[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
