[Federal Register Volume 67, Number 17 (Friday, January 25, 2002)]
[Notices]
[Pages 3723-3724]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-1925]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00E-1234]


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

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 SONATA 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 Commissioner 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 Dockets 
Management Branch (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-7), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-5645.

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 Commissioner 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

[[Page 3724]]

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 SONATA 
(zaleplon). SONATA is indicated for the short-term treatment of 
insomnia. Subsequent to this approval, the Patent and Trademark Office 
received a patent term restoration application for SONATA (U.S. Patent 
No. 4,626,538) from American Cyanamid Co., and the Patent and Trademark 
Office requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated April 13, 
2000, FDA advised the Patent and Trademark Office that this human drug 
product had undergone a regulatory review period and that the approval 
of SONATA 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 
SONATA is 3,027 days. Of this time, 2,435 days occurred during the 
testing phase of the regulatory review period, while 592 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: 
May 2, 1991. The applicant claims May 16, 1991, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was May 2, 1991, 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 30, 1997. 
The applicant claims January 13, 1998, as the date the new drug 
application (NDA) for SONATA (NDA 20-859) was initially submitted. 
However, FDA records indicate that NDA 20-859 was submitted on December 
30, 1997.
    3.The date the application was approved: August 13, 1999. FDA has 
verified the applicant's claim that NDA 20-859 was approved on August 
13, 1999.
    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 1,835 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (address above) 
written or electronic comments and ask for a redetermination by March 
26, 2002. 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 July 24, 2002. 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 Dockets 
Management Branch (address above). Three copies of any information are 
to be submitted, except that individuals may submit one copy. Comments 
and petitions 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 Dockets Management Branch between 9 a.m. and 4 p.m., Monday 
through Friday.

    Dated: September 28, 2001.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-1925 Filed 1-24-02; 8:45 am]
BILLING CODE 4160-01-S