Determination of Regulatory Review Period for Purposes of Patent Extension; DARZALEX, 7192-7194 [2018-03342]
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7192
Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
begins. The approval phase starts with
the initial submission of an application
to market the human biological product
and continues until FDA grants
permission to market the biological
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 biological 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 biologic product PORTRAZZA
(necitumumab). PORTRAZZA is
indicated, in combination with
gemcitabine and cisplatin, for first-line
treatment of patients with metastatic
squamous non-small cell lung cancer.
Subsequent to this approval, the USPTO
received a patent term restoration
application for PORTRAZZA (U.S.
Patent No. 7,598,350) from Eli Lilly and
Company, and the USPTO requested
FDA’s assistance in determining this
patent’s eligibility for patent term
restoration. In a letter dated August 30,
2016, FDA advised the USPTO that this
human biological product had
undergone a regulatory review period
and that the approval of PORTRAZZA
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
PORTRAZZA is 2,533 days. Of this
time, 2,175 days occurred during the
testing phase of the regulatory review
period, while 358 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 (21 U.S.C. 355(i))
became effective: December 19, 2008.
FDA has verified the applicant’s claim
that the date the investigational new
drug application became effective was
on December 19, 2008.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): December 2, 2014. The
applicant claims October 22, 2014, as
the date the biologics license
VerDate Sep<11>2014
17:55 Feb 16, 2018
Jkt 244001
application (BLA) for PORTRAZZA
(BLA 125547) was initially submitted.
However, FDA records indicate that
BLA 125547 was submitted on
December 2, 2014.
3. The date the application was
approved: November 24, 2015. FDA has
verified the applicant’s claim that BLA
125547 was approved on November 24,
2015.
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 1,321 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.
Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03345 Filed 2–16–18; 8:45 am]
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2016–E–1888]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; DARZALEX
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for DARZALEX 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
biological product.
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 April 23, 2018.
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 20, 2018. 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 April 23,
2018. The https://www.regulations.gov
electronic filing system will accept
comments until midnight Eastern Time
at the end of April 23, 2018. 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.
SUMMARY:
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
E:\FR\FM\20FEN1.SGM
20FEN1
Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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–
2016–E–1888 for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; DARZALEX.’’
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
VerDate Sep<11>2014
17:55 Feb 16, 2018
Jkt 244001
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.gpo.gov/
fdsys/pkg/FR-2015-09-18/pdf/201523389.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 human
biological products, the testing phase
begins when the exemption to permit
the clinical investigations of the
biological 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 biological product
and continues until FDA grants
permission to market the biological
product. Although only a portion of a
regulatory review period may count
PO 00000
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Fmt 4703
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7193
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 biological 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 biologic product DARZALEX
(daratumumab). DARZALEX is
indicated for the treatment of patients
with multiple myeloma who have
received at least three prior lines of
therapy, including a proteasome
inhibitor and an immunomodulatory
agent, or who are double-refractory to a
proteasome inhibitor and an
immunomodulatory agent. This
indication is approved under
accelerated approval based on response
rate. Continued approval for this
indication may be contingent upon
verification and description of clinical
benefit in confirmatory trials.
Subsequent to this approval, the USPTO
received a patent term restoration
application for DARZALEX (U.S. Patent
No. 7,829,673) from Genmab A/S, and
the USPTO requested FDA’s assistance
in determining this patent’s eligibility
for patent term restoration. In a letter
dated August 25, 2016, FDA advised the
USPTO that this human biological
product had undergone a regulatory
review period and that the approval of
DARZALEX 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
DARZALEX is 1,939 days. Of this time,
1,808 days occurred during the testing
phase of the regulatory review period,
while 131 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 (21 U.S.C. 355(i))
became effective: July 28, 2010. FDA has
verified the applicant’s claim that the
date the investigational new drug
application became effective was on
July 28, 2010.
2. The date the application was
initially submitted with respect to the
human biological product under section
351 of the Public Health Service Act (42
U.S.C. 262): July 9, 2015. FDA has
verified the applicant’s claim that the
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7194
Federal Register / Vol. 83, No. 34 / Tuesday, February 20, 2018 / Notices
biologics license application (BLA) for
DARZALEX (BLA 761,036) was initially
submitted on July 9, 2015.
3. The date the application was
approved: November 16, 2015. FDA has
verified the applicant’s claim that BLA
761,036 was approved on November 16,
2015.
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 1,000 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.
Dated: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018–03342 Filed 2–16–18; 8:45 am]
BILLING CODE 4164–01–P
sradovich on DSK3GMQ082PROD with NOTICES
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–XXXX]
Statement of Organization, Functions,
and Delegations of Authority
Office of Regulatory Affairs,
Office of Global Regulatory Operations
AGENCY:
VerDate Sep<11>2014
17:55 Feb 16, 2018
Jkt 244001
and Policy, Food and Drug
Administration, HHS.
ACTION: Notice.
The Food and Drug
Administration (FDA), Office of Global
Regulatory Operations and Policy,
Office of Regulatory Affairs (ORA),
Office of Regulatory Science (ORS), and
all ORA Laboratories have modified the
structure. This new organizational
structure was approved by the Secretary
of Health and Human Services and
effective on June 6, 2016.
FOR FURTHER INFORMATION CONTACT: Paul
Norris, DVM, MPA, Director, Office of
Regulatory Science, Office of Regulatory
Affairs, Office of Global Regulatory
Operations and Policy, Food and Drug
Administration, NCTR–50 Room 404,
Jefferson, Arkansas 72079, Phone: 870–
543–4099.
SUMMARY:
I. Summary
Part D, Chapter D–B (Food and Drug
Administration), the Statement of
Organization, Functions, and
Delegations of Authority for the
Department of Health and Human
Services 35 FR 3685, dated February 25,
1970; 60 FR 56605, dated November 9,
1995; 64 FR 36361, dated July 6, 1999;
72 FR 50112, dated August 30, 2007; 74
FR 41713, dated August 18, 2009; and
76 FR 45270, dated July 28, 2011, is
amended to reflect the reorganization of
the Office of Regulatory Affairs and the
Office of Regulatory Science (ORS), and
all ORA Laboratories in this
consolidation.
This organization expands current
activities in the Office of Regulatory
Science and ORA’s Laboratories in
support of the Agency’s Program
Alignment Initiative. One of the key
elements outlined in the initiative is to
transition to distinct commodity-based
and vertically integrated regulatory
programs with well-defined leads,
promoting coherent policy and strategic
development. This transforms the
regionally organized laboratory system
into a true national resource with
enhanced ability to meet its public
health mission to provide diverse
scientific expertise, leadership, and
responsive quality analytical services to
safeguard public health in a global
environment and foster continued
flexibility across its functions and
programs. It also centralizes and
streamlines laboratory operations,
scientific research, and support
functions into one Office of Regulatory
Science. Operationally this facilitates a
more efficient and strategic deployment
of these resources during public health
emergencies and food borne outbreaks.
Centralizing the laboratory system
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greatly enhances command and control
of laboratory functions.
The Food and Drug Administration,
Office of Global Regulatory Operations
and Policy, Office of Regulatory Affairs
(ORA), Office of Regulatory Science
(ORS) has been restructured as follows:
DLLRK. ORGANIZATION. The Office of
Regulatory Science is headed by the Director,
Office of Regulatory Science and includes the
following organizational units:
Office of Regulatory Science (DLLRK)
Automated Laboratory Management Staff
(DLLRK1)
Safety and Risk Management Staff (DLLRK2)
Office of Research Coordination and
Evaluation (DLLRKA)
Scientific Research Staff (DLLRKA1)
Evaluation Staff (DLLRKA2)
Office of Medical Products, Tobacco, and
Specialty Laboratory Operations (DLLRKB)
Medical Products and Tobacco Scientific
Staff (DLLRKB1)
Forensic Chemistry Center (DLLRKBA)
Inorganic Branch (DLLRKBA1)
Organic Branch (DLLRKBA2)
Winchester Engineering and Analytical
Center (DLLRKBB)
Analytical Branch (DLLRKBB1)
Engineering Branch (DLLRKBB2)
Detroit Laboratory (DLLRKBC)
Northeast Medical Products Laboratory
(DLLRKBD)
Pacific Southwest Medical Products
Laboratory (DLLRKBE)
Philadelphia Laboratory (DLLRKBF)
San Juan Laboratory (DLLRKBG)
Southeast Tobacco Laboratory (DLLRKBH)
Office of Food and Feed Laboratory
Operations (DLLRKC)
Food and Feed Scientific Staff (DLLRKC1)
Arkansas Laboratory (DLLRKCA)
Chemistry Branch I (DLLRKCA1)
Chemistry Branch II (DLLRKCA2)
Microbiology Branch (DLLRKCA3)
Denver Laboratory (DLLRKCB)
Chemistry Branch (DLLRKCB1)
Microbiology Branch (DLLRKCB2)
Kansas City Laboratory (DLLRKCC)
Chemistry Branch I (DLLRKCC1)
Chemistry Branch II (DLLRKCC2)
Northeast Food and Feed Laboratory
(DLLRKCD)
Chemistry Branch I (DLLRKCD1)
Chemistry Branch II (DLLRKCD2)
Microbiology Sciences Branch (DLLRKCD3)
Pacific Northwest Laboratory (DLLRKCE)
Chemistry Branch (DLLRKCE1)
Microbiology Branch (DLLRKCE2)
Applied Technology Branch (DLLRKCE3)
San Francisco Laboratory (DLLRKCF)
Chemistry Branch (DLLRKCF1)
Microbiology Branch (DLLRKCF2)
Southeast Food and Feed Laboratory
(DLLRKCG)
Microbiology Branch (DLLRKCG1)
Nutrient Analysis Branch (DLLRKCG2)
Chemistry Branch (DLLRKCG3)
Pacific Southwest Food and Feed Laboratory
(DLLRKCH)
Chemistry Branch (DLLRKCH1)
Microbiology Branch (DLLRKCH2)
E:\FR\FM\20FEN1.SGM
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]]>Agencies
[Federal Register Volume 83, Number 34 (Tuesday, February 20, 2018)]
[Notices]
[Pages 7192-7194]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-03342]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2016-E-1888]
Determination of Regulatory Review Period for Purposes of Patent
Extension; DARZALEX
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 DARZALEX 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
biological product.
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 April
23, 2018. 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 20, 2018.
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 April 23, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 23, 2018. 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
[[Page 7193]]
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-2016-E-1888 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; DARZALEX.'' 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 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.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 human biological products, the
testing phase begins when the exemption to permit the clinical
investigations of the biological 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 biological
product and continues until FDA grants permission to market the
biological 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 biological 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 biologic product DARZALEX
(daratumumab). DARZALEX is indicated for the treatment of patients with
multiple myeloma who have received at least three prior lines of
therapy, including a proteasome inhibitor and an immunomodulatory
agent, or who are double-refractory to a proteasome inhibitor and an
immunomodulatory agent. This indication is approved under accelerated
approval based on response rate. Continued approval for this indication
may be contingent upon verification and description of clinical benefit
in confirmatory trials. Subsequent to this approval, the USPTO received
a patent term restoration application for DARZALEX (U.S. Patent No.
7,829,673) from Genmab A/S, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated August 25, 2016, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of DARZALEX 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
DARZALEX is 1,939 days. Of this time, 1,808 days occurred during the
testing phase of the regulatory review period, while 131 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 (21 U.S.C. 355(i)) became effective: July 28,
2010. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on July 28,
2010.
2. The date the application was initially submitted with respect to
the human biological product under section 351 of the Public Health
Service Act (42 U.S.C. 262): July 9, 2015. FDA has verified the
applicant's claim that the
[[Page 7194]]
biologics license application (BLA) for DARZALEX (BLA 761,036) was
initially submitted on July 9, 2015.
3. The date the application was approved: November 16, 2015. FDA
has verified the applicant's claim that BLA 761,036 was approved on
November 16, 2015.
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 1,000 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: February 13, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-03342 Filed 2-16-18; 8:45 am]
BILLING CODE 4164-01-P
