Notice: Determination of Regulatory Review Period for Purposes of Patent 
Extension; TEKTURNA

Federal Register: May 2, 2008 (Volume 73, Number 86)       
                  Page 24295

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for TEKTURNA and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of an application to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human drug product.

ADDRESSES: Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.regulations.gov. 

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 100-670) generally provide 
that a patent may be extended for a period of up to 5 years so long as 
the patented item (human drug product, animal drug product, medical 
device, food additive, or color additive) was subject to regulatory 
review by FDA before the item was marketed. Under these acts, a 
product's regulatory review period forms the basis for determining the 
amount of extension an applicant may receive.
    A regulatory review period consists of two periods of time: A 
testing phase and an approval phase. For human drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the human drug product becomes effective and runs 
until the approval phase begins. The approval phase starts with the 
initial submission of an application to market the human drug product 
and continues until FDA grants permission to market the drug product. 
Although only a portion of a regulatory review period may count toward 
the actual amount of extension that the Director of Patents and 
Trademarks may award (for example, half the testing phase must be 
subtracted as well as any time that may have occurred before the patent 
was issued), FDA's determination of the length of a regulatory review 
period for a human drug product will include all of the testing phase 
and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA recently approved for marketing the human drug product TEKTURNA 
(aliskiren hemifumarate). TEKTURNA is indicated for treatment of 
hypertension. Subsequent to this approval, the Patent and Trademark 
Office received a patent term restoration application for TEKTURNA 
(U.S. Patent No. 5,559,111) from Novartis Corporation, and the Patent 
and Trademark Office requested FDA's assistance in determining this 
patent's eligibility for patent term restoration. In a letter dated 
November 21, 2007, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of TEKTURNA represented the first permitted 
commercial marketing or use of the product. Shortly, thereafter, the 
Patent and Trademark Office requested that FDA determine the product's 
regulatory review period.
    FDA has determined that the applicable regulatory review period for 
TEKTURNA is 2,023 days. Of this time, 1,637 days occurred during the 
testing phase of the regulatory review period, while 386 days occurred 
during the approval phase. These periods of time were derived from the 
following dates:
    1. The date an exemption under section 505(i) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355(i)) became effective: 
August 22, 2001. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on August 
22, 2001.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: February 13, 
2006. FDA has verified the applicant's claim that the new drug 
application (NDA) for TEKTURNA (NDA 21-985) was initially submitted on 
February 13, 2006.
    3. The date the application was approved: March 5, 2007. FDA has 
verified the applicant's claim that NDA 21-985 was approved on March 5, 
2007.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the U.S. 
Patent and Trademark Office applies several statutory limitations in 
its calculations of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 2,022 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by July 1, 2008. Furthermore, any interested person may petition FDA 
for a determination regarding whether the applicant for extension acted 
with due diligence during the regulatory review period by October 29, 
2008. To meet its burden, the petition must contain sufficient facts to 
merit an FDA investigation. (See H. Rept. 857, part 1, 98th Cong., 2d 
sess., pp. 41-42, 1984.) Petitions should be in the format specified in 
21 CFR 10.30.
    Comments and petitions should be submitted to the Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. Comments are to 
be identified with the docket number found in brackets in the heading 
of this document. Comments and petitions may be seen in the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
    Please note that on January 15, 2008, the FDA Web site transitioned 
to the Federal Dockets Management System (FDMS). FDMS is a Government-
wide, electronic docket management system. Electronic submissions will 
be accepted by FDA through FDMS only.

    Dated: April 21, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-9699 Filed 5-1-08; 8:45 am]

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