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FDA Draft Guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 17 2018

On July 3, 2018, the FDA issued draft guidance on Indications and Usage Section of Labeling for Human Prescription Drug and Biological Products. The


Jazz Pharmaceuticals, Inc. v. Amneal Pharmaceuticals, LLC
  • Knobbe Martens
  • USA
  • July 16 2018

References were sufficiently accessible to the public to constitute printed publication prior art even if they were not searchable or indexed because


Endo Pharmaceuticals Solutions v. Custopharm Inc.
  • Knobbe Martens
  • USA
  • July 16 2018

A prior art reference does not inherently disclose the elements of a claim limitation if the prior art describes the performance of the elements but


When is There Standing to Appeal a PGR Final Written Decision?
  • Marshall Gerstein & Borun LLP
  • USA
  • July 5 2018

In Altaire Pharm., Inc. v. Paragon Biotek, Inc., Case No. 2017-1487 (Fed. Cir. May 2, 2018), the Federal Circuit reversed in part a PGR final written


Sixth Circuit Finds Failure to Distribute Medication Guide Claim Preempted
  • Reed Smith LLP
  • USA
  • July 3 2018

Being that it was the Sixth Circuit that allowed a failure-to-update claim to proceed against a generic manufacturer, when we got the recent decision


Requirements, Benefits, and Possible Consequences of Listing Patents in FDA’s Orange Book
  • Finnegan, Henderson, Farabow, Garrett & Dunner LLP
  • USA
  • July 3 2018

The Drug Price Competition and Patent Term Restoration Act of 1984 (the Hatch-Waxman Act) amended patent law and drug law to facilitate


U.S. Supreme Court Grants Certiori to Decide Whether FDA Excluded Warnings Pre-Empt State Law Claims
  • Cozen O'Connor
  • USA
  • June 28 2018

The U.S. Supreme Court today agreed to consider a Third Circuit ruling that revived litigation over Merck’s alleged failure to warn about a risk of


Breaking News - Supreme Court Grants Review in Fosamax Preemption Case
  • Reed Smith LLP
  • USA
  • June 28 2018

Today, on the last day of the United States Supreme Court’s 2018 Term, the Court issued an order granting review (“certiorari”) in Merck Sharp & Dohme


You Say Yes, They Say No, No, No!
  • Sterne Kessler Goldstein & Fox PLLC
  • USA
  • June 28 2018

The District of New Jersey recently denied a defendant’s motion to dismiss a false advertising claim relating to advertising for its generic drug


Lower Court’s Factual Finding Given Deference in “Close Case”
  • McDermott Will & Emery
  • USA
  • June 28 2018

The US Court of Appeals for the Federal Circuit affirmed the district court's finding that a skilled artisan would have had no reasonable expectation