Determination of Regulatory Review Period for Purposes of Patent Extension; OmnicefRegister Oral Suspension

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 98E-0840]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Omnicef Oral Suspension

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 Omnicef Oral Suspension 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: 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)

[[Page 27580]]

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

Omnicef Oral Suspension (cefdinir). Omnicef Oral

Suspension is indicated for the treatment of patients with mild to

moderate infections caused by susceptible strains of specific

microorganisms in specified conditions. Subsequent to this approval,

the Patent and Trademark Office received a patent term restoration

application for Omnicef Oral Suspension (U.S. Patent No.

4,935,507) from Warner-Lambert Co., 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 14, 1998, FDA

advised the Patent and Trademark Office that this human drug product

had undergone a regulatory review period and that the approval of

Omnicef Oral Suspension 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 Omnicef Oral Suspension is 2,745 days. Of this time,

2,406 days occurred during the testing phase of the regulatory review

period, while 339 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: June

1, 1990. FDA has verified the applicant's claim that the date the

investigational new drug application became effective was on June 1,

1990.

2. The date the application was initially submitted with respect

to the human drug product under section 505 of the act: December 31,

1996. FDA has verified the applicant's claim that the new drug

application (NDA) for Omnicef Oral Suspension (NDA 50-749)

was initially submitted on December 31, 1996.

3. The date the application was approved: December 4, 1997. FDA

has verified the applicant's claim that NDA 50-749 was approved on

December 4, 1997.

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 1,213 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 16, 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. 99-12654 Filed 5-19-99; 8:45 am]

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