Abbreviated New Drug Applications and 505(b)(2) Applications, 13289-13292 [C1-2015-01666]
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Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Proposed Rules
established within a 7-mile radius of
Aurora State Airport, with segments
extending from the 7-mile radius to 20
miles northeast and 10.9 miles
northwest of the airport.
Class D and Class E airspace
designations are published in paragraph
5000, 6002, and 6005, respectively, of
FAA Order 7400.9Y, dated August 6,
2014 and effective September 15, 2014,
which is incorporated by reference in 14
CFR 71.1. The Class D and Class E
airspace designations listed in this
document will be published
subsequently in the Order.
The FAA has determined this
proposed regulation only involves an
established body of technical
regulations for which frequent and
routine amendments are necessary to
keep them operationally current.
Therefore, this proposed regulation: (1)
Is not a ‘‘significant regulatory action’’
under Executive Order 12866; (2) is not
a ‘‘significant rule’’ under DOT
Regulatory Policies and Procedures (44
FR 11034; February 26, 1979); and (3)
does not warrant preparation of a
regulatory evaluation as the anticipated
impact is so minimal. Since this is a
routine matter that will only affect air
traffic procedures and air navigation, it
is certified this proposed rule, when
promulgated, would not have a
significant economic impact on a
substantial number of small entities
under the criteria of the Regulatory
Flexibility Act.
The FAA’s authority to issue rules
regarding aviation safety is found in
Title 49 of the U.S. Code. Subtitle 1,
Section 106, describes the authority for
the FAA Administrator. Subtitle VII,
Aviation Programs, describes in more
detail the scope of the agency’s
authority. This rulemaking is
promulgated under the authority
described in Subtitle VII, Part A,
Subpart I, Section 40103. Under that
section, the FAA is charged with
prescribing regulations to assign the use
of the airspace necessary to ensure the
safety of aircraft and the efficient use of
airspace. This regulation is within the
scope of that authority as it would
establish controlled airspace at Aurora
State Airport, Aurora, OR.
with FAA Order 1050.1E,
‘‘Environmental Impacts: Policies and
Procedures’’ prior to any FAA final
regulatory action.
List of Subjects in 14 CFR Part 71
Airspace, Incorporation by reference,
Navigation (air).
The Proposed Amendment
Accordingly, pursuant to the
authority delegated to me, the Federal
Aviation Administration proposes to
amend 14 CFR part 71 as follows:
PART 71—DESIGNATION OF CLASS A,
B, C, D, AND E AIRSPACE AREAS; AIR
TRAFFIC SERVICE ROUTES; AND
REPORTING POINTS
1. The authority citation for 14 CFR
part 71 continues to read as follows:
■
Authority: 49 U.S.C. 106(g), 40103, 40113,
40120; E.O. 10854, 24 FR 9565, 3 CFR, 1959–
1963 Comp., p. 389.
§ 71.1
[Amended]
2. The incorporation by reference in
14 CFR 71.1 of FAA Order 7400.9Y,
Airspace Designations and Reporting
Points, dated August 6, 2014, and
effective September 15, 2014, is
amended as follows:
■
Paragraph 5000
Class D airspace.
*
*
*
*
*
Aurora, Aurora State Airport, OR
(Lat. 45°14′50″ N., long. 122°46′12″ W)
Canby, Workman Airpark, OR
(Lat. 45°12′27″ N., long. 122°40′09″ W)
That airspace extending upward from the
surface to and including 2,700 feet within a
5-mile radius of Aurora State Airport,
excluding that airspace below 1,300 feet
beyond 3.3 miles from the airport from the
142° bearing clockwise to the 172° bearing
from the airport, and the 250° bearing
clockwise to the 266° bearing from the
airport, and that airspace within a 0.5-mile
radius of Workman Airpark, OR. This Class
D airspace area is effective during the
specific dates and times established in
advance by a Notice to Airmen. The effective
date and time will thereafter be continuously
published in the Airport/Facility Directory.
Paragraph 6002 Class E airspace designated
as surface areas.
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*
This proposal will be subject to an
environmental analysis in accordance
ANM OR E2 Aurora, OR [New]
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*
*
*
Aurora, Aurora State Airport, OR
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Paragraph 6005 Class E airspace areas
extending upward from 700 feet or more
above the surface of the earth.
*
*
*
*
*
ANM OR E5 Aurora, OR [New]
Aurora, Aurora State Airport, OR
(Lat. 45°14′50″ N., long. 122°46′12″ W)
That airspace extending upward from 700
feet above the surface within a 7-mile radius
of Aurora State Airport, and that airspace 1.6
miles either side of the 007° bearing from
airport extending from the 7-mile radius to
20 miles northeast of the airport, and that
airspace 1.2 miles either side of the 306°
bearing from airport extending from the 7mile radius to 10.9 miles northwest of the
airport.
Issued in Seattle, Washington, on February
25, 2015.
Christopher Ramirez,
Acting Manager, Operations Support Group,
Western Service Center, AJV–W2.
[FR Doc. 2015–05700 Filed 3–12–15; 8:45 am]
ANM OR D Aurora, OR [New]
Environmental Review
(Lat. 45°14′50″ N., long. 122°46′12″ W)
Canby, Workman Airpark, OR
(Lat. 45°12′27″ N., long. 122°40′09″ W)
That airspace extending upward from the
surface to and including 2,700 feet within a
5-mile radius of Aurora State Airport,
excluding that airspace below 1,300 feet
beyond 3.3 miles from the airport from the
142° bearing clockwise to the 172° bearing
from the airport, and the 250° bearing
clockwise to the 266° bearing from the
airport, and that airspace within a 0.5-mile
radius of Workman Airpark, OR.
BILLING CODE 4910–13–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 314 and 320
[Docket No. FDA–2011–N–0830]
RIN 0910–AF97
Abbreviated New Drug Applications
and 505(b)(2) Applications
Correction
In Proposed Rule Document 2015–
01666, pages 6801–6896, publishing in
the Issue of Friday, February 6, 2015,
make the following corrections:
1. On page 6807, in the second
column in Table 1, the heading should
read:
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Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Proposed Rules
Proposed Changes
See section of this document
(identified in parentheses)
for more detailed information regarding the proposed change
2. On page 6808, in Table 1, the
second column should read:
314.95(e) .....................................
Documentation of Timely Sending and Receipt of Notice of Paragraph IV Certification, including:
a. Acceptable methods of sending notice of paragraph IV certification; and
b. Amendment documenting timely sending and confirmation of receipt of notice of paragraph IV certification.
(II.D.4).
3. On pages 6818–6819, in Table 2,
the second row should read:
Current regulations
Proposed revisions to regulations
General Requirements (§ 314.53(c)(1))
Patent information will not be accepted unless it is complete and submitted on the appropriate forms (Form FDA 3542a or 3542).
General Requirements (§ 314.53(c)(1))
• Patent information will not be accepted unless it is submitted on the
appropriate forms (Form FDA 3542a or 3542) and contains the information required in § 314.53(c)(2).
Reporting Requirements (§ 314.53(c)(2))
The required information and verification in § 314.53(c)(2)(i) and
(c)(2)(ii) includes:
• Information on whether the patent has been submitted previously for the NDA
• Information on whether the drug substance patent claims a polymorph that is the same active ingredient that is described in the
pending NDA or supplement, and, if so, has test data described
in § 314.53(b)(2)
Reporting Requirements (§ 314.53(c)(2))
The required information and verification in § 314.53(c)(2)(i) and
(c)(2)(ii) includes:
• Information on whether the patent is a re-issued patent of a patent submitted previously for listing for the NDA or supplement.
• Information on whether the drug substance patent claims only a
polymorph that is the same active ingredient that is described in
the pending NDA or supplement, and, if so, has test data described in § 314.53(b)(2).
4. On pages 6838–6839, in Table 8,
the second row should read:
Current regulations
Proposed revisions to regulations
Documentation of receipt of notice (§§ 314.52(e) and 314.95(e))
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• Applicant must amend its 505(b)(2) application or ANDA to document the date of receipt of the notice of paragraph IV certification by
each patent owner and NDA holder provided the notice.
• Applicant must include a copy of the return receipt or other similar
evidence of the date the notification was received.
— FDA will accept as adequate documentation of the date of receipt a return receipt or a letter acknowledging receipt by the
person provided the notice.
• An applicant may rely on another form of documentation only if FDA
has agreed to such documentation in advance.
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Documentation of timely sending and receipt of notice (§§ 314.52(e)
and 314.95(e))
• Applicant must amend its 505(b)(2) application or ANDA to provide
documentation of the date of receipt of the notice of paragraph IV
certification by each patent owner and NDA holder provided the notice.
—FDA will accept as adequate documentation of the date of receipt a return receipt, signature proof of delivery by a designated
delivery service, or a letter acknowledging receipt by the person
provided notice.
— Amendment must be submitted to FDA within 30 days after the
last date on which notice was received by a patent owner or
NDA holder.
• Amendment also must include adequate documentation that notice
was sent on a date that complies with the timeframe required by
§ 314.52(b) or (d) or § 314.95(b) or (d), as applicable.
—FDA will accept a copy of the registered mail receipt, certified
mail receipt, or receipt from a designated delivery service, as
adequate documentation of the date of delivery.
• An ANDA applicant’s amendment must include a dated printout of
the Orange Book entry for the RLD that includes the patent that is
the subject of the paragraph IV certification.
• An applicant may rely on another form of documentation only if FDA
has agreed in advance.
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5. On pages 6842–6843, in Table 9,
the third row should read:
Current regulations
Proposed revisions to regulations
After
a
Finding
of
Infringement
(§§ 314.50(i)(6)(i)
and
314.94(a)(12)(viii)(A))
• Change from paragraph IV certification to paragraph III certification
required after a final judgment is entered finding the patent to be infringed.
• Provision applies if patent infringement action initiated within 45 days
of receipt of notice of paragraph IV certification.
After
a
Finding
of
Infringement
(§§ 314.50(i)(6)(i)
and
314.94(a)(12)(viii)(A))
• Change from paragraph IV certification to paragraph III certification
required after court enters final decision from which no appeal has
been or can be taken, or signs settlement order or consent decree
with a finding of infringement (unless the patent also is found invalid). An applicant may instead provide a statement under
§ 314.50(i)(1)(iii) or § 314.94(a)(12)(iii) with respect to a method-ofuse patent if the 505(b)(2) application or ANDA is amended such
that the applicant is no longer seeking approval for a method of use
claimed by the patent.
• Provision applies if patent infringement action initiated after receipt of
notice of paragraph IV certification, irrespective of whether the action
is brought within the 45-day period.
6. On pages 6859–6861, in Table 12,
the third, sixth, and seventh rows
should read:
Current regulations
Proposed revisions to regulations
Date of approval letter (§ 314.107(b)(1))
• Except as provided in § 314.107(b)(3), (b)(4), and (c), approval will
become effective on the date FDA issues an approval letter if the applicant certifies that:
(i) there are no relevant patents; or
(ii) the patent information has not been submitted to FDA; or
(iii) the relevant patent has expired; or
(iv) the relevant patent is invalid, unenforceable, or will not be infringed.
Timing of approval based on patent certification or statement
(§ 314.107(b)(1))
• If none of the reasons in § 314.125 or § 314.127 for refusing to approve the application apply, and none of the reasons in § 314.107(d)
for delaying approval apply, the 505(b)(2) application or ANDA may
be approved—
(i) Immediately, if the applicant certifies that:
(A) the patent information has not been submitted to FDA; or
(B) the relevant patent has expired; or
(C) the relevant patent is invalid, unenforceable, or will not be
infringed, except as provided in § 314.107(b)(3) and (c), and
the 45-day period provided for in section 505(c)(3)(C) and
505(j)(5)(B)(iii) of the FD&C Act has expired; or
(D) there are no relevant patents.
(ii) Immediately, if the applicant submits an appropriate statement
explaining that a method-of-use patent does not claim an indication or other condition of use for which it is seeking approval.
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Disposition of patent litigation (§ 314.107(b)(3)(i))
• (A) Except as provided in § 314.107(b)(3)(ii) through (b)(3)(iv), if
— applicant submits a paragraph IV certification; and
— patent owner or its representative or the exclusive patent licensee brings suit for patent infringement within 45 days of receipt by the patent owner of the notice of paragraph IV certification,
Approval may be made effective 30 months after the date of the receipt
of the notice of paragraph IV certification by the patent owner or by
the exclusive licensee (or their representatives) unless the court has
extended or reduced the period; or
• (B) If the patented drug product qualifies for 5-year exclusivity, and
— patent owner or its representative or the exclusive patent licensee brings suit for patent infringement during the 1-year period beginning 4 years after the date the patented drug was approved and within 45 days of receipt by the patent owner of the
notice of paragraph IV certification,
Approval may be made effective at the expiration of 71⁄2 years from the
date of NDA approval for the patented drug product.
Disposition of patent litigation (§ 314.107(b)(3)(i))
• (A) Except as provided in § 314.107(b)(3)(ii) through (b)(3)(viii), if,
with respect to patents for which required information was submitted
before the date on which the 505(b)(2) application or ANDA was
submitted to FDA (excluding an amendment or supplement),
—applicant submits a paragraph IV certification; and
—patent owner or the exclusive patent licensee brings suit for patent infringement within 45 days of receipt of the notice of paragraph IV certification, 505(b)(2) application, or ANDA may be
approved 30 months after the later of the date of the receipt of
the notice of certification by any owner of the listed patent or by
the NDA holder who is an exclusive patent licensee (or their
representatives) unless the court has extended or reduced the
period; or
• (B) If the patented drug product qualifies for 5-year exclusivity, and
—patent owner or its representative or the exclusive patent licensee brings suit for patent infringement during the 1-year period beginning 4 years after the date the patented drug was approved and within 45 days of receipt of the notice of paragraph
IV certification,
the 505(b)(2) application or ANDA may be approved at the expiration
of 71⁄2 years from the date of NDA approval for the patented drug
product.
Disposition of patent litigation (§ 314.107(b)(3)(ii)–(b)(3)(iv))
Disposition of patent litigation (§ 314.107(b)(3)(ii)–(b)(3)(viii)
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Federal Register / Vol. 80, No. 49 / Friday, March 13, 2015 / Proposed Rules
Current regulations
Proposed revisions to regulations
If before the expiration of the 30-month period, or 7 ⁄ years where applicable:
• (ii) the court issues a final order that the patent is invalid, unenforceable, or not infringed, approval may be made effective on:
— the date the court enters judgment;
• (iii) the court issues a final order or judgment that the patent has
been infringed, approval may be made effective on:
— the date the court determines that the patent will expire or
otherwise orders
• (iv) the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the
drug product until the court decides the issues of patent validity
and infringement, and if the court later decides that the patent is
invalid, unenforceable, or not infringed, approval may be made
effective on:
— the date the court enters a final order or judgment that the
patent is invalid, unenforceable, or not infringed.
12
[FR Doc. C1–2015–01666 Filed 3–12–15; 8:45 am]
BILLING CODE 1505–01–D
If before the expiration of the 30-month period, or 71⁄2 years where applicable:
• (ii) the district court decides that the patent is invalid, unenforceable, or not infringed (including any substantive determination
that there is no cause of action for patent infringement or invalidity), the 505(b)(2) application or ANDA may be approved on:
—(A) the date on which the court enters judgment reflecting
the decision; or
—(B) the date of a settlement order or consent decree signed
and entered by the court stating that the patent that is the
subject of the certification is invalid or not infringed.
• (iii) the district court decides that the patent has been infringed
and the judgment is appealed, the 505(b)(2) application or
ANDA may be approved on:
—(A) the date on which the mandate is issued by the court of
appeals entering judgment that the patent is invalid or not
infringed; or
—(B) the date of a settlement order or consent decree signed
and entered by the court of appeals stating that the patent
is invalid or not infringed.
• (iv) the district court decides that the patent has been infringed
and the judgment is not appealed or is affirmed, the 505(b)(2)
application or ANDA may be approved no earlier than the date
specified by the district court in an order under 35 U.S.C.
271(e)(4)(A).
• (v) the district court grants a preliminary injunction prohibiting
the applicant from engaging in the commercial manufacture or
sale of the drug product until the court decides the issues of patent validity and infringement:
— if the court later decides the patent is invalid, unenforceable, or not infringed, the 505(b)(2) application or ANDA
may be approved per § 314.107(b)(3)(ii).
—if the court decides that the patent has been infringed, the
505(b)(2) application or ANDA may be approved per
§ 314.107(b)(3)(iii) or (b)(3)(iv), as applicable.
• (vi) the patent owner or the exclusive patent licensee (or their
representatives) agrees in writing that the 505(b)(2) application
or ANDA may be approved any time on or after the date of the
consent, approval may be granted on or after that date.
• (vii) the court enters an order requiring the 30-month or 71⁄2-year
period to be terminated, the 505(b)(2) application or ANDA may
be approved in accordance with the court’s order.
• (viii) the court enters an order of dismissal, with or without prejudice, without a finding of infringement, the 505(b)(2) application
or ANDA may be approved on or after the date of the order.
Notice of proposed rulemaking
by cross-reference to temporary
regulations.
ACTION:
In the Rules and Regulations
section of this issue of the Federal
Register, the IRS is issuing temporary
regulations relating to information
reporting by brokers for transactions
involving debt instruments and options,
including the reporting of original issue
discount (OID) and acquisition premium
on tax-exempt obligations, the treatment
of certain holder elections for reporting
a taxpayer’s adjusted basis in a debt
instrument, and transfer reporting for
section 1256 options and debt
instruments. The text of those
regulations also serves as the text of
these proposed regulations.
SUMMARY:
DEPARTMENT OF THE TREASURY
Internal Revenue Service
26 CFR Part 1
[REG–143040–14]
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RIN 1545–BM59
Reporting of Original Issue Discount
on Tax-Exempt Obligations; Basis and
Transfer Reporting by Securities
Brokers for Debt Instruments and
Options
Internal Revenue Service (IRS),
Treasury.
AGENCY:
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Written or electronic comments
must be received by June 11, 2015.
DATES:
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Send submissions to:
CC:PA:LPD:PR (REG–143040–14), Room
5203, Internal Revenue Service, P.O.
Box 7604, Ben Franklin Station,
Washington, DC 20044. Submissions
may be hand-delivered Monday through
Friday between the hours of 8 a.m. and
4 p.m. to CC:PA:LPD:PR (REG–143040–
14), Courier’s Desk, Internal Revenue
Service, 1111 Constitution Avenue NW.,
Washington, DC, or sent electronically
via the Federal eRulemaking Portal at
www.regulations.gov (IRS REG–143040–
14).
ADDRESSES:
FOR FURTHER INFORMATION CONTACT:
Concerning the proposed regulations,
Pamela Lew, (202) 317–7053;
concerning submissions of comments,
Regina Johnson, (202) 317–6901 (not
toll-free numbers).
SUPPLEMENTARY INFORMATION:
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]]>Agencies
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)]
[Proposed Rules]
[Pages 13289-13292]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: C1-2015-01666]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 314 and 320
[Docket No. FDA-2011-N-0830]
RIN 0910-AF97
Abbreviated New Drug Applications and 505(b)(2) Applications
Correction
In Proposed Rule Document 2015-01666, pages 6801-6896, publishing
in the Issue of Friday, February 6, 2015, make the following
corrections:
1. On page 6807, in the second column in Table 1, the heading
should read:
[[Page 13290]]
------------------------------------------------------------------------
Proposed Changes See
section of this document
(identified in
parentheses) for more
detailed information
regarding the proposed
change
------------------------------------------------------------------------
2. On page 6808, in Table 1, the second column should read:
------------------------------------------------------------------------
314.95(e).................................... Documentation of Timely
Sending and Receipt of
Notice of Paragraph IV
Certification,
including:
a. Acceptable methods of
sending notice of
paragraph IV
certification; and
b. Amendment documenting
timely sending and
confirmation of receipt
of notice of paragraph
IV certification.
(II.D.4).
------------------------------------------------------------------------
3. On pages 6818-6819, in Table 2, the second row should read:
------------------------------------------------------------------------
Proposed revisions to
Current regulations regulations
------------------------------------------------------------------------
General Requirements (Sec. General Requirements (Sec.
314.53(c)(1)) 314.53(c)(1))
Patent information will not be accepted Patent information
unless it is complete and submitted on will not be accepted unless it
the appropriate forms (Form FDA 3542a is submitted on the
or 3542). appropriate forms (Form FDA
3542a or 3542) and contains
the information required in
Sec. 314.53(c)(2).
------------------------------------------------------------------------
Reporting Requirements (Sec. Reporting Requirements (Sec.
314.53(c)(2)) 314.53(c)(2))
The required information and The required information and
verification in Sec. 314.53(c)(2)(i) verification in Sec.
and (c)(2)(ii) includes: 314.53(c)(2)(i) and (c)(2)(ii)
Information on whether the includes:
patent has been submitted previously Information on whether
for the NDA the patent is a re-issued
Information on whether the patent of a patent submitted
drug substance patent claims a previously for listing for the
polymorph that is the same active NDA or supplement.
ingredient that is described in the Information on whether
pending NDA or supplement, and, if so, the drug substance patent
has test data described in Sec. claims only a polymorph that
314.53(b)(2) is the same active ingredient
that is described in the
pending NDA or supplement,
and, if so, has test data
described in Sec.
314.53(b)(2).
------------------------------------------------------------------------
4. On pages 6838-6839, in Table 8, the second row should read:
------------------------------------------------------------------------
Proposed revisions to
Current regulations regulations
------------------------------------------------------------------------
Documentation of receipt of notice Documentation of timely sending
(Sec. Sec. 314.52(e) and 314.95(e)) and receipt of notice (Sec.
Sec. 314.52(e) and
314.95(e))
Applicant must amend its Applicant must amend
505(b)(2) application or ANDA to its 505(b)(2) application or
document the date of receipt of the ANDA to provide documentation
notice of paragraph IV certification of the date of receipt of the
by each patent owner and NDA holder notice of paragraph IV
provided the notice. certification by each patent
Applicant must include a copy owner and NDA holder provided
of the return receipt or other similar the notice.
evidence of the date the notification --FDA will accept as adequate
was received. documentation of the date of
-- FDA will accept as adequate receipt a return receipt,
documentation of the date of receipt a signature proof of delivery by
return receipt or a letter a designated delivery service,
acknowledging receipt by the person or a letter acknowledging
provided the notice. receipt by the person provided
An applicant may rely on notice.
another form of documentation only if -- Amendment must be submitted
FDA has agreed to such documentation to FDA within 30 days after
in advance. the last date on which notice
was received by a patent owner
or NDA holder.
Amendment also must
include adequate documentation
that notice was sent on a date
that complies with the
timeframe required by Sec.
314.52(b) or (d) or Sec.
314.95(b) or (d), as
applicable.
--FDA will accept a copy of
the registered mail
receipt, certified mail
receipt, or receipt from a
designated delivery
service, as adequate
documentation of the date
of delivery.
An ANDA applicant's
amendment must include a dated
printout of the Orange Book
entry for the RLD that
includes the patent that is
the subject of the paragraph
IV certification.
An applicant may rely
on another form of
documentation only if FDA has
agreed in advance.
------------------------------------------------------------------------
[[Page 13291]]
5. On pages 6842-6843, in Table 9, the third row should read:
------------------------------------------------------------------------
Proposed revisions to
Current regulations regulations
------------------------------------------------------------------------
After a Finding of Infringement (Sec. After a Finding of Infringement
Sec. 314.50(i)(6)(i) and (Sec. Sec. 314.50(i)(6)(i)
314.94(a)(12)(viii)(A)) and 314.94(a)(12)(viii)(A))
Change from paragraph IV Change from paragraph
certification to paragraph III IV certification to paragraph
certification required after a final III certification required
judgment is entered finding the patent after court enters final
to be infringed. decision from which no appeal
Provision applies if patent has been or can be taken, or
infringement action initiated within signs settlement order or
45 days of receipt of notice of consent decree with a finding
paragraph IV certification. of infringement (unless the
patent also is found invalid).
An applicant may instead
provide a statement under Sec.
314.50(i)(1)(iii) or Sec.
314.94(a)(12)(iii) with
respect to a method-of-use
patent if the 505(b)(2)
application or ANDA is amended
such that the applicant is no
longer seeking approval for a
method of use claimed by the
patent.
Provision applies if
patent infringement action
initiated after receipt of
notice of paragraph IV
certification, irrespective of
whether the action is brought
within the 45-day period.
------------------------------------------------------------------------
6. On pages 6859-6861, in Table 12, the third, sixth, and seventh
rows should read:
------------------------------------------------------------------------
Proposed revisions to
Current regulations regulations
------------------------------------------------------------------------
Date of approval letter (Sec. Timing of approval based on
314.107(b)(1)) patent certification or
statement (Sec.
314.107(b)(1))
Except as provided in Sec. If none of the reasons
314.107(b)(3), (b)(4), and (c), in Sec. 314.125 or Sec.
approval will become effective on the 314.127 for refusing to
date FDA issues an approval letter if approve the application apply,
the applicant certifies that: and none of the reasons in
(i) there are no relevant patents; or Sec. 314.107(d) for delaying
(ii) the patent information has not approval apply, the 505(b)(2)
been submitted to FDA; or application or ANDA may be
(iii) the relevant patent has expired; approved--
or (i) Immediately, if the
(iv) the relevant patent is invalid, applicant certifies that:
unenforceable, or will not be (A) the patent information has
infringed. not been submitted to FDA; or
(B) the relevant patent has
expired; or
(C) the relevant patent is
invalid, unenforceable, or
will not be infringed, except
as provided in Sec.
314.107(b)(3) and (c), and the
45-day period provided for in
section 505(c)(3)(C) and
505(j)(5)(B)(iii) of the FD&C
Act has expired; or
(D) there are no relevant
patents.
(ii) Immediately, if the
applicant submits an
appropriate statement
explaining that a method-of-
use patent does not claim an
indication or other condition
of use for which it is seeking
approval.
------------------------------------------------------------------------
Disposition of patent litigation (Sec. Disposition of patent
314.107(b)(3)(i)) litigation (Sec.
314.107(b)(3)(i))
(A) Except as provided in Sec. (A) Except as provided
314.107(b)(3)(ii) through in Sec. 314.107(b)(3)(ii)
(b)(3)(iv), if through (b)(3)(viii), if, with
-- applicant submits a paragraph IV respect to patents for which
certification; and required information was
-- patent owner or its representative submitted before the date on
or the exclusive patent licensee which the 505(b)(2)
brings suit for patent infringement application or ANDA was
within 45 days of receipt by the submitted to FDA (excluding an
patent owner of the notice of amendment or supplement),
paragraph IV certification, --applicant submits a paragraph
Approval may be made effective 30 IV certification; and
months after the date of the receipt --patent owner or the exclusive
of the notice of paragraph IV patent licensee brings suit
certification by the patent owner or for patent infringement within
by the exclusive licensee (or their 45 days of receipt of the
representatives) unless the court has notice of paragraph IV
extended or reduced the period; or certification, 505(b)(2)
(B) If the patented drug application, or ANDA may be
product qualifies for 5-year approved 30 months after the
exclusivity, and later of the date of the
-- patent owner or its representative receipt of the notice of
or the exclusive patent licensee certification by any owner of
brings suit for patent infringement the listed patent or by the
during the 1-year period beginning 4 NDA holder who is an exclusive
years after the date the patented drug patent licensee (or their
was approved and within 45 days of representatives) unless the
receipt by the patent owner of the court has extended or reduced
notice of paragraph IV certification, the period; or
Approval may be made effective at the (B) If the patented
expiration of 7\1/2\ years from the drug product qualifies for 5-
date of NDA approval for the patented year exclusivity, and
drug product. --patent owner or its
representative or the
exclusive patent licensee
brings suit for patent
infringement during the 1-year
period beginning 4 years after
the date the patented drug was
approved and within 45 days of
receipt of the notice of
paragraph IV certification,
the 505(b)(2) application or
ANDA may be approved at the
expiration of 7\1/2\ years
from the date of NDA approval
for the patented drug product.
------------------------------------------------------------------------
Disposition of patent litigation (Sec. Disposition of patent
314.107(b)(3)(ii)-(b)(3)(iv)) litigation (Sec.
314.107(b)(3)(ii)-(b)(3)(viii)
[[Page 13292]]
If before the expiration of the 30- If before the expiration of the
month period, or 7\1/2\ years where 30-month period, or 7\1/2\
applicable: years where applicable:
(ii) the court issues a final (ii) the district
order that the patent is invalid, court decides that the patent
unenforceable, or not infringed, is invalid, unenforceable, or
approval may be made effective on: not infringed (including any
-- the date the court enters judgment; substantive determination that
(iii) the court issues a final there is no cause of action
order or judgment that the patent has for patent infringement or
been infringed, approval may be made invalidity), the 505(b)(2)
effective on: application or ANDA may be
-- the date the court determines that approved on:
the patent will expire or otherwise --(A) the date on which the
orders court enters judgment
(iv) the court grants a reflecting the decision; or
preliminary injunction prohibiting the --(B) the date of a settlement
applicant from engaging in the order or consent decree signed
commercial manufacture or sale of the and entered by the court
drug product until the court decides stating that the patent that
the issues of patent validity and is the subject of the
infringement, and if the court later certification is invalid or
decides that the patent is invalid, not infringed.
unenforceable, or not infringed, (iii) the district
approval may be made effective on: court decides that the patent
-- the date the court enters a final has been infringed and the
order or judgment that the patent is judgment is appealed, the
invalid, unenforceable, or not 505(b)(2) application or ANDA
infringed. may be approved on:
--(A) the date on which the
mandate is issued by the court
of appeals entering judgment
that the patent is invalid or
not infringed; or
--(B) the date of a settlement
order or consent decree signed
and entered by the court of
appeals stating that the
patent is invalid or not
infringed.
(iv) the district
court decides that the patent
has been infringed and the
judgment is not appealed or is
affirmed, the 505(b)(2)
application or ANDA may be
approved no earlier than the
date specified by the district
court in an order under 35
U.S.C. 271(e)(4)(A).
(v) the district
court grants a preliminary
injunction prohibiting the
applicant from engaging in
the commercial manufacture
or sale of the drug product
until the court decides the
issues of patent validity
and infringement:
-- if the court later
decides the patent is
invalid, unenforceable,
or not infringed, the
505(b)(2) application or
ANDA may be approved per
Sec. 314.107(b)(3)(ii).
--if the court decides
that the patent has been
infringed, the 505(b)(2)
application or ANDA may
be approved per Sec.
314.107(b)(3)(iii) or
(b)(3)(iv), as
applicable.
(vi) the patent
owner or the exclusive
patent licensee (or their
representatives) agrees in
writing that the 505(b)(2)
application or ANDA may be
approved any time on or
after the date of the
consent, approval may be
granted on or after that
date.
(vii) the court
enters an order requiring
the 30-month or 7\1/2\-year
period to be terminated,
the 505(b)(2) application
or ANDA may be approved in
accordance with the court's
order.
(viii) the court
enters an order of
dismissal, with or without
prejudice, without a
finding of infringement,
the 505(b)(2) application
or ANDA may be approved on
or after the date of the
order.
------------------------------------------------------------------------
[FR Doc. C1-2015-01666 Filed 3-12-15; 8:45 am]
BILLING CODE 1505-01-D
