Originally published in Law360, New York on November 15, 2012.
Signed into law by President Obama on Sept. 16, 2011, the America Invents Act represents the most sweeping changes to U.S. patent law in over 60 years. Among its many provisions, the AIA created a new administrative patent challenge proceeding at the United States Patent and Trademark Office: inter partes review. The new IPR replaces inter partes re-examinations (“IPRex”) as a parallel or alternative to district court litigation to adjudicate patentability of issued patents. Whereas IPRex was seldom utilized by generic defendants in Hatch-Waxman actions, several key features of the new IPR proceedings make it an attractive strategic complement or alternative to abbreviated new drug application litigation.
Federal district courts play a central role in the Hatch-Waxman scheme. Generic applicants who wish to introduce competing products prior to expiration of any Orange Book patent must submit a Paragraph IV certification with the U.S. Food and Drug Administration asserting that the patents are either not infringed, invalid and/or unenforceable, and send notification of any such certification to the brand company. Once notice is received, brand owners have 45 days to bring an infringement action in federal district court which invokes an automatic 30-month stay of FDA approval of the generic application.
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