[Federal Register Volume 69, Number 25 (Friday, February 6, 2004)]
[Notices]
[Pages 5859-5860]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 04-2547]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003E-0081]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ORTHO-EVRA

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 ORTHO-EVRA 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 ORTHO-
EVRA (norelgestromin/ethinyl estradiol transdermal system). ORTHO-EVRA 
is indicated for the prevention of pregnancy. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for ORTHO-EVRA (U.S. Patent No. 5,876,746) from 
Johnson and Johnson, and the Patent and Trademark Office requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated July 16, 2003, FDA advised the 
Patent and Trademark Office that this human drug product had undergone 
a regulatory review period and that the approval of ORTHO-EVRA 
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 
ORTHO-EVRA is 2,001 days. Of this time, 1,666 days occurred during the 
testing phase of the regulatory review period, while 335 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 31, 1996. The applicant claims May 30, 1996, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was May 31, 1996, 
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 21, 2000. 
FDA has verified the applicant's claim that the new drug application 
(NDA) for ORTHO-EVRA (NDA 21-180) was initially submitted on December 
21, 2000.
    3. The date the application was approved: November 20, 2001. FDA 
has verified the applicant's claim that NDA

[[Page 5860]]

21-180 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 664 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 comments or electronic comments and ask for a 
redetermination by April 6, 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 August 4, 2004. 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: January 13, 2004.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 04-2547 Filed 2-5-04; 8:45 am]
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