[Federal Register Volume 67, Number 24 (Tuesday, February 5, 2002)]
[Notices]
[Pages 5289-5290]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 02-2671]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 01E-0097]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; REFACTO

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 REFACTO 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: Submit written comments and petitions to the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers 
Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to 
http://www.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of 
Regulatory Policy (HFD-7), Food and Drug Administration, 5600 Fishers 
Lane, Rockville, MD 20857, 301-594-5645.

SUPPLEMENTARY INFORMATION: The Drug Price Competition and Patent Term 
Restoration Act of 1984 (Public Law 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Public Law 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 
REFACTO (novel procoagulant proteins). REFACTO is indicated for the 
control and prevention of hemorrhagic episodes and for short-term 
routine and surgical prophylaxis in patients with hemophilia A. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for REFACTO (U.S. Patent No. 
4,868,112) from the Genetics Institute, Inc., 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 
11, 2001, FDA advised the Patent and Trademark Office that this human 
biological product had undergone a regulatory review period and that 
the approval of REFACTO 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 
REFACTO is 1,751 days. Of this time, 987 days occurred during the 
testing phase of the regulatory review period, while 764 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: May 23, 
1995. The applicant claims March 14, 1994, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was May 23, 1995, 
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 351 of the Public Health 
Service Act (42 U.S.C. 262): February 2, 1998. FDA has verified the 
applicant's claim that the product license application (PLA) for 
REFACTO (PLA 98-0137) was initially submitted on February 2, 1998.
    3. The date the application was approved: March 6, 2000. FDA has 
verified the applicant's claim that PLA 98-0137 was approved on March 
6, 2000.
    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 1,475 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Dockets Management Branch (address above) 
written or electronic comments and ask for a redetermination by April 
8, 2002. Furthermore, any interested person may petition FDA for a 
determination regarding whether the applicant for extension acted with 
due diligence during the regulatory review period by August 5, 2002. 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. Three copies of any information are to be submitted, 
except that individuals may submit one copy.

[[Page 5290]]

 Comments are to be 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: September 28, 2001.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 02-2671 Filed 2-4-02; 8:45 am]
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