FDA Law Blog

APRIL 16, 2024

Under the Medicaid Drug Rebate statute, a pharmaceutical manufacturer whose drug prices increase faster than the rate of inflation must pay additional per-unit rebates to the program. The statute defines a “line extension” as a “new formulation” of an existing drug, with certain exceptions. Vanda Pharmaceuticals, Inc. 23-1457 (4th Cir.

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Diane Drain

DECEMBER 31, 2020

It is possible that these interpretations of the new Act will change with new legislation or court decisions, so never assume what you read one day will be interpreted the same way the next day. This provision, if it becomes effective, will sunset on December 27, 2022. This provision sunsets in two years on December 27, 2022.

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Conflict of Laws

SEPTEMBER 1, 2022

The revision of this regulation, which will enter into force on 1 July 2022, provides an opportunity to examine the current and future rules by taking the example of the international service of writs of summons. The Cologne court decision combined several precedents of the German Federal Court and the European Court of Justice.

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Patently O

MARCH 3, 2022

In 2021, the Supreme Court sided with the patentee in holding that the AIA trial system violated the Appointments Clause of the U.S. The Court concluded that PTAB judges were wielding the substantial power of the U.S. Oral arguments in this round of the appeal are set for March 30, 2022. by Dennis Crouch. Arthrex, Inc.

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Statute Court Decisions Court Laws 63

SCOTUSBlog

FEBRUARY 21, 2022

How is it possible that the sentence rendered by the Court of Indian Offenses was dramatically less severe than the sentence rendered in federal court? The statute was later amended to allow, in limited situations, tribal court sentences of up to three years. The justices granted review on Oct.

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SCOTUSBlog

JUNE 29, 2022

It may have been Justice Clarence Thomas’s 74th birthday, but he was the one delivering gifts on June 23, 2022. Joseph Greenlee is the director of constitutional studies at FPC Law. Namely, the restoration of millions of Americans’ Second Amendment rights.

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Patently O

FEBRUARY 10, 2022

On appeal, however, the Federal Circuit has reversed–holding that the Eddings letter constituted a “commercial offer for sale of the claimed design” and therefore created a bar to patentability under the statute. by Dennis Crouch. Larry Junker v. Medical Components, Inc. ( Junker’s U.S. Design Patent No.

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Contract Manufacturing Statute Contract Law 78

Patently O

SEPTEMBER 21, 2022

In its 2022 Caltech decision, the Federal Circuit overturned its prior Shaw precedent and found that the estoppel broadly applies to all claims challenged in an IPR and all grounds “which reasonably could have been asserted” against the petitioned claims. 2022) (“Caltech”). 2022) (“Caltech”).

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FDA Law Blog

FEBRUARY 27, 2024

Part 1: Multiple PTEs Under the PTE statute at 35 U.S.C. § For years after the enactment of the Hatch-Waxman Amendments the PTO interpreted the PTE statute to permit multiple PTEs, provided there are separate, but not necessarily different, regulatory review periods. 351, 355-56 (1985). 156(d)(5) (see our prior post here.)

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FDA Law Blog

NOVEMBER 30, 2022

The district court dismissed the complaint, concluding primarily that the Realtor failed to sufficiently allege that Grifols’ claims for payment to government programs that contained records or statements material to a fraudulent claim.

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Constitutional Law Reporter

MAY 10, 2023

Supreme Court has concluded its oral arguments for the 2022-2023 Term. The Court’s final week included four cases, with issues ranging from bankruptcy to RICO to government takings. Below is a brief summary of the issues before the Court: Lac du Flambeau Band of Lake Superior Chippewa Indians v.

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Government Statute Court Legal 59

Constitutional Law Reporter

FEBRUARY 16, 2023

Supreme Court issued its first opinion of the 2022-2023 Term. S. _ (2023), a unanimous Court held that the effective date of an award of service-related disability compensation to a veteran of the United States military determined pursuant to 38 U.S.C. §§ 5110(a)(1) and 5110(b)(1) is not subject to equitable tolling.

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Patently O

OCTOBER 5, 2022

The 4th Circuit noted a second problem–the statute provides discretionary authority (“the district court … may order …”), and here discretion was properly denied. The opinion conflicts with the Second Circuit’s decision in In re del Valle Ruiz , 939 F.3d ” In re Eli Lilly and Co. ,

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FDA Law Blog

JANUARY 11, 2024

With the ambiguity of the statutory text, FDA looked at the plain language, context, and the structure and purpose of the statute—including both parties’ positions on those points. Notably, the purpose of the statute seemed to govern much of FDA’s interpretation. mL was approved on March 18, 2022. mL and 20 mg/0.4

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Patently O

SEPTEMBER 16, 2022

Unfortunately, the PTA statute is not a model of clarity and has been the subject of numerous court battles over various quirky elements. The provision at issue in Sawstop has to do with PTA added for PTAB appeals and district court challenges. by Dennis Crouch. Vidal , — F.4th 4th — (Fed. 35 U.S.C. § See Kappos v.

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Constitutional Law Reporter

MAY 14, 2024

105 (2001), the Supreme Court recognized that §1 is limited to transportation workers. The Court revisited the scope of the residual clause in Southwest Airlines Co. 450 (2022). All this “complexity and uncertainty” would “‘breed[] litigation from a statute that seeks to avoid it.’” Adams , 532 U.S. Saxon , 596 U.S.

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Contract Court Construction Constitutional Law 52

Patently O

AUGUST 18, 2022

August 17, 2022). In particular, if you look at the estoppel statute, it appears to apply only to claims that were part of the inter partes review. The court identifies this case as a unique situation resulting from an intervening Supreme Court decision. Ingenio, Inc. , 22-1016, — F.4th 4th — (Fed.

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At the Lectern

MAY 1, 2024

California Commerce Club : Does California’s test for determining whether a party has waived its right to compel arbitration by engaging in litigation remain valid after the United States Supreme Court decision in Morgan v. 2022) _ U.S. _ [142 S.Ct. The court granted review in August 2022. Sundance, Inc.

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At the Lectern

OCTOBER 27, 2022

McCune , where the First District, Division Five, published opinion held the superior court could set the amount a defendant was required to pay in restitution to a crime victim even though the defendant’s parole had been terminated. Zuniga (2022) 79 Cal.App.5th ” Restitution jurisdiction.

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Court Statute Court Decisions Attorney 56

Constitutional Law Reporter

AUGUST 13, 2024

According to the Court, when an individual has been found by a court to pose a credible threat to the physical safety of another, that individual may be temporarily disarmed consistent with the Second Amendment. The District Court denied Rahimi’s motion to dismiss the indictment on Second Amendment grounds. Bruen , 597 U.S.

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Laws Court Constitutional Law Statute 52

Patently O

JANUARY 3, 2024

Court of Appeals for the Federal Circuit has begun 2023 with its first precedential patent decision in DexCom, Inc. In an opinion by Judge Stoll, the court affirmed a district court decision denying DexCom’s motion for a preliminary injunction. Abbott Diabetes Care, Inc., 2023-1795 (Fed. January 3, 2024).

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Contract Court Statute Court Decisions 64

Conflict of Laws

JANUARY 11, 2024

Court decisions In 2019, a US District Judge for the Central District of California, applying Spanish law, found that court filings did not demonstrate a “willful blindness” on the part of the Museum, when it added the painting to its collection.

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Statute Laws Court Court Rules 45

ClimateChange-ClimateLaw

DECEMBER 11, 2020

A Hawaii court held that the Hawai‘i Environmental Policy Act requires environmental review for commercial taking of aquarium fish and that Department of Land and Natural Resources issuance and renewal of licenses for commercial aquarium collection without environmental review was invalid and illegal. EPA (Supreme Court of Guyana).

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Court Government Litigating Litigation 59

Patently O

MARCH 24, 2022

Hirshfeld has the legal power to fulfill the expanded job as required by the Supreme Court’s decision. Guest post by Nina Mendelson , Following one Supreme Court decision posing dangers for the integrity of all sorts of agency adjudication, the ongoing litigation in Arthrex v. — Dennis Crouch.

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Statute Court Litigating Litigation 78

The Crime Report

JUNE 23, 2022

Report authors highlighted a recent Supreme Court decision in Canada. This month in a landmark decision in R v Bissonnette , the Canadian Supreme unanimously ruled life without parole sentences unconstitutional on the basis that sentences that extend beyond a person’s natural ability to outlive them are cruel and unusual punishments.

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Statute Court Decisions Court 142

At the Lectern

OCTOBER 11, 2023

At the Supreme Court’s conference today, a double one, there were no straight grants , but there were actions of note, including: Reproductive rights legislation. There were eight criminal case grant-and-holds : three more waiting for a decision in People v. ” Review was denied in Carpenter v.

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Court Felony Statute Court Decisions 45

At the Lectern

MAY 30, 2024

.’ ” The appellate court also found inapplicable the Legislature’s intent statement in newly enacted Assembly Bill 600 that, in resentencing proceedings under section 1172.1 , which the bill amended, “courts have full discretion. ” The urging went unheeded, except for Justice Evans.

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Court Manufacturing Contract Attorney 45

Constitutional Law Reporter

AUGUST 2, 2023

In 2022, as the COVID–19 pandemic came to its end, the Secretary invoked the HEROES Act to issue “waivers and modifications” reducing or eliminating the federal student debt of most borrowers. Supreme Court’s Decision By a vote of 6-3, the Supreme Court agreed with the states that the HEROES Act does not authorize the loan cancellation plan.

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Conflict of Laws

SEPTEMBER 28, 2022

Update of 28 September 2022: New entries are printed bold. Brexit and the Future of Private International Law in English Courts”, Oxford 2022. A Guide to Global Private International Law”, Oxford 2022, forthcoming. Please email us if you miss something in it, we will update immediately…. Explanatory Reports. Bibliography.

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Drafting Laws Litigating Litigation 40

Conflict of Laws

AUGUST 31, 2022

Update of 31 August 2022: New entries are printed bold. Brexit and the Future of Private International Law in English Courts”, Oxford 2022. A Guide to Global Private International Law”, Oxford 2022, forthcoming. Please email us if you miss something in it, we will update immediately…. Explanatory Reports. Bibliography.

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Drafting Laws Litigating Litigation 40

FDA Law Blog

JUNE 2, 2023

Price Transparency Surveys The MDRP statute requires manufacturers to submit only three prices: average manufacturer price (AMP), best price, and nominal prices. Absent from the statute is any requirement to report information on manufacturer costs and price setting. that is not supported by the statute and applicable regulations.”

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Conflict of Laws

APRIL 20, 2022

In preparation of the Conference on the HCCH 2019 Judgments Convention on 9/10 September 2022, taking place on campus of the University of Bonn, Germany, we are offering here a Repository of contributions to the HCCH 2019 Judgments Convention. Update of 20 April 2022: New entries are printed bold. Biresaw, Samuel Maigreg. He, Qisheng.

Drafting 52

Drafting Laws Litigating Litigation 52

Conflict of Laws

JUNE 21, 2022

Update of 7 June 2022: New entries are printed bold. Brexit and the Future of Private International Law in English Courts”, Oxford 2022. A Guide to Global Private International Law”, Oxford 2022, forthcoming. Please email us if you miss something in it, we will update immediately…. Explanatory Reports. Bibliography.

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Drafting Laws Litigating Litigation 40

SCOTUSBlog

MARCH 26, 2025

A series of Supreme Court decisions have weighed in on the 1971 laws campaign-spending rules. Valeo , the court struck down the limits on independent expenditures but generally upheld the limits on contributions. In 2022, then-Sen. In its landmark 1976 ruling in Buckley v. Vance and former Rep. Energetic Tank, Inc.

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Court Court Decisions Tort Government 96

Conflict of Laws

JANUARY 11, 2022

Rescheduled: “The HCCH 2019 Judgments Convention: Prospects for Judicial Cooperation in Civil Matters between the EU and Third Countries” – Conference on 9 and 10 September 2022, University of Bonn, Germany. Update of 12 January 2022: New entries are printed bold. A Guide to Global Private International Law”, Oxford 2022, forthcoming.

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Drafting Laws Litigating Litigation 52

Conflict of Laws

FEBRUARY 16, 2022

In preparation of the Conference on the HCCH 2019 Judgments Convention on 9/10 September 2022, taking place on campus of the University of Bonn, Germany, we are offering here a Repository of contributions to the HCCH 2019 Judgments Convention. Update of 16 February 2022: New entries are printed bold. Biresaw, Samuel Maigreg.

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Drafting Laws Litigating Litigation 52

Conflict of Laws

DECEMBER 7, 2021

Rescheduled: “The HCCH 2019 Judgments Convention: Prospects for Judicial Cooperation in Civil Matters between the EU and Third Countries” – Conference on 9 and 10 September 2022, University of Bonn, Germany. A Guide to Global Private International Law”, Oxford 2022, forthcoming. Balbi, Francesca. “La Biresaw, Samuel Maigreg.

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