【转载】314 Part B 314.52

【转载】314 Part B 314.52  

2014-10-16 22:42:09|  分类： FDA|举报|字号 [url=]订阅[/url]

本文转载自aimerjiaer《314 Part B 314.52》http://zhuyujiao1972.blog.163.com/blog/static/98694727201491610429948/
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Sec. 314.52 Notice of certification of invalidity or noninfringement of a patent.

Sec.314.52 专利无效或未侵权声明的通知

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(a)Notice of certification. For each patent which claims the drug or drugs on which investigations that are relied upon by the applicant for approval of its application were conducted or which claims a use for such drug or drugs and which the applicant certifies under 314.50(i)(1)(i)(A)(4 ) that a patent is invalid, unenforceable, or will not be infringed, the applicant shall send notice of such certification by registered or certified mail, return receipt requested to each of the following persons:

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(a)声明的通知 申请人寻求申请批准所依赖的临床研究已实施的药品的专利，或者该类药品使用的专利，申请人按照314.50(i)(1)(i)(A)(4 )声明专利无效，不能强制履行，或者不会被侵权的，申请人应当通过注册或者认证的邮件通知该声明，需要以下人员的回执：

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(1) Each owner of the patent that is the subject of the certification or the representative designated by the owner to receive the notice. The name and address of the patent owner or its representative may be obtained from the United States Patent and Trademark Office; and

(1)声明中专利的每个拥有人或者拥有人指定接收通知的代表人员。专利拥有人或者代表的姓名和地址可以到美国专利局和商标局查询

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(2) The holder of the approved application under section 505(b) of the act for each drug product which is claimed by the patent or a use of which is claimed by the patent and for which the applicant is seeking approval, or, if the application holder does not reside or maintain a place of business within the United States, the application holder's attorney, agent, or other authorized official. The name and address of the application holder or its attorney, agent, or authorized official may be obtained from the Orange Book Staff, Office of Generic Drugs, 7500 Standish Pl., Rockville, MD 20855.

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(2)按照法案505(b)批准的，其药品有专利或者申请人寻求批准的药品使用有专利的申请持有人，或者，如果已批准申请的拥有人未在美国境内居住或在美国境内没有商业场所的，通知申请拥有人的商业代理人，法律代理人或者其他授权人员。申请拥有人，及其商业代理人，法律代理人或者其他授权人员的姓名和地址可以到仿制药办公室，负责橙皮书人员处查询，地址美国马里兰州，罗克韦尔市，斯坦迪士7500号，邮编20855.

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(3) This paragraph does not apply to a use patent that claims no uses for which the applicant is seeking approval.

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(3)本段落不适用于申请人寻求批准的使用不在专利保护范围内的情况

(b)Sending the notice. The applicant shall send the notice required by paragraph (a) of this section when it receives from FDA an acknowledgment letter stating that its application has been filed. At the same time, the applicant shall amend its application to include a statement certifying that the notice has been provided to each person identified under paragraph (a) of this section and that the notice met the content requirement under paragraph (c) of this section.

(b)发布通知  申请人从FDA处收到申请已备案的通知后，应当按照本部分(a)的要求发布通知，同时申请人应当修订申请增加一份声明，声明通知已经提供给本部分段落(a)指定的所有人员并且通知的内容符合本部分段落(c)的要求。

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(c)Content of a notice. In the notice, the applicant shall cite section 505(b)(3)(B) of the act and shall include, but not be limited to, the following information:

(c)通知的内容  在通知中，申请人应引用法案505(b)(3)(B)部分，并且包括，但不仅限于以下内容;

(1) A statement that a 505(b)(2) application submitted by the applicant has been filed by FDA.

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(1) 申请人递交的505(b)(2)的申请已被FDA备案的陈述

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(2) The application number.

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(2)申请号

(3) The established name, if any, as defined in section 502(e)(3) of the act, of the proposed drug product.

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(3)药品，如果有的话，按照法案502(e)(3)的定义的名称，

(4) The active ingredient, strength, and dosage form of the proposed drug product.

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(4)药品的原料药，规格和剂型

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(5) The patent number and expiration date, as submitted to the agency or as known to the applicant, of each patent alleged to be invalid, unenforceable, or not infringed.

(5)申请人认为无效，不能强制履行或者不会侵权的每个专利，需提供递交给当局的或者申请人知晓的专利号与失效期

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(6) A detailed statement of the factual and legal basis of the applicant's opinion that the patent is not valid, unenforceable, or will not be infringed. The applicant shall include in the detailed statement:

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(6)申请人认为专利无效，不能强制执行或者不侵权的事实和法律依据，提供一份详细的陈述。申请人应当在陈述中包括以下内容：

(i) For each claim of a patent alleged not to be infringed, a full and detailed explanation of why the claim is not infringed.

(i)对于每个专利不会侵权的主张，需要提供一份完整详细的解释说明为什么专利不会被侵权

(ii) For each claim of a patent alleged to be invalid or unenforceable, a full and detailed explanation of the grounds supporting the allegation.

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(ii) 对于每个专利无效或者不能强制履行的主张，提供一份完整详细的解释支持这一判断。

(7) If the applicant does not reside or have a place of business in the United States, the name and address of an agent in the United States authorized to accept service of process for the applicant.

(7)如果申请人未在美国境内居住或者在美国境内没有商业场所，提供授权的美国代理机构的姓名和地址

(d)Amendment to an application. If an application is amended to include the certification described in 314.50(i), the applicant shall send the notice required by paragraph (a) of this section at the same time that the amendment to the application is submitted to FDA.

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(d)申请的修订  如果修订申请，增加314.50(i)描述的声明，申请人将修订递交给FDA的同时，应按照本部分段落(a)发布通知。

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(e)Documentation of receipt of notice. The applicant shall amend its application to document receipt of the notice required under paragraph (a) of this section by each person provided the notice. The applicant shall include a copy of the return receipt or other similar evidence of the date the notification was received. FDA will accept as adequate documentation of the date of receipt a return receipt or a letter acknowledging receipt by the person provided the notice. An applicant may rely on another form of documentation only if FDA has agreed to such documentation in advance. A copy of the notice itself need not be submitted to the agency.

(e)通知已接收的证明文件  申请人应修订申请，用文件证明本部分段落(a)规定的通知人员已收到通知。申请人可以提供回执的复印件或其他类似的可以证明通知接收日期的证据。只要能用足够的文件证明收到回执的日期或者能提供通知接收人确认通知接收的信件，FDA都是认可的。如果事先得到FDA的同意，申请人也可以选用其他方式。通知本身不需要递交给当局。

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(f)Approval. If the requirements of this section are met, the agency will presume the notice to be complete and sufficient, and it will count the day following the date of receipt of the notice by the patent owner or its representative and by the approved application holder as the first day of the 45-day period provided for in section 505(c)(3)(C) of the act. FDA may, if the applicant amends its application with a written statement that a later date should be used, count from such later date.

(f)批准  如果符合本部分的要求，当局将相信通知是完整并且充分的，并且法案505(c)(3)(C)规定的45天的期限，将从专利拥有人或代表，或已批准申请拥有人接收通知之日算起。申请人如果修订申请，书面声明日期应当延迟的，FDA可能会从延迟日期开始算起。

[59 FR 50362, Oct. 3, 1994, as amended at 68 FR 36703, June 18, 2003; 69 FR 11310, Mar. 10, 2004; 74 FR 9766, Mar. 6, 2009; 74 FR 36605, July 24, 2009]

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