Document ID: FDA-2010-E-0022-0005
Agency: fda
Document Type: Notice
Title: Determinations of Regulatory Review Periods for Purposes of Patent Extensions: VIBATIV
Posted Date: 2010-12-14T05:00Z

[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77877-77878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2010-31250]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2010-E-0022; FDA-2010-E-0023; FDA-2010-E-0024]

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

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 VIBATIV and is publishing this notice of 
that determination as required by law. FDA has made the determination 
because of the submission 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 electronic comments to http://www.regulations.gov. 
Submit written petitions along with three copies and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.

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 (Pub. L. 98-417) and the Generic Animal Drug 
and Patent Term Restoration Act (Pub. L. 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 drug 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.

[[Page 77878]]

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 VIBATIV 
(televancin hydrochloride). VIBATIV is indicated for treatment of adult 
patients with complicated skin and skin structure infections caused by 
susceptible Gram-positive bacteria. Subsequent to this approval, the 
Patent and Trademark Office received patent term restoration 
applications for VIBATIV (U.S. Patent Nos. 6,635,618; 6,872,701; and 
7,208,471) from Theravance, Inc., and the Patent and Trademark Office 
requested FDA's assistance in determining the patents' eligibility for 
patent term restoration. In a letter dated March 3, 2010, FDA advised 
the Patent and Trademark Office that this human drug product had 
undergone a regulatory review period and that the approval of VIBATIV 
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 
VIBATIV is 2,635 days. Of this time, 1,637 days occurred during the 
testing phase of the regulatory review period, while 998 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 (FD&C Act) (21 U.S.C. 355(i)) became effective: 
June 27, 2002. FDA has verified the applicant's claim that the date the 
investigational new drug application became effective was on June 27, 
2002.
    2. The date the application was initially submitted with respect to 
the human drug product under section 505(b) of the FD&C Act: December 
19, 2006. The applicant claims December 7, 2006, as the date the new 
drug application (NDA) for VIBATIV (NDA 22-110) was initially 
submitted. However, FDA records indicate that NDA 22-110 was submitted 
on December 19, 2006.
    3. The date the application was approved: September 11, 2009. FDA 
has verified the applicant's claim that NDA 22-110 was approved on 
September 11, 2009.
    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 
applications for patent extension, this applicant seeks 719, 828, or 
863 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) either electronic or written comments and ask for a 
redetermination by February 14, 2011. 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 June 13, 2011. 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.
    Interested persons may submit to the Division of Dockets Management 
(see ADDRESSES) electronic or written comments and written petitions. 
It is only necessary to send one set of comments. It is no longer 
necessary to send three copies of mailed comments.
    However, if you submit a written petition, you must submit three 
copies of the petition. Identify comments with the docket number found 
in brackets in the heading of this document. Comments and petitions 
that have not been made publicly available on regulations.gov may be 
viewed in the Division of Dockets Management between 9 a.m. and 4 p.m., 
Monday through Friday.

    Dated: October 22, 2010.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. 2010-31250 Filed 12-13-10; 8:45 am]
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