2754.02 Filing Window for an Application Under 35 U.S.C. 156(d)(5) [R-10.2019]

A first application for interim extension under 35 U.S.C. 156(d)(5) (to extend the patent term before product approval) must be filed within the period beginning six months and ending fifteen days before the patent is due to expire. Each subsequent application for interim extension must be filed during the period beginning sixty days before and ending thirty days before the expiration of the preceding interim extension. 35 U.S.C. 156(d)(5)(C). An interim extension granted under 35 U.S.C. 156(d)(5) terminates sixty days after permission for commercial marketing or use of the product is granted, except, if within the sixty-day period any additional information needed for an application for patent term extension under 35 U.S.C. 156(d)(1) is submitted, the patent may be further extended. 35 U.S.C. 156(d)(5)(E). The additional information required to be submitted includes the fee for an application for patent term extension under 35 U.S.C. 156(d)(1), identification of the date the product received permission for commercial marketing or use, a statement that the application is being submitted within sixty days of such date, and identification of the last date that the application could be submitted. When the interim extension lapses under 35 U.S.C. 156(d)(5), because the product has received permission for commercial marketing or use, an interim extension pursuant to the provisions of 35 U.S.C. 156(e)(2) would be granted to keep the patent in force. An extension under 35 U.S.C. 156(e)(2) can be granted provided that the patent owner or its agent promptly files an application under 35 U.S.C. 156(d)(1) with sufficient time to permit the Office to grant an interim extension under 35 U.S.C. 156(e)(2). See 37 CFR 1.740(a)(3) and (5). However, if the product is not approved within the period of interim extension under 35 U.S.C. 156(d)(5), a new request for interim extension must be filed and another interim extension granted to keep the patent in force. An applicant is generally limited to four one-year interim extensions.

See MPEP § 2755.02 for additional information pertaining to the interim extension of patent term under 35 U.S.C. 156(d)(5).