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Smart & Biggar

PM(NOC) Regulations: seven-year anniversary of major amendments

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September 21, 2024, marked the seventh anniversary of the significant amendments to the Patented Medicines (Notice of Compliance) Regulations (Regulations). This article provides an update on activities in the seventh year...more

Foley Hoag LLP - Cannabis and the Law

4th Circuit Challenges DEA’s Findings on the Legality of Certain Hemp Derived Cannabinoids

The United States Court of Appeals for the Fourth Circuit ruled that the Drug Enforcement Agency’s (“DEA”) classification of certain hemp-derived cannabinoids as unlawful was not entitled to deference, given that the language...more

Proskauer - Health Care Law Brief

No Surprises Here!  Fifth Circuit Upholds Health Care Provider Challenge to No Surprises Act Regulations

In a recent win for health care providers, the United States Court of Appeals for the Fifth Circuit has affirmed a lower court’s decision to vacate key portions of regulations issued by the U.S. Departments of Treasury,...more

Davis Wright Tremaine LLP

Banking and Consumer Regulatory Digest - February 2024 - 3

Editor's Note: The following newsletter provides a roundup summarizing enforcement actions, guidance, rulemakings, and other public statements taken by a federal and/or state financial services regulatory agency, specifically...more

Walkers

Exercise of regulatory powers in Guernsey: GFSC v Domaille and others

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In our recent article (available here) we reported that the Guernsey Financial Services Commission (the "GFSC") had been granted leave to appeal to the Court of Appeal. The GFSC obtained leave to appeal on the basis of a...more

Smart & Biggar

2023 Highlights in Canadian Life Sciences IP and Regulatory Law

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Eli Lilly v Teva, Pharmascience, Riva, Apotex, Mylan (tadalafil, CIALIS) – Following a summary trial, Lilly’s infringement actions were dismissed: composition claims directed to “a physiologically acceptable salt” of...more

Mitchell, Williams, Selig, Gates & Woodyard,...

Mine Safety and Health Administration Act Enforcement: Federal Appellate Court Addresses Application of Methane Safety Regulations

Co-Author: Elizabeth Strickland The United States Court of Appeals for the D.C. Circuit (“Court”) addressed in a June 16th decision certain Mining Safety and Health Administration (“MSHA”) regulations. See Peabody Midwest...more

Proskauer - Health Care Law Brief

Recent FCA and AKS Litigation Highlights Use of Different Standards in Different Circuits

In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more

Harris Beach PLLC

Federal Circuit Imposes Heightened Standard for Written Description Support of Negative Claim Limitations

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In Novartis Pharmaceuticals Corp. v. Accord Healthcare, Inc., the U.S. Court of Appeals for the Federal Circuit (“Federal Circuit”) held patent claims invalid for lack of written description where a negative limitation was...more

Littler

New Opinion Allowing Plaintiff to Present His Class Action Willful FCRA Claims to a Jury Reinforces Need to Remain Vigilant About...

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The Fair Credit Reporting Act (FCRA) is a federal law that governs employment-related background checks.  Most lawsuits asserting federal claims proceed in federal court. The FCRA is atypical in that FCRA claims can proceed...more

Faegre Drinker Biddle & Reath LLP

New FDA Policy on Homeopathic Drugs Survives Preliminary Injunction Appeal

The FDA’s recent policy shift regarding homeopathic drugs was recently supported by the D.C. Circuit Court of Appeals in MediNatura v. FDA, No. 20-5341 (D.C. Cir. 2021), when it upheld the denial of a preliminary injunction...more

Cozen O'Connor

Eleventh Circuit Court of Appeals Refuses to Extend ADA Liability to Websites

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Title III of the Americans with Disabilities Act (ADA) requires that disabled persons have equal access to goods and services provided by any “place of public accommodation.” ...more

Burr & Forman

Glasser v. Hilton: Citing Principles of Statutory Interpretation, the Eleventh Circuit Drastically Reduces the Scope of TCPA

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The Telephone Consumer Protection Act (“TCPA” or the “Act”) has limited telephone calls that can be placed using certain automated equipment since 1991.  However, since passage of the Act there has been considerable debate...more

Seyfarth Shaw LLP

Appellate Court Considers the Illinois “Employee Credit Privacy Act”

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Seyfarth Synopsis: On December 3, 2019, the Appellate Court of Illinois affirmed summary judgment in favor of a public utility company that considered credit checks for individuals applying for a customer service...more

Ballard Spahr LLP

Defendant files answer brief, trade groups file amicus brief in Montana lawsuit challenging healthcare provider’s use of prepaid...

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Last week, the defendant filed its answer brief in Bratton v. Sisters of Charity of Leavenworth Health System, Inc., an appeal now pending before the Montana Supreme Court involving a challenge to the defendant’s use of...more

Rumberger | Kirk

More ADA Lawsuits Targeting Mobile Apps Are Likely Ahead

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The U.S. Court of Appeals for the Ninth Circuit earlier this year in Robles v. Domino’s Pizza LLC, became the first circuit to expressly extend Title III of the Americans with Disabilities Act to mobile applications. ...more

Foley Hoag LLP - Environmental Law

DOE Must Promulgate Energy Efficiency Standards Finalized By the Obama Administration

Last week, the 9th Circuit Court of Appeals affirmed a District Court ruling requiring the Department of Energy to publish in the Federal Register four rules finalized by the Obama administration, but not previously...more

Hogan Lovells

CJEU: Trademark use in clinical trials, no bar to non-use revocation

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This month, the Court of Justice of the European Union (CJEU) addressed a case of particular interest for pharmaceutical companies that are in the process of developing a new product. Regulatory and commercial considerations...more

Hogan Lovells

Stuttgart Court of Appeals: Unfair conduct when textile components are indicated in English in Germany

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At the end of 2018, the Stuttgart Court of Appeals [Oberlandesgericht] clarified that, pursuant to Regulation (EU) No. 1007/2011 on textile fibre names and related labelling and marking of the fibre composition of textile...more

Littler

Certainty is (Even Closer) on the Horizon for the New York Home Care Industry

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The New York home care industry has faced collapse since a series of New York Appellate Division decisions invalidated New York Department of Labor (NY DOL) policy and held that home care attendants working 24-hour shifts who...more

Seyfarth Shaw LLP

Ninth Circuit Allow the Robles v. Domino’s Website and Mobile App Accessibility Lawsuit to Move Forward

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Seyfarth Synopsis: Ninth Circuit overturns district court’s dismissal of website accessibility lawsuit on due process and primary jurisdiction grounds, remands case to proceed with discovery....more

BCLP

Ninth Circuit Issues Important Decision in Domino’s Website Accessibility Action

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As businesses continue to face lawsuits and demand letters alleging that their websites are inaccessible to blind and deaf patrons in violation of the Americans with Disabilities Act (“ADA”), courts across the country...more

Hogan Lovells

Parent company liability – Court of Appeal upholds decision rejecting jurisdiction over claims brought against Unilever by victims...

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On 4 July 2018, the Court of Appeal handed down judgment in AAA & Ors. v Unilever PLC and Unilever Tea Kenya Limited [2018] EWCA Civ 1532, dismissing an appeal by victims of the 2007 post-election violence in Kenya....more

Hogan Lovells

FDA proposes streamlining combination product regulations

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On May 15, 2018, the Food and Drug Administration (FDA) proposed amending its product classification rules for combination products, found in 21 CFR Part 3. Generally, the proposed rule purports to clarify language in the...more

Cozen O'Connor

Third Circuit Issues Precedential Ruling on Express Preemption for Hybrid Medical Devices

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The Third Circuit has become the first U.S. Court of Appeals to address the application of the express preemption provision in the Medical Device Amendments of 1976 to hybrid medical devices. Hybrid medical devices are...more

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