Generic Drugmakers Embrace Inter Partes Review Process image

RAPS Regulatory Focus , September 4, 2018
Zachary Brennan. quoting Jonathan Darrow (Student Fellow Alumnus)


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From the article: 

[Generic Drugmakers Embrace Inter Partes Review Process]Thanks to Congress’ administrative alternative to court litigation of patents, generic drug manufacturers have embraced a new process, known as inter partes review (IPR), and successfully challenged patents about 50% of the time, according to a new study published in Applied Health Economics and Health Policy.

The study, written by researchers at the Program On Regulation, Therapeutics, And Law (PORTAL) at Harvard Medical School and Brigham & Women’s Hospital, reveals that the IPR process “can help clear weak patent claims, especially those directed to formulations and methods of use,” the authors write.

First author Jonathan Darrow told Focus that in general, generic drug companies “are most interested in going after large markets, where profit margins are high, and where the original patent on the active ingredient has expired. Follow-on patents, like those directed to formulations or methods of use, tend to be weaker and more likely to be invalidated.  

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