[Federal Register Volume 64, Number 95 (Tuesday, May 18, 1999)]
[Pages 26986-26987]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-12392]



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.


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, 
    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]