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Determination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for MEDIBEACON and is publishing this notice of that determination as required b...

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<title>Federal Register, Volume 91 Issue 2 (Monday, January 5, 2026)</title>
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[Federal Register Volume 91, Number 2 (Monday, January 5, 2026)]
[Notices]
[Pages 282-283]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2025-24268]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2025-E-0921 and FDA-2025-E-0922]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; MEDIBEACON

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 MEDIBEACON 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.

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 March 6, 2026. 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-2025-E-0921 and FDA-2025-E-0922 for ``Determination of Regulatory 
Review Period for Purposes of Patent Extension; MEDIBEACON.'' 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 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

[[Page 283]]

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 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 (for example, 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, MEDIBEACON. 
MEDIBEACON is intended to assess the Glomerular Filtration Rate (GFR) 
in adult patients with impaired or normal renal function by 
noninvasively monitoring fluorescent light emission from an exogenous 
tracer agent over time. This device has been validated in patients with 
stable renal function. The MediBeacon[supreg] TGFR is not approved for 
use in patients with GFR <15 ml/min/1.73 m2, GFR >120 ml/min/1.73m2, 
patients on dialysis, or anuric patients. The use of this device in 
patients with dynamic and rapidly changing renal function has not been 
validated. This device is not intended to diagnose acute kidney injury 
(AKI). The MediBeacon[supreg] TGFR Sensor and exogenous tracer agent, 
Lumitrace[supreg] injection, are single use and are only used with the 
MediBeacon[supreg] TGFR. The MediBeacon[supreg] TGFR Sensor is a single 
use device intended to attach to the patient's skin and excite 
fluorescence in Lumitrace[supreg] injection, the tracer agent, and 
measure the returning light intensity. The data is sent to the 
MediBeacon[supreg] TGFR Monitor. Lumitrace[supreg] is an injectable 
exogenous fluorescent tracer indicated for use with the 
MediBeacon[supreg] Transdermal GFR System (TGFR) for Glomerular 
Filtration Rate assessment. Subsequent to this approval, the USPTO 
received patent term restoration applications for MEDIBEACON (U.S. 
Patent Nos. 8,115,000; RE47,413) from Medibeacon Inc., and the USPTO 
requested FDA's assistance in determining this patents' eligibility for 
patent term restoration. In a letter dated June 27, 2025, FDA advised 
the Patent and Trademark Office that this medical device had undergone 
a regulatory review period and that the approval of MEDIBEACON 
represented the first permitted commercial marketing or use of the 
product. Thereafter, the USPTO requested that the FDA determine the 
product's regulatory review period.

II. Determination of Regulatory Review Period

    FDA has determined that the applicable regulatory review period for 
MEDIBEACON is 4,175 days. Of this time, 3,598 days occurred during the 
testing phase of the regulatory review period, while 577 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 act) (21 U.S.C. 360j(g)) involving this 
device became effective: August 15, 2013. FDA has verified the 
applicant's claim that the date the investigational device exemption 
(IDE) required under section 520(g) of the act for human tests to begin 
became effective August 15, 2013.
    2. The date an application was initially submitted with respect to 
the device under section 515 of the Federal Food, Drug, and Cosmetic 
Act (21 U.S.C. 360e): June 21, 2023. FDA has verified the applicant's 
claim that the premarket approval application (PMA) for MEDIBEACON (PMA 
P230019) was initially submitted June 21, 2023.
    3. The date the application was approved: January 17, 2025. FDA has 
verified the applicant's claim that PMA P230019 was approved on January 
17, 2025.
    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(s) for patent 
extension, this applicant seeks 5 years 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.

Brian Fahey,
Associate Commissioner for Legislation.
[FR Doc. 2025-24268 Filed 1-2-26; 8:45 am]
BILLING CODE 4164-01-P


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“Determination of Regulatory Review Period for Purposes of Patent Extension; MEDIBEACON,” thefederalregister.org (January 5, 2026), https://thefederalregister.org/documents/2025-24268/determination-of-regulatory-review-period-for-purposes-of-patent-extension-medibeacon.