82 FR 49031 - Determination of Regulatory Review Period for Purposes of Patent Extension; OBIZUR

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 203 (October 23, 2017)

Page Range		49031-49032
FR Document		2017-22898

The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for OBIZUR 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 82 Issue 203 (Monday, October 23, 2017)

[Federal Register Volume 82, Number 203 (Monday, October 23, 2017)]
[Notices]
[Pages 49031-49032]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-22898]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2015-E-2660, FDA-2015-E-2662, FDA-2015-E-2722, and
FDA-2015-E-2965]

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

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 OBIZUR 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
December 22, 2017. 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 April 23,
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 December 22, 2017. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of December 22, 2017. 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-2660, FDA-2015-E-2662, FDA-2015-E-2722, and FDA-2015-E-2965
for ``Determination of Regulatory Review Period for Purposes of Patent
Extension; OBIZUR.'' 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.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,

[[Page 49032]]

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 OBIZUR
(rpFVIII). OBIZUR is indicated for the treatment of bleeding episodes
in adults with acquired hemophilia A. Subsequent to this approval, the
USPTO received patent term restoration applications for OBIZUR (U.S.
Patent Nos. 6,180,371; 6,458,563; and 7,560,107) from Emory University
and (U.S. Patent No. 7,576,181) from Emory University, Baxter
International, Inc., and Baxter Healthcare SA; and the USPTO requested
FDA's assistance in determining the patents' eligibility for patent
term restoration. In letters dated October 19, 2015, and January 11,
2016, FDA advised the USPTO that this human biological product had
undergone a regulatory review period and that the approval of OBIZUR
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
OBIZUR is 4,216 days. Of this time, 3,883 days occurred during the
testing phase of the regulatory review period, while 333 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: April 10,
2003. The applicant claims May 27, 2003, as the date the
investigational new drug application (IND) became effective. However,
FDA records indicate that the IND effective date was April 10, 2003.
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): November 25, 2013. The applicant claims
October 10, 2013, as the date the biologics license application (BLA)
for OBIZUR (BLA 125512/0) was initially submitted. However, FDA records
indicate that BLA 125512/0 was submitted on November 25, 2013.
3. The date the application was approved: October 23, 2014. FDA has
verified the applicant's claim that BLA 125512/0 was approved on
October 23, 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 5 years of patent term extension.

III. Petitions

Anyone with knowledge that any of the dates as published are
incorrect may submit either electronic or written comments and, under
21 CFR 60.24, ask for a redetermination (see DATES). Furthermore, as
specified in Sec. 60.30 (21 CFR 60.30), any interested person may
petition FDA for a determination regarding whether the applicant for
extension acted with due diligence during the regulatory review period.
To meet its burden, the petition must comply with all the requirements
of Sec. 60.30, including but not limited to: Must be timely (see
DATES), must be filed in accordance with Sec. 10.20, must contain
sufficient facts to merit an FDA investigation, and must certify that a
true and complete copy of the petition has been served upon the patent
applicant. (See H. Rept. 857, part 1, 98th Cong., 2d sess., pp. 41-42,
1984.) Petitions should be in the format specified in 21 CFR 10.30.
Submit petitions electronically to https://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

Dated: October 17, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-22898 Filed 10-20-17; 8:45 am]
BILLING CODE 4164-01-P

49032 Federal Register / Vol. 82, No. 203 / Monday, October 23, 2017 / Notices

Rm. 6250, Silver Spring, MD 20993, commercial marketing or use of the investigation, and must certify that a
301–796–3600. product. Thereafter, the USPTO true and complete copy of the petition
SUPPLEMENTARY INFORMATION: requested that FDA determine the has been served upon the patent
product’s regulatory review period. applicant. (See H. Rept. 857, part 1, 98th
I. Background Cong., 2d sess., pp. 41–42, 1984.)
II. Determination of Regulatory Review
The Drug Price Competition and Petitions should be in the format
Period
Patent Term Restoration Act of 1984 specified in 21 CFR 10.30.
(Pub. L. 98–417) and the Generic FDA has determined that the Submit petitions electronically to
Animal Drug and Patent Term applicable regulatory review period for https://www.regulations.gov at Docket
Restoration Act (Pub. L. 100–670) OBIZUR is 4,216 days. Of this time, No. FDA–2013–S–0610. Submit written
generally provide that a patent may be 3,883 days occurred during the testing petitions (two copies are required) to the
extended for a period of up to 5 years phase of the regulatory review period, Dockets Management Staff (HFA–305),
so long as the patented item (human while 333 days occurred during the Food and Drug Administration, 5630
drug product, animal drug product, approval phase. These periods of time Fishers Lane, Rm. 1061, Rockville, MD
medical device, food additive, or color were derived from the following dates: 20852.
additive) was subject to regulatory 1. The date an exemption under
section 505(i) of the Federal Food, Drug, Dated: October 17, 2017.
review by FDA before the item was
and Cosmetic Act (21 U.S.C. 355(i)) Leslie Kux,
marketed. Under these acts, a product’s
regulatory review period forms the basis became effective: April 10, 2003. The Associate Commissioner for Policy.
for determining the amount of extension applicant claims May 27, 2003, as the [FR Doc. 2017–22898 Filed 10–20–17; 8:45 am]
an applicant may receive. date the investigational new drug BILLING CODE 4164–01–P
A regulatory review period consists of application (IND) became effective.
two periods of time: A testing phase and However, FDA records indicate that the
an approval phase. For human IND effective date was April 10, 2003. DEPARTMENT OF HEALTH AND
biological products, the testing phase 2. The date the application was HUMAN SERVICES
begins when the exemption to permit initially submitted with respect to the
the clinical investigations of the human biological product under section Food and Drug Administration
biological product becomes effective 351 of the Public Health Service Act (42 [Docket No. FDA–2017–P–3581]
and runs until the approval phase U.S.C. 262): November 25, 2013. The
begins. The approval phase starts with applicant claims October 10, 2013, as Determination That ELAVIL
the initial submission of an application the date the biologics license (Amitriptyline Hydrochloride) Oral
to market the human biological product application (BLA) for OBIZUR (BLA Tablets, 10, 25, 50, 75, 100, and 150
and continues until FDA grants 125512/0) was initially submitted. Milligrams, Were Not Withdrawn From
permission to market the biological However, FDA records indicate that Sale for Reasons of Safety or
product. Although only a portion of a BLA 125512/0 was submitted on Effectiveness
regulatory review period may count November 25, 2013.
3. The date the application was AGENCY: Food and Drug Administration,
toward the actual amount of extension
that the Director of USPTO may award approved: October 23, 2014. FDA has HHS.
(for example, half the testing phase must verified the applicant’s claim that BLA ACTION: Notice.
be subtracted as well as any time that 125512/0 was approved on October 23, SUMMARY: The Food and Drug
may have occurred before the patent 2014. Administration (FDA or Agency) has
was issued), FDA’s determination of the This determination of the regulatory
determined that ELAVIL (amitriptyline
length of a regulatory review period for review period establishes the maximum
hydrochloride) oral tablets, 10
a human biological product will include potential length of a patent extension.
milligrams (mg), 25 mg, 50 mg, 75 mg,
all of the testing phase and approval However, the USPTO applies several
100 mg, and 150 mg, were not
phase as specified in 35 U.S.C. statutory limitations in its calculations
withdrawn from sale for reasons of
156(g)(1)(B). of the actual period for patent extension.
safety or effectiveness. This
FDA has approved for marketing the In its applications for patent extension,
human biologic product OBIZUR determination will allow FDA to
this applicant seeks 5 years of patent
(rpFVIII). OBIZUR is indicated for the approve abbreviated new drug
term extension.
treatment of bleeding episodes in adults applications (ANDAs) for amitriptyline
with acquired hemophilia A. III. Petitions hydrochloride oral tablets, 10 mg, 25
Subsequent to this approval, the USPTO Anyone with knowledge that any of mg, 50 mg, 75 mg, 100 mg, and 150 mg,
received patent term restoration the dates as published are incorrect may if all other legal and regulatory
applications for OBIZUR (U.S. Patent submit either electronic or written requirements are met.
Nos. 6,180,371; 6,458,563; and comments and, under 21 CFR 60.24, ask FOR FURTHER INFORMATION CONTACT:
7,560,107) from Emory University and for a redetermination (see DATES). Stacy Kane, Center for Drug Evaluation
(U.S. Patent No. 7,576,181) from Emory Furthermore, as specified in § 60.30 (21 and Research, Food and Drug
University, Baxter International, Inc., CFR 60.30), any interested person may Administration, 10903 New Hampshire
and Baxter Healthcare SA; and the petition FDA for a determination Ave., Bldg. 51, Rm. 6236, Silver Spring,
USPTO requested FDA’s assistance in regarding whether the applicant for MD 20993–0002, 301–796–8363,
determining the patents’ eligibility for extension acted with due diligence stacy.kane@fda.hhs.gov.
ethrower on DSK3G9T082PROD with NOTICES

patent term restoration. In letters dated during the regulatory review period. To SUPPLEMENTARY INFORMATION: In 1984,
October 19, 2015, and January 11, 2016, meet its burden, the petition must Congress enacted the Drug Price
FDA advised the USPTO that this comply with all the requirements of Competition and Patent Term
human biological product had § 60.30, including but not limited to: Restoration Act of 1984 (Pub. L. 98–417)
undergone a regulatory review period Must be timely (see DATES), must be (the 1984 amendments), which
and that the approval of OBIZUR filed in accordance with § 10.20, must authorized the approval of duplicate
represented the first permitted contain sufficient facts to merit an FDA versions of drug products under an

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Document Created: 2017-10-21 02:35:29
Document Modified: 2017-10-21 02:35:29

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 December 22, 2017. 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 April 23, 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		82 FR 49031

82 FR 49031 - Determination of Regulatory Review Period for Purposes of Patent Extension; OBIZUR

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 203 (October 23, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration