80 FR 80774 - Determination of Regulatory Review Period for Purposes of Patent Extension; KADCYLA

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 248 (December 28, 2015)

Page Range		80774-80775
FR Document		2015-32475

The Food and Drug Administration (FDA) has determined the regulatory review period for KADCYLA 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 biological product.

Federal Register, Volume 80 Issue 248 (Monday, December 28, 2015)

[Federal Register Volume 80, Number 248 (Monday, December 28, 2015)]
[Notices]
[Pages 80774-80775]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-32475]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket Nos. FDA-2013-E-1692 and FDA-2013-E-1691]

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for KADCYLA 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 biological 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
February 26, 2016. 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 June 27,
2016. See ``Petitions'' in the SUPPLEMENTARY INFORMATION section for
more information.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2013-E-1692 and FDA-2013-E-1691 for ``Determination of Regulatory
Review Period for Purposes of Patent Extension; KADCYLA''.
Received comments will be placed in the docket and, except for
those submitted as ``Confidential Submissions'', publicly viewable at
http://www.regulations.gov or at the Division of Dockets Management
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 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

[[Page 80775]]

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 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 KADCYLA
(ado-trastuzumab emtansine). KADCYLA is indicated as a single agent,
for the treatment of patients with HER2-positive metastatic breast
cancer who previously received trastuzumab and a taxane, separately or
in combination. Subsequent to this approval, the USPTO received patent
term restoration applications for KADCYLA (U.S. Patent Nos. 7,097,840
and 8,337,856) from Genentech, Inc., and the USPTO requested FDA's
assistance in determining these patents' eligibility for patent term
restoration. In a letter dated May 23, 2014, FDA advised the USPTO that
this human biological product had undergone a regulatory review period
and that the approval of KADCYLA 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
KADCYLA is 2,594 days. Of this time, 2,414 days occurred during the
testing phase of the regulatory review period, while 180 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: January 18,
2006. FDA has verified the applicant's claim that the date the
investigational new drug application became effective was on January
18, 2006.
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): August 27, 2012. The applicant claims
August 24, 2012, as the date the biologics license application (BLA)
for KADCYLA (BLA 125427) was initially submitted. However, FDA records
indicate that BLA 125427 was submitted on August 27, 2012.
3. The date the application was approved: February 22, 2013. FDA
has verified the applicant's claim that BLA 125427 was approved on
February 22, 2013.
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 1,277 or 60 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 ask for
a redetermination (see DATES). 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.
To meet its burden, the petition must be timely (see DATES) and contain
sufficient facts to merit an FDA investigation. (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 http://www.regulations.gov at
Docket No. FDA-2013-S-0610. Submit written petitions (two copies are
required) to the Division of Dockets Management (HFA-305), Food and
Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Petitions that have not been made publicly available on http://www.regulations.gov may be viewed in the Division of Dockets Management
between 9 a.m. and 4 p.m., Monday through Friday.

Dated: December 21, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-32475 Filed 12-24-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 248 / Monday, December 28, 2015 / Notices 80775

so long as the patented item (human approval phase. These periods of time Dated: December 21, 2015.
drug product, animal drug product, were derived from the following dates: Leslie Kux,
medical device, food additive, or color 1. The date an exemption under Associate Commissioner for Policy.
additive) was subject to regulatory section 505(i) of the Federal Food, Drug, [FR Doc. 2015–32475 Filed 12–24–15; 8:45 am]
review by FDA before the item was and Cosmetic Act (21 U.S.C. 355(i)) BILLING CODE 4164–01–P
marketed. Under these acts, a product’s became effective: January 18, 2006. FDA
regulatory review period forms the basis has verified the applicant’s claim that
for determining the amount of extension the date the investigational new drug DEPARTMENT OF HEALTH AND
an applicant may receive. HUMAN SERVICES
application became effective was on
A regulatory review period consists of
two periods of time: A testing phase and January 18, 2006.
Food and Drug Administration
an approval phase. For human 2. The date the application was
biological products, the testing phase initially submitted with respect to the [Docket No. FDA–2015–P–1898]
begins when the exemption to permit human biological product under section
Determination That KYTRIL
the clinical investigations of the 351 of the Public Health Service Act (42
(Granisetron Hydrochloride) Tablets,
biological becomes effective and runs U.S.C. 262): August 27, 2012. The
Equivalent 1 Milligram and 2 Milligram
until the approval phase begins. The applicant claims August 24, 2012, as the
Base, Were Not Withdrawn From Sale
approval phase starts with the initial date the biologics license application
for Reasons of Safety or Effectiveness
submission of an application to market (BLA) for KADCYLA (BLA 125427) was
the human biological product and initially submitted. However, FDA AGENCY: Food and Drug Administration,
continues until FDA grants permission records indicate that BLA 125427 was HHS.
to market the biological product. submitted on August 27, 2012. ACTION: Notice.
Although only a portion of a regulatory 3. The date the application was
review period may count toward the approved: February 22, 2013. FDA has SUMMARY: The Food and Drug
actual amount of extension that the Administration (FDA or Agency) has
verified the applicant’s claim that BLA
Director of USPTO may award (for determined that KYTRIL (granisetron
125427 was approved on February 22,
example, half the testing phase must be hydrochloride) tablets, equivalent (EQ)
2013.
subtracted as well as any time that may 1 milligram (mg) and 2 mg base, were
have occurred before the patent was This determination of the regulatory not withdrawn from sale for reasons of
issued), FDA’s determination of the review period establishes the maximum safety or effectiveness. This
length of a regulatory review period for potential length of a patent extension. determination will allow FDA to
a human biological product will include However, the USPTO applies several approve abbreviated new drug
all of the testing phase and approval statutory limitations in its calculations applications (ANDAs) for KYTRIL
phase as specified in 35 U.S.C. of the actual period for patent extension. (granisetron hydrochloride) tablets, EQ
156(g)(1)(B). In its applications for patent extension, 1 mg and 2 mg base, if all other legal
FDA has approved for marketing the this applicant seeks 1,277 or 60 days of and regulatory requirements are met.
human biologic product KADCYLA patent term extension. FOR FURTHER INFORMATION CONTACT:
(ado-trastuzumab emtansine).
III. Petitions Daniel Orr, Center for Drug Evaluation
KADCYLA is indicated as a single agent,
and Research, Food and Drug
for the treatment of patients with HER2- Anyone with knowledge that any of Administration, 10903 New Hampshire
positive metastatic breast cancer who the dates as published are incorrect may Ave., Bldg. 51, Rm. 6246, Silver Spring,
previously received trastuzumab and a submit either electronic or written
taxane, separately or in combination. MD 20993–0002, 240–402–0979.
comments and ask for a redetermination SUPPLEMENTARY INFORMATION: In 1984,
Subsequent to this approval, the USPTO (see DATES). Furthermore, any interested
received patent term restoration Congress enacted the Drug Price
person may petition FDA for a Competition and Patent Term
applications for KADCYLA (U.S. Patent
determination regarding whether the Restoration Act of 1984 (Pub. L. 98–417)
Nos. 7,097,840 and 8,337,856) from
applicant for extension acted with due (the 1984 amendments), which
Genentech, Inc., and the USPTO
diligence during the regulatory review authorized the approval of duplicate
requested FDA’s assistance in
period. To meet its burden, the petition versions of drug products under an
determining these patents’ eligibility for
must be timely (see DATES) and contain ANDA procedure. ANDA applicants
patent term restoration. In a letter dated
sufficient facts to merit an FDA must, with certain exceptions, show that
May 23, 2014, FDA advised the USPTO
investigation. (See H. Rept. 857, part 1, the drug for which they are seeking
that this human biological product had
98th Cong., 2d sess., pp. 41–42, 1984.) approval contains the same active
undergone a regulatory review period
Petitions should be in the format ingredient in the same strength and
and that the approval of KADCYLA
specified in 21 CFR 10.30. dosage form as the listed drug, which is
represented the first permitted
commercial marketing or use of the Submit petitions electronically to a version of the drug that was
product. Thereafter, the USPTO http://www.regulations.gov at Docket previously approved. ANDA applicants
requested that FDA determine the No. FDA–2013–S–0610. Submit written do not have to repeat the extensive
product’s regulatory review period. petitions (two copies are required) to the clinical testing otherwise necessary to
Division of Dockets Management (HFA– gain approval of a new drug application
II. Determination of Regulatory Review
mstockstill on DSK4VPTVN1PROD with NOTICES

305), Food and Drug Administration, (NDA).
Period 5630 Fishers Lane, Rm. 1061, Rockville, The 1984 amendments include what
FDA has determined that the MD 20852. Petitions that have not been is now section 505(j)(7) of the Federal
applicable regulatory review period for made publicly available on http:// Food, Drug, and Cosmetic Act (21 U.S.C.
KADCYLA is 2,594 days. Of this time, www.regulations.gov may be viewed in 355(j)(7)), which requires FDA to
2,414 days occurred during the testing the Division of Dockets Management publish a list of all approved drugs.
phase of the regulatory review period, between 9 a.m. and 4 p.m., Monday FDA publishes this list as part of the
while 180 days occurred during the through Friday. ‘‘Approved Drug Products With

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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 February 26, 2016. 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 June 27, 2016. 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		80 FR 80774

80 FR 80774 - Determination of Regulatory Review Period for Purposes of Patent Extension; KADCYLA

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 248 (December 28, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration