[Federal Register Volume 66, Number 45 (Wednesday, March 7, 2001)]
[Notices]
[Page 13770]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-5513]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00E-1235]
Determination of Regulatory Review Period for Purposes of Patent
Extension; Aciphex\TM\
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 Aciphex\TM\ 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
Commissioner of Patents and Trademarks, Department of Commerce, for the
extension of a patent which 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.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Regulatory Policy
Staff (HFD-007), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-594-2041.
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 Commissioner 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
Aciphex\TM\ (rabeprazole sodium). Aciphex\TM\ is
indicated for healing of erosive or ulcerative gastroesophageal reflux
disease (GERD), maintenance of healing of erosive or ulcerative GERD,
healing of duodenal ulcer, and treatment of pathological hypersecretory
conditions, including Zollinger-Ellison Syndrome. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for Aciphex\TM\ (U.S. Patent No.
5,045,552) from Eisai 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 April 12, 2000, FDA advised
the Patent and Trademark Office that this human drug product had
undergone a regulatory review period and that the approval of
Aciphex\TM\ 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
Aciphex\TM\ is 2,922 days. Of this time, 2,415 days occurred
during the testing phase of the regulatory review period, while 507
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:
August 21, 1991. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was on August
21, 1991.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the act: March 31, 1998.
FDA has verified the applicant's claim that the new drug application
(NDA) for Aciphex\TM\ (NDA 20-973) was initially submitted
on March 31, 1998.
3. The date the application was approved: August 19, 1999. FDA has
verified the applicant's claim that NDA 20-973 was approved on August
19, 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 1,713 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may submit to the Dockets Management Branch (address above)
written comments and ask for a redetermination by May 7, 2001.
Furthermore, any interested person may petition for a determination
regarding whether the applicant for extension acted with due diligence
during the regulatory review period by September 4, 2001. 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 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: February 16, 2001.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 01-5513 Filed 3-6-01; 8:45 am]
BILLING CODE 4160-01-S