Notice2025-11034
Determination of Regulatory Review Period for Purposes of Patent Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT]
Primary source
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Published
June 16, 2025
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications 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.
Full Text
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<title>Federal Register, Volume 90 Issue 114 (Monday, June 16, 2025)</title>
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[Federal Register Volume 90, Number 114 (Monday, June 16, 2025)]
[Notices]
[Pages 25333-25334]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11034]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2023-E-3298; FDA-2023-E-3302; FDA-2023-E-3303; FDA-
2023-E-3304; FDA-2023-E-3305; FDA-2023-E-3306; FDA-2023-E-3307; FDA-
2023-E-3308;FDA-2023-E-3309]
Determination of Regulatory Review Period for Purposes of Patent
Extension; [NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT]
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for NAVITOR TRANSCATHETER
AORTIC VALVE IMPLANT and is publishing this notice of that
determination as required by law. FDA has made the determination
because of the submission of applications 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.
DATES: Anyone with knowledge that any of the dates as published (see
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by August 15, 2025.
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 15, 2025. See
``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. The <a href="https://www.regulations.gov">https://www.regulations.gov</a> electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 15, 2025. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are received on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> For written/paper comments submitted to the Dockets
Management Staff, 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-2023-E-3298; FDA-2023-E-3302; FDA-2023-E-3303; FDA-2023-E-3304;
FDA-2023-E-3305; FDA-2023-E-3306; FDA-2023-E-3307; FDA-2023-E-3308;
FDA-2023-E-3309 for Determination of Regulatory Review Period for
Purposes of Patent Extension; NAVITOR TRANSCATHETER AORTIC VALVE
IMPLANT. Received comments, those filed in a timely manner (see
ADDRESSES), will be placed in the docket and, except for those
submitted as ``Confidential Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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
[[Page 25334]]
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>. Submit both copies to the Dockets Management
Staff. 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 Sec.
10.20 (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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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 Dockets Management Staff, 5630 Fishers Lane,
Rm. 1061, Rockville, MD 20852, 240-402-7500.
FOR FURTHER INFORMATION CONTACT: Jack Dan, Office of Regulatory Policy,
Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 51, Rm.
6250, Silver Spring, MD 20993, 240-402-6940.
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 or biological 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 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 NAVITOR
TRANSCATHETER AORTIC VALVE IMPLANT. NAVITOR TRANSCATHETER AORTIC VALVE
IMPLANT is indicated for design changes including modification of the
valve inner skirt material, addition of an outer skirt, and minor
changes to the valve stent frame and loading system. Subsequent to this
approval, the USPTO received patent term restoration applications for
NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT (U.S. Patent Nos. 9,220,594;
9,289,296; 9,351,828; 9,545,307; 9,681,949; 9,693,859; 9,820,851;
10,314,694; and 11,007,053) from St. Jude Medical, LLC, and the USPTO
requested FDA's assistance in determining this patents' eligibility for
patent term restoration. In a letter dated February 7, 2024, FDA
advised the USPTO that this medical device had undergone a regulatory
review period and that the approval of NAVITOR TRANSCATHETER AORTIC
VALVE IMPLANT 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
NAVITOR TRANSCATHETER AORTIC VALVE IMPLANT is 453 days. Of this time, 0
days occurred during the testing phase of the regulatory review period,
while 453 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 (FD&C Act) (21 U.S.C. 360j(g)) involving this
device became effective: not applicable. The applicant does not claim a
date on which the device was first used with human subjects as part of
a clinical investigation to be filed with FDA to secure premarket
approval of the device.
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): October
18, 2021. FDA has verified the applicant's claim that the premarket
approval application (PMA) for NAVITOR TRANSCATHETER AORTIC VALVE
IMPLANT (PMA P190023/S002) was initially submitted October 18, 2021
3. The date the application was approved: January 13, 2023. FDA has
verified the applicant's claim that PMA P190023/S002 was approved on
January 13, 2023.
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 453 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, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), 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 comply with all the requirements
of Sec. 60.30, including but not limited to: must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Dated: June 11, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11034 Filed 6-13-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on June 16, 2025.
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