Determination of Regulatory Review Period for Purposes of Patent Extension; GIVLAARI, 32936-32938 [2021-13176]
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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices
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approval from the Office of Management
and Budget (OMB) for each collection of
information they conduct or sponsor.
The term ‘‘collection of information’’ is
defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA
requires federal agencies to publish a
60-day notice in the Federal Register
concerning each proposed collection of
information, including each proposed
extension or reinstatement of an existing
collection of information, before
submitting the collection to OMB for
approval. To comply with this
requirement, CMS is publishing this
notice.
Information Collection
1. Type of Information Collection
Request: Revision of a currently
approved collection; Title of
Information Collection: Solicitation for
Applications for Medicare Prescription
Drug Plan 2023 Contracts; Use: Coverage
for the prescription drug benefit is
provided through contracted
prescription drug plans (PDPs) or
through Medicare Advantage (MA)
plans that offer integrated prescription
drug and health care coverage (MA–PD
plans). Cost Plans that are regulated
under Section 1876 of the Social
Security Act, and Employer Group
Waiver Plans (EGWP) may also provide
a Part D benefit. Organizations wishing
to provide services under the
Prescription Drug Benefit Program must
complete an application, negotiate rates,
and receive final approval from CMS.
Existing Part D Sponsors may also
expand their contracted service area by
completing the Service Area Expansion
(SAE) application.
Collection of this information is
mandated in Part D of the Medicare
Prescription Drug, Improvement, and
Modernization Act of 2003 (MMA) in
Subpart 3. The application requirements
are codified in Subpart K of 42 CFR 423
entitled ‘‘Application Procedures and
Contracts with PDP Sponsors.’’
The information will be collected
under the solicitation of proposals from
PDP, MA–PD, Cost Plan, Program of All
Inclusive Care for the Elderly (PACE),
and EGWP applicants. The collected
information will be used by CMS to: (1)
Ensure that applicants meet CMS
requirements for offering Part D plans
(including network adequacy,
contracting requirements, and
compliance program requirements, as
described in the application), (2)
support the determination of contract
awards. Form Number: CMS–10137
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(OMB control number: 0938–0936);
Frequency: Yearly; Affected Public:
Businesses or other for-profits, Not-forprofit institutions; Number of
Respondents: 716; Total Annual
Responses: 382; Total Annual Hours:
1,716. (For policy questions regarding
this collection contact Arianne
Spaccarelli at 410–786–5715.)
2. Type of Information Collection
Request: Extension of a currently
approved collection; Title of
Information Collection: Collection of
Prescription Drug Event Data From
Contracted Part D Providers for
Payment; Use: The PDE data is used in
the Payment Reconciliation System to
perform the annual Part D payment
reconciliation, any PDE data within the
Coverage Gap Phase of the Part D benefit
is used for invoicing in the CGDP, and
the data are part of the report provided
to the Secretary of the Treasury for
Section 9008.
CMS has used PDE data to create
summarized dashboards and tools,
including the Medicare Part D Drug
Spending Dashboard & Data, the Part D
Manufacturer Rebate Summary Report,
and the Medicare Part D Opioid
Prescribing Mapping Tool. The data are
also used in the Medicare Trustees
Report. Due to the market sensitive
nature of PDE data, external uses of the
data are subject to significant
limitations. However, CMS does analyze
the data on a regular basis to determine
drug cost and utilization patterns in
order to inform programmatic patterns
and to develop informed policy in the
Part D program.
The information users will be
Pharmacy Benefit Managers (PBMs),
third party administrators and
pharmacies, and the PDPs, MA–PDs,
Fallbacks and other plans that offer
coverage of outpatient prescription
drugs under the Medicare Part D benefit
to Medicare beneficiaries. The
statutorily required data is used
primarily for payment and is used for
claim validation as well as for other
legislated functions such as quality
monitoring, program integrity and
oversight. Form Number: CMS–10174
(OMB control number: 0938–0982);
Frequency: Yearly; Affected Public:
Businesses or other for-profits, Not-forprofit institutions; Number of
Respondents: 739; Total Annual
Responses: 1,499,238,090; Total Annual
Hours: 2,998. (For policy questions
regarding this collection contact Ivan
Iveljic at 410–786–3312.)
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Dated: June 17, 2021.
William N. Parham, III,
Director, Paperwork Reduction Staff, Office
of Strategic Operations and Regulatory
Affairs.
[FR Doc. 2021–13194 Filed 6–22–21; 8:45 am]
BILLING CODE 4120–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2020–E–1642]
Determination of Regulatory Review
Period for Purposes of Patent
Extension; GIVLAARI
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or the Agency) has
determined the regulatory review period
for GIVLAARI 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 the
SUPPLEMENTARY INFORMATION section) are
incorrect may submit either electronic
or written comments and ask for a
redetermination by August 23, 2021.
Furthermore, any interested person may
petition FDA for a determination
regarding whether the applicant for
extension acted with due diligence
during the regulatory review period by
December 20, 2021. See ‘‘Petitions’’ in
the SUPPLEMENTARY INFORMATION section
for more information.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before August 23,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of August 23, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
confidential information that you or a
third party may not wish to be posted,
such as medical information, your or
anyone else’s Social Security number, or
confidential business information, such
as a manufacturing process. Please note
that if you include your name, contact
information, or other information that
identifies you in the body of your
comments, that information will be
posted on https://www.regulations.gov.
• If you want to submit a comment
with confidential information that you
do not wish to be made available to the
public, submit the comment as a
written/paper submission and in the
manner detailed (see ‘‘Written/Paper
Submissions’’ and ‘‘Instructions’’).
Written/Paper Submissions
Submit written/paper submissions as
follows:
• Mail/Hand Delivery/Courier (for
written/paper submissions): Dockets
Management Staff (HFA–305), Food and
Drug Administration, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
• For written/paper comments
submitted to the Dockets Management
Staff, FDA will post your comment, as
well as any attachments, except for
information submitted, marked and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All submissions received
must include the Docket No. FDA–
2020–E–1642for ‘‘Determination of
Regulatory Review Period for Purposes
of Patent Extension; GIVLAARI.’’
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
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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, 240–420–7500.
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
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32937
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 GIVLAARI
(givosiran). GIVLAARI is indicated for
the treatment of adults with acute
hepatic porphyria. Subsequent to this
approval, the USPTO received a patent
term restoration application for
GIVLAARI (U.S. Patent No. 9,133,461)
from Alnylam Pharmaceuticals, Inc.,
and the USPTO requested FDA’s
assistance in determining the patent’s
eligibility for patent term restoration. In
a letter dated August 20, 2020, FDA
advised the USPTO that this human
drug product had undergone a
regulatory review period and that the
approval of GIVLAARI 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
GIVLAARI is 1,533 days. Of this time,
1,363 days occurred during the testing
phase of the regulatory review period,
while 170 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: September 11,
2015. FDA has verified the applicant’s
claim that the date the investigational
new drug application became effective
was on September 11, 2015.
2. The date the application was
initially submitted with respect to the
human drug product under section 505
of the FD&C Act: June 4, 2019. The
applicant claims November 15, 2018, as
the date the new drug application
(NDA) for GIVLAARI (NDA 212194) was
initially submitted. However, FDA
records indicate that NDA 212194 was
submitted on June 4, 2019.
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Federal Register / Vol. 86, No. 118 / Wednesday, June 23, 2021 / Notices
3. The date the application was
approved: November 20, 2019. FDA has
verified the applicant’s claim that NDA
212194 was approved on November 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 application for patent extension,
this applicant seeks 190 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: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–13176 Filed 6–22–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
jbell on DSKJLSW7X2PROD with NOTICES
Food and Drug Administration
[Docket No. FDA–2020–N–1729]
Authorization and Revocation of
Emergency Use of Drugs During the
COVID–19 Pandemic; Availability
AGENCY:
Food and Drug Administration,
HHS.
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ACTION:
Notice.
SUPPLEMENTARY INFORMATION:
The Food and Drug
Administration (FDA) is announcing the
issuance of an Emergency Use
Authorization (EUA) (the Authorization)
for a drug for use during the COVID–19
pandemic. FDA issued the
Authorization under the Federal Food,
Drug, and Cosmetic Act (FD&C Act), as
requested by B. Braun Melsungen AG.
The Authorization contains, among
other things, conditions on the
emergency use of the authorized drug.
The Authorization follows the February
4, 2020, determination by the Secretary
of HHS that there is a public health
emergency that has a significant
potential to affect national security or
the health and security of United States
citizens living abroad and that involves
a novel (new) coronavirus. The virus is
now named SARS–CoV–2, which causes
the illness COVID–19. On the basis of
such determination, the Secretary of
HHS declared on March 27, 2020, that
circumstances exist justifying the
authorization of emergency use of drugs
and biological products during the
COVID–19 pandemic, pursuant to the
FD&C Act, subject to the terms of any
authorization issued under that section.
FDA is also announcing the revocation
of the Authorization issued to Eli Lilly
and Company for bamlanivimab alone.
FDA revoked this authorization on April
16, 2021. Reprinted in this document is
the issuance of the Authorization and
the revocation, which include an
explanation of the reasons for issuance
or revocation.
DATES: The Authorization for B. Braun
Melsungen AG was effective as of March
12, 2021 and the revocation for Eli Lilly
and Company was effective as of April
16, 2021.
ADDRESSES: Submit written requests for
single copies of the Authorization and/
or revocation to the Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4338, Silver Spring, MD 20993–0002.
Send one self-addressed adhesive label
to assist that office in processing your
request or include a fax number to
which the Authorizations may be sent.
See the SUPPLEMENTARY INFORMATION
section for electronic access to the
Authorizations.
FOR FURTHER INFORMATION CONTACT:
Michael Mair, Office of
Counterterrorism and Emerging Threats,
Food and Drug Administration, 10903
New Hampshire Ave., Bldg. 1, Rm.
4332, Silver Spring, MD 20993–0002,
301–796–8510 (this is not a toll free
number).
SUMMARY:
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I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb–3) allows FDA to
strengthen the public health protections
against biological, chemical, nuclear,
and radiological agents. Among other
things, section 564 of the FD&C Act
allows FDA to authorize the use of an
unapproved medical product or an
unapproved use of an approved medical
product in certain situations.
II. Criteria for EUA Authorization
Section 564(b)(1) of the FD&C Act
provides that, before an EUA may be
issued, the Secretary of HHS must
declare that circumstances exist
justifying the authorization based on
one of the following grounds: (1) A
determination by the Secretary of
Homeland Security that there is a
domestic emergency, or a significant
potential for a domestic emergency,
involving a heightened risk of attack
with a biological, chemical, radiological,
or nuclear agent or agents; (2) a
determination by the Secretary of
Defense that there is a military
emergency, or a significant potential for
a military emergency, involving a
heightened risk to United States (U.S.)
military forces, including personnel
operating under the authority of title 10
or title 50, United States Code, of attack
with (i) a biological, chemical,
radiological, or nuclear agent or agents;
or (ii) an agent or agents that may cause,
or are otherwise associated with, an
imminently life-threatening and specific
risk to U.S. military forces; 1 (3) a
determination by the Secretary of HHS
that there is a public health emergency,
or a significant potential for a public
health emergency, that affects, or has a
significant potential to affect, national
security or the health and security of
U.S. citizens living abroad, and that
involves a biological, chemical,
radiological, or nuclear agent or agents,
or a disease or condition that may be
attributable to such agent or agents; or
(4) the identification of a material threat
by the Secretary of Homeland Security
pursuant to section 319F–2 of the Public
Health Service (PHS) Act (42 U.S.C.
247d–6b) sufficient to affect national
security or the health and security of
U.S. citizens living abroad.
Once the Secretary of HHS has
declared that circumstances exist
justifying an authorization under
1 In the case of a determination by the Secretary
of Defense, the Secretary of HHS shall determine
within 45 calendar days of such determination,
whether to make a declaration under section
564(b)(1) of the FD&C Act, and, if appropriate, shall
promptly make such a declaration.
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]]>Agencies
[Federal Register Volume 86, Number 118 (Wednesday, June 23, 2021)]
[Notices]
[Pages 32936-32938]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13176]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-E-1642]
Determination of Regulatory Review Period for Purposes of Patent
Extension; GIVLAARI
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 GIVLAARI 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
the SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by August
23, 2021. Furthermore, any interested person may petition FDA for a
determination regarding whether the applicant for extension acted with
due diligence during the regulatory review period by December 20, 2021.
See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more
information.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before August 23, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of August 23, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
Electronic Submissions
Submit electronic comments in the following way:
[[Page 32937]]
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
will be posted to the docket unchanged. Because your comment will be
made public, you are solely responsible for ensuring that your comment
does not include any confidential information that you or a third party
may not wish to be posted, such as medical information, your or anyone
else's Social Security number, or confidential business information,
such as a manufacturing process. Please note that if you include your
name, contact information, or other information that identifies you in
the body of your comments, that information will be posted on https://www.regulations.gov.
If you want to submit a comment with confidential
information that you do not wish to be made available to the public,
submit the comment as a written/paper submission and in the manner
detailed (see ``Written/Paper Submissions'' and ``Instructions'').
Written/Paper Submissions
Submit written/paper submissions as follows:
Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Dockets
Management Staff, FDA will post your comment, as well as any
attachments, except for information submitted, marked and identified,
as confidential, if submitted as detailed in ``Instructions.''
Instructions: All submissions received must include the Docket No.
FDA-2020-E-1642for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; GIVLAARI.'' 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.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, 240-420-7500.
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 GIVLAARI
(givosiran). GIVLAARI is indicated for the treatment of adults with
acute hepatic porphyria. Subsequent to this approval, the USPTO
received a patent term restoration application for GIVLAARI (U.S.
Patent No. 9,133,461) from Alnylam Pharmaceuticals, Inc., and the USPTO
requested FDA's assistance in determining the patent's eligibility for
patent term restoration. In a letter dated August 20, 2020, FDA advised
the USPTO that this human drug product had undergone a regulatory
review period and that the approval of GIVLAARI 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
GIVLAARI is 1,533 days. Of this time, 1,363 days occurred during the
testing phase of the regulatory review period, while 170 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:
September 11, 2015. FDA has verified the applicant's claim that the
date the investigational new drug application became effective was on
September 11, 2015.
2. The date the application was initially submitted with respect to
the human drug product under section 505 of the FD&C Act: June 4, 2019.
The applicant claims November 15, 2018, as the date the new drug
application (NDA) for GIVLAARI (NDA 212194) was initially submitted.
However, FDA records indicate that NDA 212194 was submitted on June 4,
2019.
[[Page 32938]]
3. The date the application was approved: November 20, 2019. FDA
has verified the applicant's claim that NDA 212194 was approved on
November 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 application for patent extension,
this applicant seeks 190 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: June 16, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13176 Filed 6-22-21; 8:45 am]
BILLING CODE 4164-01-P
