Federal Register / Vol. 60, No. 102 / Friday, May 26, 1995 / Notices 27981

Dated: May 15, 1995.

Gary J. Dykstra,

Acting Associate Commissioner for

Regulatory Affairs.

[FR Doc. 95–13034 Filed 5–25–95; 8:45 am]

BILLING CODE 4160–01–F

[Docket No. 95E–0055]

Determination of Regulatory Review

Period for Purposes of Patent

Extension; FRAGMIN

AGENCY: Food and Drug Administration,

HHS.

ACTION: Notice.

SUMMARY: The Food and Drug

Administration (FDA) has determined

the regulatory review period for

FRAGMIN 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,

rm. 1–23, 12420 Parklawn Dr.,

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 FRAGMIN

(dalteparin sodium). FRAGMIN is

indicated for prophylaxis against deep

vein thrombosis, which may lead to

pulmonary embolism, in patients

undergoing abdominal surgery who are

at risk for thromboembolic

complications. Subsequent to this

approval, the Patent and Trademark

Office received a patent term restoration

application for FRAGMIN (U.S. Patent

No. 4,303,651) from Pharmacia

Aktiebolag, 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 23, 1995, FDA

advised the Patent and Trademark

Office that this human drug product had

undergone a regulatory review period

and that the approval of FRAGMIN

represented the first permitted

commercial marketing or use of the

product. Shortly thereafter, the Patent

and Trademark Office requested that

FDA determine the products’s

regulatory review period.

FDA has determined that the

applicable regulatory review period for

FRAGMIN is 3,555 days. Of this time,

2,832 days occurred during the testing

phase of the regulatory review period,

while 723 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: March 31, 1985. The

applicant did not state an

investigational new drug application

(IND) effective date, stating that foreign

studies were used in lieu of an IND.

However, FDA records indicate that

certain studies material to the approval

of the product were conducted under

IND 25,924. Therefore, the IND effective

date was March 31, 1985, which was 30

days after FDA receipt of IND 25,924.

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 30, 1992. The

applicant claims February 28, 1993, as

the date the new drug application

(NDA) for FRAGMIN (NDA 20–287)

was initially submitted, whereas it is

actually the filing date. FDA records

indicate that NDA 20–287 was refused

to file on September 25, 1992. The

correct resubmission date for NDA 20–

287 is December 30, 1992, which was

the date the resubmission was actually

received by the agency. Therefore, the

NDA initial submission date for NDA

20–287 is December 30, 1992, the same

as the resubmission date.

3. The date the application was

approved: December 22, 1994. FDA has

verified the applicant’s claim that NDA

20–287 was approved on December 22,

1994.

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 661 days of patent

term extension.

Anyone with knowledge that any of

the dates as published is incorrect may

on or before July 25, 1995, 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 22, 1995, 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 15, 1995

Stuart L. Nightingale,

Associate Commissioner for Health Afairs.

[FR Doc. 95–13032 Filed 5–25–95; 8:45 am]

BILLING CODE 4160–01–F