Document ID: FDA-2009-E-0058-0006
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; TAPENTADOL HYDROCHLORIDE
Posted Date: 2009-09-01T04:00Z

[Federal Register: September 1, 2009 (Volume 74, Number 168)]
[Notices]               
[Page 45225-45226]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr01se09-80]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2009-E-0058]

 
Determination of Regulatory Review Period for Purposes of Patent 
Extension; TAPENTADOL HYDROCHLORIDE

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 TAPENTADOL HYDROCHLORIDE 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://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 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

[[Page 45226]]

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 
TAPENTADOL HYDROCHLORIDE (tapentadol hydrochloride). TAPENTADOL 
HYDROCHLORIDE is indicated for the relief of moderate to severe acute 
pain in patients 18 years of age or older. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for TAPENTADOL HYDROCHLORIDE (U.S. Patent No. RE 39,593) 
from Grunenthal GmbH, 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 TAPENTADOL 
HYDROCHLORIDE 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 
TAPENTADOL HYDROCHLORIDE is 2,880 days. Of this time, 2,577 days 
occurred during the testing phase of the regulatory review period, 
while 303 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: 
January 3, 2001. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
January 3, 2001.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: January 23, 
2008. FDA has verified the applicant's claim that the new drug 
application (NDA) 22-304 was submitted on January 23, 2008, as the date 
the NDA for TAPENTADOL HYDROCHLORIDE (NDA 22-304) was initially 
submitted.
    3. The date the application was approved: November 20, 2008. FDA 
has verified the applicant's claim that NDA 22-304 was approved on 
November 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 
application for patent extension, this applicant seeks 1,492 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 November 2, 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 March 
1, 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: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-21100 Filed 8-31-09; 8:45 am]

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