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USPTO Says Overlapping Range In Prior Art Insufficient to Invalidate Method of Treatment Patent
  • Dechert LLP
  • USA
  • April 13 2018

Pharmaceutical patents frequently claim treatment methods that utilize a range of amounts or concentrations for the active ingredient or excipients

The Past, Present, and Future of Government Regulation of Off-Label Communications - Part 4
  • Mintz
  • USA
  • August 14 2017

Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent

Providing Scientific Information in Patents after Nautilus
  • Squire Patton Boggs
  • USA
  • July 12 2017

Scientific informationfeatures of an invention that are known through physical analysisoften provides the foundation for patent claims. But

Senators Urge the Administration to Certify Imports of Prescription Drugs from Canada, Pharmaceutical & Medical Device Update, Vol. IV, Issue III
  • Jones Day
  • USA
  • June 4 2017

On May 15, 2017, Sens. Charles Grassley (R-IA), John McCain (R-AZ), and Amy Klobuchar (D-MN) sent a letter to the Office of Management and Budget

Federal Circuit Finds Infringement Under Akami Of Two-Step Method Of Treatment
  • Foley & Lardner LLP
  • USA
  • January 24 2017

In Eli Lilly & Co. v. Teva Parenteral Medicines, Inc., the Federal Circuit affirmed the district court decision finding infringement under Akami of a

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act
  • Reed Smith LLP
  • USA
  • December 15 2016

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act)...

The EpiPen Controversy Signals Intensifying Scrutiny of Drug Classification Under Medicaid Rebate Program
  • Foley & Lardner LLP
  • USA
  • September 7 2016

Price increases threatening the availability of EpiPen and EpiPen Jr Auto-Injectors (“EpiPen”) have touched off the latest firestorm over drug

Collateral lies: effect on insurance claims
  • Buddle Findlay
  • United Kingdom
  • August 22 2016

In a decision which could have a significant impact for insurers and the insured alike, a 4:1 majority in the UK Supreme Court recently delivered

NAD Determines 5-Star Ratings Claims Unsubstantiated
  • Reed Smith LLP
  • USA
  • August 8 2016

The advertising industry's self-regulatory arm, the National Advertising Division ("NAD"), recently reviewed certain advertising messages made by

FDA Releases Flurry of Compounding-Related Documents
  • Quarles & Brady LLP
  • USA
  • July 19 2016

Busy, busy, busy! That is the only way to describe the FDA over the past few weeks, issuing multiple draft guidance documents affecting both 503A and