Document ID: FDA-2011-N-0830-0005
Agency: fda
Document Type: Proposed Rule
Title: Abbreviated New Drug Applications and 505(b)(2) Applications
Posted Date: 2015-03-13T04:00Z

[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:
    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