83 FR 2454 - Determination of Regulatory Review Period for Purposes of Patent Extension; DAKLINZA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 83, Issue 11 (January 17, 2018)

Page Range		2454-2455
FR Document		2018-00675

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

Federal Register, Volume 83 Issue 11 (Wednesday, January 17, 2018)

[Federal Register Volume 83, Number 11 (Wednesday, January 17, 2018)]
[Notices]
[Pages 2454-2455]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2018-00675]

[[Page 2454]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2016-E-1265]

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

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 DAKLINZA 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 (in the
SUPPLEMENTARY INFORMATION section) are incorrect may submit either
electronic or written comments and ask for a redetermination by March
19, 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 July 16, 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 March 19, 2018. The https://www.regulations.gov electronic filing system will accept comments until
midnight Eastern Time at the end of March 19, 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 No.
FDA-2016-E-1265 for ``Determination of Regulatory Review Period for
Purposes of Patent Extension; DAKLINZA.'' 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

[[Page 2455]]

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 DAKLINZA
(daclatasvir dihydrochloride). DAKLINZA is indicated for use with
sofosbuvir for the treatment of chronic HCV genotype 3 infection.
Subsequent to this approval, the USPTO received a patent term
restoration application for DAKLINZA (U.S. Patent No. 8,329,159) from
Bristol-Myers Squibb Company, and the USPTO requested FDA's assistance
in determining this patent's eligibility for patent term restoration.
In a letter dated July 12, 2016, FDA advised the USPTO that this human
drug product had undergone a regulatory review period and that the
approval of DAKLINZA 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
DAKLINZA is 2,808 days. Of this time, 2,327 days occurred during the
testing phase of the regulatory review period, while 481 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 (the FD&C Act) (21 U.S.C. 355(i))
became effective: November 17, 2007. The applicant claims November
16, 2007, as the date the investigational new drug application (IND)
became effective. However, FDA records indicate that the IND
effective date was November 17, 2007, which was 30 days after FDA
receipt of the IND.
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 31, 2014. FDA has verified the applicant's claim that the new
drug application (NDA) for DAKLINZA (NDA 206843) was initially
submitted on March 31, 2014.
3. The date the application was approved: July 24, 2015. FDA has
verified the applicant's claim that NDA 206843 was approved on July
24, 2015.

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 467 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 11, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-00675 Filed 1-16-18; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 83, No. 11 / Wednesday, January 17, 2018 / Notices 2455

actual amount of extension that the Act: March 31, 2014. FDA has verified the Dated: January 11, 2018.
Director of USPTO may award (for applicant’s claim that the new drug Leslie Kux,
example, half the testing phase must be application (NDA) for DAKLINZA (NDA Associate Commissioner for Policy.
subtracted as well as any time that may 206843) was initially submitted on March 31, [FR Doc. 2018–00675 Filed 1–16–18; 8:45 am]
have occurred before the patent was 2014.
BILLING CODE 4164–01–P
issued), FDA’s determination of the 3. The date the application was approved:
length of a regulatory review period for July 24, 2015. FDA has verified the
a human drug product will include all applicant’s claim that NDA 206843 was DEPARTMENT OF HEALTH AND
of the testing phase and approval phase approved on July 24, 2015. HUMAN SERVICES
as specified in 35 U.S.C. 156(g)(1)(B).
This determination of the regulatory
FDA has approved for marketing the Food and Drug Administration
human drug product DAKLINZA review period establishes the maximum
(daclatasvir dihydrochloride). potential length of a patent extension. [Docket No. FDA–2017–N–0002]
DAKLINZA is indicated for use with However, the USPTO applies several
statutory limitations in its calculations Delcor Asset Corp. et al.; Withdrawal
sofosbuvir for the treatment of chronic of Approval of 22 Abbreviated New
HCV genotype 3 infection. Subsequent of the actual period for patent extension.
In its application for patent extension, Drug Applications
to this approval, the USPTO received a
patent term restoration application for this applicant seeks 467 days of patent AGENCY: Food and Drug Administration,
DAKLINZA (U.S. Patent No. 8,329,159) term extension. HHS.
from Bristol-Myers Squibb Company, III. Petitions ACTION: Notice.
and the USPTO requested FDA’s
assistance in determining this patent’s Anyone with knowledge that any of SUMMARY: The Food and Drug
eligibility for patent term restoration. In the dates as published are incorrect may Administration (FDA or Agency) is
a letter dated July 12, 2016, FDA submit either electronic or written withdrawing approval of 22 abbreviated
advised the USPTO that this human comments and, under 21 CFR 60.24, ask new drug applications (ANDAs) from
drug product had undergone a for a redetermination (see DATES). multiple applicants. The holders of the
regulatory review period and that the Furthermore, as specified in § 60.30 (21 applications notified the Agency in
approval of DAKLINZA represented the CFR 60.30), any interested person may writing that the drug products were no
first permitted commercial marketing or longer marketed and requested that the
petition FDA for a determination
use of the product. Thereafter, the approval of the applications be
regarding whether the applicant for
USPTO requested that FDA determine withdrawn.
extension acted with due diligence
the product’s regulatory review period. DATES: Approval is withdrawn as of
during the regulatory review period. To
II. Determination of Regulatory Review meet its burden, the petition must February 16, 2018.
Period comply with all the requirements of FOR FURTHER INFORMATION CONTACT:
FDA has determined that the § 60.30, including but not limited to: Trang Tran, Center for Drug Evaluation
applicable regulatory review period for Must be timely (see DATES), must be and Research, Food and Drug
DAKLINZA is 2,808 days. Of this time, filed in accordance with § 10.20, must Administration, 10903 New Hampshire
2,327 days occurred during the testing contain sufficient facts to merit an FDA Ave., Bldg. 75, Rm. 1671, Silver Spring,
phase of the regulatory review period, investigation, and must certify that a MD 20993–0002, 240–402–7945,
while 481 days occurred during the true and complete copy of the petition Trang.Tran@fda.hhs.gov.
approval phase. These periods of time has been served upon the patent SUPPLEMENTARY INFORMATION: The
were derived from the following dates: applicant. (See H. Rept. 857, part 1, 98th holders of the applications listed in
1. The date an exemption under section Cong., 2d sess., pp. 41–42, 1984.) table 1 have informed FDA that these
505(i) of the Federal Food, Drug, and Petitions should be in the format drug products are no longer marketed
Cosmetic Act (the FD&C Act) (21 U.S.C. specified in 21 CFR 10.30. and have requested that FDA withdraw
355(i)) became effective: November 17, 2007. approval of the applications under the
The applicant claims November 16, 2007, as Submit petitions electronically to process in § 314.150(c) (21 CFR
the date the investigational new drug https://www.regulations.gov at Docket 314.150(c)). The applicants have also,
application (IND) became effective. However, No. FDA–2013–S–0610. Submit written by their requests, waived their
FDA records indicate that the IND effective petitions (two copies are required) to the
date was November 17, 2007, which was 30
opportunity for a hearing. Withdrawal
Dockets Management Staff (HFA–305), of approval of an application or
days after FDA receipt of the IND.
2. The date the application was initially Food and Drug Administration, 5630 abbreviated application under
submitted with respect to the human drug Fishers Lane, Rm. 1061, Rockville, MD § 314.150(c) is without prejudice to
product under section 505(b) of the FD&C 20852. refiling.

TABLE 1—ANDAS FOR WHICH FDA IS WITHDRAWING APPROVAL
Application No. Drug Applicant

ANDA 060577 .......... Mycostatin (nystatin) Vaginal Tablets, 100,000 units ........... Delcor Asset Corp., 411 South State St., Suite E–100,
Newtown, PA 18940.
ethrower on DSK3G9T082PROD with NOTICES

ANDA 063302 .......... Cefamandole Nafate for Injection ......................................... ACS Dobfar SpA, c/o Interchem Corp., 120 Route 17
North, Paramus, NJ 07653.
ANDA 070462 .......... Diazepam Tablets USP, 2 milligrams (mg) .......................... Virtus Pharmaceuticals, 12 Penns Trail, Newtown, PA
18940.
ANDA 070463 .......... Diazepam Tablets USP, 5 mg .............................................. Do.
ANDA 070998 .......... Potassium Chloride Extended-Release Tablets, 8 milli- Future Pak, Ltd., 28115 Lakeview Dr., Wixom, MI 48393.
equivalents (mEq).
ANDA 070999 .......... Potassium Chloride Extended-Release Tablets, 10 mEq .... Do.

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Document Created: 2018-10-26 09:55:29
Document Modified: 2018-10-26 09:55:29

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 March 19, 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 July 16, 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 2454

83 FR 2454 - Determination of Regulatory Review Period for Purposes of Patent Extension; DAKLINZA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 83, Issue 11 (January 17, 2018)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration