[Federal Register Volume 69, Number 132 (Monday, July 12, 2004)]
[Notices]
[Page 41812]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-15712]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1999E-5116]


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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for XOPENEX 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, 240-453-6699.

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 XOPENEX 
(levalbuterol). XOPENEX is indicated for the treatment or prevention of 
bronchospasm in adults, adolescents, and children 6 years of age or 
older with reversible obstructive airway disease. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for XOPENEX (U.S. Patent No. 5,362,755) from 
Sepracor, 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 December 30, 2002, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of XOPENEX 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 
XOPENEX is 1,458 days. Of this time, 824 days occurred during the 
testing phase of the regulatory review period, while 634 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: 
March 30, 1995. The applicant claims February 28, 1995, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was March 30, 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(b) of the act: June 30, 1997. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for XOPENEX (NDA 20-837) was initially submitted on June 30, 
1997.
    3. The date the application was approved: March 25, 1999. FDA has 
verified the applicant's claim that NDA 20-837 was approved on March 
25, 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 502 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by September 10, 2004. 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 January 
10, 2005. 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 21, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-15712 Filed 7-9-04; 8:45 am]
BILLING CODE 4160-01-S