[Federal Register Volume 75, Number 239 (Tuesday, December 14, 2010)]
[Notices]
[Pages 77877-77878]
From the Federal Register Online via the Government Publishing 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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