[Federal Register Volume 74, Number 148 (Tuesday, August 4, 2009)]
[Notices]
[Pages 38659-38660]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-18530]


-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-E-0551]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; XIENCE V EECSS

AGENCY:  Food and Drug Administration, HHS.

ACTION:  Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for XIENCE V EECSS 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 medical device.

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 medical devices, the testing 
phase begins with a clinical investigation of the device and runs until 
the approval phase begins. The approval phase starts with the initial 
submission of an application to market the device and continues until 
permission to market the device is granted. 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 (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 medical device will include 
all of the testing phase and approval phase as specified in 35 U.S.C. 
156(g)(3)(B).
    FDA recently approved for marketing the medical device, XIENCE V 
EECSS. XIENCE V EECSS is indicated for improving coronary luminal 
diameter in patients with symptomatic heart disease due to de novo 
native coronary artery lesions (length = 28 millimeters (mm)) with 
reference vessel diameters of 2.5 mm to 4.25 mm. Subsequent to this 
approval, the Patent and Trademark Office received a patent term 
restoration application for XIENCE V EECSS (U.S. Patent No. 5,451,233) 
from Abbott Cardiovascular Systems, Inc., and the Patent and Trademark 
Office requested

[[Page 38660]]

FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated February 18, 2009, FDA advised the 
Patent and Trademark Office that this medical device had undergone a 
regulatory review period and that the approval of XIENCE V EECSS 
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 
XIENCE V EECSS is 1,157 days. Of this time, 759 days occurred during 
the testing phase of the regulatory review period, while 398 days 
occurred during the approval phase. These periods of time were derived 
from the following dates:
    1. The date an exemption under section 520(g) of the Federal Food, 
Drug, and Cosmetic Act (the act) (21 U.S.C. 360j(g)) involving this 
device became effective: May 4, 2005. FDA has verified the applicant's 
claim that the date the investigational device exemption (IDE) required 
under section 520(g) of the act for human tests to begin became 
effective on May 4, 2005.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the act (21 U.S.C. 360e): June 1, 2007. 
The applicant claims the premarket approval application (PMA) XIENCE V 
EECSS (PMA 70015) was submitted in three modules and that Module 1 was 
initially submitted on July 14, 2006. The applicant claims July 14, 
2006, as the date PMA 70015 was initially submitted. It is FDA's 
position that the approval phase begins when the marketing application 
is complete. A review of FDA records indicates that PMA 70015 was 
submitted as a complete application on June 1, 2007, which is 
considered to be the initially submitted date for PMA 70015.
    3. The date the application was approved: July 2, 2008. FDA has 
verified the applicant's claim that PMA 70015 was approved on July 2, 
2008.
    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 937 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 October 5, 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 February 1, 
2010. 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.

    Dated: June 8, 2009.
Jane A. Axelrad,
Associate Director for Policy, Center for Drug Evaluation and Research.
[FR Doc. E9-18530 Filed 8-3-09; 8:45 am]
BILLING CODE 4160-01-S