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ARTICLE · 01 MARCH 2017

PTAB Rejects Flawed Inherency Argument Against Drug Composition Patent

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On February 3, 2017, the PTAB denied a petition by Amneal Pharmaceuticals LLC ("Amneal") to institute an inter partes review of Hospira Inc.'s patent directed to pharmaceutical compositions of...

United StatesIntellectual Property

On February 3, 2017, the PTAB denied a petition by Amneal Pharmaceuticals LLC ("Amneal") to institute an inter partes review of Hospira Inc.'s patent directed to pharmaceutical compositions of the sedative dexmedetomidine. The patent's only independent claim recites:

1. A ready to use liquid pharmaceutical composition for parenteral administration to a subject, comprising dexmedetomidine or a pharmaceutically acceptable salt thereof disposed within a sealed glass container, wherein the liquid pharmaceutical composition when stored in the glass container for at least five months exhibits no more than about 2% decrease in the concentration of dexmedetomidine.

In its petition, Amneal relied in large part on the 2010 drug label for FDA approved Precedex, which is a concentrated dexmedetomidine solution that must be diluted in 0.9% sodium chloride prior to administration. Amneal argued that a person of ordinary skill in the art would have diluted Precedex according

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