| Page Range | 13289-13292 | |
| FR Document | C1-2015-01666 |
[Federal Register Volume 80, Number 49 (Friday, March 13, 2015)] [Proposed Rules] [Pages 13289-13292] From the Federal Register Online [www.thefederalregister.org] [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 acceptedPatent 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
| 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 | Proposed Rules | |
| FR Citation | 80 FR 13289 | |
| RIN Number | 0910-AF97 | |
| CFR Citation | 21
CFR
314 21 CFR 320 |