Determination of Regulatory Review Period for Purposes of Patent Extension; TAVALISSE, 56687-56689 [2022-19993]
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Federal Register / Vol. 87, No. 178 / Thursday, September 15, 2022 / Notices
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:
lotter on DSK11XQN23PROD with NOTICES1
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 biologic 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 human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug product
becomes effective and runs until the
approval phase begins. The approval
phase starts with the initial submission
of an application to market the human
drug product and continues until FDA
grants permission to market the drug
product. 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 human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product, CAPLYTA
(lumateperone tosylate). CAPLYTA is
indicated for the treatment of
schizophrenia. Subsequent to this
approval, the USPTO received a patent
term restoration application for
CAPLYTA (U.S. Patent Nos. 8,598,119
and 8,648,077) from Intra-Cellular
Therapies, Inc., and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
June 8, 2021, FDA advised the USPTO
that this human drug product had
VerDate Sep<11>2014
16:56 Sep 14, 2022
Jkt 256001
undergone a regulatory review period
and that the approval of CAPLYTA
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
CAPLYTA is 4,421 days. Of this time,
3,970 days occurred during the testing
phase of the regulatory review period,
while 451 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: November 15,
2007. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on November 15, 2007.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: September 27, 2018.
FDA has verified the applicant’s claim
that the new drug application (NDA) for
CAPLYTA (NDA 209500) was initially
submitted on September 27, 2018.
3. The date the application was
approved: December 20, 2019. FDA has
verified the applicant’s claim that NDA
209500 was approved on December 20,
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 applications for patent extension,
this applicant seeks 1,294 days or 1,329
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
PO 00000
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Fmt 4703
Sfmt 4703
56687
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 7, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19898 Filed 9–14–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–E–1080]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; TAVALISSE
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for TAVALISSE 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 human drug
product.
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 November 14, 2022.
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 14, 2023. 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
SUMMARY:
E:\FR\FM\15SEN1.SGM
15SEN1
56688
Federal Register / Vol. 87, No. 178 / Thursday, September 15, 2022 / Notices
November 14, 2022. Comments received
by mail/hand delivery/courier (for
written/paper submissions) will be
considered timely if they are received
on or before that date.
lotter on DSK11XQN23PROD with NOTICES1
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–
2019–E–1080 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; TAVALISSE.’’
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
VerDate Sep<11>2014
16:56 Sep 14, 2022
Jkt 256001
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 § 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:
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
PO 00000
Frm 00069
Fmt 4703
Sfmt 4703
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 human drug
products, the testing phase begins when
the exemption to permit the clinical
investigations of the drug becomes
effective and runs until the approval
phase begins. The approval phase starts
with the initial submission of an
application to market the human drug
product and continues until FDA grants
permission to market the drug product.
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 human drug product will include all
of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the
human drug product TAVALISSE
(fostamatinib disodium hexahydrate).
TAVALISSE is indicated for the
treatment of thrombocytopenia in adult
patients with chronic immune
thrombocytopenia who have had an
insufficient response to a previous
treatment. Subsequent to this approval,
the USPTO received a patent term
restoration application for TAVALISSE
(U.S. Patent No. 7,449,458) from Rigel
Pharmaceuticals, Inc. and the USPTO
requested FDA’s assistance in
determining the patent’s eligibility for
patent term restoration. In a letter dated
June 12, 2019, FDA advised the USPTO
that this human drug product had
undergone a regulatory review period
and that the approval of TAVALISSE
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
TAVALISSE is 4,564 days. Of this time,
4,198 days occurred during the testing
phase of the regulatory review period,
while 366 days occurred during the
approval phase. These periods of time
were derived from the following dates:
1. The date an exemption under
section 505(i) of the Federal Food, Drug,
and Cosmetic Act (FD&C Act) (21 U.S.C.
355(i)) became effective: October 20,
2005. FDA has verified the applicant’s
claim that the date the investigational
E:\FR\FM\15SEN1.SGM
15SEN1
Federal Register / Vol. 87, No. 178 / Thursday, September 15, 2022 / Notices
new drug application became effective
was on October 20, 2005.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: April 17, 2017. FDA
has verified the applicant’s claim that
the new drug application (NDA) for
TAVALISSE (NDA 209299) was initially
submitted on April 17, 2017.
3. The date the application was
approved: April 17, 2018. FDA has
verified the applicant’s claim that NDA
209299 was approved on April 17, 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 5 years of patent
term extension.
III. Petitions
lotter on DSK11XQN23PROD with NOTICES1
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.
Dated: September 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–19993 Filed 9–14–22; 8:45 am]
BILLING CODE 4164–01–P
VerDate Sep<11>2014
16:56 Sep 14, 2022
Jkt 256001
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Health Resources and Services
Administration
Notice of Availability of Health Center
Program Scope of Project and
Telehealth Policy Information Notice
Health Resources and Services
Administration (HRSA), Department of
Health and Human Services (HHS).
ACTION: Request for public comment on
Draft Health Center Program Scope of
Project and Telehealth Policy
Information Notice.
AGENCY:
HRSA is inviting public
comment on the Draft Health Center
Program Scope of Project and Telehealth
Policy Information Notice (Telehealth
PIN). The purpose of the Telehealth PIN
is to establish policy for health centers
that provide services via telehealth
within the HRSA-approved scope of
project. The Telehealth PIN also
describes considerations and criteria
health centers must meet for providing
services via telehealth within the Health
Center Program scope of project.
The Health Center Program is
authorized by section 330 of the Public
Health Service Act, 42 U.S.C. 254b.
HRSA provides federal award funding
to health centers to deliver required
primary care and additional health
services to medically underserved areas
and populations. HRSA also certifies
entities that it has determined to meet
section 330 requirements as Health
Center Program look-alikes. Health
centers provide required primary care
and additional health services to
residents of the area served by the
health center.
Each health center is responsible for
maintaining its operations, including
developing and implementing its own
operating procedures for providing
health services through telehealth, in
compliance with all Health Center
Program requirements and all other
applicable federal, state, and local laws
and regulations.1
Health centers are increasingly using
telehealth as a means of delivering
required and additional services to
health center patients. Providing health
care via telehealth 2 can increase patient
access and improve clinical outcomes,
quality of care, continuity of care, and
reduce the need for hospitalization.
SUMMARY:
1 42
CFR 51c.304(d)(3)(v).
defines telehealth as the use of electronic
information and telecommunication technologies to
support long-distance clinical health care, patient
and professional health-related education, health
administration, and public health.
2 HRSA
PO 00000
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Fmt 4703
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56689
Within the context of the Health Center
Program scope of project, telehealth is
not a service or a service delivery
method requiring specific HRSA
approval; rather, telehealth is a
mechanism or means for delivering a
health service(s) to health center
patients using telecommunications
technology or equipment.
DATES: Submit comments no later than
November 14, 2022.
ADDRESSES: The PIN is available at the
Scope of Project and Telehealth PIN
Public Comments web page. Written
comments should be submitted through
the HRSA Bureau of Primary Health
Care Contact Form (https://
hrsa.force.com/feedback/s/policyinformation-notice), by November 14,
2022.
FOR FURTHER INFORMATION CONTACT:
Jennifer Joseph, Director, Office of
Policy and Program Development,
Bureau of Primary Health Care, HRSA,
5600 Fishers Lane, Rockville, Maryland
20857; email: jjoseph@hrsa.gov;
telephone: 301–594–4300; fax: 301–
594–4997.
SUPPLEMENTARY INFORMATION: HRSA
provides grants to eligible applicants
under section 330 of the PHS Act, as
amended (42 U.S.C. 254b), to support
the delivery of preventive and primary
care services to the nation’s underserved
individuals and families. HRSA also
certifies eligible applicants under the
Health Center Look-Alike Program (see
sections 1861(aa)(4)(B) and 1905(l)(2)(B)
of the Social Security Act). Look-alikes
do not receive Health Center Program
funding but must meet the Health
Center Program statutory and regulatory
requirements. Nearly 1,400 Health
Center Program-funded health centers
and approximately 100 Health Center
Program look-alike organizations
collectively operate over 14,000 service
delivery sites that provide care to over
30 million patients in every U.S. state,
the District of Columbia, Puerto Rico,
the U.S. Virgin Islands, and the Pacific
Basin. Note that for the purposes of this
document, the term ‘‘health center’’
refers to entities that receive a federal
award under section 330 of the PHS Act,
as amended, as well as subrecipients
and organizations designated as lookalikes, unless otherwise stated.
Section A of the Telehealth PIN
includes considerations for health
centers delivering services via telehealth
within the HRSA-approved scope of
project. Each health center is
responsible for maintaining its
operations, including developing and
implementing its own operating
procedures for telehealth, in compliance
with all Health Center Program
E:\FR\FM\15SEN1.SGM
15SEN1
]]>Agencies
[Federal Register Volume 87, Number 178 (Thursday, September 15, 2022)]
[Notices]
[Pages 56687-56689]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-19993]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-E-1080]
Determination of Regulatory Review Period for Purposes of Patent
Extension; TAVALISSE
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 TAVALISSE 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 human drug
product.
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 November 14, 2022.
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 14, 2023. 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
[[Page 56688]]
November 14, 2022. 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:
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-2019-E-1080 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; TAVALISSE.'' 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 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 human drug products, the
testing phase begins when the exemption to permit the clinical
investigations of the drug becomes effective and runs until the
approval phase begins. The approval phase starts with the initial
submission of an application to market the human drug product and
continues until FDA grants permission to market the drug product.
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 human
drug product will include all of the testing phase and approval phase
as specified in 35 U.S.C. 156(g)(1)(B).
FDA has approved for marketing the human drug product TAVALISSE
(fostamatinib disodium hexahydrate). TAVALISSE is indicated for the
treatment of thrombocytopenia in adult patients with chronic immune
thrombocytopenia who have had an insufficient response to a previous
treatment. Subsequent to this approval, the USPTO received a patent
term restoration application for TAVALISSE (U.S. Patent No. 7,449,458)
from Rigel Pharmaceuticals, Inc. and the USPTO requested FDA's
assistance in determining the patent's eligibility for patent term
restoration. In a letter dated June 12, 2019, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of TAVALISSE 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
TAVALISSE is 4,564 days. Of this time, 4,198 days occurred during the
testing phase of the regulatory review period, while 366 days occurred
during the approval phase. These periods of time were derived from the
following dates:
1. The date an exemption under section 505(i) of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355(i)) became effective:
October 20, 2005. FDA has verified the applicant's claim that the date
the investigational
[[Page 56689]]
new drug application became effective was on October 20, 2005.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: April 17,
2017. FDA has verified the applicant's claim that the new drug
application (NDA) for TAVALISSE (NDA 209299) was initially submitted on
April 17, 2017.
3. The date the application was approved: April 17, 2018. FDA has
verified the applicant's claim that NDA 209299 was approved on April
17, 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 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 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 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-19993 Filed 9-14-22; 8:45 am]
BILLING CODE 4164-01-P
