[Federal Register Volume 89, Number 31 (Wednesday, February 14, 2024)]
[Notices]
[Pages 11286-11288]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-03024]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2022-E-2222 and FDA-2022-E-2223]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; SIMPLIFY CERVICAL ARTIFICIAL DISC

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 SIMPLIFY CERVICAL 
ARTIFICIAL DISC 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 
patents which claim that medical device.

DATES: Anyone with knowledge that any of the dates as published (see 
SUPPLEMENTARY INFORMATION) are incorrect must submit either electronic 
or written comments and ask for a redetermination by April 15, 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 August 12, 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 April 15, 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 Nos. 
FDA-2022-E-2222 and FDA-2022-E-2223 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; SIMPLIFY CERVICAL 
ARTIFICIAL DISC.'' 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

[[Page 11287]]

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 SIMPLIFY CERVICAL 
ARTIFICIAL DISC. SIMPLIFY CERVICAL ARTIFICIAL DISC is indicated for use 
in skeletally mature patients for reconstruction of the disc at one 
level from C3-C7 following single-level discectomy for intractable 
radiculopathy (arm pain and/or a neurological deficit) with or without 
neck pain, or myelopathy due to a single-level abnormality localized to 
the level of the disc space and manifested by at least one of the 
following conditions confirmed by radiographic imaging (e.g., X-rays, 
computed tomography, magnetic resonance imaging): herniated nucleus 
pulposus, spondylosis (defined by the presence of progressive symptoms 
(e.g., numbness or tingling)) prior to implantation. Subsequent to this 
approval, the USPTO received patent term restoration applications for 
SIMPLIFY CERVICAL ARTIFICIAL DISC (U.S. Patent Nos. 7,753,956 and 
9,107,762) from Simplify Medical Pty Ltd., and the USPTO requested 
FDA's assistance in determining the patents' eligibility for patent 
term restoration. In a letter dated January 18, 2023, FDA advised the 
USPTO that this medical device had undergone a regulatory review period 
and that the approval of SIMPLIFY CERVICAL ARTIFICIAL DISC 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 
SIMPLIFY CERVICAL ARTIFICIAL DISC is 2,020 days. Of this time, 1,842 
days occurred during the testing phase of the regulatory review period, 
while 178 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: March 11, 2015. FDA has verified the 
applicant's claim that the date the investigational device exemption 
for human tests to begin, as required under section 520(g) of the FD&C 
Act, became effective March 11, 2015.
    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): March 
25, 2020. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for SIMPLIFY CERVICAL ARTIFICIAL DISC (PMA 
P200022) was initially submitted March 25, 2020.
    3. The date the application was approved: September 18, 2020. FDA 
has verified the applicant's claim that PMA P200022 was approved on 
September 18, 2020.
    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 1,098 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

[[Page 11288]]

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 9, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-03024 Filed 2-13-24; 8:45 am]
BILLING CODE 4164-01-P