Determination of Regulatory Review Period for Purposes of Patent Extension; PALYNZIQ, 66916-66918 [2019-26327]
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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices
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Drug Administration, 10903 New
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SUPPLEMENTARY INFORMATION:
Agenda: The committees will discuss
new drug application 211802 for
oxycodegol, a new molecular entity full
mu-opioid receptor agonist, submitted
by Nektar Therapeutics, for the
management of chronic low back pain
in adult patients with pain severe
enough to require daily, around-theclock, long-term opioid treatment and
for which alternative treatment options
are inadequate. The committees will be
asked to discuss the safety and efficacy
data as well as the overall risk-benefit
profile of the product.
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than 2 business days before the meeting.
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location of the advisory committee
meeting, and the background material
will be posted on FDA’s website after
the meeting. Background material is
available at https://www.fda.gov/
AdvisoryCommittees/Calendar/
default.htm. Scroll down to the
appropriate advisory committee meeting
link.
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Notice of this meeting is given under
the Federal Advisory Committee Act (5
U.S.C. app. 2).
Dated: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26338 Filed 12–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA–2019–E–1076 and FDA–
2019–E–1079]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; PALYNZIQ
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for PALYNZIQ and is publishing this
notice of that determination as required
by law. FDA has made the
determination because of the
submission of applications to the
Director of the U.S. Patent and
Trademark Office (USPTO), Department
of Commerce, for the extension of a
patent which claims that human
biological 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 February 4, 2020.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
SUMMARY:
E:\FR\FM\06DEN1.SGM
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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices
extension acted with due diligence
during the regulatory review period by
June 3, 2020. See ‘‘Petitions’’ in the
SUPPLEMENTARY INFORMATION section for
more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before February 4,
2020. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of February 4, 2020.
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’’).
lotter on DSKBCFDHB2PROD with NOTICES
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.’’
VerDate Sep<11>2014
16:11 Dec 05, 2019
Jkt 250001
Instructions: All submissions received
must include the Docket No. FDA–
2019–E–1076 and FDA–2019–E–1079
For ‘‘Determination of Regulatory
Review Period for Purposes of Patent
Extension; PALYNZIQ.’’ 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 § 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,
PO 00000
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66917
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 PALYNZIQ
(pegvaliase-pqpz). PALYNZIQ is
indicated to reduce blood phenylalanine
concentrations in adult patients with
phenylketonuria who have uncontrolled
blood phenylalanine concentrations
greater than 600 micromole/L on
existing management. Subsequent to
this approval, the USPTO received
patent term restoration applications for
PALYNZIQ (U.S. Patent Nos. 7,534,595
and 7,537,923) from Biomarin
Pharmaceutical Inc., and the USPTO
requested FDA’s assistance in
determining a patent’s eligibility for
patent term restoration. In a letter dated
May 13, 2019, FDA advised the USPTO
that this human biological product had
undergone a regulatory review period
and that the approval of PALYNZIQ
represented the first permitted
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Federal Register / Vol. 84, No. 235 / Friday, December 6, 2019 / Notices
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
PALYNZIQ is 3,803 days. Of this time,
3,474 days occurred during the testing
phase of the regulatory review period,
while 329 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 27, 2007. FDA has
verified the applicant’s claim that the date
the investigational new drug application
became effective was on December 27, 2007.
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):
June 30, 2017. FDA has verified the
applicant’s claim that the biologics license
application (BLA) for PALYNZIQ (BLA
B761079) was initially submitted on June 30,
2017.
3. The date the application was approved:
May 24, 2018. FDA has verified the
applicant’s claim that BLA B761079 was
approved on May 24, 2018.
lotter on DSKBCFDHB2PROD with NOTICES
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 1,743 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.
VerDate Sep<11>2014
16:11 Dec 05, 2019
Jkt 250001
Submit petitions electronically to
https://www.regulations.gov at Docket
Nos. 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: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019–26327 Filed 12–5–19; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–N–5611]
Joint Meeting of the Anesthetic and
Analgesic Drug Products Advisory
Committee and the Drug Safety and
Risk Management Advisory
Committee; Notice of Meeting;
Establishment of a Public Docket;
Request for Comments
AGENCY:
Food and Drug Administration,
HHS.
Notice, establishment of a
public docket; request for comments.
ACTION:
The Food and Drug
Administration (FDA) announces a
forthcoming joint public advisory
committee meeting of the Anesthetic
and Analgesic Drug Products Advisory
Committee and the Drug Safety and Risk
Management Advisory Committee. The
general function of the committees is to
provide advice and recommendations to
FDA on regulatory issues. The meeting
will be open to the public. FDA is
establishing a docket for public
comment on this document.
DATES: The meeting will be held on
January 15, 2020, from 8 a.m. to 5:30
p.m.
ADDRESSES: FDA White Oak Campus,
10903 New Hampshire Ave., Bldg. 31
Conference Center, the Great Room (Rm.
1503), Silver Spring, MD 20993–0002.
Answers to commonly asked questions
including information regarding special
accommodations due to a disability,
visitor parking, and transportation may
be accessed at: https://www.fda.gov/
AdvisoryCommittees/
AboutAdvisoryCommittees/
ucm408555.htm.
FDA is establishing a docket for
public comment on this meeting. The
docket number is FDA–2019–N–5611.
The docket will close on January 14,
2020. Submit either electronic or
written comments on this public
SUMMARY:
PO 00000
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meeting by January 14, 2020. Please
note that late, untimely filed comments
will not be considered. Electronic
comments must be submitted on or
before January 14, 2020. The https://
www.regulations.gov electronic filing
system will accept comments until
11:59 p.m. Eastern Time at the end of
January 14, 2020. 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.
Comments received on or before
December 31, 2019, will be provided to
the committees. Comments received
after that date will be taken into
consideration by FDA. In the event that
the meeting is cancelled, FDA will
continue to evaluate any relevant
applications or information, and
consider any comments submitted to the
docket, as appropriate.
You may submit comments as
follows:
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
E:\FR\FM\06DEN1.SGM
06DEN1
]]>Agencies
[Federal Register Volume 84, Number 235 (Friday, December 6, 2019)]
[Notices]
[Pages 66916-66918]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-26327]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket Nos. FDA-2019-E-1076 and FDA-2019-E-1079]
Determination of Regulatory Review Period for Purposes of Patent
Extension; PALYNZIQ
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 PALYNZIQ and is publishing
this notice of that determination as required by law. FDA has made the
determination because of the submission of applications to the Director
of the U.S. Patent and Trademark Office (USPTO), Department of
Commerce, for the extension of a patent which claims that human
biological 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 February 4, 2020.
Furthermore, any interested person may petition FDA for a determination
regarding whether the applicant for
[[Page 66917]]
extension acted with due diligence during the regulatory review period
by June 3, 2020. See ``Petitions'' in the SUPPLEMENTARY INFORMATION
section for more information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before February 4, 2020. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of February 4, 2020. 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-2019-E-1076 and FDA-2019-E-1079 For ``Determination of Regulatory
Review Period for Purposes of Patent Extension; PALYNZIQ.'' 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 PALYNZIQ
(pegvaliase-pqpz). PALYNZIQ is indicated to reduce blood phenylalanine
concentrations in adult patients with phenylketonuria who have
uncontrolled blood phenylalanine concentrations greater than 600
micromole/L on existing management. Subsequent to this approval, the
USPTO received patent term restoration applications for PALYNZIQ (U.S.
Patent Nos. 7,534,595 and 7,537,923) from Biomarin Pharmaceutical Inc.,
and the USPTO requested FDA's assistance in determining a patent's
eligibility for patent term restoration. In a letter dated May 13,
2019, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of PALYNZIQ
represented the first permitted
[[Page 66918]]
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
PALYNZIQ is 3,803 days. Of this time, 3,474 days occurred during the
testing phase of the regulatory review period, while 329 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 27, 2007. FDA has verified the applicant's claim that the
date the investigational new drug application became effective was
on December 27, 2007.
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): June 30, 2017. FDA has verified
the applicant's claim that the biologics license application (BLA)
for PALYNZIQ (BLA B761079) was initially submitted on June 30, 2017.
3. The date the application was approved: May 24, 2018. FDA has
verified the applicant's claim that BLA B761079 was approved on May
24, 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 applications for patent extension,
this applicant seeks 1,743 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 Nos. 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: December 2, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-26327 Filed 12-5-19; 8:45 am]
BILLING CODE 4164-01-P
