Determination of Regulatory Review Period for Purposes of Patent Extension; NormifloRegister

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 97E-0367]

Determination of Regulatory Review Period for Purposes of Patent

Extension; Normiflo

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the

regulatory review period for Normiflo 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

Normiflo (ardeparin sodium). Normiflo is indicated

for the prevention of deep venous thrombosis which may lead to

pulmonary embolism following knee replacement surgery. Subsequent to

this approval, the Patent and Trademark Office received a patent term

restoration application for Normiflo (U.S. Patent No.

4,757,057) from Pharmacia & Upjohn 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

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 Normiflo 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

Normiflo is 3,503 days. Of this time, 1,883 days occurred

during the testing phase of the regulatory review period, while 1,620

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:

October 22, 1987. The applicant claims September 21, 1987, as the date

the investigational new drug application (IND) became effective.

However, FDA records indicate that the IND effective date was October

22, 1987, 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: December 16,

1992. The applicant claims February 28, 1992, as the date the new drug

application (NDA) for Normiflo (NDA 20-227) was initially

submitted. However, FDA records indicate that NDA 20-227 was

incomplete. FDA refused this application and notified the applicant of

this fact by letter dated April 20, 1992. The completed NDA was then

submitted on December 16, 1992, which

[[Page 54718]]

is considered to be the NDA initially submitted date.

3. The date the application was approved: May 23, 1997. FDA has

verified the applicant's claim that NDA 20-227 was approved on May 23,

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 1,820 days of

patent term extension.

Anyone with knowledge that any of the dates as published is

incorrect may, on or before December 14, 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 April 12, 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: September 28, 1998.

Thomas J. McGinnis,

Deputy Associate Commissioner for Health Affairs.

[FR Doc. 98-27286 Filed 10-9-98; 8:45 am]

BILLING CODE 4160-01-F