16166 Federal Register / Vol. 62, No. 65 / Friday, April 4, 1997 / Notices

[Docket No. 96E–0441]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; TRITEC

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

TRITEC 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,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs

(HFY–20), Food and Drug

Administration, 5600 Fishers Lane,

Rockville, MD 20857, 301–443–1382.

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 TRITEC

(ranitidine bismuth citrate). TRITEC in

combination with clarithromycin is

indicated for the treatment of patients

with an active duodenal ulcer

associated with H. pylori infection.

Subsequent to this approval, the Patent

and Trademark Office received a patent

term restoration application for

TRITEC (U.S. Patent No. 5,008,256)

from Glaxo Wellcome, Inc., and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patient’s eligibility for patent term

restoration. In a letter dated January 13,

1997, FDA advised the Patent and

Trademark Office that this human drug

product had undergone a regulatory

review period and that the approval of

TRITEC 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

TRITEC is 1,074 days. Of this time,

485 days occurred during the testing

phase of the regulatory review period,

while 589 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 505(i) of the Federal Food, Drug,

and Cosmetic Act (21 U.S.C. 355(i))

became effective: September 1, 1993.

FDA has verified the applicant’s claim

that the date that the investigation new

drug application became effective was

on September 1, 1993.

2. The date the application was

initially submitted with respect to the

human drug product under section

505(b) of the Federal Food, Drug, and

Cosmetic Act: December 29, 1994. FDA

has verified the applicant’s claim that

the new drug application (NDA) for

TRITEC (NDA 20–559) was initially

submitted on December 29, 1994.

3. The date the application was

approved: August 8, 1996. FDA has

verified the applicant’s claim that NDA

20–559 was approved on August 8,

1996.

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 831 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before June 3, 1997 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 October 1, 1997 for a

determination regarding whether the

applicant for extension acted with due

diligence during the regulatory review

period. To meet, 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: March 27, 1997.

Allen B. Duncan,

Acting Associate Commissioner for Health

Affairs.

[FR Doc. 97–8624 Filed 4–3–97; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 96E–0505]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; MERETEK UBTTM Breath

Test

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

MERETEK UBTTM Breath Test 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,

12420 Parklawn Dr., rm. 1–23,

Rockville, MD 20857.

FOR FURTHER INFORMATION CONTACT:

Brian J. Malkin, Office of Health Affairs