[Federal Register Volume 63, Number 149 (Tuesday, August 4, 1998)]
[Notices]
[Pages 41579-41580]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-20742]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 97E-0168]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; BeneFIX<SUP>TM</SUP>

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 BeneFIX<SUP>TM</SUP> 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 biological 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 biological products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the biological becomes effective and runs until the 
approval phase begins. The approval phase starts with the initial 
submission of an application to market the human biological product and 
continues until FDA grants permission to market the biological 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 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 
BeneFIX<SUP>TM</SUP> (coagulation factor IX (Recombinant)). 
BeneFIX<SUP>TM</SUP> is indicated for the control and prevention of 
hemorrhagic episodes in patients with hemophilia B, including the peri-
operative management of hemophilia B patients undergoing surgery. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for BeneFIX<SUP>TM</SUP> (U.S. 
Patent No. 5,171,569) from British Technology Group Ltd., and the 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated May 21, 1997, FDA advised the Patent and Trademark Office that 
this human biological product had undergone a regulatory review period 
and that the approval of BeneFIX<SUP>TM</SUP> 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

[[Page 41580]]

BeneFIX<SUP>TM</SUP> is 749 days. Of this time, 583 days occurred 
during the testing phase of the regulatory review period, while 166 
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: January 26, 1995. FDA has verified the 
applicant's claim that the date the investigational new drug 
application became effective was on January 26, 1995.
    2. The date the application was initially submitted with respect to 
the human biological product under section 351 of the Public Health 
Service Act: August 30, 1996. The applicant claims August 29, 1996, as 
the date the Product License Application (PLA) for BeneFIX<SUP>TM</SUP> 
(PLA 96-1048) was initially submitted. However, FDA records indicate 
that PLA 96-1048 was submitted on August 30, 1996.
    3. The date the application was approved: February 11, 1997. FDA 
has verified the applicant's claim that PLA 96-1048 was approved on 
February 11, 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 423 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before October 5, 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 February 1, 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: July 8, 1998.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 98-20742 Filed 8-3-98; 8:45 am]
BILLING CODE 4160-01-F