Determination of Regulatory Review Period for Purposes of Patent Extension; LotemaxSUPTM/SUP and AlrexSUPTM/SUP

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]

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