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Tribal Sovereign Immunity Doctrine Does Not Insulate Tribes From Board Actions
  • Jones Day
  • USA
  • February 27 2018

In a case of first impression, the PTAB recently decided that the doctrine of tribal sovereign immunity does not apply to inter partes review


DOJ Limits the Use of Agencies' Guidance Documents in Civil Enforcement Actions
  • Jones Day
  • USA
  • January 31 2018

The Department of Justice ("DOJ") recently issued a memorandum limiting the ability of its litigators to use agency guidance documents in civil


Artificial Intelligence and Health CareKey Regulatory Considerations for U.S. Operations
  • Jones Day
  • USA
  • January 26 2018

Artificial intelligence is being used in innovative ways in the health care industry to drive down costs and improve clinical outcomes. The health


FDA's Evolving Regulation of Artificial Intelligence in Digital Health Products
  • Jones Day
  • USA
  • January 22 2018

FDA has been grappling with regulation of rapidly advancing digital products, including artificial intelligence. While Congress and FDA have provided


Food, Dietary Supplement & Cosmetics Update Vol. V, Issue 1
  • Jones Day
  • USA, European Union
  • January 12 2018

On January 4, 2018, the U.S. Food and Drug Administration ("FDA") issued a guidance announcing that it does not intend to enforce certain provisions


False Claims Act's "Rigorous" Materiality Standard Enforced by Second Circuit
  • Jones Day
  • USA
  • January 11 2018

A decision by the U.S. Court of Appeals for the Second Circuit reinforces the growing body of case law regarding the strict materiality requirements


Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 7
  • Jones Day
  • USA, European Union
  • November 16 2017

The USDA Inspector General ("IG") reviewed the Agricultural Marketing Service's ("AMS") process used in determining whether exporting countries'


PTAB Grants Rare Rehearing Due To Insufficient Evidence Of Obviousness
  • Jones Day
  • USA
  • September 21 2017

In Coalition For Affordable Drugs VI, LLC v. Celgene Corp. (2015-01096, -01102, -01103), the PTAB granted Patent Owner Celgene's request for


Global Privacy & Cybersecurity Update Vol. 15
  • Jones Day
  • USA, European Union, Global
  • September 13 2017

On June 19, the Federal Trade Commission ("FTC") submitted comments to a working group organized by the Department of Commerce's National


Food, Dietary Supplement & Cosmetics Update Vol. IV, Issue 6
  • Jones Day
  • USA
  • September 9 2017

On September 13, 2017, the Food and Drug Administration issued a proposed rule to extend, for covered produce other than sprouts, the dates for