[Federal Register Volume 71, Number 189 (Friday, September 29, 2006)]
[Pages 57546-57547]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-15987]



Food and Drug Administration

[Docket No. 2005E-0253]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for TARCEVA 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 drug 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.fda.gov/dockets/ecomments.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of Regulatory

[[Page 57547]]

Policy (HFD-7), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-594-2041.

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 drug products, the 
testing phase begins when the exemption to permit the clinical 
investigations of the human drug 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 drug product 
and continues until FDA grants permission to market the 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 drug 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 drug product TARCEVA 
(erlotinib). TARCEVA is indicated for the treatment of patients with 
locally advanced or metastatic non-small cell lung cancer after failure 
of at least one prior chemotherapy regimen. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for TARCEVA (U.S. Patent No. 5,747,498) from 
Pfizer, 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 8, 2005, FDA advised the Patent and 
Trademark Office that this human drug product had undergone a 
regulatory review period and that the approval of TARCEVA 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 
TARCEVA is 2,653 days. Of this time, 2,541 days occurred during the 
testing phase of the regulatory review period, while 112 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: 
August 16, 1997. The applicant claims October 10, 1997, as the date the 
investigational new drug application (IND) became effective. However, 
FDA records indicate that the IND effective date was August 16, 1997, 
which was 30 days after FDA receipt of the IND.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: July 30, 2004. 
The applicant claims January 20, 2004, as the date the new drug 
application (NDA) for TARCEVA (NDA 21-743) was initially submitted. The 
applicant claims this is the date it submitted the first module of NDA 
21-743, which was submitted in several modules as part of a rolling NDA 
submission 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 marketing application was 
submitted on July 30, 2004, which is considered to be the NDA initially 
submitted date.
    3. The date the application was approved: November 18, 2004. FDA 
has verified the applicant's claim that NDA 21-743 was approved on 
November 18, 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 1,261 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 November 28, 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 March 
28, 2007. 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: September 3, 2006.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E6-15987 Filed 9-28-06; 8:45 am]