits of their due process case.” Order at 24.

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Customs & International Trade Law

NOVEMBER 23, 2021

now states: “Products of the United States when returned after having been exported, or any other products when returned within 3 years after having been exported, without having been advanced in value or improved in condition by any process of manufacture or other means while abroad.” manufacturer are not clearly stated. claim (p.s.

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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. Caraco (2012). See 21 U.S.C. § 355(j)(2)(A)(viii). c)(2)(i)(O)(2), (c)(2)(i)(P)(2).

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Manufacturing Healthcare Court Statute 58

FDA Law Blog

SEPTEMBER 19, 2023

The six-page statement explains that “Brand drug manufacturers may be harming generic competition through the improper listing of patents in the. Of course, the statute says that only drug formulation, composition, or method of use patents are listable, but FDA has not defined the scope of the “drug” that must be covered by the patent.

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Manufacturing Statute Healthcare Litigation 105

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. Animal Legal Defense Fund.

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Statute Stare Decisis Court Manufacturing 105

Patently O

MARCH 9, 2022

But, in the 1800s, Congress created a special statute that substantially limits proper venue in patent cases (well before the expansion seen in Section 1391. In Fourco (1957), and again in TC Heartland (2017), the Supreme Court gave weight to the patent-focused statute. Thus, for most federal cases, venue is not a major hurdle.

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SCOTUSBlog

MARCH 26, 2024

Justice Clarence Thomas returns to the Comstock Act in his questioning of Jessica Ellsworth, representing the drug manufacturer, Danco. “My The statute doesn’t have this sort of safe harbor that you’re suggesting. There are so many questions I could think of to ask her about various pending legal matters.

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Court Manufacturing Legal Legal 105

FDA Law Blog

JUNE 12, 2022

Walsh — Legal doctrines can be like parrots. established by statute and case law. The DOJ notes that “device manufacturers are required to investigate adverse events and report information to the FDA within 30 days of becoming aware of information that the marketed device “[h]as malfunctioned. . . By Jeffrey K.

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SCOTUSBlog

OCTOBER 12, 2023

4 in the challenge to the legality of the bankruptcy plan for Purdue Pharma, the manufacturer of the highly addictive opioid painkiller OxyContin. Natural Resources Defense Council , holding that courts should defer to a federal agency’s interpretation of a statute as long as that interpretation is reasonable, for argument in December.

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FDA Law Blog

AUGUST 26, 2021

In its Compliance Guidance for Pharmaceutical Manufacturers , the HHS OIG notes: The OIG recognizes that the implementation of a compliance program may not entirely eliminate improper conduct from the operations of a pharmaceutical manufacturer.

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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. In their comprehensive legal analysis of U.S. Although U.S. conduct at all.

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Manufacturing Technology Statute Laws 60

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

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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At the Lectern

NOVEMBER 16, 2023

The court wants a Court of Appeal opinion on the constitutionality of a state statute barring public employers from discouraging union membership. He argued that the statute criminalizing his conduct violates the Second Amendment. Clark about the legislation’s application. Lopez already has its own grant-and-hold.

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FDA Law Blog

APRIL 25, 2023

Shapiro — Does your firm manufacture a “cyber device”? However, FDA’s legal standing to insist on cybersecurity features, especially within the substantial equivalence paradigm, has been questionable. Now, with explicit statutory authority, FDA’s push for cybersecurity has a firm legal footing. By Philip Won & Jeffrey K.

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FDA Law Blog

NOVEMBER 7, 2023

But there’s no telling what the implicated manufacturers will do, because again, it is legally unclear whether the listing of the device patents is actually anticompetitive. FDA has asked for comments and published a report, but really nothing has come of that other than repeated requests from industry for guidance in this space.

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Manufacturing Lawyer Lawyers Statute 59

Hoban Law Group

JUNE 8, 2021

If you manufacture, distribute, or sell hemp products in the U.S., First, ensure your product label adheres to federal labeling regulations governing the type of product you are manufacturing, distributing, or selling. 5) Name and Place of Business of the Manufacturer, Distributor or Packer. Supplement Facts panel); and. (5)

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Manufacturing Government Laws Statute 132

JonathanTurley

NOVEMBER 21, 2021

” The Oklahoma Supreme Court last week struck down a $465 million opioid award against Johnson & Johnson based on a legal theory that has previously been tried and failed against guns. Judge Polster pushed drug makers to settle before clearly establishing legal liability. Yet it leaves the matter far from resolved.

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The Fashion Law

FEBRUARY 10, 2022

And wven without Rogers and the First Amendment, they note that “the federal dilution statute expressly excludes ‘noncommercial’ uses,” which is what is at play here, they argue, given the artistic elements of Rothschild’s MetaBirkins. As for what brands stand to gain in legal battles over NFTs, we take a look at that here.

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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.

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The IP Law Blog

JUNE 16, 2022

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.”. On the other hand, AK Futures argued that delta-8 THC fell within the definition of hemp, which Congress had legalized in its 2018 Farm Act. on a dry weight basis.”

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Laws Manufacturing Litigation Litigating 52

FDA Law Blog

DECEMBER 20, 2021

FDA did not consider that NAC was legally marketed as a dietary supplement before 1994. As a matter of statutory construction, absent explicit language, statutes are generally intended to apply prospectively. Seemingly that should give a plaintiff standing. Second, was DSHEA intended by Congress to apply retroactively?

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Manufacturing Construction Legal Legal 52

Customs & International Trade Law

SEPTEMBER 17, 2021

According to the State Department, Keysight cooperated in the investigation by submitting a voluntary disclosure that acknowledged the charged conduct, implemented remedial compliance measures, and signed a statute of limitations agreement tolling the statutory period. In-House Legal Counsel . Department of Commerce; the U.S.

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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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Customs & International Trade Law

MAY 13, 2022

On May 9, 2022, the FDA issued a Constituent Update stating that Glanbia Performance Nutrition (Manufacturing), Inc. The complaint, as supplemented, further alleges that an industry in the United States exists as required by the applicable Federal Statute. Here is a recap of the latest customs and international trade law news: FDA.

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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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Statute Manufacturing Court Laws 97

Customs & International Trade Law

OCTOBER 28, 2022

DOC determines that imports of quartz slab manufactured in the People’s Republic of China (China) and processed in Malaysia are covered by the scope of the antidumping duty (AD) and countervailing duty (CVD) orders on certain quartz surface products from China. . Secretary of Commerce has determined that U.S.

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Manufacturing Government Laws Administrative Law 52