[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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