[Federal Register: February 6, 2004 (Volume 69, Number 25)]
[Notices]
[Page 5859-5860]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr06fe04-87]
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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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&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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