[Federal Register Volume 64, Number 42 (Thursday, March 4, 1999)]
[Notices]
[Pages 10474-10475]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5388]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 98E-0841]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Regranex and Becaplermin Concentrate

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 Regranex and Becaplermin 
Concentrate 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 those human biological products.

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 products 
Regranex and Becaplermin Concentrate (becaplermin). 
Regranex is indicated for the treatment of lower extremity 
diabetic neuropathic ulcers that extend into the subcutaneous tissue or 
beyond and have an adequate blood supply. Subsequent to this approval, 
the Patent and Trademark Office received a patent term restoration 
application for Regranex and Becaplermin Concentrate (U.S. 
Patent No. 4,845,075) from ZymoGenetics, Inc., and the Patent and 
Trademark Office requested FDA's assistance in determining this 
patent's

[[Page 10475]]

eligibility for patent term restoration. In a letter dated January 29, 
1999, FDA advised the Patent and Trademark Office that this human 
biological product had undergone a regulatory review period and that 
the approval of Regranex and Becaplermin Concentrate 
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 
Regranex and Becaplermin Concentrate is 2,790 days. Of this 
time, 2,424 days occurred during the testing phase of the regulatory 
review period, while 366 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: 
April 29, 1990. The applicant claims March 30, 1990, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was April 29, 1990, 
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human biological product under section 505 of the act: December 16, 
1996. FDA has verified the applicant's claim that the product license 
applications (PLA's) for Regranex (PLA 96-1408) and 
Becaplermin Concentrate (PLA 96-1422) were initially submitted on 
December 16, 1996.
    3. The date the application was approved: December 16, 1997. FDA 
has verified the applicant's claim that PLA 96-1408 and PLA 96-1422 
were approved on December 16, 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 1,593 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published is 
incorrect may, on or before May 3, 1999, 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 August 31, 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: February 16, 1999.
Thomas J. McGinnis,
Deputy Associate Commissioner for Health Affairs.
[FR Doc. 99-5388 Filed 3-3-99; 8:45 am]
BILLING CODE 4160-01-F