[Federal Register Volume 89, Number 43 (Monday, March 4, 2024)]
[Notices]
[Pages 15586-15588]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-04478]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2019-E-5740]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM

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 the SAPIEN 3 ULTRA 
TRANSCATHETER HEART VALVE SYSTEM and is publishing this notice of that 
determination as required by law. FDA has made the determination

[[Page 15587]]

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.

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 May 3, 2024. 
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 September 3, 2024. 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 https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 3, 2024. 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: https://www.regulations.gov. 
Follow the instructions for submitting comments. Comments submitted 
electronically, including attachments, to https://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 https://www.regulations.gov.
    <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 No. 
FDA-2019-E-5740 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE 
SYSTEM.'' 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 https://www.regulations.gov 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 https://www.regulations.gov. 
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
    Docket: For access to the docket to read background documents or 
the electronic and written/paper comments received, go to https://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 Dockets Management Staff, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852, 240-402-7500.

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 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 SAPIEN 3 ULTRA 
TRANSCATHETER HEART VALVE SYSTEM. The SAPIEN 3 ULTRA TRANSCATHETER 
HEART VALVE SYSTEM is indicated 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. The device is indicated for patients with 
symptomatic heart disease

[[Page 15588]]

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 percent 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 a patent term restoration application for the SAPIEN 
3 ULTRA TRANSCATHETER HEART VALVE SYSTEM (U.S. Patent No. 7,780,723) 
from Edwards Lifesciences Corporation, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated January 21, 2020, FDA advised the USPTO 
that this medical device had undergone a regulatory review period and 
that the approval of the SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE 
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.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
the SAPIEN 3 ULTRA TRANSCATHETER HEART VALVE SYSTEM is 101 days. Of 
this time, 0 days occurred during the testing phase of the regulatory 
review period, while 101 days occurred during the approval phase. These 
periods of time were derived from the following dates:
    1. The date an exemption for this device, under section 520(g) of 
the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 
360j(g)), became effective: not available. The applicant claims that 
the testing phase began on April 6, 2018. However, FDA is unable to 
validate the beginning of a testing phase. No investigational device 
exemption as required under section 520(g) of the FD&C Act for human 
tests to begin was referenced, no evidence of institutional review 
board approval was found, and no confirmation of the 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 could be determined in available FDA records.
    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): 
September 18, 2018. The applicant claims September 14, 2018, as the 
date the premarket approval application (PMA) for the SAPIEN 3 ULTRA 
TRANSCATHETER HEART VALVE SYSTEM (PMA P140031S074) was initially 
submitted. However, FDA records indicate that PMA P140031S074 was 
submitted on September 18, 2018.
    3. The date the application was approved: December 27, 2018. FDA 
has verified the applicant's claim that PMA P140031S074 was approved on 
December 27, 2018.
    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 184 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 https://www.regulations.gov 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: February 28, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-04478 Filed 3-1-24; 8:45 am]
BILLING CODE 4164-01-P