[Federal Register Volume 60, Number 102 (Friday, May 26, 1995)]
[Notices]
[Page 27981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-13032]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES
[Docket No. 95E-0055]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; FRAGMIN<Register>

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for FRAGMIN<Register> 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<Register> (dalteparin sodium). FRAGMIN<Register> 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<Register> (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<Register> 
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<Register> 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<Register> 
(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