This PDF is the current document as it appeared on Public Inspection on 12/26/2013 at 08:45 am.
United States Patent and Trademark Office, Commerce.
Notice of interim patent term extension.
The United States Patent and Trademark Office has issued an order granting interim extension under 35 U.S.C. 156(d)(5) for a one-year interim extension of the term of U.S. Patent No. 5,496,801.Start Further Info
FOR FURTHER INFORMATION CONTACT:
Mary C. Till by telephone at (571) 272-7755; by mail marked to her attention and addressed to the Commissioner for Patents, Mail Stop Hatch-Waxman PTE, P.O. Box 1450, Alexandria, VA 22313-1450; by fax marked to her attention at (571) 273-7755; or by email to Mary.Till@uspto.gov.End Further Info End Preamble Start Supplemental Information
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 December 6, 2013, NPS Pharmaceuticals, Inc., timely filed an application under 35 U.S.C. 156(d)(5) for an interim extension of the term of U.S. Patent No. 5,496,801. The patent claims the human biological product recombinant human parathyroid hormone. The application indicates that Biologics License Application 125511 for the drug product, recombinant human parathyroid hormone, was filed on October 24, 2013, 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 the regulatory review period has continued beyond the original expiration date of the patent, December 23, 2013, 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. 5,496,801 is granted for a period of one year from the original expiration date of the patent.Start Signature
Dated: December 20, 2013.
Deputy Commissioner for Patent Examination Policy, United States Patent and Trademark Office.
[FR Doc. 2013-31017 Filed 12-26-13; 8:45 am]
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