Daily Rules, Proposed Rules, and Notices of the Federal Government
Section 156 of Title 35, United States Code, generally provides that the term of a patent may be extended for a period of up to five years if the patent claims a product, or a method of making or using a product, that has been subject to certain defined regulatory review, and that the patent may be extended for interim periods of up to one year if the regulatory review is anticipated to extend beyond the expiration date of the patent.
On September 6, 2012, the Regents of the University of California timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 5,454,779. The patent claims the medical device, ResQPump® in connection with the ResQPOD® ITD. The application indicates that a Premarket Approval Application, PMA No. P110024, for the medical device has been filed, and is currently undergoing regulatory review before the Food and Drug Administration for permission to market or use the product commercially.
Review of the application indicates that, except for permission to market or use the product commercially, the subject patent would be eligible for an extension of the patent term under 35 U.S.C. 156, and that the patent should be extended for one year as required by 35 U.S.C. 156(d)(5)(B). Because it is apparent that the regulatory review period will continue beyond the original expiration date of the patent, October 3, 2012, interim extension of the patent term under 35 U.S.C. 156(d)(5) is appropriate.
An interim extension under 35 U.S.C. 156(d)(5) of the term of U.S. Patent No. 5,454,779 is granted for a period of one year from the original expiration date of the patent.