[Federal Register Volume 73, Number 218 (Monday, November 10, 2008)]
[Notices]
[Pages 66647-66648]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-26679]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0229]


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

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 TYKERB 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.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 drug

[[Page 66648]]

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 drug 
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 TYKERB 
(lapatinib). TYKERB is indicated in combination with capecitabine, for 
the treatment of patients with advanced or metastatic breast cancer 
whose tumors overexpress HER2 and who have received prior therapy 
including an anthracycline, a taxane, and trastuzumab. Subsequent to 
this approval, the Patent and Trademark Office received a patent term 
restoration application for TYKERB (U.S. Patent No. 6,713,485) from 
SmithKline Beecham Corp. (doing business as GlaxoSmithKline), and the 
Patent and Trademark Office requested FDA's assistance in determining 
this patent's eligibility for patent term restoration. In a letter 
dated April 28, 2008, FDA advised the Patent and Trademark Office that 
this human drug product had undergone a regulatory review period and 
that the approval of TYKERB 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 
TYKERB is 2,260 days. Of this time, 2,078 days occurred during the 
testing phase of the regulatory review period, while 182 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: 
January 5, 2001. FDA has verified the applicant's claim that the date 
the investigational new drug application became effective was on 
January 5, 2001.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the act: September 13, 
2006. FDA has verified the applicant's claim that the new drug 
application (NDA) for TYKERB (NDA 22-059) was initially submitted on 
September 13, 2006.
    3. The date the application was approved: March 13, 2007. FDA has 
verified the applicant's claim that NDA 22-059 was approved on March 
13, 2007.
    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 628 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 January 9, 2009. 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 May 11, 2009. 
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 Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: October 20, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-26679 Filed 11-7-08; 8:45 am]
BILLING CODE 4160-01-S