81_FR_39765 81 FR 39648 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT

81 FR 39648 - Determination of Regulatory Review Period for Purposes of Patent Extension; ZILVER PTX DRUG ELUTING PERIPHERAL STENT

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 81, Issue 117 (June 17, 2016)

Page Range39648-39649
FR Document2016-14357

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.

Federal Register, Volume 81 Issue 117 (Friday, June 17, 2016) 
[Federal Register Volume 81, Number 117 (Friday, June 17, 2016)]
[Notices]
[Pages 39648-39649]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2016-14357]


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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.

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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

39648 Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices Cal. 1996), pertinent regulations and ORR comment does not include any www.regulations.gov. Submit both policies and procedures. confidential information that you or a copies to the Division of Dockets Christopher Beach, third party may not wish to be posted, Management. If you do not wish your Senior Grants Policy Specialist, Office of such as medical information, your or name and contact information to be Administration, Office of Financial Services, anyone else’s Social Security number, or made publicly available, you can Division of Grants Policy. confidential business information, such provide this information on the cover [FR Doc. 2016–14378 Filed 6–16–16; 8:45 am] as a manufacturing process. Please note sheet and not in the body of your BILLING CODE 4184–01–P that if you include your name, contact comments and you must identify this information, or other information that information as ‘‘confidential.’’ Any identifies you in the body of your information marked as ‘‘confidential’’ DEPARTMENT OF HEALTH AND comments, that information will be will not be disclosed except in HUMAN SERVICES posted on http://www.regulations.gov. accordance with 21 CFR 10.20 and other • If you want to submit a comment applicable disclosure law. For more Food and Drug Administration with confidential information that you information about FDA’s posting of do not wish to be made available to the comments to public dockets, see 80 FR [Docket Nos. FDA–2013–E–0681 and FDA– 2013–E–0676] public, submit the comment as a 56469, September 18, 2015, or access written/paper submission and in the the information at: http://www.fda.gov/ Determination of Regulatory Review manner detailed (see ‘‘Written/Paper regulatoryinformation/dockets/ Period for Purposes of Patent Submissions’’ and ‘‘Instructions’’). default.htm. Extension; ZILVER PTX DRUG Written/Paper Submissions Docket: For access to the docket to ELUTING PERIPHERAL STENT read background documents or the Submit written/paper submissions as electronic and written/paper comments AGENCY: Food and Drug Administration, follows: received, go to http:// HHS. • Mail/Hand delivery/Courier (for www.regulations.gov and insert the ACTION: Notice. written/paper submissions): Division of docket number, found in brackets in the Dockets Management (HFA–305), Food SUMMARY: The Food and Drug heading of this document, into the and Drug Administration, 5630 Fishers Administration (FDA) has determined ‘‘Search’’ box and follow the prompts Lane, Rm. 1061, Rockville, MD 20852. the regulatory review period for ZILVER • For written/paper comments and/or go to the Division of Dockets PTX DRUG ELUTING PERIPHERAL submitted to the Division of Dockets Management, 5630 Fishers Lane, Rm. STENT and is publishing this notice of Management, FDA will post your 1061, Rockville, MD 20852. that determination as required by law. comment, as well as any attachments, FOR FURTHER INFORMATION CONTACT: FDA has made the determination except for information submitted, Beverly Friedman, Office of Regulatory because of the submission of marked and identified, as confidential, Policy, Food and Drug Administration, applications by Boston Scientific if submitted as detailed in 10903 New Hampshire Ave., Bldg. 51, Scimed, Inc., to the Director of the U.S. ‘‘Instructions.’’ Rm. 6250, Silver Spring, MD 20993, Patent and Trademark Office (USPTO), Instructions: All submissions received 301–796–3600. Department of Commerce, for the must include the Docket Nos. FDA– SUPPLEMENTARY INFORMATION: extension of patents which claim that 2013–E–0681 and FDA–2013–E–0676 medical device. for ‘‘Determination of Regulatory I. Background DATES: Anyone with knowledge that any Review Period for Purposes of Patent The Drug Price Competition and of the dates as published (see the Extension; ZILVER PTX DRUG Patent Term Restoration Act of 1984 SUPPLEMENTARY INFORMATION section) are ELUTING PERIPHERAL STENT.’’ (Pub. L. 98–417) and the Generic incorrect may submit either electronic Received comments will be placed in Animal Drug and Patent Term or written comments and ask for a the dockets and, except for those Restoration Act (Pub. L. 100–670) redetermination by August 16, 2016. submitted as ‘‘Confidential generally provide that a patent may be Furthermore, any interested person may Submissions,’’ publicly viewable at extended for a period of up to 5 years petition FDA for a determination http://www.regulations.gov or at the so long as the patented item (human regarding whether the applicant for Division of Dockets Management drug product, animal drug product, extension acted with due diligence between 9 a.m. and 4 p.m., Monday medical device, food additive, or color during the regulatory review period by through Friday. additive) was subject to regulatory December 14, 2016. See ‘‘Petitions’’ in • Confidential Submissions—To review by FDA before the item was the SUPPLEMENTARY INFORMATION section submit a comment with confidential marketed. Under these acts, a product’s for more information. information that you do not wish to be regulatory review period forms the basis ADDRESSES: You may submit comments made publicly available, submit your for determining the amount of extension as follows: comments only as a written/paper an applicant may receive. submission. You should submit two A regulatory review period consists of Electronic Submissions copies total. One copy will include the two periods of time: A testing phase and Submit electronic comments in the information you claim to be confidential an approval phase. For medical devices, following way: with a heading or cover note that states the testing phase begins with a clinical • Federal eRulemaking Portal: http:// ‘‘THIS DOCUMENT CONTAINS investigation of the device and runs www.regulations.gov. Follow the CONFIDENTIAL INFORMATION.’’ The until the approval phase begins. The sradovich on DSK3TPTVN1PROD with NOTICES instructions for submitting comments. Agency will review this copy, including approval phase starts with the initial Comments submitted electronically, the claimed confidential information, in submission of an application to market including attachments, to http:// its consideration of comments. The the device and continues until www.regulations.gov will be posted to second copy, which will have the permission to market the device is the docket unchanged. Because your claimed confidential information granted. Although only a portion of a comment will be made public, you are redacted/blacked out, will be available regulatory review period may count solely responsible for ensuring that your for public viewing and posted on http:// toward the actual amount of extension VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00025 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1

Federal Register / Vol. 81, No. 117 / Friday, June 17, 2016 / Notices 39649 that the Director of USPTO may award 2. The date an application was DEPARTMENT OF HEALTH AND (half the testing phase must be initially submitted with respect to the HUMAN SERVICES subtracted as well as any time that may device under section 515 of the FD&C have occurred before the patent was Act (21 U.S.C. 360e): June 4, 2010. The Food and Drug Administration issued), FDA’s determination of the applicant claims April 1, 2009, as the [Docket No. FDA–2015–E–2585] length of a regulatory review period for date the premarket approval application a medical device will include all of the (PMA) for ZILVER PTX DRUG ELUTING Determination of Regulatory Review testing phase and approval phase as PERIPHERAL STENT (PMA P100022) Period for Purposes of Patent specified in 35 U.S.C. 156(g)(3)(B). was initially submitted. However, FDA Extension; ORBACTIV FDA has approved for marketing the records indicate that PMA P100022 was AGENCY: Food and Drug Administration, medical device, ZILVER PTX DRUG ELUTING PERIPHERAL STENT. submitted in full on June 4, 2010. HHS. ZILVER PTX DRUG ELUTING 3. The date the application was ACTION: Notice. PERIPHERAL STENT is indicated for approved: November 14, 2012. The SUMMARY: The Food and Drug improving luminal diameter for the applicant claims that the PMA P100022 Administration (FDA) has determined treatment of de novo or restenotic was approved on November 15, 2012. symptomatic lesions in native vascular the regulatory review period for However, FDA records indicate that ORBACTIV and is publishing this notice disease of the above-the-knee PMA P100022 was approved on femoropopliteal arteries having of that determination as required by November 14, 2012. law. FDA has made the determination reference vessel diameters from 4 millimeters (mm) to 9 mm and total This determination of the regulatory because of the submission of an lesion lengths up to 140 mm per limb review period establishes the maximum application to the Director of the U.S. and 280 mm per patient. Subsequent to potential length of a patent extension. Patent and Trademark Office (USPTO), this approval, the USPTO received a However, the USPTO applies several Department of Commerce, for the patent term restoration application for statutory limitations in its calculations extension of a patent which claims that ZILVER PTX DRUG ELUTING of the actual period for patent extension. human drug product. PERIPHERAL STENT (U.S. Patent Nos. In its applications for patent extension, DATES: Anyone with knowledge that any 6,515,009 and 7,820,193) from Boston this applicant seeks 1,826 days or 751 of the dates as published (in the Scientific Scimed, Inc., and the USPTO days of patent term extension. SUPPLEMENTARY INFORMATION section) are requested FDA’s assistance in incorrect may submit either electronic determining this patent’s eligibility for III. Petitions or written comments and ask for a patent term restoration. In a letter dated redetermination by August 16, 2016. Anyone with knowledge that any of May 11, 2015, FDA advised the USPTO Furthermore, any interested person may the dates as published are incorrect may that this medical device had undergone petition FDA for a determination submit either electronic or written a regulatory review period and that the regarding whether the applicant for comments and ask for a redetermination extension acted with due diligence approval of ZILVER PTX DRUG (see DATES). Furthermore, any interested during the regulatory review period by ELUTING PERIPHERAL STENT person may petition FDA for a December 14, 2016. See ‘‘Petitions’’ in represented the first permitted commercial marketing or use of the determination regarding whether the the SUPPLEMENTARY INFORMATION section product. Thereafter, the USPTO applicant for extension acted with due for more information. requested that FDA determine the diligence during the regulatory review ADDRESSES: You may submit comments product’s regulatory review period. period. To meet its burden, the petition as follows: must be timely (see DATES) and contain II. Determination of Regulatory Review sufficient facts to merit an FDA Electronic Submissions Period investigation. (See H. Rept. 857, part 1, Submit electronic comments in the FDA has determined that the 98th Cong., 2d sess., pp. 41–42, 1984.) following way: applicable regulatory review period for Petitions should be in the format • Federal eRulemaking Portal: http:// ZILVER PTX DRUG ELUTING specified in 21 CFR 10.30. www.regulations.gov. Follow the PERIPHERAL STENT is 3,075 days. Of instructions for submitting comments. Submit petitions electronically to this time, 2,180 days occurred during Comments submitted electronically, the testing phase of the regulatory http://www.regulations.gov at Docket including attachments, to http:// review period, while 895 days occurred No. FDA–2013–S–0610. Submit written www.regulations.gov will be posted to during the approval phase. These petitions (two copies are required) to the the docket unchanged. Because your periods of time were derived from the Division of Dockets Management (HFA– comment will be made public, you are following dates: 305), Food and Drug Administration, solely responsible for ensuring that your 1. The date an exemption under 5630 Fishers Lane, Rm. 1061, Rockville, comment does not include any section 520(g) of the Federal Food, Drug, MD 20852. confidential information that you or a and Cosmetic Act (the FD&C Act) (21 Dated: June 13, 2016. third party may not wish to be posted, U.S.C. 360j(g)) involving this device such as medical information, your or Leslie Kux, became effective: June 16, 2004. The anyone else’s Social Security number, or applicant claims that the investigational Associate Commissioner for Policy. confidential business information, such device exemption (IDE) required under [FR Doc. 2016–14357 Filed 6–16–16; 8:45 am] as a manufacturing process. Please note sradovich on DSK3TPTVN1PROD with NOTICES section 520(g) of the FD&C Act for BILLING CODE 4164–01–P that if you include your name, contact human tests to begin became effective information, or other information that on July 28, 2004. However, FDA records identifies you in the body of your indicate that the IDE was determined comments, that information will be substantially complete for clinical posted on http://www.regulations.gov. studies to have begun on June 16, 2004, • If you want to submit a comment which represents the IDE effective date. with confidential information that you VerDate Sep<11>2014 16:48 Jun 16, 2016 Jkt 238001 PO 00000 Frm 00026 Fmt 4703 Sfmt 4703 E:\FR\FM\17JNN1.SGM 17JNN1


Document Created: 2016-06-17 01:04:48
Document Modified: 2016-06-17 01:04:48
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice.
DatesAnyone 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.
ContactBeverly Friedman, Office of Regulatory Policy, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm. 6250, Silver Spring, MD 20993, 301-796-3600.
FR Citation81 FR 39648 
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