[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; BeneFIXTM
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 BeneFIXTM 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
BeneFIXTM (coagulation factor IX (Recombinant)).
BeneFIXTM 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 BeneFIXTM (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 BeneFIXTM 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]]
BeneFIXTM 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 BeneFIXTM
(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]
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