80 FR 23801 - Determination of Regulatory Review Period for Purposes of Patent Extension; Xience Xpedition Everolimus Eluting Coronary Stent System

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 80, Issue 82 (April 29, 2015)

Page Range		23801-23802
FR Document		2015-09902

The Food and Drug Administration (FDA) has determined the regulatory review period for Xience Xpedition Everolimus Eluting Coronary Stent System 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 medical device.

Federal Register, Volume 80 Issue 82 (Wednesday, April 29, 2015)

[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23801-23802]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2015-09902]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-E-0102]

Determination of Regulatory Review Period for Purposes of Patent
Extension; Xience Xpedition Everolimus Eluting Coronary Stent System

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

-----------------------------------------------------------------------

SUMMARY: The Food and Drug Administration (FDA) has determined the
regulatory review period for Xience Xpedition Everolimus Eluting
Coronary Stent System 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 medical device.

ADDRESSES: Submit electronic comments to http://www.regulations.gov.
Submit written petitions (two copies are required) and written comments
to the Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Submit petitions electronically to http://www.regulations.gov at Docket
No. FDA-2013-S-0610.

FOR FURTHER INFORMATION CONTACT: Beverly Friedman, Office of
Management, Center for Drug Evaluation and Research, Food and Drug
Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180,
Silver Spring, MD 20993-0002, 301-796-7900.

SUPPLEMENTARY INFORMATION: 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 medical devices, the testing
phase begins with a clinical investigation of the device and runs until
the approval phase begins. The approval phase starts with the initial
submission of an application to market the device and continues until
permission to market the device is granted. Although only a portion of
a regulatory review period may count toward the actual amount of
extension that the Director of Patents and Trademarks may award (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 medical device will include
all of the testing phase and approval phase as specified in 35 U.S.C.
156(g)(3)(B).
FDA has approved for marketing the medical device, Xience Xpedition
Everolimus Eluting Coronary Stent System. Xience Xpedition Everolimus
Eluting Coronary Stent System is indicated for improving coronary
luminal diameter in subjects with symptomatic heart disease due to de
novo native coronary artery lesions (length <=32 millimeters (mm)) with
reference vessel diameter of >=2.25 mm and <=4.25 mm. Subsequent to
this approval, the USPTO received a patent term restoration application
for Xience Xpedition Everolimus Eluting Coronary Stent System (U.S.
Patent No. 7,828,766) from Abbott Cardiovascular Systems Inc., and the
USPTO requested FDA's assistance in determining this patent's
eligibility for patent term restoration. In a letter dated May 22,
2014, FDA advised the USPTO that this medical device had undergone a
regulatory review period and that the approval of Xience Xpedition
Everolimus Eluting Coronary Stent System represented the first
permitted commercial marketing or use of the product. Thereafter, the
USPTO requested that FDA determine the product's regulatory review
period.
FDA has determined that the applicable regulatory review period for
Xience Xpedition Everolimus Eluting Coronary Stent System is 178 days.
Of this time, zero (0) days occurred during the testing phase of the
regulatory review period, while 178 days occurred during the approval
phase. These periods of time were derived from the following dates:
1. The date an exemption under section 520(g) of the Federal Food,
Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360j(g)) involving
this device became effective: Not Applicable. Applicant did not perform
clinical investigations utilizing the patented device, but, rather,
sought and was granted marketing approval based on a supplemental
filing to a previously approved premarket approval application (PMA).
2. The date an application was initially submitted with respect to
the device under section 515 of the FD&C Act (21 U.S.C. 360e): June 27,
2012. FDA has verified the applicant's claim that the PMA for Xience
Xpedition Everolimus Eluting Coronary Stent System (PMA P110019S025)
was initially submitted June 27, 2012.
3. The date the application was approved: December 21, 2012. FDA
has verified the applicant's claim that PMA P110019S025 was approved on
December 21, 2012.
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 178 days of patent term extension.
Anyone with knowledge that any of the dates as published are
incorrect may submit to the Division of Dockets Management (see
ADDRESSES) either electronic or written comments and ask for a
redetermination by June 29, 2015. 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 October 26, 2015. To meet its burden, the petition must
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.

[[Page 23802]]

Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) electronic or written comments and written or
electronic petitions. It is only necessary to send one set of comments.
Identify comments with the docket number found in brackets in the
heading of this document. If you submit a written petition, two copies
are required. A petition submitted electronically must be submitted to
http://www.regulations.gov, Docket No. FDA-2013-S-0610. Comments and
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: April 23, 2015.
Peter Lurie,
Associate Commissioner for Public Health Strategy and Analysis.
[FR Doc. 2015-09902 Filed 4-28-15; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices 23801

2. ‘‘Guidance for Industry and FDA Staff: Evaluation and Research, Food and Xience Xpedition Everolimus Eluting
Balancing Premarket and Postmarket Drug Administration, 10001 New Coronary Stent System represented the
Data Collection for Devices Subject to Hampshire Ave., Hillandale Campus, first permitted commercial marketing or
Premarket Approval,’’ April 2015,
Rm. 3180, Silver Spring, MD 20993– use of the product. Thereafter, the
available at http://www.fda.gov/ucm/
groups/fdagov-public/@fdagov-meddev- 0002, 301–796–7900. USPTO requested that FDA determine
gen/documents/document/ SUPPLEMENTARY INFORMATION: The Drug the product’s regulatory review period.
ucm393994.pdf. Price Competition and Patent Term FDA has determined that the
3. ‘‘Guidance for Industry and FDA Staff: Restoration Act of 1984 (Pub. L. 98–417) applicable regulatory review period for
Expedited Access for Premarket and the Generic Animal Drug and Patent Xience Xpedition Everolimus Eluting
Approval and De Novo Medical Devices Coronary Stent System is 178 days. Of
Term Restoration Act (Pub. L. 100–670)
Intended for Unmet Medical Need for this time, zero (0) days occurred during
Life Threatening or Irreversibly generally provide that a patent may be
Debilitating Diseases or Conditions,’’ extended for a period of up to 5 years the testing phase of the regulatory
April 2015, available at http://www.fda. so long as the patented item (human review period, while 178 days occurred
gov/ucm/groups/fdagov-public/@fdagov- drug product, animal drug product, during the approval phase. These
meddev-gen/documents/document/ medical device, food additive, or color periods of time were derived from the
ucm393978.pdf. additive) was subject to regulatory following dates:
Dated: April 22, 2015. review by FDA before the item was 1. The date an exemption under
Peter Lurie, marketed. Under these acts, a product’s section 520(g) of the Federal Food, Drug,
Associate Commissioner for Public Health regulatory review period forms the basis and Cosmetic Act (the FD&C Act) (21
Strategy and Analysis. for determining the amount of extension U.S.C. 360j(g)) involving this device
[FR Doc. 2015–09884 Filed 4–28–15; 8:45 am] an applicant may receive. became effective: Not Applicable.
A regulatory review period consists of Applicant did not perform clinical
BILLING CODE 4164–01–P
two periods of time: A testing phase and investigations utilizing the patented
an approval phase. For medical devices, device, but, rather, sought and was
DEPARTMENT OF HEALTH AND the testing phase begins with a clinical granted marketing approval based on a
HUMAN SERVICES investigation of the device and runs supplemental filing to a previously
until the approval phase begins. The approved premarket approval
Food and Drug Administration approval phase starts with the initial application (PMA).
submission of an application to market 2. The date an application was
[Docket No. FDA–2014–E–0102]
the device and continues until initially submitted with respect to the
Determination of Regulatory Review permission to market the device is device under section 515 of the FD&C
Period for Purposes of Patent granted. Although only a portion of a Act (21 U.S.C. 360e): June 27, 2012. FDA
Extension; Xience Xpedition regulatory review period may count has verified the applicant’s claim that
Everolimus Eluting Coronary Stent toward the actual amount of extension the PMA for Xience Xpedition
System that the Director of Patents and Everolimus Eluting Coronary Stent
Trademarks may award (half the testing System (PMA P110019S025) was
AGENCY: Food and Drug Administration, phase must be subtracted as well as any initially submitted June 27, 2012.
HHS. time that may have occurred before the 3. The date the application was
ACTION: Notice. patent was issued), FDA’s determination approved: December 21, 2012. FDA has
of the length of a regulatory review verified the applicant’s claim that PMA
SUMMARY: The Food and Drug period for a medical device will include P110019S025 was approved on
Administration (FDA) has determined all of the testing phase and approval December 21, 2012.
the regulatory review period for Xience phase as specified in 35 U.S.C. This determination of the regulatory
Xpedition Everolimus Eluting Coronary 156(g)(3)(B). review period establishes the maximum
Stent System and is publishing this FDA has approved for marketing the potential length of a patent extension.
notice of that determination as required medical device, Xience Xpedition However, the USPTO applies several
by law. FDA has made the Everolimus Eluting Coronary Stent statutory limitations in its calculations
determination because of the System. Xience Xpedition Everolimus of the actual period for patent extension.
submission of an application to the Eluting Coronary Stent System is In its application for patent extension,
Director of the U.S. Patent and indicated for improving coronary this applicant seeks 178 days of patent
Trademark Office (USPTO), Department luminal diameter in subjects with term extension.
of Commerce, for the extension of a symptomatic heart disease due to de Anyone with knowledge that any of
patent which claims that medical novo native coronary artery lesions the dates as published are incorrect may
device. (length ≤32 millimeters (mm)) with submit to the Division of Dockets
ADDRESSES: Submit electronic reference vessel diameter of ≥2.25 mm Management (see ADDRESSES) either
comments to http:// and ≤4.25 mm. Subsequent to this electronic or written comments and ask
www.regulations.gov. Submit written approval, the USPTO received a patent for a redetermination by June 29, 2015.
petitions (two copies are required) and term restoration application for Xience Furthermore, any interested person may
written comments to the Division of Xpedition Everolimus Eluting Coronary petition FDA for a determination
Dockets Management (HFA–305), Food Stent System (U.S. Patent No. 7,828,766) regarding whether the applicant for
and Drug Administration, 5630 Fishers
mstockstill on DSK4VPTVN1PROD with NOTICES

from Abbott Cardiovascular Systems extension acted with due diligence
Lane, Rm. 1061, Rockville, MD 20852. Inc., and the USPTO requested FDA’s during the regulatory review period by
Submit petitions electronically to assistance in determining this patent’s October 26, 2015. To meet its burden,
http://www.regulations.gov at Docket eligibility for patent term restoration. In the petition must contain sufficient facts
No. FDA–2013–S–0610. a letter dated May 22, 2014, FDA to merit an FDA investigation. (See H.
FOR FURTHER INFORMATION CONTACT: advised the USPTO that this medical Rept. 857, part 1, 98th Cong., 2d sess.,
Beverly Friedman, Office of device had undergone a regulatory pp. 41–42, 1984.) Petitions should be in
Management, Center for Drug review period and that the approval of the format specified in 21 CFR 10.30.

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23802 Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices

Interested persons may submit to the DATES: Although you can comment on focuses on the categorical exclusion for
Division of Dockets Management (see any guidance at any time (see 21 CFR actions on NDAs and NDA supplements
ADDRESSES) electronic or written 10.115(g)(5)), to ensure that the Agency that would increase the use of an active
comments and written or electronic considers your comment on this draft moiety, but the estimated concentration
petitions. It is only necessary to send guidance before it begins work on the of the substance at the point of entry
one set of comments. Identify comments final version of the guidance, submit into the aquatic environment would be
with the docket number found in either electronic or written comments below 1 part per billion (1 ppb)
brackets in the heading of this on the draft guidance by June 29, 2015. (§ 25.31(b)). Although an action that
document. If you submit a written ADDRESSES: Submit written requests for qualifies for this exclusion ordinarily
petition, two copies are required. A single copies of the draft guidance to the does not require an EA, FDA will
petition submitted electronically must Division of Drug Information, Center for require ‘‘at least an EA’’ if
be submitted to http:// Drug Evaluation and Research, Food ‘‘extraordinary circumstances’’ indicate
www.regulations.gov, Docket No. FDA– and Drug Administration, 10001 New that the specific proposed action (e.g.,
2013–S–0610. Comments and petitions Hampshire Ave., Hillandale Building, the approval of the NDA) may
that have not been made publicly 4th Floor, Silver Spring, MD 20993– significantly affect the quality of the
available on http://www.regulations.gov 0002. Send one self-addressed adhesive human environment (§ 25.21). Research
may be viewed in the Division of label to assist that office in processing indicates that drugs with endocrine-
Dockets Management between 9 a.m. your requests. See the SUPPLEMENTARY related activity and, more specifically,
and 4 p.m., Monday through Friday. INFORMATION section for electronic drugs with E, A, or T activity have the
Dated: April 23, 2015. access to the draft guidance document. potential to cause developmental or
Peter Lurie, Submit electronic comments on the reproductive effects when present in the
draft guidance to http:// aquatic environment at concentrations
Associate Commissioner for Public Health
Strategy and Analysis. www.regulations.gov. Submit written below 1 ppb.1
comments to the Division of Dockets FDA has, on a case-by-case basis,
[FR Doc. 2015–09902 Filed 4–28–15; 8:45 am]
Management (HFA–305), Food and Drug requested additional information from
BILLING CODE 4164–01–P
Administration, 5630 Fishers Lane, Rm. sponsors of NDAs and NDA
1061, Rockville, MD 20852. supplements for drugs with E, A, or T
DEPARTMENT OF HEALTH AND FOR FURTHER INFORMATION CONTACT: activity to help it determine whether
HUMAN SERVICES Raanan A. Bloom, Environmental extraordinary circumstances exist.
Assessment Team, Center for Drug However, late cycle requests for
Food and Drug Administration Evaluation and Research, Food and additional environmental information
Drug Administration, 10903 New have the potential to delay approval of
[Docket No. FDA–2015–D–1213] Hampshire Ave., Silver Spring, MD applications. Accordingly, this guidance
20993–0002, 301–796–2185, is intended to clarify that sponsors of
Environmental Assessment: Questions drugs with potential E, A, or T activity
and Answers Regarding Drugs With CDER.EA.Team@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
should consult with the Agency early in
Estrogenic, Androgenic, or Thyroid product development concerning the
Activity; Draft Guidance for Industry; I. Background information FDA may need to determine
Availability whether an EA will be required or
FDA is announcing the availability of
AGENCY: Food and Drug Administration, a draft guidance for industry entitled whether a claim of categorical exclusion
HHS. ‘‘Environmental Assessment: Questions will be acceptable, and what
and Answers Regarding Drugs With information should be included in the
ACTION: Notice.
Estrogenic, Androgenic, or Thyroid EA or claim of categorical exclusion.
SUMMARY: The Food and Drug Activity.’’ The National Environmental This draft guidance is being issued
Administration (FDA or Agency) is Policy Act of 1969 (Pub. L. 91–190) consistent with FDA’s good guidance
announcing the availability of a draft requires all Federal agencies to assess practices regulation (21 CFR 10.115).
guidance for industry entitled the environmental impact of their The draft guidance, when finalized, will
‘‘Environmental Assessment: Questions actions and to ensure that the interested represent the Agency’s current thinking
and Answers Regarding Drugs With and affected public is informed of the on this topic. It does not create or confer
Estrogenic, Androgenic, or Thyroid environmental analyses. FDA any rights for or on any person and does
Activity.’’ This guidance is intended to regulations at 21 CFR part 25 specify not operate to bind FDA or the public.
supplement CDER’s guidance for that EAs must be submitted as part of An alternative approach may be used if
industry on ‘‘Environmental Assessment certain NDAs, abbreviated new drug such approach satisfies the
of Human Drug and Biologics applications (ANDAs), biologic license requirements of the applicable statutes
Applications,’’ issued July 1998, by applications (BLAs), supplements to and regulations.
addressing specific considerations for such applications, and investigational
1 For example, see Section II.C (pp. 7–13) of
drugs that have potential estrogenic, new drug applications (INDs), and for
USFDA, 2013, ‘‘Response to Citizen Petition to the
androgenic, or thyroid pathway activity various other actions, unless the action FDA Commissioner under the National
(E, A, or T activity) in environmental qualifies for a categorical exclusion. Environmental Policy Act and Administrative
organisms. It is intended to help Failure to submit either an EA or a Procedure Act Requesting an Amendment to an
FDA Rule Regarding Human Drugs and Biologics,’’
mstockstill on DSK4VPTVN1PROD with NOTICES

sponsors of such drugs determine claim of categorical exclusion is
Docket No. FDA–2010–P–0377; U.S. Environmental
whether they should submit sufficient grounds for FDA to refuse to Protection Agency (USEPA), Endocrine Disruptor
environmental assessments (EA) for new file or approve an application Screening Program (EDSP), last accessed February
drug applications (NDAs) and certain (§ 25.15(a), 21 CFR 314.101(d)(4), and 17, 2015, at http://www.epa.gov/endo; and
NDA supplements, and to clarify what 601.2(a) and (c)). Organisation for Economic Co-operation and
Development (OECD), OECD Work Related to
information such sponsors should Categorical exclusions for actions Endocrine Disrupters, last accessed February 17,
include if they submit a claim of related to human drugs and biologics 2015, at http://www.oecd.org/env/ehs/testing/
categorical exclusion instead of an EA. are listed at § 25.31. This draft guidance oecdworkrelatedtoendocrinedisrupters.htm.

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Document Created: 2015-12-16 08:26:25
Document Modified: 2015-12-16 08:26:25

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.
Contact		Beverly Friedman, Office of Management, Center for Drug Evaluation and Research, Food and Drug Administration, 10001 New Hampshire Ave., Hillandale Campus, Rm. 3180, Silver Spring, MD 20993-0002, 301-796-7900.
FR Citation		80 FR 23801

80 FR 23801 - Determination of Regulatory Review Period for Purposes of Patent Extension; Xience Xpedition Everolimus Eluting Coronary Stent System

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 80, Issue 82 (April 29, 2015)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration