New bill allows unintentional delays in filings for drug patent term extensions

Last week, Representative Jenkins introduced H.R. 5120 “…to conform certain filing provisions within the Patent and Trademark Office.”  The bill amends 35 U.S.C. 156 to allow the USPTO to excuse late filings of applications that are due to unintentional delays.  Section 156 is that part of the patent law that provides patent term extensions for products that are subject to regulatory review prior to commercial marketing or use, such as pharmaceuticals, biologics and some medical devices.

While the Patent and Trademark Office is able to excuse late filings of several types of papers for unintentional delays, section 156, as currently written, does not provide the Office any discretion to do so.

Patent term extensions under section 156 are critically important to the pharmaceutical industry.  A missed filing for an extension translates to lost patent term which can, of course, mean significant revenue loss.  If enacted, the bill would provide an avenue to avoid such losses in the case of unintentional delays.

Interestingly, the bill provides a 5 day period, measured from the date of enactment of the bill, for filing a petition relating to an unintentional delay for applications for patent term extension that are pending as of the enactment of the bill or is the subject of a request for reconsideration of a denial of a 156 extension.

Makes you wonder who missed a filing….

Information on the bill, including the text as introduced, is available here.