83 FR 53260 - Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

Page Range		53260-53262
FR Document		2018-22956

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

Federal Register, Volume 83 Issue 204 (Monday, October 22, 2018)

[Federal Register Volume 83, Number 204 (Monday, October 22, 2018)]
[Notices]
[Pages 53260-53262]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-22956]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2017-E-6715, FDA-2017-E-6721, and FDA-2017-E-6726]

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

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 TYMLOS 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

[[Page 53261]]

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
December 21, 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 April 22,
2019. 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 21, 2018. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of December 21, 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-2017-E-6715, FDA-2017-E-6721, and FDA-2017-E-6726 for
``Determination of Regulatory Review Period for Purposes of Patent
Extension; TYMLOS.'' 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, 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 TYMLOS
(abaloparatide). TYMLOS is indicated for the treatment of
postmenopausal women with osteoporosis at high risk for fracture.
Subsequent to this approval, the USPTO received patent term restoration
applications for TYMLOS (U.S. Patent Nos. 7,803,770; 8,148,333; and
8,748,382) from Radius Health, Inc., and the USPTO requested FDA's
assistance in determining the patents' eligibility for patent term

[[Page 53262]]

restoration. In a letter dated February 8, 2018, FDA advised the USPTO
that this human drug product had undergone a regulatory review period
and that the approval of TYMLOS 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
TYMLOS is 4,130 days. Of this time, 3,735 days occurred during the
testing phase of the regulatory review period, while 395 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:
January 8, 2006. FDA has verified the applicant's claim that the date
the investigational new drug application became effective was January
8, 2006.
2. The date the application was initially submitted with respect to
the human drug product under section 505(b) of the FD&C Act: March 30,
2016. FDA has verified the applicant's claim that the new drug
application (NDA) for TYMLOS (NDA 208743) was initially submitted on
March 30, 2016.
3. The date the application was approved: April 28, 2017. FDA has
verified the applicant's claim that NDA 208743 was approved on April
28, 2017.
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 724 days, 1,123 days, or 1,128 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: October 16, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-22956 Filed 10-19-18; 8:45 am]
BILLING CODE 4164-01-P

53262 Federal Register / Vol. 83, No. 204 / Monday, October 22, 2018 / Notices

restoration. In a letter dated February 8, investigation, and must certify that a North, 10A–12M, 11601 Landsdown St.,
2018, FDA advised the USPTO that this true and complete copy of the petition North Bethesda, MD 20852, 301–796–
human drug product had undergone a has been served upon the patent 3794, PRAStaff@fda.hhs.gov.
regulatory review period and that the applicant. (See H. Rept. 857, part 1, 98th SUPPLEMENTARY INFORMATION: In
approval of TYMLOS represented the Cong., 2d sess., pp. 41–42, 1984.) compliance with 44 U.S.C. 3507, FDA
first permitted commercial marketing or Petitions should be in the format has submitted the following proposed
use of the product. Thereafter, the specified in 21 CFR 10.30. collection of information to OMB for
USPTO requested that FDA determine Submit petitions electronically to review and clearance.
the product’s regulatory review period. https://www.regulations.gov at Docket
No. FDA–2013–S–0610. Submit written Guidance for Industry on Formal
II. Determination of Regulatory Review Meetings With Sponsors and
petitions (two copies are required) to the
Period Applicants for Prescription Drug User
Dockets Management Staff (HFA–305),
FDA has determined that the Food and Drug Administration, 5630 Fee Act Products
applicable regulatory review period for Fishers Lane, Rm. 1061, Rockville, MD OMB Control Number 0910–0429—
TYMLOS is 4,130 days. Of this time, 20852. Extension
3,735 days occurred during the testing
Dated: October 16, 2018. This information collection supports
phase of the regulatory review period,
while 395 days occurred during the Leslie Kux, the above captioned Agency guidance
approval phase. These periods of time Associate Commissioner for Policy. document. The guidance document was
were derived from the following dates: [FR Doc. 2018–22956 Filed 10–19–18; 8:45 am] issued to help individuals with
1. The date an exemption under BILLING CODE 4164–01–P procedures on formal meetings between
section 505(i) of the Federal Food, Drug, FDA and sponsors or applicants
and Cosmetic Act (FD&C Act) (21 U.S.C. regarding the development and review
355(i)) became effective: January 8, DEPARTMENT OF HEALTH AND of Prescription Drug User Fee Act
2006. FDA has verified the applicant’s HUMAN SERVICES (PDUFA) products. The guidance
claim that the date the investigational describes procedures for requesting,
Food and Drug Administration scheduling, conducting, and
new drug application became effective
was January 8, 2006. [Docket No. FDA–2018–N–2434] documenting such formal meetings. The
2. The date the application was guidance provides information on how
initially submitted with respect to the Agency Information Collection FDA interprets and applies section
human drug product under section Activities; Submission for Office of 119(a) of the Food and Drug
505(b) of the FD&C Act: March 30, 2016. Management and Budget Review; Administration Modernization Act of
FDA has verified the applicant’s claim Comment Request; Guidance for 2007 (Pub. L. 105–115), specific PDUFA
that the new drug application (NDA) for Industry on Formal Meetings With goals for the management of meetings
TYMLOS (NDA 208743) was initially Sponsors and Applicants for associated with the review of human
submitted on March 30, 2016. Prescription Drug User Fee Act drug applications for PDUFA products,
3. The date the application was Products and provisions of existing regulations
approved: April 28, 2017. FDA has describing certain meetings (§§ 12.47
AGENCY: Food and Drug Administration, and 312.82 (21 CFR 312.47 and 312.82)).
verified the applicant’s claim that NDA HHS.
208743 was approved on April 28, 2017. The collection of information described
This determination of the regulatory ACTION: Notice. in the guidance reflects the current and
review period establishes the maximum SUMMARY: The Food and Drug past practice of sponsors and applicants
potential length of a patent extension. Administration (FDA, Agency, or we) is to submit meeting requests and
However, the USPTO applies several announcing that a proposed collection background information prior to a
statutory limitations in its calculations of information has been submitted to the scheduled meeting. Agency regulations
of the actual period for patent extension. Office of Management and Budget currently permit such requests and
In its applications for patent extension, (OMB) for review and clearance under recommend the submission of an
this applicant seeks 724 days, 1,123 the Paperwork Reduction Act of 1995. information package before an ‘‘end-of-
days, or 1,128 days of patent term phase 2 meeting’’ (§§ 312.47(b)(1)(ii)
DATES: Fax written comments on the
extension. and (iv)) and a ‘‘pre-NDA meeting’’
collection of information by November
(§ 312.47(b)(2)). While the information
III. Petitions 21, 2018.
collection provisions of § 312.47 are
Anyone with knowledge that any of ADDRESSES: To ensure that comments on
currently approved under OMB control
the dates as published are incorrect may the information collection are received, number 0910–0014, the guidance
submit either electronic or written OMB recommends that written provides additional recommendations
comments and, under 21 CFR 60.24, ask comments be faxed to the Office of for submitting information to FDA in
for a redetermination (see DATES). Information and Regulatory Affairs, support of a meeting request. The
Furthermore, as specified in § 60.30 (21 OMB, Attn: FDA Desk Officer, Fax: 202– guidance document is available on our
CFR 60.30), any interested person may 395–7285, or emailed to oira_ website at: https://www.fda.gov/
petition FDA for a determination submission@omb.eop.gov. All downloads/Drugs/Guidance
regarding whether the applicant for comments should be identified with the ComplianceRegulatoryInformation/
extension acted with due diligence OMB control number 0910–0429. Also Guidances/UCM590547.pdf.
daltland on DSKBBV9HB2PROD with NOTICES

during the regulatory review period. To include the FDA docket number found Request for a Meeting—Consistent
meet its burden, the petition must in brackets in the heading of this with recommendations found in the
comply with all the requirements of document. guidance, a sponsor or applicant
§ 60.30, including but not limited to: FOR FURTHER INFORMATION CONTACT: interested in meeting with the Center for
Must be timely (see DATES), must be JonnaLynn Capezzuto, Office of Drug Evaluation and Research (CDER) or
filed in accordance with § 10.20, must Operations, Food and Drug the Center for Biologics Evaluation and
contain sufficient facts to merit an FDA Administration, Three White Flint Research (CBER) should submit a

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Document Created: 2018-10-20 01:49:17
Document Modified: 2018-10-20 01:49:17

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 (see the SUPPLEMENTARY INFORMATION section) are incorrect may submit either electronic or written comments and ask for a redetermination by December 21, 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 April 22, 2019. 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 53260

83 FR 53260 - Determination of Regulatory Review Period for Purposes of Patent Extension; TYMLOS

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 204 (October 22, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration