[Federal Register: February 17, 2006 (Volume 71, Number 33)]
[Notices]
[Page 8595-8596]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17fe06-74]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 2005E-0254]
Determination of Regulatory Review Period for Purposes of Patent
Extension; ERBITUX
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 ERBITUX 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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/dockets/ecomments.
FOR FURTHER INFORMATION CONTACT: Claudia V. Grillo, Office of
Regulatory Policy (HFD-013), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 240-453-6681.
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 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
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 biological product
ERBITUX (cetuximab). ERBITUX, used in combination with irinotecan, is
indicated for the treatment of epidermal growth factor receptor (EGFR)-
expressing metastatic colorectal carcinoma in patients who are
refractory to irinotecan-based chemotherapy. Subsequent to this
approval, the Patent and Trademark Office received a patent term
restoration application for ERBITUX (U.S. Patent No. 6,217,866) from
Aventis Pharmaceuticals, 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 8, 2005, FDA advised the
Patent and Trademark Office that this human biological product had
undergone a regulatory review period and that the approval of ERBITUX
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
ERBITUX is 3,375 days. Of this time, 3,192 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: November
18, 1994. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on November
18, 1994.
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): August 14, 2003. The applicant claims
August 12, 2003, as the date the product license application (BLA) for
ERBITUX (BLA 125084) was initially submitted. However, FDA records
indicate that BLA 125084 was submitted on August 14, 2003.
3. The date the application was approved: February 12, 2004. FDA
has verified the applicant's claim that BLA 125084 was approved on
February 12, 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 391 days of
patent term extension.
Anyone with knowledge that any of the dates as published is
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) written comments and ask for a redetermination by April 18,
2006. 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 16, 2006.
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
[[Page 8596]]
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: Janury 5, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-2354 Filed 2-16-06; 8:45 am]
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