[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39648-39649]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-14357]


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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-0681 and FDA-2013-E-0676]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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

SUMMARY: The Food and Drug Administration (FDA) has determined the 
regulatory review period for ZILVER PTX DRUG ELUTING PERIPHERAL STENT 
and is publishing this notice of that determination as required by law. 
FDA has made the determination because of the submission of 
applications by Boston Scientific Scimed, Inc., to the Director of the 
U.S. Patent and Trademark Office (USPTO), Department of Commerce, for 
the extension of patents which claim that medical device.

DATES: Anyone with knowledge that any of the dates as published (see 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by August 
16, 2016. 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 December 14, 2016. 
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 
information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to http://www.regulations.gov 
will be posted to the docket unchanged. Because your comment will be 
made public, you are solely responsible for ensuring that your comment 
does not include any confidential information that you or a third party 
may not wish to be posted, such as medical information, your or anyone 
else's Social Security number, or confidential business information, 
such as a manufacturing process. Please note that if you include your 
name, contact information, or other information that identifies you in 
the body of your comments, that information will be posted on http://www.regulations.gov.
     If you want to submit a comment with confidential 
information that you do not wish to be made available to the public, 
submit the comment as a written/paper submission and in the manner 
detailed (see ``Written/Paper Submissions'' and ``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     Mail/Hand delivery/Courier (for written/paper 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
     For written/paper comments submitted to the Division of 
Dockets Management, FDA will post your comment, as well as any 
attachments, except for information submitted, marked and identified, 
as confidential, if submitted as detailed in ``Instructions.''
    Instructions: All submissions received must include the Docket Nos. 
FDA-2013-E-0681 and FDA-2013-E-0676 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING 
PERIPHERAL STENT.'' Received comments will be placed in the dockets 
and, except for those submitted as ``Confidential Submissions,'' 
publicly viewable at http://www.regulations.gov or at the Division of 
Dockets Management between 9 a.m. and 4 p.m., Monday through Friday.
     Confidential Submissions--To submit a comment with 
confidential information that you do not wish to be made publicly 
available, submit your comments only as a written/paper submission. You 
should submit two copies total. One copy will include the information 
you claim to be confidential with a heading or cover note that states 
``THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.'' The Agency will 
review this copy, including the claimed confidential information, in 
its consideration of comments. The second copy, which will have the 
claimed confidential information redacted/blacked out, will be 
available for public viewing and posted on http://www.regulations.gov. 
Submit both copies to the Division of Dockets Management. If you do not 
wish your name and contact information to be made publicly available, 
you can provide this information on the cover sheet and not in the body 
of your comments and you must identify this information as 
``confidential.'' Any information marked as ``confidential'' will not 
be disclosed except in accordance with 21 CFR 10.20 and other 
applicable disclosure law. For more information about FDA's posting of 
comments to public dockets, see 80 FR 56469, September 18, 2015, or 
access the information at: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to http://www.regulations.gov and insert the docket number, found in brackets in 
the heading of this document, into the ``Search'' box and follow the 
prompts and/or go to the Division of Dockets Management, 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. 6250, Silver Spring, MD 20993, 301-796-3600.

SUPPLEMENTARY INFORMATION:

I. Background

    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

[[Page 39649]]

that the Director of USPTO 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, ZILVER PTX DRUG 
ELUTING PERIPHERAL STENT. ZILVER PTX DRUG ELUTING PERIPHERAL STENT is 
indicated for improving luminal diameter for the treatment of de novo 
or restenotic symptomatic lesions in native vascular disease of the 
above-the-knee femoropopliteal arteries having reference vessel 
diameters from 4 millimeters (mm) to 9 mm and total lesion lengths up 
to 140 mm per limb and 280 mm per patient. Subsequent to this approval, 
the USPTO received a patent term restoration application for ZILVER PTX 
DRUG ELUTING PERIPHERAL STENT (U.S. Patent Nos. 6,515,009 and 
7,820,193) from Boston Scientific Scimed, Inc., and the USPTO requested 
FDA's assistance in determining this patent's eligibility for patent 
term restoration. In a letter dated May 11, 2015, FDA advised the USPTO 
that this medical device had undergone a regulatory review period and 
that the approval of ZILVER PTX DRUG ELUTING PERIPHERAL STENT 
represented the first permitted commercial marketing or use of the 
product. Thereafter, the USPTO requested that FDA determine the 
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
ZILVER PTX DRUG ELUTING PERIPHERAL STENT is 3,075 days. Of this time, 
2,180 days occurred during the testing phase of the regulatory review 
period, while 895 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: June 16, 2004. 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 
July 28, 2004. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
June 16, 2004, 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): June 4, 
2010. The applicant claims April 1, 2009, as the date the premarket 
approval application (PMA) for ZILVER PTX DRUG ELUTING PERIPHERAL STENT 
(PMA P100022) was initially submitted. However, FDA records indicate 
that PMA P100022 was submitted in full on June 4, 2010.
    3. The date the application was approved: November 14, 2012. The 
applicant claims that the PMA P100022 was approved on November 15, 
2012. However, FDA records indicate that PMA P100022 was approved on 
November 14, 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 applications for patent extension, 
this applicant seeks 1,826 days or 751 days of patent term extension.

III. Petitions

    Anyone with knowledge that any of the dates as published are 
incorrect may submit either electronic or written comments and ask for 
a redetermination (see DATES). 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. 
To meet its burden, the petition must be timely (see DATES) and 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.
    Submit petitions electronically to http://www.regulations.gov at 
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are 
required) to the Division of Dockets Management (HFA-305), Food and 
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

    Dated: June 13, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-14357 Filed 6-16-16; 8:45 am]
 BILLING CODE 4164-01-P