Document ID: FDA-2008-E-0258-0006
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; RECOTHROM
Posted Date: 2009-08-04T04:00Z

[Federal Register: August 4, 2009 (Volume 74, Number 148)]
[Notices]               
[Page 38658-38659]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr04au09-62]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0258; FDA-2008-E-0260; and FDA-2008-E-0261]

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

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 RECOTHROM and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission of three applications to the Director of 
Patents and Trademarks, Department of Commerce, for the extension of 
patents which claim that human biological product.

ADDRESSES:  Submit written comments and petitions to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.regulations.gov.

FOR FURTHER INFORMATION CONTACT:  Beverly Friedman, Office of 
Regulatory Policy, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 51, rm. 6222, Silver Spring, MD 20993-0002, 301-796-3602.

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 human biological product 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 human 
biological product. Although only a portion of a regulatory review 
period may count toward the actual amount of extension that the 
Director 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

[[Page 38659]]

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 
RECOTHROM (Thrombin, topical (Recombinant)). RECOTHROM is indicated as 
an aid to hemostasis whenever oozing blood and minor bleeding from 
capillaries and small venules is accessible and control of bleeding by 
standard surgical techniques is ineffective or impractical. Subsequent 
to this approval, the Patent and Trademark Office received patent term 
restoration applications for RECOTHROM (U.S. Patent Nos. 5,476,777, 
5,502,034, and 5,527,692) from ZymoGenetics, Inc., and the Patent and 
Trademark Office requested FDA's assistance in determining the patents' 
eligibilities for patent term restoration. In a letter dated February 
26, 2009, FDA advised the Patent and Trademark Office that this human 
biological product had undergone a regulatory review period and that 
the approval of RECOTHROM represented the first permitted commercial 
marketing or use of the product. 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 
RECOTHROM is 1,511 days. Of this time, 1,115 days occurred during the 
testing phase of the regulatory review period, while 396 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 (the act) (21 U.S.C. 355(i)) became effective: 
November 30, 2003. FDA has verified the applicant's claims that the 
date the investigational new drug application became effective was on 
November 30, 2003.
    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): December 18, 2006. FDA has verified the 
applicant's claims that the biologics license application (BLA) for 
RECOTHROM (BLA 125248/0) was initially submitted on December 18, 2006.
    3. The date the application was approved: January 17, 2008. FDA has 
verified the applicant's claims that BLA 125248/0 was approved on 
January 17, 2008.
    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 952 days of 
patent term extension.
    Anyone with knowledge that any of the dates as published are 
incorrect may submit to the Division of Dockets Management (see 
ADDRESSES) written or electronic comments and ask for a redetermination 
by October 5, 2009. 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 February 1, 
2010. 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 Division of 
Dockets Management. Three copies of any mailed information are to be 
submitted, except that individuals may submit one copy. 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 Division of Dockets 
Management between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-18528 Filed 8-3-09; 8:45 am]

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