[Federal Register: May 12, 2008 (Volume 73, Number 92)]
[Notices]
[Page 27000-27001]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr12my08-47]
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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