Abbreviated New Drug Applications and 505(b)(2) Applications
Federal Register, Volume 80 Issue 49 (Friday, March 13, 2015)
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
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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:
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On page 6807, in the second column in Table 1, the heading should read:
Page 13290
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Proposed Changes See
section of this document
(identified in
parentheses) for more
detailed information
regarding the proposed
change
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On page 6808, in Table 1, the second column should read:
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314.95(e).................................... Documentation of Timely
Sending and Receipt of
Notice of Paragraph IV
Certification,
including:
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Acceptable methods of
sending notice of
paragraph IV
certification; and
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Amendment documenting
timely sending and
confirmation of receipt
of notice of paragraph
IV certification.
(II.D.4).
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-
-
On pages 6818-6819, in Table 2, the second row should read:
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Proposed revisions to
Current regulations regulations
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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).
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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).
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On pages 6838-6839, in Table 8, the second row should read:
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Proposed revisions to
Current regulations regulations
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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.
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Page 13291
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On pages 6842-6843, in Table 9, the third row should read:
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Proposed revisions to
Current regulations regulations
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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.
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On pages 6859-6861, in Table 12, the third, sixth, and seventh rows should read:
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Proposed revisions to
Current regulations regulations
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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.
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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.
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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.
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FR Doc. C1-2015-01666 Filed 3-12-15; 8:45 am
BILLING CODE 1505-01-D
