[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23801-23802]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-09902]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0102]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Xience Xpedition Everolimus 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 Xience Xpedition Everolimus 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 the U.S. 
Patent and Trademark Office (USPTO), 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, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, 
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, Xience Xpedition 
Everolimus Eluting Coronary Stent System. Xience Xpedition Everolimus 
Eluting Coronary Stent System is indicated for improving coronary 
luminal diameter in subjects with symptomatic heart disease due to de 
novo native coronary artery lesions (length <=32 millimeters (mm)) with 
reference vessel diameter of >=2.25 mm and <=4.25 mm. Subsequent to 
this approval, the USPTO received a patent term restoration application 
for Xience Xpedition Everolimus Eluting Coronary Stent System (U.S. 
Patent No. 7,828,766) from Abbott Cardiovascular Systems Inc., and the 
USPTO requested FDA's assistance in determining this patent's 
eligibility for patent term restoration. In a letter dated May 22, 
2014, FDA advised the USPTO that this medical device had undergone a 
regulatory review period and that the approval of Xience Xpedition 
Everolimus Eluting Coronary Stent System represented the first 
permitted commercial marketing or use of the product. Thereafter, the 
USPTO requested that FDA determine the product's regulatory review 
period.
    FDA has determined that the applicable regulatory review period for 
Xience Xpedition Everolimus Eluting Coronary Stent System is 178 days. 
Of this time, zero (0) days occurred during the testing phase of the 
regulatory review period, while 178 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: Not Applicable. Applicant did not perform 
clinical investigations utilizing the patented device, but, rather, 
sought and was granted marketing approval based on a supplemental 
filing to a previously approved premarket approval application (PMA).
    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): June 27, 
2012. FDA has verified the applicant's claim that the PMA for Xience 
Xpedition Everolimus Eluting Coronary Stent System (PMA P110019S025) 
was initially submitted June 27, 2012.
    3. The date the application was approved: December 21, 2012. FDA 
has verified the applicant's claim that PMA P110019S025 was approved on 
December 21, 2012.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension. However, the USPTO 
applies several statutory limitations in its calculations of the actual 
period for patent extension. In its application for patent extension, 
this applicant seeks 178 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 June 29, 2015. 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 October 26, 2015. 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.

[[Page 23802]]

    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: April 23, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-09902 Filed 4-28-15; 8:45 am]
 BILLING CODE 4164-01-P