Document ID: FDA-2007-E-0227-0003
Agency: fda
Document Type: Notice
Title: Determination of Regulatory Review Period for Purposes of Patent Extension; TYZEKA
Posted Date: 2008-05-15T04:00Z

[Federal Register: May 15, 2008 (Volume 73, Number 95)]
[Notices]               
[Page 28119-28120]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr15my08-56]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2007-E-0035 (formerly Docket No. 2007E-0133) and 
[Docket No. FDA-2007-E-0227 (formerly Docket No. 2007E-0148)]

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

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 TYZEKA and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submissions of applications to the Director of Patents 
and Trademarks, Department of Commerce, for the extension of patents 
which claim 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 28120]]

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 approved for marketing the human drug product TYZEKA. TYZEKA is 
indicated for the treatment of chronic hepatitis B in adult patients 
with evidence of viral replication and either evidence of persistent 
elevations in serum aminotransferases or histologically active disease. 
Subsequent to this approval, the Patent and Trademark Office received 
patent term restoration applications for TYZEKA (U.S. Patent Nos. 
6,395,716 and 6,569,837) from Idenix Pharmaceuticals, Inc., Centre 
National de La Recherche Scientifique, and L'Universite Montpellier II, 
and the Patent and Trademark Office requested FDA's assistance in 
determining the patents' eligibility for patent term restoration. In a 
letter dated May 16, 2007, FDA advised the Patent and Trademark Office 
that this human drug product had undergone a regulatory review period 
and that the approval of TYZEKA 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 
TYZEKA is 2,309 days. Of this time, 2,009 days occurred during the 
testing phase of the regulatory review period, while 300 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: 
July 1, 2000. The applicant claims the investigational new drug 
application (IND) was under clinical hold until August 15, 2000, and 
claims that date as the date the IND became effective. However, 
according to FDA records, the IND was considered safe to proceed with 
some recommendations that were sent to the sponsor to consider prior to 
commencement of the study. The IND effective date was July 1, 2000, 
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: December 30, 
2005. FDA has verified the applicant's claim that the new drug 
application (NDA) for TYZEKA (NDA 22-011) was initially submitted on 
December 30, 2005.
    3. The date the application was approved: October 25, 2006. FDA has 
verified the applicant's claim that NDA 22-011 was approved on October 
25, 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 of the actual period for patent extension. In its 
application for patent extension, this applicant seeks 442 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 14, 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 12, 
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 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 
through FDMS only.

    Dated: April 28, 2008.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E8-10857 Filed 5-14-08; 8:45 am]

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