【转载】505(j)(5)-仿制药申请-专利部分（2/2)

巴西木

本文转载自aimerjiaer《505(j)(5)-仿制药申请-专利部分（2/2)》


本文转载自aimerjiaer《505(j)(5)-仿制药申请-专利部分（2/2)》

(iii) SUBSEQUENT APPLICANT.—If all first applicants forfeit the 180-day exclusivity period under clause (ii)—

（iii）随后的申请者-在（ii）情况下如果所有的首仿者们都丧失了180天的独占期

(I) approval of any application containing a certification described in paragraph (2)(A)(vii)(IV) shall be made effective in accordance with subparagraph (B)(iii); and (II) no applicant shall be eligible for a 180-day exclusivity period.

（I）根据（B）（iii）要求，所有包含P(IV)声明的申请都应当生效；（II）将没有申请者获得180天的市场独占期

(E) If the Secretary decides to disapprove an application, the Secretary shall give the applicant notice of an opportunity for a hearing before the Secretary on the question of whether such application is approvable. If the applicant elects to accept the opportunity for hearing by written request within thirty days after such notice, such hearing shall commence not more than ninety days after the expiration of such thirty days unless the Secretary and the applicant otherwise agree. Any such hearing shall thereafter be conducted on an expedited basis and the Secretary’s order thereon shall be issued within ninety days after the date fixed by the Secretary for filing final briefs.

（E）如果卫生部决定不批准申请，应当通知申请人，就申请是否应该被批准的问题，给予申请人听证的机会。如果申请人在接收通知30日内书面请求听证会，在该30个工作到期之后90天内必须开始听证会，除非卫生部和申请人都同意延后。所有这样的听证会都应当快速处理并且卫生部应当在填写最终摘要的90天内发布卫生部的命令。

(F)(i) If an application (other than an abbreviated new drug application) submitted under subsection (b) of this section for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b) of this section, was approved during the period beginning January 1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted effective before the expiration of ten years from the date of the approval of the application under subsection (b) of this section.

（F）(i)如果NDA申请，在1982年1月1日至1984年9月24日期间被批准，其活性成分（包括该活性成分的脂类和盐）未在其他申请中被批准过，在该申请批准生效十年内不能批准其他参照此药品的申请。

(ii) If an application submitted under subsection (b) of this section for a drug, no active ingredient (including any ester or salt of the active ingredient) of which has been approved in any other application under subsection (b) of this section, is approved after September 24, 1984, no application may be submitted under this subsection which refers to the drug for which the subsection (b) application was submitted before the expiration of five years from the date of the approval of the application under subsection (b) of this section, except that such an application may be submitted under this subsection after the expiration of four years from the date of the approval of the subsection (b) application if it contains a certification of patent invalidity or noninfringement described in subclause (IV) of paragraph (2)(A)(vii). The approval of such an application shall be made effective in accordance with subparagraph (B) except that, if an action for patent infringement is commenced during the one-year period beginning forty-eight months after the date of the approval of the subsection (b) application, the thirty-month period referred to in subparagraph (B)(iii) shall be extended by such amount of time (if any) which is required for seven and one-half years to have elapsed from the date of approval of the subsection (b) application.

(ii) 如果申请人递交NDA申请，申请的活性成分（包括其脂类或者盐）没有在之前的申请中批准过，这份申请在1984年9月24日之后被批准，自该申请生效之日起五年内任何参照该申请的仿制药申请将不予批准，一个包含PIV专利声明的申请可以在此NDA批准之日算起的4年的有效期过后递交，此申请根据挑战专利部分的规定生效，除非4年之后的一年内，专利诉讼开始，30个月的期限在这种情况下应当延期，也就是仿制药申请的批准自NDA申请生效之日起总共将耗费七年半的时间。

备注：也就是说30个月（两年半）计算的起点是五年而不是四年。

(iii) If an application submitted under subsection (b) of this section for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application approved under subsection (b) of this section, is approved after September 24, 1984, and if such application contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the application and conducted or sponsored by the applicant, the Secretary may not make the approval of an application submitted under this subsection for the conditions of approval of such drug in the subsection (b) application effective before the expiration of three years from the date of the approval of the application under subsection (b) of this section for such drug.

（iii）如果NDA申请，其药品的活性成分（包括活性成分的脂类或者盐）已经在先前的申请中被批准，该申请在1984年9月24日之后被批准并且包含了新的临床研究的数据（不包括生物利用度研究），这些临床研究是由申请人实施或者赞助实施的，并且是申请批准所必须的。在此申请生效的三年内，卫生部不得批准符合该药品审批条件的仿制药申请。

(iv) If a supplement to an application approved under subsection (b) of this section is approved after September 24, 1984, and the supplement contains reports of new clinical investigations (other than bioavailability studies) essential to the approval of the supplement and conducted or sponsored by the person submitting the supplement, the Secretary may not make the approval of an application submitted under this subsection for a change approved in the supplement effective before the expiration of three years from the date of the approval of the supplement under subsection (b) of this section.

（iv）如果NDA补充申请在1984年9月24日之后递交，补充申请中包含了新的临床研究的数据（不包括生物利用度研究），这些临床研究是由补充递交人实施或者赞助实施的，并且是补充批准所必须的。在此补充生效的三年内，卫生部不得批准涉及到该补充变更的仿制药申请。

(v) If an application (or supplement to an application) submitted under subsection (b) of this section for a drug, which includes an active ingredient (including any ester or salt of the active ingredient) that has been approved in another application under subsection (b) of this section, was approved during the period beginning January 1, 1982, and ending on September 24, 1984, the Secretary may not make the approval of an application submitted under this subsection which refers to the drug for which the subsection (b) application was submitted or which refers to a change approved in a supplement to the subsection (b) application effective before the expiration of two years from September 24, 1984.

(v)如果NDA补充申请，其药品的活性成分（包括活性成分的脂类和盐）已经在其他NDA申请中被批准，该申请在1982年1月1日至1984年9月24日期间被批准，自1984年9月24日起2年的有效期内卫生部不得批准参照该申请或者该修订变更的仿制药申请。

一沙一叶

巴西木发的东西真不错。

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