[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Notices]
[Pages 26986-26987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12392]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 98E-0789]
Determination of Regulatory Review Period for Purposes of Patent
Extension; LotemaxTM and AlrexTM
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 LotemaxTM and
AlrexTM 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
[[Page 26987]]
Trademarks, Department of Commerce, for the extension of a patent which
claims that human drug product.
ADDRESSES: Written comments and petitions should be directed to the
Dockets Management Branch (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Brian J. Malkin, Office of Health
Affairs (HFY-20), Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20857, 301-827-6620.
SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term
Restoration Act of 1984 (Pub. L. 98-417) and the Generic Animal Drug
and Patent Term Restoration Act (Pub. L. 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
LotemaxTM and AlrexTM (loteprednol etabonate).
LotemaxTM is indicated for the treatment of steroid
responsive inflammatory conditions of the palpebral and bulbar
conjunctiva, conrnea and anterior segment of the globe such as allergic
conjunctivitis, acne rosacea, superficial punctate keratitis, herpes
zoster keratitis, iritis, cyclitis, selective infective
conjunctivitides, when the inherent hazard of steroid use is accepted
to obtain an advisable dimunition in edema and inflammation.
AlrexTM is indicated for the temporary relief of the signs
and symptoms of seasonal allergic conjunctivitis. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for LotemaxTM and AlrexTM
(U.S. Patent No. 4,996,335) from Nicholas S. Bodor, 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 16, 1998, FDA advised the Patent and Trademark Office that
this human drug product had undergone a regulatory review period and
that the approval of LotemaxTM and AlrexTM
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
LotemaxTM and AlrexTM is 3,092 days. Of this
time, 2,017 days occurred during the testing phase of the regulatory
review period, while 1,075 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:
September 22, 1989. The applicant claims January 2, 1989, as the date
the investigational new drug application (IND) became effective.
However, FDA records indicate that the IND effective date was September
22, 1989, 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: March 31,
1995. The applicant claims March 29, 1995, as the date the new drug
application (NDA) for LotemaxTM and AlrexTM (NDA
20-583) was initially submitted. However, FDA records indicate that NDA
20-583 was submitted on March 31, 1995.
3. The date the application was approved: March 9, 1998. FDA has
verified the applicant's claim that NDA 20-583 was approved on March 9,
1998.
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 1,284 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may, on or before July 19, 1999, submit to the Dockets
Management Branch (address above) written comments and ask for a
redetermination. Furthermore, any interested person may petition FDA,
on or before November 15, 1999, for a determination regarding whether
the applicant for extension acted with due diligence during the
regulatory review period. 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 (address above) in three copies (except that
individuals may submit single copies) and 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: May 4, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-12392 Filed 5-17-99; 8:45 am]
BILLING CODE 4160-01-F
