[Federal Register Volume 79, Number 102 (Wednesday, May 28, 2014)]
[Notices]
[Pages 30623-30624]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-12295]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-E-1246]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

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 RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING 
CORONARY STENT SYSTEM 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 electronic comments to http://www.regulations.gov. 
Submit written petitions (two copies are required) and written comments 
to the Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. 
Submit petitions electronically to http://www.regulations.gov at Docket 
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of 
Management, Center for Drug Evaluation and Research, Food and Drug 
Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6257, Silver 
Spring, MD 20993-0002, 301-796-7900.

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 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 has approved for marketing the medical device, RESOLUTE 
INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM. RESOLUTE INTEGRITY 
ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM is indicated for improving 
coronary luminal diameters in patients, including those with diabetes 
mellitus, with symptomatic ischemic heart disease due to de novo 
lesions of length less than or equal to 27 millimeters (mm) in native

[[Page 30624]]

coronary arteries with reference vessel diameters of 2.25 mm to 4.2 mm. 
Subsequent to this approval, the Patent and Trademark Office received a 
patent term restoration application for RESOLUTE INTEGRITY ZOTAROLIMUS-
ELUTING CORONARY STENT SYSTEM (U.S. Patent No. 7,419,696) from 
Medtronic, Inc., and the Patent and Trademark Office requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated March 4, 2013, FDA advised the Patent 
and Trademark Office that this medical device had undergone a 
regulatory review period and that the approval of RESOLUTE INTEGRITY 
ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM 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 
RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM is 1,586 
days. Of this time, 1,263 days occurred during the testing phase of the 
regulatory review period, while 323 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 FD&C Act) (21 U.S.C. 360j(g)) involving 
this device became effective: October 17, 2007. The applicant claims 
that the investigational device exemption (IDE) required under section 
520(g) of the FD&C Act for human tests to begin became effective on 
June 13, 2008. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
October 17, 2007, which represents the IDE effective date.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the FD&C Act (21 U.S.C. 360e): April 1, 
2011. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for RESOLUTE INTEGRITY ZOTAROLIMUS-ELUTING 
CORONARY STENT SYSTEM (PMA P110013) was initially submitted April 1, 
2011.
    3. The date the application was approved: February 17, 2012. FDA 
has verified the applicant's claim that PMA P110013 was approved on 
February 17, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the 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 794 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 July 28, 2014. 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 24, 2014. 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 or 
electronic petitions. It is only necessary to send one set of comments. 
Identify comments with the docket number found in brackets in the 
heading of this document. If you submit a written petition, two copies 
are required. A petition submitted electronically must be submitted to 
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and 
petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management 
between 9 a.m. and 4 p.m., Monday through Friday.

    Dated: May 21, 2014.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2014-12295 Filed 5-27-14; 8:45 am]
BILLING CODE 4160-01-P