by Brian Malkin
On February 22, FDA granted in part denied in part a citizen petition filed on behalf of Hoffman-La Roche ("Roche") requesting that FDA confirm that it will stay approval for Orchid Healthcare's ("Orchid's") abbreviated new drug application ("ANDA") for generic Boniva® (ibandronate sodium) consistent with the 30-month stay provisions. FDA's decision confirms its position taken in a draft guidance that conversion of a patent certification to approve an application following a patent's expiration (a "Paragraph III Certification") to a patent challenge (a "Paragraph IV Certification") can result in a new 30-month stay.
Orchid originally submitted its ANDA for generic Boniva with both Paragraph III and Paragraph IV Certifications. Roche sued Orchid within 45 days of receiving Orchid's Paragraph IV Certification notifications, resulting in an initial 30-month stay. The stay was dissolved, however, when Roche dismissed its claims for infringement of the patents-at-issue. Orchid then converted its Paragraph III Certification to a Paragraph IV Certification, provided Roche with the applicable notice, and was sued within 45 days of such notice, resulting in the subsequent 30-month stay. Potentially complicating factors raised by Orchid in its response to Roche's petition were that Orchid filed its ANDA during the last year of Roche's new chemical entity exclusivity ("NCE") and the patent-at-issue was extended under 35 U.S.C. 156 following submission of Orchid's original ANDA.
FDA determined that Roche's NCE for Boniva® and its patent term extension for the patent that Orchid had subsequently filed a Paragraph IV Certification for did not change the applicable 30-month stay for the revised certification. FDA also said that the 30-month stay would expire with the expiration of the patent or if the patent infringement suit were resolved in favor of Orchid. FDA's decision appears, therefore, consistent with FDA's guidance and its prior position with how 30-month stays will expire when a patent expires.