November 22, 2017
Authored and Edited by Paula E. Miller; Thomas L. Irving
On November 21, 2017, FDA introduced an update to the Orange Book to include the date patent information was submitted to FDA by the NDA holder. The change was made to “help generic drug manufacturers determine the earliest date when they may be able to market new generic medicines.” The submission dates are now listed in the “Patent and Exclusivity Information” section, where data is available. FDA has been collecting data on the patent submission date since 2013 and included submission dates for about 4,000 patent records in this current update.
NDA holders are required to file the relevant patent information with FDA for listing in the Orange Book. In most instances submission of patent information is required within 30 days of a triggering event, such as NDA approval, issuance of the patent, or a change that requires an update to the Orange Book listing. See e.g., 21 CFR 314.53(c)(2)(ii), 314.53(d). If the NDA holder fails to timely submit the patent information, an ANDA or 505(b)(2) filer is not required to submit a patent certification or statement to address the patent that is late-listed. 21 CFR 314.94(a)(12)(vi), 314.50(i)(4). Prior to this update, the submission date information was only available by contacting the Orange Book staff. Therefore, allowing direct access to the submission dates allows an ANDA or 505(b)(2) filer to more easily learn if there are any patents for which it can avoid submitting a Paragraph IV Certification, with less of a burden on the staff.
FDA committed to making this change in the October 2016 final rule “Abbreviated New Drug Applications and 505(b)(2) Applications.” Abbreviated New Drug Applications and 505(b)(2) Applications, 81(194) Fed. Reg. 69580-69658, 69603 (Oct. 6, 2016) (to be codified at 21 C.F.R. pts. 314, 320). Further information about that final rule can be found on Finnegan’s IP FDA Blog.
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