Document ID: FDA-2010-E-0660-0006
Agency: fda
Document Type: Notice
Title: Regulatory Review Period for Purposes of Patent Extension: PROLIA
Posted Date: 2012-05-07T04:00Z

[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Page 26768]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10959]

[[Page 26768]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2011-E-0014, FDA-2010-E-0660, and FDA-2010-E-0659]

Determination of Regulatory Review Period for Purposes of Patent 
Extension; PROLIA

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 PROLIA 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 a patent 
which claims that human biological product.

ADDRESSES: Submit electronic comments to http://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 
51, rm. 6284, Silver Spring, MD 20993-0002, 301-796-3602.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 biological 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 biological product 
PROLIA (denosumab). PROLIA is indicated for treatment of postmenopausal 
women with osteoporosis at high risk for fracture. Subsequent to this 
approval, the Patent and Trademark Office received patent term 
restoration applications for PROLIA (U.S. Patent Nos. 6,740,522; 
7,097,834; and 7,411,050) from Amgen, Inc., and the Patent and 
Trademark Office requested FDA's assistance in determining the patents' 
eligibility for patent term restoration. In a letter dated April 27, 
2011, FDA advised the Patent and Trademark Office that this human 
biological product had undergone a regulatory review period and that 
the approval of PROLIA 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 
PROLIA is 3,269 days. Of this time, 2,739 days occurred during the 
testing phase of the regulatory review period, while 530 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 (21 U.S.C. 355(i)) became effective: June 21, 
2001. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on June 21, 
2001.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act (42 U.S.C. 262): December 19, 2008. FDA has verified the 
applicant's claim that the biologics license application (BLA) for 
PROLIA (BLA125320) was submitted on December 19, 2008.
    3. The date the application was approved: June 1, 2010. FDA has 
verified the applicant's claim that BLA125320 was approved on June 1, 
2010.
    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 1,365 days; 952 
days; and 595 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) either electronic or written comments and ask for a 
redetermination by July 6, 2012. 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 November 5, 2012. 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. However, if you 
submit a written petition, you must submit three copies of the 
petition. Identify comments with the docket numbers found in brackets 
in the heading of this document.
    Comments and petitions that have not been made publicly available 
on http://www.regulations.gov may be viewed in the Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: April 16, 2012.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2012-10959 Filed 5-4-12; 8:45 am]
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