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Federal Circuit Dissent Declares “No ‎Skinny-Label Generic is Safe”

On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

Federal Circuit Places “Skinny Labels” Back in Danger

On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

Federal Circuit Hints at Reversed Course on “Skinny Labels”

On October 2, 2020, the Federal Circuit issued a precedential opinion vacating a district court’s judgment as a matter of law and reinstating a jury verdict finding of induced infringement of a patented use that had been...more

Federal Circuit Places “Skinny Labels” in Danger

Section viii of the Hatch-Waxman Act, 21 U.S.C. § 355(j)(2)(A)(viii), allows a generic applicant to “carve out” indications and other use information from its labeling that are protected by patents listed in FDA’s Orange Book...more

FDA Announces “New Steps to Facilitate Efficient Generic Drug Review to Enhance Competition, Promote Access and Lower Drug Prices”

The FDA has taken action to accelerate the approval of Abbreviated New Drug Applications (“ANDAs”). With a goal of reducing the number of review cycles needed to reach approval, the FDA will save generic drug companies money...more

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