[Federal Register Volume 73, Number 92 (Monday, May 12, 2008)]
[Notices]
[Pages 27000-27001]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-10512]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0047] (formerly Docket No. 2007E-0139)


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

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 VECTIBIX 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 recently approved for marketing the human biologic product 
VECTIBIX (panitumumab). VECTIBIX is indicated for the treatment of 
EGFR-expressing, metastatic colorectal carcinoma with disease 
progression on or following fluoropyrimidine-, oxaliplatin-, and 
irinotecan-containing chemotherapy regimens. Subsequent to this 
approval, the Patent and
    Trademark Office received a patent term restoration application for 
VECTIBIX (U.S. Patent No. 6,235,883) from Amgen Fremont 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 16, 2007, FDA advised the Patent and Trademark Office that 
this human biological product had undergone a regulatory review period 
and that the approval of VECTIBIX 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 
VECTIBIX is 2,662 days. Of this time, 2,479 days occurred during the 
testing phase of the regulatory review period, while 183 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: June 16, 
1999. The applicant claims June 19, 1999, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was June 16, 1999, 
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): March 29, 2006. The applicant claims 
December 15, 2005, as the date the original biologics license 
application (BLA) for VECTIBIX (BLA 125147/0) was initially submitted. 
However, FDA records indicate that BLA 125147/0 was submitted in 
several modules under the continuous marketing application pilot 
program. It is FDA's position that the approval phase begins when the 
marketing application is complete for review. The final module of the 
BLA making it complete for review was submitted on March 29, 2006.
    3. The date the application was approved: September 27, 2006. FDA 
has verified the applicant's claim that BLA 125147/0 was approved on 
September 27, 2006.
    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

[[Page 27001]]

of the actual period for patent extension. In its application for 
patent extension, this applicant seeks 1,122 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 11, 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. E8-10512 Filed 5-9-08; 8:45 am]
BILLING CODE 4160-01-S