[Federal Register Volume 71, Number 117 (Monday, June 19, 2006)]
[Notices]
[Pages 35274-35275]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-9509]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2006E-0040]


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

AGENCY: Food and Drug Administration, HHS.

[[Page 35275]]


ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ROZEREM 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.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 human drug product 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 ROZEREM 
(ramelteon). ROZEREM is indicated for the treatment of insomnia 
characterized by difficulty with sleep onset. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for ROZEREM (U.S. Patent No. 6,034,239) from 
Takeda Pharmaceutical Co., Ltd., 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 24, 2006, FDA 
advised the Patent and Trademark Office that this human drug product 
had undergone a regulatory review period and that the approval of 
ROZEREM 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 regulatory review period for 
ROZEREM is 2,224 days. Of this time, 1,920 days occurred during the 
testing phase of the regulatory review period, while 304 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: 
June 22, 1999. The applicant claims May 5, 1999, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was June 22, 1999, 
when the applicant was notified that the IND studies were allowed to 
proceed after being on clinical hold.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: September 22, 
2004. FDA has verified the applicant's claim that the new drug 
application (NDA) for Rozerem (NDA 21-782) was initially submitted on 
September 22, 2004.
    3. The date the application was approved: July 22, 2005. FDA has 
verified the applicant's claim that NDA 21-782 was approved on July 22, 
2005.
    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 808 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 August 18, 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 December 18, 
2006. 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: May 17, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-9509 Filed 6-16-06; 8:45 am]
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