83 FR 5440 - Determination of Regulatory Review Period for Purposes of Patent Extension; BLINCYTO

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

Page Range		5440-5441
FR Document		2018-02419

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BLINCYTO 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.

Federal Register, Volume 83 Issue 26 (Wednesday, February 7, 2018)

[Federal Register Volume 83, Number 26 (Wednesday, February 7, 2018)]
[Notices]
[Pages 5440-5441]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-02419]

[[Page 5440]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA 2015-E-3854 and FDA-2015-E-3855]

Determination of Regulatory Review Period for Purposes of Patent
Extension; BLINCYTO

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA or the Agency) has
determined the regulatory review period for BLINCYTO 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by April
9, 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 6, 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 9, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of April 9, 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 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 Nos.
FDA 2015-E-3854 and FDA-2015-E-3855 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; BLINCYTO.'' Received
comments, those filed in a timely manner (see ADDRESSES) will be placed
in the dockets 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.thefederalregister.org/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

[[Page 5441]]

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 BLINCYTO
(blinatumomab). BLINCYTO is indicated for the treatment of Philadelphia
chromosome-negative relapsed or refractory B-cell precuror acute
lymphoblastic leukemia. This indication is approved under accelerated
approval. Continued approval for this indication may be contingent upon
verification of clinical benefit in subsequent trials. Subsequent to
this approval, the USPTO received patent term restoration applications
for BLINCYTO (U.S. Patent Nos. 7,112,324 and 8,007,796) from Amgen
Research (Munich) GMBH, and the USPTO requested FDA's assistance in
determining this patent's eligibility for patent term restoration. In a
letter dated October 30, 2015, FDA advised the USPTO that this human
biological product had undergone a regulatory review period and that
the approval of BLINCYTO 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
BLINCYTO is 2,850 days. Of this time, 2,774 days occurred during the
testing phase of the regulatory review period, while 76 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: February
15, 2007. FDA has verified the applicant's claims that the date the
investigational new drug application became effective was on February
15, 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): September 19, 2014. FDA has verified the
applicant's claim that the biologics license application (BLA) for
BLINCYTO (BLA 125557) was initially submitted on September 19, 2014.
3. The date the application was approved: December 3, 2014. FDA has
verified the applicant's claim that BLA 125557 was approved on December
3, 2014.
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 1,462 or 432 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: January 31, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-02419 Filed 2-6-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 26 / Wednesday, February 7, 2018 / Notices 5441

product. Although only a portion of a initially submitted on September 19, DEPARTMENT OF HEALTH AND
regulatory review period may count 2014. HUMAN SERVICES
toward the actual amount of extension 3. The date the application was
that the Director of USPTO may award Food and Drug Administration
approved: December 3, 2014. FDA has
(for example, half the testing phase must [Docket No. FDA–2018–N–0270]
verified the applicant’s claim that BLA
be subtracted as well as any time that
125557 was approved on December 3,
may have occurred before the patent Agency Information Collection
was issued), FDA’s determination of the 2014.
Activities; Proposed Collection;
length of a regulatory review period for This determination of the regulatory Comment Request; Survey on the
a human biological product will include review period establishes the maximum Occurrence of Foodborne Illness Risk
all of the testing phase and approval potential length of a patent extension. Factors in Selected Institutional
phase as specified in 35 U.S.C. However, the USPTO applies several Foodservice and Retail Food Stores
156(g)(1)(B). statutory limitations in its calculations Facility Types
FDA has approved for marketing the of the actual period for patent extension.
human biologic product BLINCYTO AGENCY: Food and Drug Administration,
In its applications for patent extension,
(blinatumomab). BLINCYTO is HHS.
this applicant seeks 1,462 or 432 days
indicated for the treatment of ACTION: Notice.
of patent term extension.
Philadelphia chromosome-negative
SUMMARY: The Food and Drug
relapsed or refractory B-cell precuror III. Petitions
Administration (FDA or Agency) is
acute lymphoblastic leukemia. This
Anyone with knowledge that any of announcing an opportunity for public
indication is approved under
the dates as published are incorrect may comment on the proposed collection of
accelerated approval. Continued
submit either electronic or written certain information by the Agency.
approval for this indication may be
comments and, under 21 CFR 60.24, ask Under the Paperwork Reduction Act of
contingent upon verification of clinical
benefit in subsequent trials. Subsequent for a redetermination (see DATES). 1995 (PRA), Federal Agencies are
to this approval, the USPTO received Furthermore, as specified in § 60.30 (21 required to publish notice in the
patent term restoration applications for Federal Register concerning each
CFR 60.30), any interested person may
BLINCYTO (U.S. Patent Nos. 7,112,324 proposed collection of information,
petition FDA for a determination
and 8,007,796) from Amgen Research including each proposed reinstatement
regarding whether the applicant for
(Munich) GMBH, and the USPTO of an existing collection of information,
extension acted with due diligence and to allow 60 days for public
requested FDA’s assistance in during the regulatory review period. To
determining this patent’s eligibility for comment in response to the notice. This
meet its burden, the petition must notice solicits comments on the ‘‘Survey
patent term restoration. In a letter dated comply with all the requirements of
October 30, 2015, FDA advised the on the Occurrence of Foodborne Illness
§ 60.30, including but not limited to: Risk Factors in Selected Institutional
USPTO that this human biological must be timely (see DATES), must be
product had undergone a regulatory Foodservice and Retail Food Stores
filed in accordance with § 10.20, must Facility Types.’’
review period and that the approval of
contain sufficient facts to merit an FDA DATES: Submit either electronic or
BLINCYTO represented the first
permitted commercial marketing or use investigation, and must certify that a written comments on the collection of
of the product. Thereafter, the USPTO true and complete copy of the petition information by April 9, 2018.
requested that FDA determine the has been served upon the patent ADDRESSES: You may submit comments
product’s regulatory review period. applicant. (See H. Rept. 857, part 1, 98th as follows. Please note that late,
Cong., 2d sess., pp. 41–42, 1984.) untimely filed comments will not be
II. Determination of Regulatory Review Petitions should be in the format considered. Electronic comments must
Period specified in 21 CFR 10.30. be submitted on or before April 9, 2018.
FDA has determined that the Submit petitions electronically to The https://www.regulations.gov
applicable regulatory review period for https://www.regulations.gov at Docket electronic filing system will accept
BLINCYTO is 2,850 days. Of this time, No. FDA–2013–S–0610. Submit written comments until midnight Eastern Time
2,774 days occurred during the testing at the end of April 9, 2018. Comments
petitions (two copies are required) to the
phase of the regulatory review period, received by mail/hand delivery/courier
Dockets Management Staff (HFA–305),
while 76 days occurred during the (for written/paper submissions) will be
Food and Drug Administration, 5630
approval phase. These periods of time considered timely if they are
were derived from the following dates: Fishers Lane, Rm. 1061, Rockville, MD
postmarked or the delivery service
1. The date an exemption under 20852.
acceptance receipt is on or before that
section 505(i) of the Federal Food, Drug, Dated: January 31, 2018. date.
and Cosmetic Act (21 U.S.C. 355(i)) Leslie Kux,
became effective: February 15, 2007. Electronic Submissions
Associate Commissioner for Policy.
FDA has verified the applicant’s claims Submit electronic comments in the
[FR Doc. 2018–02419 Filed 2–6–18; 8:45 am]
that the date the investigational new following way:
drug application became effective was BILLING CODE 4164–01–P • Federal eRulemaking Portal:
on February 15, 2007. https://www.regulations.gov. Follow the
2. The date the application was instructions for submitting comments.
sradovich on DSK3GMQ082PROD with NOTICES

initially submitted with respect to the Comments submitted electronically,
human biological product under section including attachments, to https://
351 of the Public Health Service Act (42 www.regulations.gov will be posted to
U.S.C. 262): September 19, 2014. FDA the docket unchanged. Because your
has verified the applicant’s claim that comment will be made public, you are
the biologics license application (BLA) solely responsible for ensuring that your
for BLINCYTO (BLA 125557) was comment does not include any

VerDate Sep<11>2014 18:17 Feb 06, 2018 Jkt 244001 PO 00000 Frm 00042 Fmt 4703 Sfmt 4703 E:\FR\FM\07FEN1.SGM 07FEN1

Document Created: 2018-10-26 13:57:34
Document Modified: 2018-10-26 13:57:34

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice.
Dates		Anyone with knowledge that any of the dates as published (in the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by April 9, 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 6, 2018. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for more 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.
FR Citation		83 FR 5440

83 FR 5440 - Determination of Regulatory Review Period for Purposes of Patent Extension; BLINCYTO

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 26 (February 7, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration