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 22, 2010, Discovery Laboratories Inc., on behalf of patent owner Scripps Research Institute, timely filed an application under 35 U.S.C. 156(d)(5) for an additional interim extension of the term of U.S. Patent No. 5,407,914. The patent claims the human drug product, SURFAXIN® (lucinactant) and a method of using SURFAXIN® (lucinactant). The application indicates that a New Drug Application, NDA No. 21-746, for the human drug product SURFAXIN® (lucinactant) 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 an additional 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 extended expiration date of the patent, November 17, 2010, 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. 5,407,914 is granted for a period of one additional year from the extended expiration date of the patent,