[Federal Register Volume 84, Number 185 (Tuesday, September 24, 2019)]
[Notices]
[Pages 50042-50044]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2018-E-0267]


Determination of Regulatory Review Period for Purposes of Patent 
Extension; Med-El Electric and Acoustic Stimulation Hybrid Hearing 
Prosthesis 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 MED-EL Electric and 
Acoustic Stimulation Hybrid Hearing Prosthesis System (MED-EL EAS) and 
is publishing this notice of that determination as required by law. FDA 
has made the determination 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 
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either 
electronic or written comments and ask for a redetermination by 
November 25, 2019. 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 March 23, 
2020. 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. Electronic comments 
must be submitted on or before November 25, 2019. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of November 25, 2019. Comments 
received by mail/hand delivery/courier (for written/paper submissions) 
will be considered timely if they are postmarked or the delivery 
service acceptance receipt is on or before that date.

Electronic Submissions

    Submit electronic comments in the following way:
     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.
     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

[[Page 50043]]

manner detailed (see ``Written/Paper Submissions'' and 
``Instructions'').

Written/Paper Submissions

    Submit written/paper submissions as follows:
     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.
     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-2018-E-0267 for ``Determination of Regulatory Review Period for 
Purposes of Patent Extension; MED-EL Electric and Acoustic Stimulation 
Hybrid Hearing Prosthesis 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.
     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 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.gpo.gov/fdsys/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.

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 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 MED-EL EAS. The 
MED-EL EAS is intended to provide electrical stimulation to the mid- to 
high-frequency region of the cochlea and acoustic amplification to the 
low-frequency regions, for candidates with residual low frequency 
hearing sensitivity. The MED-EL EAS is indicated for partially deaf 
individuals aged 18 years and older who have residual hearing 
sensitivity in the low frequencies sloping to a severe/profound 
sensorineural hearing loss in the mid to high frequencies, and who 
obtain minimal benefit from conventional acoustic amplification. 
Subsequent to this approval, the USPTO received a patent term 
restoration application for MED-EL EAS (U.S. Patent No. 7,917,224) from 
Med-El Electromedizinische Gerate GmbH, and the USPTO requested FDA's 
assistance in determining this patent's eligibility for patent term 
restoration. In a letter dated April 5, 2018, FDA advised the USPTO 
that this medical device had undergone a regulatory review period and 
that the approval of MED-EL EAS represented the first permitted 
commercial marketing or use of this 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 
MED-EL EAS is 4,537 days. Of this time, 4,269 days occurred during the 
testing phase of the regulatory review period, while 268 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: April 16, 2004. The applicant claims that 
the investigational device exemption (IDE) required under section 
520(g) of the FD&C Act for human tests to begin became effective on 
January 2, 2004. However, FDA records indicate that the IDE was 
determined substantially complete for clinical studies to have begun on 
April 16, 2004, which represents the IDE effective date.
    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): December 
23, 2015. FDA has verified the applicant's claim that the premarket 
approval application (PMA) for MED-EL EAS (PMA P000025 S084) was 
initially submitted December 23, 2015.
    3. The date the application was approved: September 15, 2016. FDA 
has verified the applicant's claim that PMA P000025 S084 was approved 
on September 15, 2016.
    This determination of the regulatory review period establishes the 
maximum potential length of a patent extension.

[[Page 50044]]

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 998 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: September 17, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-20657 Filed 9-23-19; 8:45 am]
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