[Federal Register Volume 74, Number 195 (Friday, October 9, 2009)]
[Notices]
[Pages 52241-52242]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-24457]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2009-E-0073 and FDA-2009-E-0015]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ENTEREG; U.S. Patent Nos. 5,250,542 and 5,434,171

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ENTEREG and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of applications to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of patents 
which claim 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://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

[[Page 52242]]

products, the testing phase begins when the exemption to permit the 
clinical investigations of the drug 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 ENTEREG 
(alvimopan). ENTEREG is a peripherally acting micro-opioid receptor 
antagonist indicated to accelerate the time to upper and lower 
gastrointestinal recovery following partial large or small bowel 
resection surgery with primary anastomosis. Subsequent to this 
approval, the Patent and Trademark Office received patent term 
restoration applications for ENTEREG (U.S. Patent Nos. 5,250,542 and 
5,434,171) from Eli Lilly and Company, and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated February 26, 
2009, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of ENTEREG represented the first permitted commercial marketing or use 
of the product. 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 
ENTEREG is 5,305 days. Of this time, 3,879 days occurred during the 
testing phase of the regulatory review period, while 1,426 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: 
November 12, 1993. The applicant claims November 11, 1993, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was November 
12, 1993, which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: June 25, 2004. 
FDA has verified the applicant's claim that the new drug application 
(NDA) 21-775 was submitted on June 25, 2004.
    3. The date the application was approved: May 20, 2008. FDA has 
verified the applicant's claim that NDA 21-775 was approved on May 20, 
2008.
    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 
applications for patent extension, this applicant seeks 1,827 days of 
patent term extension for U.S. Patent No. 5,250,542 and 1,826 days of 
patent term extension for U.S. Patent No. 5,434,171.
    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 December 8, 2009. 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 April 
7, 2010. 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.

    Dated: August 31, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-24457 Filed 10-8-09; 8:45 am]
BILLING CODE 4160-01-S