[Federal Register Volume 71, Number 18 (Friday, January 27, 2006)]
[Notices]
[Pages 4592-4593]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-1050]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2004E-0314]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; SPIRIVA HANDIHALER

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 SPIRIVA HANDIHALER 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 that 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: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 240-453-6681.

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 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 SPIRIVA 
HANDIHALER (tiotropium bromide monohydrate). SPIRIVA HANDIHALER is 
indicated for the long-term, once daily, maintenance treatment of 
bronchospasm associated with chronic obstructive pulmonary disease 
(COPD), including chronic bronchitis and emphysema. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for SPIRIVA HANDIHALER (U.S. Patent No. 
5,610,163) from Boehringer Ingelheim 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

[[Page 4593]]

August 31, 2004, FDA advised the Patent and Trademark Office that this 
human drug product had undergone a regulatory review period and that 
the approval of SPIRIVA HANDIHALER 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 
SPIRIVA HANDIHALER is 3,318 days. Of this time, 2,557 days occurred 
during the testing phase of the regulatory review period, while 761 
days occurred during the approval phase. These periods of time were 
derived from the following dates:
    1. The date an exemption under section 505 of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 355) became effective: 
January 1, 1995. The applicant claims February 2, 1995, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was January 1, 1995, 
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 of the act: December 31, 2001. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for Spiriva HandiHaler (NDA 21-395) was initially submitted on 
December 31, 2001.
    3. The date the application was approved: January 30, 2004. FDA has 
verified the applicant's claim that NDA 21-395 was approved on January 
30, 2004.
    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 1,421 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before March 28, 2006, submit to the Division of 
Dockets Management (see ADDRESSES) written comments and ask for a 
redetermination. Furthermore, any interested person may petition FDA, 
on or before July 26, 2006, for a determination regarding whether the 
applicant for extension acted with due diligence during the regulatory 
review period. 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: January 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-1050 Filed 1-26-06; 8:45 am]
BILLING CODE 4160-01-S