[Federal Register Volume 71, Number 196 (Wednesday, October 11, 2006)]
[Notices]
[Pages 59797-59798]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-16816]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E-0444]


Redetermination of Regulatory Review Period for Purposes of 
Patent Extension; BONIVA; Correction

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice; correction.

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SUMMARY:  The Food and Drug Administration (FDA) is correcting a notice 
that appeared in the Federal Register of June 22, 2006 (71 FR 35918). 
The document announced that FDA had determined the regulatory review 
period for BONIVA. The notice provided that on or before August 21, 
2006, anyone with knowledge that any of the dates as published are 
incorrect may submit a request for a redetermination of the regulatory 
review period. A request for revision of the regulatory review period 
was filed for the product on July 25, 2006. FDA reviewed its records 
and found that the effective date of the investigational new drug 
application (IND) was incorrect because of a clerical error. Therefore, 
FDA is republishing a determination of the regulatory review period to 
reflect the corrected effective date for the IND. FDA has made a 
determination of the regulatory review period 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://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory 
Policy (HFD-007), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 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 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 BONIVA 
(ibandronate sodium). BONIVA is indicated for treatment and prevention 
of osteoporosis in postmenopausal women. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for BONIVA (U.S. Patent No. 4,927,814) from Hoffmann-La 
Roche, Inc., and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated October 19, 2004, FDA advised the Patent 
and Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of BONIVA 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 adjusted regulatory review 
period for BONIVA is 3,122 days. Of this time, 2,817 days occurred 
during the testing phase of the regulatory review period, while 305 
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: 
October 30, 1994. FDA has verified the applicant's claim that the date 
the IND became effective was on October 30, 1994.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: July 16, 2002. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for BONIVA (NDA 21-455) was initially submitted on July 16, 2002.
    3. The date the application was approved: May 16, 2003. FDA has 
verified the applicant's claim that NDA 21-455 was approved on May 16, 
2003.
    This redetermination 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

[[Page 59798]]

of the actual period for patent extension. In its application for 
patent extension, this applicant seeks 1,713 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 December 11, 2006. 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 
9, 2007. 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: September 22, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-16816 Filed 10-10-06; 8:45 am]
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