Notice2025-11603
Determination of Regulatory Review Period for Purposes of Patent Extension; [EDWARDS SAPIEN 3 ULTRA RESILIA-PMA 140031 S-141]
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Published
June 25, 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 EDWARDS SAPIEN 3 ULTRA RESILIA premarket approval application (PMA) 140031 supplement (S-141) 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 120 (Wednesday, June 25, 2025)</title>
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[Federal Register Volume 90, Number 120 (Wednesday, June 25, 2025)]
[Notices]
[Pages 27025-27027]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-11603]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2023-E-2803; FDA-2023-E-2804; FDA-2023-E-2805; FDA-
2023-E-2806]
Determination of Regulatory Review Period for Purposes of Patent
Extension; [EDWARDS SAPIEN 3 ULTRA RESILIA--PMA 140031 S-141]
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 EDWARDS SAPIEN 3 ULTRA
RESILIA premarket approval application (PMA) 140031 supplement (S-141)
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 25, 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 22, 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 25, 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
[[Page 27026]]
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-2803 FDA-2023-E-2804; FDA-2023-E-2805; and FDA-2023-E-2806
for Determination of Regulatory Review Period for Purposes of Patent
Extension; EDWARDS SAPIEN 3 ULTRA RESILIA. Received comments, those
filed in a timely manner (see ADDRESSES), will be placed in the dockets
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 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.
6200, 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 EDWARDS SAPIEN 3
ULTRA RESILIA. The EDWARDS SAPIEN 3 ULTRA RESILIA Transcatheter Heart
Valve system is indicated (1) for relief of aortic stenosis in patients
with symptomatic heart disease due to severe native calcific aortic
stenosis who are judged by a Heart Team, including a cardiac surgeon,
to be appropriate for the transcatheter heart valve replacement therapy
and (2) for patients with symptomatic heart disease due to failing
(stenosed, insufficient, or combined) of a surgical or transcatheter
bioprosthetic aortic valve, a surgical bioprosthetic mitral valve, or a
native mitral valve with an annuloplasty ring who are judged by a Heart
team, including a cardiac surgeon, to be at high or greater risk for
open surgical therapy (i.e., predicted risk of surgical mortality 8% at
30 days, based on the Society of Thoracic Surgeons (STS) risk score and
other clinical co-morbidities unmeasured by the STS risk calculator).
Subsequent to this approval, the USPTO received patent term restoration
applications for EDWARDS SAPIEN 3 ULTRA RESILIA (U.S. Patent Nos.
10,413,407; 10,433,958; 10,849,741; and 11,213,388) from Edwards
Lifesciences Corporation, and the USPTO requested FDA's assistance in
determining the patents' eligibility for patent term restoration. In a
letter dated January 18, 2024, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of EDWARDS SAPIEN 3 ULTRA RESILIA 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
EDWARDS SAPIEN 3 ULTRA RESILIA is 88 days. Of this time, zero (0) days
occurred during the testing phase of the regulatory review period,
while 88 days occurred during the approval phase.
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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 claims that the
length of the testing phase of the regulatory review period is 0 days.
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): May 2,
2022. FDA has verified the applicant's claim that the premarket
approval application (PMA) for EDWARDS SAPIEN 3 ULTRA RESILIA (PMA
P140031/Supplement (S141)) was initially submitted May 2, 2022.
3. The date the application was approved: July 28, 2022. FDA has
verified the applicant's claim that PMA P140031/S141 was approved on
July 28, 2022.
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 87 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 18, 2025.
Grace R. Graham,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2025-11603 Filed 6-24-25; 8:45 am]
BILLING CODE 4164-01-P
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</html>Indexed from Federal Register on June 25, 2025.
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