FDA Law Blog: June 10, 2014 A First? Orange Book Patent Delisting Counterclam denied ni Litigation Over Acetaminophen Injection by Kurt R. Karst

In what might very well be the first decision in a case involving a counterclaim seeking an order to correct or delete patent information from the Orange Book (and not concerning a patent use code), last week the U.S. District Court for the Southern District of California denied a Motion for Summary Judgment filed by Fresenius Kabi USA, LLC (“Fresenius”) to remove a patent – U.S. Patent No. 6,992,218 (“the ‘218 patent”) – from the Orange Book listed by Cadence Pharmaceuticals (“Cadence”) for OFIRMEV (acetaminophen) Injection.  FDA approved OFIRMEV on November 2, 2010 under NDA No. 022450 for the management of mild-to-moderate pain, for the management of moderate-to-severe pain with adjunctive opioid analgesics, and for the reduction of fever.  In 2012, Fresenius submitted a 505(b)(2) application – NDA No. 204767 – to FDA containing Paragraph IV certifications to the ‘218 patent and to U.S Patent No. 6,028,222, both of which are listed in the Orange Book as drug product patents.
Before we get into the specific of the OFIRMEV case, some background is necessary for those who don’t necessarily get into every nook and cranny of the Hatch-Waxman Amendments. . . .

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