Document ID: FDA-2007-E-0102-0003
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; AVASTIN
Posted Date: 2008-05-14T04:00Z

[Federal Register: May 14, 2008 (Volume 73, Number 94)]
[Notices]               
[Page 27836-27837]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14my08-83]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0102] (formerly Docket No. 2007E-0184)

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

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 AVASTIN 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 Director of Patents 
and Trademarks, Department of Commerce, for the extension of a patent 
which claims that human biological product.

ADDRESSES: Submit written or electronic 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 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 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 all of the testing 
phase and approval phase as specified in 35 U.S.C. 156(g)(1)(B).
    FDA approved for marketing the human biologic product AVASTIN 
(bevacizumab). AVASTIN, used in combination with intravenous 5-
fluorouracil-based chemotherapy, is indicated for first-line treatment 
of patients with metastatic carcinoma of the colon or rectum. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for AVASTIN (U.S. Patent No. 
6,639,055) from Genentech, 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 July 24, 2007, FDA advised 
the Patent and Trademark Office that this human biological product had 
undergone a regulatory review period and that the approval of AVASTIN 
represented the

[[Page 27837]]

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 
AVASTIN is 2,551 days. Of this time, 2,401 days occurred during the 
testing phase of the regulatory review period, while 150 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: March 5, 
1997. The applicant claims February 3, 1997, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was March 5, 1997, 
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): September 30, 2003. The applicant claims 
August 29, 2003, as the date the biologics license application (BLA) 
for AVASTIN (BLA 125085/0) was initially submitted. The applicant 
claims this is the date it submitted the first unit of BLA 125085/0, 
which was submitted in several units as part of a rolling application 
procedure. It is FDA's position that the approval phase begins when the 
marketing application is complete. A review of FDA records reveals that 
the final module of the BLA 125085/0 was submitted on September 30, 
2003, which is considered to be the date the complete marketing 
application was initially submitted.
    3. The date the application was approved: February 26, 2004. FDA 
has verified the applicant's claim that BLA 125085/0 was approved on 
February 26, 2004.
    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 121 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 July 14, 2008. 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 November 10, 
2008. 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.
     Please note that on January 15, 2008, the FDA Web site 
transitioned to the Federal Dockets Management System (FDMS). FDMS is a 
Government-wide, electronic docket management system. Electronic 
submissions will be accepted by FDA through FDMS only.

    Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-10726 Filed 5-13-08; 8:45 am]

BILLING CODE 4160-01-S