[Federal Register: November 26, 2003 (Volume 68, Number 228)]
[Page 66449-66450]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food and Drug Administration

[Docket No. 2003E-0150]

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

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.


SUMMARY:  The Food and Drug Administration (FDA) has determined the
regulatory review period for ABILIFY and is publishing this notice of
that determination as required by law. FDA has made the determination

[[Page 66450]]

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.

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 ABILIFY
(aripiprazole). ABILIFY is indicated for the treatment of
schizophrenia. Subsequent to this approval, the Patent and Trademark
Office received a patent term restoration application for ABILIFY (U.S.
Patent No. 5,006,528) from Otsuka Pharmaceutical Co., Ltd., 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 ABILIFY 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
ABILIFY is 3,416 days. Of this time, 3,035 days occurred during the
testing phase of the regulatory review period, while 381 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: July
11, 1993. The applicant claims July 10, 1993, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was July 11, 1993,
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: October 31, 2001.
FDA has verified the applicant's claim that the new drug application
(NDA) for ABILIFY (NDA 21-436) was initially submitted on October 31,
    3. The date the application was approved: November 15, 2002. FDA
has verified the applicant's claim that NDA 21-436 was approved on
November 15, 2002.
    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 5 years 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 and ask for a redetermination by January
26, 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 May 24, 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
    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: October 30, 2003.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 03-29464 Filed 11-25-03; 8:45 am]