[Federal Register Volume 68, Number 88 (Wednesday, May 7, 2003)]
[Notices]
[Pages 24485-24486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-11215]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 02E-0064]


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

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 TRACLEER 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 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-013), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-827-3460.

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

[[Page 24486]]

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 TRACLEER 
(bosentan). TRACLEER is indicated for the treatment of pulmonary 
arterial hypertension. Subsequent to this approval, the Patent and 
Trademark Office received a patent term restoration application for 
TRACLEER (U.S. Patent No. 5,292,740) from Hoffman-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 April 26, 2002, FDA advised the Patent and Trademark 
Office that this human drug product had undergone a regulatory review 
period and that the approval of TRACLEER 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 
TRACLEER is 2,176 days. Of this time, 1,807 days occurred during the 
testing phase of the regulatory review period, while 369 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: 
December 8, 1995. The applicant claims December 9, 1995, as the date 
the investigational new drug application (IND) became effective. 
However, FDA records indicate that the IND effective date was December 
8, 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: November 17, 2000. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for TRACLEER (NDA 21-290) was initially submitted on November 17, 
2000.
    3. The date the application was approved: November 20, 2001. FDA 
has verified the applicant's claim that NDA 21-290 was approved on 
November 20, 2001.
    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 1,259 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may submit to the Dockets Management Branch (see ADDRESSES) 
written comments and ask for a redetermination by July 9, 2003. 
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 November 3, 2003. 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. 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 Dockets 
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: March 31, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-11215 Filed 5-6-03; 8:45 am]
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