(5)(A) Within one hundred and eighty days of the initial receipt of an application under paragraph (2) or within such additional period as may be agreed upon by the Secretary and the applicant, the Secretary shall approve or disapprove the application.
（A）根据（2）要求接收申请之日起180天内或者经卫生部和申请人商定的额外的期限内，卫生部应当作出批准或者不批准申请的决定
(B) The approval of an application submitted under paragraph (2) shall be made effective on the last applicable date determined by applying the following to each certification made under paragraph (2)(A)(vii):
(B) 在最后的适用日期，根据（2）递交的申请批准应当生效，最后的适用日期由以下几条相对应（2）（A）（vii）的声明所决定：
(i) If the applicant only made a certification described in subclause (I) or (II) of paragraph (2)(A)(vii) or in both such subclauses, the approval may be made effective immediately.
（i）如果申请中只包含P（I）或P（II）声明，批准应当立即生效
(ii) If the applicant made a certification described in subclause (III) of paragraph (2)(A)(vii), the approval may be made effective on the date certified under subclause (III).
(ii) 如果申请中包含P（III）声明，批准将在专利失效的日期生效
(iii) If the applicant made a certification described in subclause (IV) of paragraph (2)(A)(vii), the approval shall be made effective immediately unless, before the expiration of 45 days after the date on which the notice described in paragraph (2)(B) is received, an action is brought for infringement of the patent that is the subject of the certification and for which information was submitted to the Secretary under subsection (b)(1) or (c)(2) of this section before the date on which the application (excluding an amendment or supplement to the application), which the Secretary later determines to be substantially complete, was submitted. If such an action is brought before the expiration of such days, the approval shall be made effective upon the expiration of the thirty-month period beginning on the date of the receipt of the notice provided under paragraph (2)(B)(i) or such shorter or longer period as the court may order because either party to the action failed to reasonably cooperate in expediting the action, except that—
(iii)如果申请中包含P（IV）声明,批准应当立即生效，除非通知接收之日起45天内，专利拥有人或者NDA持有人提起诉讼，批准将在通知收到日期算起30个月后生效，或者批准将会根据法庭的判决，由于一方败诉而延长或缩短30个月的批准时间，除非
(I) if before the expiration of such period the district court decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity), the approval shall be made effective on—
（I）如果30个月到期前，当地法院裁定该专利无效或者不造成侵权，申请应当在以下日期生效
(aa) the date on which the court enters judgment reflecting the decision; or
（aa）法院判决之日起；或者
(bb) 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;
（bb）和解令或者和解协议签署日期并由法院裁定之日，声明专利无效或者不造成侵权；
(II) if before the expiration of such period the district court decides that the patent has been infringed—
（II）在30个月到期前，如果当地法院裁定专利被侵权-
(aa) if the judgment of the district court is appealed, the approval shall be made effective on—
(aa) 如果申请人对当地法院的判决进行上诉，申请应当在以下日期生效-
(AA) the date on which the court of appeals decides that the patent is invalid or not infringed (including any substantive determination that there is no cause of action for patent infringement or invalidity); or
（AA）上诉法院判定专利无效或者不造成侵权的日期；或者
(BB) the date of a settlement order or consent decree signed and entered by the court of appeals stating that the patent that is the subject of the certification is invalid or not infringed; or
（BB）上诉法院签署和判定和解令或和解协议，声明专利是无效的或者不造成侵权的日期；或者
(bb) if the judgment of the district court is not appealed or is affirmed, the approval shall be made effective on the date specified by the district court in a court order under section 271(e)(4)(A) of title 35;
(bb) 如果申请人对法院的判决不进行上诉或者已确认，申请按照法院指令上指定的日期生效。
(III) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent is invalid or not infringed, the approval shall be made effective as provided in subclause (I); or
（III）如果30个月过期前，法院颁布了临时禁令，禁止申请人在法院判定专利是否有效和侵权之前商业化生产或者销售药品，并且如果法院判决专利无效或者不造成侵权，申请应当按照（I）的情况生效；或者
(IV) if before the expiration of such period the court grants a preliminary injunction prohibiting the applicant from engaging in the commercial manufacture or sale of the drug until the court decides the issues of patent validity and infringement and if the court decides that such patent has been infringed, the approval shall be made effective as provided in subclause (II). In such an action, each of the parties shall reasonably cooperate in expediting the action.
（IV）如果30个月过期前，法院颁布了临时禁令，禁止申请人在法院判定专利是否有效与是否侵权之前商业化生产或者销售药品，并且如果法院判决对专利侵权，申请应当按照（II）的情况生效.
在这样的诉讼中，双方都应当合理配合加速诉讼的解决
备注：临时禁令是原研药公司为了防止仿制药公司冒险上市，分割原研药的市场
(iv) 180-DAY EXCLUSIVITY PERIOD.—180天的独占期
(I) EFFECTIVENESS OF APPLICATION.—Subject to subparagraph (D), if the application contains a certification described in paragraph (2)(A)(vii)(IV) and is for a drug for which a first applicant has submitted an application containing such a certification, the application shall be made effective on the date that is 180 days after the date of the first commercial marketing of the drug (including the commercial marketing of the listed drug) by any first applicant.
（I）申请生效。-包含PIV声明的药品申请，如果已经有首仿者，该申请在首仿者的药品首次商业化上市（期间对照药的商品也在上市）的第180天之后才能生效。
(II) DEFINITIONS.—In this paragraph: （II）本段话中的术语
(aa) 180-DAY EXCLUSIVITY PERIOD.—The term ‘‘180-day exclusivity period’’ means the 180-day period ending on the day before the date on which an application submitted by an applicant other than a first applicant could become effective under this clause.
(aa) 180天的独占期。-指的是根据本条款，除了首仿者，其他递交的仿制药申请在180天之后才能生效
(bb) FIRST APPLICANT.—As used in this subsection, the term ‘‘first applicant’’ means an applicant that, on the first day on which a substantially complete application containing a certification described in paragraph (2)(A)(vii)(IV) is submitted for approval of a drug, submits a substantially complete application that contains and lawfully maintains a certification described in paragraph (2)(A)(vii)(IV) for the drug.
（bb）首仿者-本小节中“首仿者”指的是第一天递交了包含PIV声明的申请，并且所递交的申请是非常完整的，包含并且依法维护了PIV声明。
(cc) SUBSTANTIALLY COMPLETE APPLICATION.—（cc）充分完整的申请-
As used in this subsection, the term ‘‘substantially complete application’’ means an application under this subsection that on its face is sufficiently complete to permit a substantive review and contains all the information required by paragraph (2)(A).
本小节中“充分完整的申请”指的是表面上内容足够完整可以进行实质性的审核并且包含了仿制药申请所需要的所有信息
(dd) TENTATIVE APPROVAL.—临时性批准
(AA) IN GENERAL.—The term ‘‘tentative approval’’ means notification to an applicant by the Secretary that an application under this subsection meets the requirements of paragraph (2)(A), but cannot receive effective approval because the application does not meet the requirements of this subparagraph, there is a period of exclusivity for the listed drug under subparagraph (F) or section 355a of this title, or there is a 7-year period of exclusivity for the listed drug under section 360cc of this title.
（AA）广义-“临时性批准”指的是卫生部通知申请人，申请人所递交的ANDA满足要求，但是由于已批准上市药的专利独占期未结束或罕见病7年的专利独占期还没有结束，而不能获得有效批准。
(BB) LIMITATION.—A drug that is granted tentative approval by the Secretary is not an approved drug and shall not have an effective approval until the Secretary issues an approval after any necessary additional review of the application.
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（BB）狭义-被卫生部临时性批准的药品并不是已批准药品，并且在卫生部完成任何必要的审核，发布批准之前都不能生效。
C) CIVIL ACTION TO OBTAIN PATENT CERTAINTY.—
通过民事诉讼解决专利问题
(i) DECLARATORY JUDGMENT ABSENT INFRINGEMENT ACTION.—
不存在侵权行为的宣告式判决
(I) IN GENERAL.—No action may be brought under section 2201 of title 28 by an applicant under paragraph (2) for a declaratory judgment with respect to a patent which is the subject of the certification referred to in subparagraph (B)(iii) unless—
（I）广义—仿制药申请者不应按照标题28 2201针对P（IV）声明中的专利问题提出宣告式判决的诉讼，除非-
(aa) the 45-day period referred to in such subparagraph has expired;
(aa)45天已经失效；
(bb) neither the owner of such patent nor the holder of the approved application under subsection (b) of this section for the drug that is claimed by the patent or a use of which is claimed by the patent brought a civil action against the applicant for infringement of the patent before the expiration of such period; and
（bb）不论专利拥有者还是NDA持有人，声称对该药品有专利或者该药品的使用有专利，在此期间都没有对仿制药申请人提起专利侵权的民事诉讼；并且
(cc) in any case in which the notice provided under paragraph (2)(B) relates to noninfringement, the notice was accompanied by a document described in subclause (III).
（cc）不论哪种情况，专利通知都需要随附一份授权访问申请的机密文件
(II) FILING OF CIVIL ACTION.—If the conditions described in items (aa), (bb), and as applicable, (cc) of subclause (I) have been met, the applicant referred to in such subclause may, in accordance with section 2201 of title 28, bring a civil action under such section against the owner or holder referred to in such subclause (but not against any owner or holder that has brought such a civil action against the applicant, unless that civil action was dismissed without prejudice) for a declaratory judgment that the patent is invalid or will not be infringed by the drug for which the applicant seeks approval, except that such civil action may be brought for a declaratory judgment that the patent will not be infringed only in a case in which the condition described in subclause (I)(cc) is applicable. A civil action referred to in this subclause shall be brought in the judicial district where the defendant has its principal place of business or a regular and established place of business.
（II）提起民事诉讼-如果符合（aa）（bb）或者（cc）（I）（若适用）的情况，申请人，按照标题28 2201的要求，应当向专利的拥有人或者NDA持有人提起民事诉讼以得到专利无效或者申请不会侵权的宣告式判决（专利拥有人或者NDA持有人已经向仿制药申请者提起诉讼的除外，除非其民事诉讼被正当驳回），此类的民事诉讼只有在符合（I）（cc）所描述的情况下才会判决为专利未侵权。以上民事诉讼应当递交给被告主要营业场所或者建立常规业务所在地的司法管辖区。
备注：宣告式判决的出发点是为了保护仿制药厂家，防止45天后仿制药上市，原研药公司提起专利诉讼，仿制药厂家可能需支付巨额赔偿。
(III) OFFER OF CONFIDENTIAL ACCESS TO APPLICATION.—
For purposes of subclause (I)(cc), the document described in this subclause is a document providing an offer of confidential access to the application that is in the custody of the applicant under paragraph (2) for the purpose of determining whether an action referred to in subparagraph (B)(iii) should be brought. The document providing the offer of confidential access shall contain such restrictions as to persons entitled to access, and on the use and disposition of any information accessed, as would apply had a protective order been entered for the purpose of protecting trade secrets and other confidential business information. A request for access to an application under an offer of confidential access shall be considered acceptance of the offer of confidential access with the restrictions as to persons entitled to access, and on the use and disposition of any information accessed, contained in the offer of confidential access, and those restrictions and other terms of the offer of confidential access shall be considered terms of an enforceable contract. Any person provided an offer of confidential access shall review the application for the sole and limited purpose of evaluating possible infringement of the patent that is the subject of the certification under paragraph (2)(A)(vii)(IV) and for no other purpose, and may not disclose information of no relevance to any issue of patent infringement to any person other than a person provided an offer of confidential access. Further, the application may be redacted by the applicant to remove any information of no relevance to any issue of patent infringement.
（III）授权访问申请的机密部分-为了满足（I）（cc）的情况,本条款要求提供的文件指的是一份授权查看申请保密部分的文件，以便专利药厂家判定是否需要针对P（IV）提起诉讼，保密部分在仿制药申请者的监管之下。授权保密部分的文件应当包括有权访问的人员，限制查看信息的使用和所在的位置，也将用于申请保护令，以保护商业机密以及其他保密的商业信息。拥有授权信，请求查看申请资料的应当被视作接受授权信中的限制条款（有权访问的人员，限制查看的信息的使用和所在位置），那些限制条款以及其他与授权信相关的内容都应被视作可以强制执行的合同条款。任何提供授权信的人员应当审核申请，基于唯一的有限的目的，即为了评估可能存在的P（IV）声明中的专利的侵权，而不是出于其他目的。并且不得公开与专利侵权无关的信息给任何人，除非该人员可以提供授权书。此外，申请人可以编辑申请，将与专利侵权无关的信息删除。
备注：授权访问的申请由仿制药公司授权原研药公司，以便原研药公司判定是否要针对PIV声明提起诉讼。授权文件要包含在挑战专利的通知中。
(ii) COUNTERCLAIM TO INFRINGEMENT ACTION.—对侵权行为提起反诉
(I) IN GENERAL.—If an owner of the patent or the holder of the approved application under subsection (b) of this section for the drug that is claimed by the patent or a use of which is claimed by the patent brings a patent infringement action against the applicant, the applicant may assert a counterclaim seeking an order requiring the holder to correct or delete the patent information submitted by the holder under subsection (b) or (c) of this section on the ground that the patent does not claim either—
（I）广义-如果专利的拥有者或者NDA持有人所声称药品的专利或者声称药品的使用造成了侵权行为起诉申请者，申请人可以提起反诉，要求专利拥有人更正或者撤销根据本部分（c）和（b）递交的专利信息，基于的理由是以下两点-
(aa) the drug for which the application was approved; or
（aa）已批准申请没有包含专利；或者
(bb) an approved method of using the drug.
（bb）已批准的药品使用不包含专利
(II) NO INDEPENDENT CAUSE OF ACTION.—非独立诉讼理由
Subclause (I) does not authorize the assertion of a claim described in subclause (I) in any civil action or proceeding other than a counterclaim described in subclause (I).
（I）除反诉外，条款（I）不适用于任何其他民事诉讼的主张
(iii) NO DAMAGES.—An applicant shall not be entitled to damages in a civil action under clause (i) or a counterclaim under clause (ii).
没有损害赔偿-（i）中的民事诉讼和（ii）中的反诉，申请人都无权获得民事赔偿
(D) FORFEITURE OF 180-DAY EXCLUSIVITY PERIOD.—
丧失180天的市场独占期
(i) DEFINITION OF FORFEITURE EVENT.—In this subparagraph, the term ‘‘forfeiture event’’, with respect to an application under this subsection, means the occurrence of any of the following:
丧失独占期的定义-本部分，与申请有关的“丧失独占期”指的是以下任一情况的发生：
(I) FAILURE TO MARKET.—The first applicant fails to market the drug by the later of—
上市失败-首仿者未在以下期限内上市药品
(aa) the earlier of the date that is—以下两个时间取较早的时间点-
(AA) 75 days after the date on which the approval of the application of the first applicant is made effective under subparagraph (B)(iii); or
根据（B）（iii）首仿者申请生效之日起75天后；或者
(BB) 30 months after the date of submission of the application of the first applicant; or
首仿者递交申请30个月之后，或者
(bb) with respect to the first applicant or any other applicant (which other applicant has received tentative approval), the date that is 75 days after the date as of which, as to each of the patents with respect to which the first applicant submitted and lawfully maintained a certification qualifying the first applicant for the 180-day exclusivity period under subparagraph (B)(iv), at least 1 of the following has occurred:
关于首仿者或者其他申请人（已获得临时批准的申请人），第一个递交专利声明并且获得180天市场专营权的，以下至少任一情况发生75天之后未上市：
(AA) In an infringement action brought against that applicant with respect to the patent or in a declaratory judgment action brought by that applicant with respect to the patent, a court enters a final decision from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the patent is invalid or not infringed.
（AA）在针对申请人的与专利相关的侵权诉讼中或者该申请者提起的与专利相关的诉讼中，法院最终裁定对专利无效或者没有侵权的判决没有上诉（向最高法院请求复审令的除外）
(BB) In an infringement action or a declaratory judgment action described in subitem (AA), a court signs a settlement order or consent decree that enters a final judgment that includes a finding that the patent is invalid or not infringed.
（BB）（AA）项下描述的民事诉讼，法院签署了一份解决的调令或者调解书，最终判决专利无效或者没有侵权行为
(CC) The patent information submitted under subsection (b) or (c) of this section is withdrawn by the holder of the application approved under subsection (b) of this section.
（CC）根据（b）部分批准的申请的持有人撤销了根据（b）或者（c）递交的专利信息
(II) WITHDRAWAL OF APPLICATION.—The first applicant withdraws the application or the Secretary considers the application to have been withdrawn as a result of a determination by the Secretary that the application does not meet the requirements for approval under paragraph (4).
（II）撤销申请-首仿者撤销了申请或者卫生部认为申请不符合（4）的批准要求，认为申请应当被撤销
(III) AMENDMENT OF CERTIFICATION.—The first applicant amends or withdraws the certification for all of the patents with respect to which that applicant submitted a certification qualifying the applicant for the 180- day exclusivity period.
（III）修订声明-首仿者修订或者撤销了所有专利相关的声明，该声明确认了首仿者180天的市场专营权
(IV) FAILURE TO OBTAIN TENTATIVE APPROVAL.—The first applicant fails to obtain tentative approval of the application within 30 months after the date on which the application is filed, unless the failure is caused by a change in or a review of the requirements for approval of the application imposed after the date on which the application is filed.
（IV）未获得临时批准-首仿者未在申请归档后的30个月内获得临时批准，除非未取得的原因是申请归档之后强加的批准申请的要求的变更。
(V) AGREEMENT WITH ANOTHER APPLICANT, THE LISTED DRUG APPLICATION HOLDER, OR A PATENT OWNER.—The first applicant enters into an agreement with another applicant under this subsection for the drug, the holder of the application for the listed drug, or an owner of the patent that is the subject of the certification under paragraph (2)(A)(vii)(IV), the Federal Trade Commission or the Attorney General files a complaint, and there is a final decision of the Federal Trade Commission or the court with regard to the complaint from which no appeal (other than a petition to the Supreme Court for a writ of certiorari) has been or can be taken that the agreement has violated the antitrust laws (as defined in section 12 of title 15, except that the term includes section 45 of title 15 to the extent that that section applies to unfair methods of competition).
（V）与另一家仿制药申请人，专利的拥有人或者对照药申请的持有人达成了协议-首仿者与另一家仿制药申请者，对照药申请的持有者，或者P（IV）的声明中专利的持有人达成了协议，联邦贸易协会或者律政司进行了投诉，联邦贸易协会或者法院最终对该投诉进行了判决并且对该协议违反反垄断法的裁定没有上诉（向最高法院请求复审令的除外），（根据标题15 第12部分的定义，符合标题15第45部分的定义，使用不公平竞争的手段）
(VI) EXPIRATION OF ALL PATENTS.—All of the patents as to which the applicant submitted a certification qualifying it for the 180-day exclusivity period have expired.
（IV）过期的专利-首仿者递交的声明寻求180天专营权的专利都已经到期
(ii) FORFEITURE.—The 180-day exclusivity period described in subparagraph (B)(iv) shall be forfeited by a first applicant if a forfeiture event occurs with respect to that first applicant.
（iii）丧失独占期-如果与首仿者相关的丧失独占期事件发生，该首仿者拥有的（B）（iv）情况中描述的180天的市场独占期应被没收
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总结下180天丧失事件：
1.ANDA批准后75天未上市；
2.ANDA申报满30个月满未上市；（和1相比取更早的日期）；
3.法庭终审判决仿制药胜诉75天未上市（向最高法院请求复审令的除外）；
4.庭外和解75天未上市；
5.被挑战的专利撤销75天后未上市；
6.ANDA撤销或被卫生部撤销；
7.PIV声明改成PIII声明
8.递交30个月ANDA未获得临时批准（除非原因是递交之后批准申请的要求改变或强加的要求）
9.仿制药公司与专利药公司达成协议，违反反垄断法；
10.专利过期
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