[Federal Register Volume 63, Number 197 (Tuesday, October 13, 1998)]
[Notices]
[Pages 54717-54718]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-27286]


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

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