Determination of Regulatory Review Period for Purposes of Patent Extension; HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM, 14445-14447 [2021-05371]
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
14445
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1—Continued
Number of
responses per
respondent
Number of
respondents
Average burden per response
Total hours
HCP Screener ...................................
Consumer Study ...............................
HCP Study ........................................
1,233
493
493
1
1
1
1,233
493
493
.08 (5 minutes) .................................
.33 (20 minutes) ...............................
.33 (20 minutes) ...............................
98.64
162.69
162.69
Total ...........................................
........................
........................
........................
...........................................................
522.66
1 There
are no capital costs or operating and maintenance costs associated with this collection of information.
References
The following references are on
display with the Dockets Management
Staff, HFA–305, Food and Drug
Administration, 5630 Fishers Lane,
Room 1061, Rockville, MD 20852, 240–
402–7500 and are available for viewing
by interested persons between 9 a.m.
and 4 p.m., Monday through Friday;
these are not available electronically at
https://www.regulations.gov as these
references are copyright protected.
Some may be available at the website
address, if listed. FDA has verified the
website addresses, as of the date this
document publishes in the Federal
Register, but websites are subject to
change over time.
1. Krosnick, J.A. and S. Presser,
‘‘Question and Questionnaire
Design.’’ In P.V. Marsden and J.D.
Wright (Eds.). Handbook of Survey
Research (2nd Ed.). Emerald:
Bingley, UK, 2010.
2. Fishbein, M. and I. Ajzen, Predicting
and Changing Behavior: The
Reasoned Action Approach. New
York, NY: Psychology Press, 2010.
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05330 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–0340]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; HINTERMANN SERIES H3
TOTAL ANKLE REPLACEMENT
SYSTEM
jbell on DSKJLSW7X2PROD with NOTICES
Total annual
respondents
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
SUMMARY:
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
for HINTERMANN SERIES H3 TOTAL
ANKLE REPLACEMENT SYSTEM 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
SUPPLEMENTARY INFORMATION) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by May 17, 2021.
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 13, 2021. 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 May 17, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 17, 2021. 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
PO 00000
Frm 00043
Fmt 4703
Sfmt 4703
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
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–
2020–E–0340 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; HINTERMANN
SERIES H3 TOTAL ANKLE
REPLACEMENT 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.
• 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
E:\FR\FM\16MRN1.SGM
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14446
Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
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 § 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-201509-18/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:
jbell on DSKJLSW7X2PROD with NOTICES
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
VerDate Sep<11>2014
16:52 Mar 15, 2021
Jkt 253001
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 HINTERMANN SERIES
H3 TOTAL ANKLE REPLACEMENT
SYSTEM. HINTERMANN SERIES H3
TOTAL ANKLE REPLACEMENT
SYSTEM is indicated for use as a noncemented implant to replace a painful
arthritic ankle joint due to primary
osteoarthritis, post-traumatic
osteoarthritis, or arthritis secondary to
inflammatory disease (e.g., rheumatoid
arthritis, hemochromatosis, etc.). The
device system is for prescription use.
Subsequent to this approval, the USPTO
received a patent term restoration
application for HINTERMANN SERIES
H3 TOTAL ANKLE REPLACEMENT
SYSTEM (U.S. Patent No. 6,409,767)
from European Foot Platform, and the
USPTO requested FDA’s assistance in
determining this patent’s eligibility for
patent term restoration. In a letter dated
July 14, 2020, FDA advised the USPTO
that this medical device had undergone
a regulatory review period and that the
approval of HINTERMANN SERIES H3
TOTAL ANKLE REPLACEMENT
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
HINTERMANN SERIES H3 TOTAL
ANKLE REPLACEMENT SYSTEM is
4,676 days. Of this time, 3,661 days
occurred during the testing phase of the
regulatory review period, while 1,015
days occurred during the approval
phase. These periods of time were
derived from the following dates:
1. The date on which the device is
first used with human subjects as part
of a clinical investigation to be filed
with FDA to secure premarket approval
PO 00000
Frm 00044
Fmt 4703
Sfmt 4703
of the device: August 17, 2006. FDA has
verified the applicant’s claim that the
date on which the device is first used
with human subjects as part of a clinical
investigation to be filed with FDA to
secure premarket approval of the device
was August 17, 2006.
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): August 24, 2016.
FDA has verified the applicant’s claim
that the premarket approval application
(PMA) for HINTERMANN SERIES H3
TOTAL ANKLE REPLACEMENT
SYSTEM (PMA 160036) was initially
submitted August 24, 2016.
3. The date the application was
approved: June 4, 2019. FDA has
verified the applicant’s claim that PMA
160036 was approved on June 4, 2019.
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 1,825 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 § 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
§ 60.30, including but not limited to:
Must be timely (see DATES), must be
filed in accordance with § 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.
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Federal Register / Vol. 86, No. 49 / Tuesday, March 16, 2021 / Notices
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–05371 Filed 3–15–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2021–N–0212]
Bristol-Meyers Squibb Company, et al.;
Withdrawal of Approval of 19 New
Drug Applications
AGENCY:
Food and Drug Administration,
HHS.
Notice.
The Food and Drug
Administration (FDA or Agency) is
withdrawing approval of 19 new drug
applications (NDAs) from multiple
applicants. The applicants notified the
Agency in writing that the drug
products were no longer marketed and
requested that the approval of the
applications be withdrawn.
DATES: Approval is withdrawn as of
April 15, 2021.
FOR FURTHER INFORMATION CONTACT:
Kimberly Lehrfeld, Center for Drug
Evaluation and Research, Food and
Drug Administration, 10903 New
Hampshire Ave., Bldg. 51, Rm. 6226,
Silver Spring, MD 20993–0002, 301–
SUMMARY:
Application No.
Drug
NDA 009218 ......
NDA 017481 ......
Coumadin (warfarin sodium) Tablets, 1 milligram (mg), 2 mg,
2.5 mg, 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg.
Coumadin (warfarin sodium) Injection, 5 mg/vial, 50 mg/vial,
and 75 mg/vial.
Decadron (dexamethasone) Tablets, 0.25 mg, 0.5 mg, 0.75
mg, 1.5 mg, 4 mg, and 6 mg.
Vermox (mebendazole) Chewable Tablets, 100 mg ...............
NDA 018538 ......
Lozol (indapamide) Tablets, 1.25 mg, and 2.5 mg ..................
NDA 018986 ......
Pralidoxime Chloride Injection (auto-injector), 600 mg/2 milliliters (mL) (300 mg/mL).
Morphine Sulfate Injection (auto-injector), 10 mg/0.7 mL .......
Famvir (famciclovir) Tablets, 125 mg, 250 mg, and 500 mg ...
NDA 011664 ......
NDA 019999 ......
NDA 020363 ......
NDA 020711 ......
NDA 020809 ......
NDA 021713 ......
Abilify (aripiprazole) Oral Solution, 1 mg/mL ...........................
NDA 021729 ......
Abilify (aripiprazole) Discmelt Orally Disintegrating Tablets,
10 mg, 15 mg, 20 mg, and 30 mg.
Abilify (aripiprazole) Injection, 9.75 mg/1.3 mL (7.5 mg/mL) ...
Actoplus Met XR (metformin HCl and pioglitazone) ExtendedRelease Tablets, 1gram (g)/Equivalent to (EQ) 15 mg base
and 1 g/EQ 30 mg base.
Ceftin (cefuroxime axetil) Tablets, EQ 125 mg base, EQ 250
mg base, and EQ 500 mg base.
NDA 050605 ......
NDA 050672 ......
NDA 207988 ......
Ceftin (cefuroxime axetil) Oral Suspension, EQ 125 mg base/
5 mL and EQ 250 mg base/5 mL.
Zurampic (lesinurad) Tablets, 200mg ......................................
NDA 208383 ......
Bevyxxa (betrixaban) Capsules, 40 mg and 80 mg ................
NDA 210709 ......
Tekturna (aliskiren hemifumarate) Capsules (Pellets), EQ
37.5 mg base.
Qternmet XR (dapagliflozin, metformin HCl and saxagliptin)
Extended-Release Tablets, 2.5 mg/1 g/EQ 2.5 mg base, 5
mg/1 g/EQ 2.5 mg base, 5 mg/1 g/EQ 5 mg base, and 10
mg/1 g/EQ 5 mg base.
NDA 210874 ......
Therefore, approval of the
applications listed in the table, and all
amendments and supplements thereto,
is hereby withdrawn as of April 15,
2021. Approval of each entire
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16:52 Mar 15, 2021
Jkt 253001
The
applicants listed in the table have
informed FDA that these drug products
are no longer marketed and have
requested that FDA withdraw approval
of the applications under the process in
§ 314.150(c) (21 CFR 314.150(c)). The
applicants have also, by their requests,
waived their opportunity for a hearing.
Withdrawal of approval of an
application or abbreviated application
under § 314.150(c) is without prejudice
to refiling.
SUPPLEMENTARY INFORMATION:
Bristol-Myers Squibb Co., P.O. Box 4000, Princeton, NJ
08543.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co.,
Inc., 1 Merck Dr., Whitehouse Station, NJ 08889.
Janssen Pharmaceuticals, Inc., 1125 Trenton-Harbourton
Rd., Titusville, NJ 08560.
Sanofi-aventis U.S. LLC, 55 Corporate Dr., Bridgewater, NJ
08807.
Meridian Medical Technologies, Inc., 1945 Craig Rd., St.
Louis, MO 63146.
Do.
Novartis Pharmaceuticals Corp., 1 Health Plaza, East Hanover, NJ 07936–1080.
GlaxoSmithKline LLC, 5 Crescent Dr., Philadelphia, PA
19112.
Alcon Research, LLC, 6201 South Freeway, Fort Worth, TX
76134.
Otsuka Pharmaceutical Co., Ltd. c/o Otsuka Pharmaceutical
Development & Commercialization, Inc., 2440 Research
Blvd., Rockville, MD 20850.
Do.
Do.
Takeda Pharmaceutical U.S.A. Inc., 95 Hayden Ave., Lexington, MA 02421.
GlaxoSmithKline Intellectual Property (no. 2) Ltd. England, c/
o GlaxoSmithKline, 1250 South Collegeville Rd.,
Collegeville, PA 19426.
Do.
Ironwood Pharmaceuticals, Inc., 100 Summer St., Suite
2300, Boston MA 02110.
Portola Pharmaceuticals, Inc., 270 East Grand Ave., South
San Francisco, CA 94080.
Nodem Pharma DAC, 4820 Emperor Blvd., Durham, NC
27703.
AstraZeneca AB, c/o AstraZeneca Pharmaceuticals LP, 1800
Concord Pike, Wilmington, DE 19803.
application is withdrawn, including any
strengths and dosage forms
inadvertently missing from the table.
Introduction or delivery for introduction
into interstate commerce of products
PO 00000
796–3137, Kimberly.Lehrfeld@
fda.hhs.gov.
Applicant
Zyban (bupropion hydrochloride (HCl)) Extended-Release
Tablets, 100 mg, and 150 mg.
Diclofenac Sodium Ophthalmic Solution, 0.1% .......................
NDA 021866 ......
NDA 022024 ......
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ACTION:
14447
Frm 00045
Fmt 4703
Sfmt 4703
without approved new drug
applications violates section 301(a) and
(d) of the Federal Food, Drug, and
Cosmetic Act (21 U.S.C. 331(a) and (d)).
Drug products that are listed in the table
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]]>Agencies
[Federal Register Volume 86, Number 49 (Tuesday, March 16, 2021)]
[Notices]
[Pages 14445-14447]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-05371]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-E-0340]
Determination of Regulatory Review Period for Purposes of Patent
Extension; HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for HINTERMANN SERIES H3 TOTAL
ANKLE REPLACEMENT SYSTEM 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
SUPPLEMENTARY INFORMATION) are incorrect may submit either electronic
or written comments and ask for a redetermination by May 17, 2021.
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 13, 2021. 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 May 17, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 17, 2021. 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 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-2020-E-0340 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; HINTERMANN SERIES H3 TOTAL ANKLE
REPLACEMENT 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.
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
[[Page 14446]]
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 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 HINTERMANN SERIES
H3 TOTAL ANKLE REPLACEMENT SYSTEM. HINTERMANN SERIES H3 TOTAL ANKLE
REPLACEMENT SYSTEM is indicated for use as a non-cemented implant to
replace a painful arthritic ankle joint due to primary osteoarthritis,
post-traumatic osteoarthritis, or arthritis secondary to inflammatory
disease (e.g., rheumatoid arthritis, hemochromatosis, etc.). The device
system is for prescription use. Subsequent to this approval, the USPTO
received a patent term restoration application for HINTERMANN SERIES H3
TOTAL ANKLE REPLACEMENT SYSTEM (U.S. Patent No. 6,409,767) from
European Foot Platform, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated July 14, 2020, FDA advised the USPTO that this medical
device had undergone a regulatory review period and that the approval
of HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT 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
HINTERMANN SERIES H3 TOTAL ANKLE REPLACEMENT SYSTEM is 4,676 days. Of
this time, 3,661 days occurred during the testing phase of the
regulatory review period, while 1,015 days occurred during the approval
phase. These periods of time were derived from the following dates:
1. The date on which the device is first used with human subjects
as part of a clinical investigation to be filed with FDA to secure
premarket approval of the device: August 17, 2006. FDA has verified the
applicant's claim that the date on which the device is first used with
human subjects as part of a clinical investigation to be filed with FDA
to secure premarket approval of the device was August 17, 2006.
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): August
24, 2016. FDA has verified the applicant's claim that the premarket
approval application (PMA) for HINTERMANN SERIES H3 TOTAL ANKLE
REPLACEMENT SYSTEM (PMA 160036) was initially submitted August 24,
2016.
3. The date the application was approved: June 4, 2019. FDA has
verified the applicant's claim that PMA 160036 was approved on June 4,
2019.
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 1,825 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.
[[Page 14447]]
Dated: March 9, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-05371 Filed 3-15-21; 8:45 am]
BILLING CODE 4164-01-P
