37398 Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices

length of a regulatory review period for

a human biological 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 biological product

VERLUMATM (nofetumomab).

VERLUMATM is indicated for the

detection of extensive stage disease in

patients with biopsy confirmed,

previously untreated small cell lung

cancer. Subsequent to this approval, the

Patent and Trademark Office received a

patent term restoration application for

VERLUMATM (U.S. Patent No.

4,897,255) from NeoRx Corp., and the

Patent and Trademark Office requested

FDA’s assistance in determining this

patent’s eligibility for patent term

restoration. In a letter dated July 9,

1997, FDA advised the Patent and

Trademark Office that this human

biological product had undergone a

regulatory review period and that the

approval of VERLUMATM represented

the first permitted commercial

marketing or use of the product. Shortly

thereafter, the Patent and Trademark

Office requested that the FDA determine

the product’s regulatory review period.

FDA has determined that the

applicable regulatory review period for

VERLUMATM is 3,360 days. Of this

time, 925 days occurred during the

testing phase of the regulatory review

period, 2,435 days occurred during the

approval phase. These periods of time

were derived from the following dates:

1. The date an exemption under

section 351 of the Public Health Service

Act became effective: June 11, 1987. The

applicant claims September 4, 1987, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was June 11, 1987,

which was 30 days after FDA receipt of

the IND.

2. The date the application was

initially submitted with respect to the

human biological product under section

351 of the Public Health Service Act:

December 21, 1989. FDA has verified

the applicant’s claim that the Product

License Application (PLA) for

VERLUMATM (PLA 90–0150) was

initially submitted on December 21,

1989.

3. The date the application was

approved: August 20, 1996. FDA has

verified the applicant’s claim that PLA

90–0150 was approved on August 20,

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 1,298 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 8, 1998, 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 January 6, 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: June 29, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–18408 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0061]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; STROMECTOL

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

STROMECTOL 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)

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

STROMECTOL (ivermectin).

STROMECTOL is indicated for

treatment of strongyloidiasis and

onchocerciasis. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for STROMECTOL (U.S.

Patent No. 4,199,569) from Merck & Co.,

Inc., and the Patent and Trademark

Office requested FDA’s assistance in

determining this patent’s eligibility for

patent term restoration. In a letter dated

March 7, 1997, FDA advised the Patent

and Trademark Office that this human

drug product had undergone a

regulatory review period and that the
Federal Register / Vol. 63, No. 132 / Friday, July 10, 1998 / Notices 37399

approval of STROMECTOL

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

STROMECTOL is 2,291 days. Of this

time, 2,055 days occurred during the

testing phase of the regulatory review

period, while 236 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: August 17, 1990.

The applicant claims July 17, 1990, as

the date the investigational new drug

application (IND) became effective.

However, FDA records indicate that the

IND effective date was August 17, 1990,

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: April 1, 1996. The applicant

claims March 29, 1996, as the date the

new drug application (NDA) for

STROMECTOL (NDA 50–742) was

initially submitted. However, FDA

records indicate that NDA 50–742 was

submitted on April 1, 1996.

3. The date the application was

approved: November 22, 1996. FDA has

verified the applicant’s claim that NDA

50–742 was approved on November 22,

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 1,026 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may,

on or before September 8, 1998, 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 January 6, 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: June 23, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health

Affairs.

[FR Doc. 98–18400 Filed 7–9–98; 8:45 am]

BILLING CODE 4160–01–F

DEPARTMENT OF HEALTH AND

HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E–0359]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; FlowmaxTM

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

FlowmaxTM 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)

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 FlowmaxTM

(tamsulosin hydrochloride). FlowmaxTM

is indicated for the treatment of the

signs and symptoms of benign prostatic

hyperplasia (BPH). Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for FlowmaxTM (U.S. Patent

No. 4,868,216) from Yamanouchi

Pharmaceutical, and the Patent and

Trademark Office requested FDA’s

assistance in determining this patent’s

eligibility for patent term restoration. In

a letter dated November 7, 1997, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of FlowmaxTM

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that the

FDA determine the product’s regulatory

review period.

FDA has determined that the

applicable regulatory review period for

FlowmaxTM is 3,529 days. Of this time,

3,163 days occurred during the testing

phase of the regulatory review period,

366 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: August 19, 1987.

FDA has verified the applicant’s claim

that the date the investigational new