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Articles

Hatch-Waxman at the Federal Circuit: Sustaining validity of formulation patents is no easy task

December 31, 2013

Articles

Hatch-Waxman at the Federal Circuit: Sustaining validity of formulation patents is no easy task

December 31, 2013

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In the hierarchy of patenting strategies used to protect some of the most valuable pharmaceutical innovations, patents related to formulation innovations have long been relegated to second-class citizenship, especially when compared to the class of patents directed to the molecular structure of the active drug itself.  This second-class status is the result of a perception, if not outright truth, that it is more difficult to sustain the validity of formulation patents, whether on appeal or otherwise.  A look back at 2013, while limited in sheer number of data points, appears to support this trend.  Of the almost ten Hatch-Waxman based cases that made their way to the Federal Circuit in 2013, 50% of those cases resulted in the claims either being affirmed as invalid or a determination that those patents were invalid on appeal.  Two other cases resulted in non-infringement findings and one was a mixed result.   A chart summarizing the more interesting of these cases is available on Fish’s Litigation Blog.

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