【转载】314.53 submission of patent information(2/2)

【转载】314.53 submission of patent information(2/2)  

2014-10-16 22:40:45|  分类： FDA|举报|字号 [url=]订阅[/url]

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本文转载自aimerjiaer《314.53 submission of patent information(2/2)》
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(3)No relevant patents. If the applicant believes that there are no relevant patents that claim the drug substance (active ingredient), drug product (formulation or composition), or the method(s) of use for which the applicant has received approval, and with respect to which a claim of patent infringement could reasonably be asserted if a person not licensed by the owner of the patent engaged in the manufacture, use, or sale of the drug product, the applicant will verify this information in the appropriate forms, FDA Forms 3542 or 3542a.
8 c' T0 D0 @3 A, e; D(3) 没有相关专利  如果申请人认为没有关于原料药（活性成分），成品（处方或组分），或适应症的专利，并且如果任何人未经专利拥有人授权进行药品生产，使用或销售活动的，专利侵权相关的赔偿将得到合理的维护，申请人需要在FDA表格3542或3542a中确认该信息。
(4)Authorized signature. The declarations required by this section shall be signed by the applicant or patent owner, or the applicant's or patent owner's attorney, agent (representative), or other authorized official.
(4) 授权签字  本部分声明需要申请人或专利拥有人，或申请人，专利拥有人的商业代理，法律代理机构（代理人），或其他授权的人员签字。
. _7 {- H" p$ n  M/ R7 m) X(d)When and where to submit patent information --(1)Original application. An applicant shall submit with its original application submitted under this part, including an application described in section 505(b)(2) of the act, the information described in paragraph (c) of this section on each drug (ingredient), drug product (formulation and composition), and method of use patent issued before the application is filed with FDA and for which patent information is required to be submitted under this section. If a patent is issued after the application is filed with FDA but before the application is approved, the applicant shall, within 30 days of the date of issuance of the patent, submit the required patent information in an amendment to the application under 314.60.
(d) 何时递交，在哪里递交专利信息—(1)原始申请 申请人应按照本部分要求递交原始申请，包括按照法案505(b)(2)递交的申请，按照本部分段落(c)递交的FDA备案ANDA之前发布的有关每个药物（成分），成品（配方和组成），以及使用方法的专利。如果专利在ANDA备案之后批准之前被发布，申请人应当自专利发布之日起30日内，按照314.60以修订的形式递交专利信息。
# U/ {+ x; @, E1 H2 N6 q(2)Supplements. (i) An applicant shall submit patent information required under paragraph (c) of this section for a patent that claims the drug, drug product, or method of use for which approval is sought in any of the following supplements:
(2) 补充 (i) 以下补充的批准，需要申请人按照本部分段落(c)的要求递交主张药物，成品，或适应症的专利信息：
(A) To change the formulation;
- M  j1 ^1 b, t$ E+ {0 ~(A)变更处方；
(B) To add a new indication or other condition of use, including a change in route of administration;
3 G! w% R1 r+ L- }(B)增加新的适应症或其他使用条件，包括给药途径的变更；
(C) To change the strength;
+ b0 Q8 a7 o! F( l: c, M(C) 变更规格；
# d7 f' M. }8 S! Q(D) To make any other patented change regarding the drug, drug product, or any method of use.
3 g% p6 r  i2 j(D) 其他任何有关药物，药品或适应症的专利变更。
/ \0 \' |* d; M  ?" l# L) e(ii) If the applicant submits a supplement for one of the changes listed under paragraph (d)(2)(i) of this section and existing patents for which information has already been submitted to FDA claim the changed product, the applicant shall submit a certification with the supplement identifying the patents that claim the changed product.
(ii) 如果申请人递交了段落(d)(2)(i)中所列的变更的补充，并且与变更产品相关的专利信息先前已递交给FDA，申请人应在补充中递交一份声明指出主张该变更产品的专利。
  \$ d9 D# b; _(iii) If the applicant submits a supplement for one of the changes listed under paragraph (d)(2)(i) of this section and no patents, including previously submitted patents, claim the changed product, it shall so certify.
(iii) 如果申请人递交了段落(d)(2)(i)中所列的变更的补充，并且没有专利（包含先前递交的专利），是主张该变更的产品的，需要对此进行证明。
9 g/ E$ Q; R8 E3 f& }6 E* |% h  t(iv) The applicant shall comply with the requirements for amendment of formulation or composition and method of use patent information under paragraphs (c)(2)(ii) and (d)(3) of this section.
(iv) 申请人对配方或组成以及适应症专利信息的修订应符合段落(c)(2)(ii)到(d)(3)的要求
(3)Patent information deadline. If a patent is issued for a drug, drug product, or method of use after an application is approved, the applicant shall submit to FDA the required patent information within 30 days of the date of issuance of the patent.
0 @) k- V! |2 F; U, M(3)专利信息递交期限 如果药物，药品或者适应症专利在申请批准后发布，申请人应当自专利发布之日起30日内向FDA递交专利信息。
(4)Copies. The applicant shall submit two copies of each submission of patent information, an archival copy and a copy for the chemistry, manufacturing, and controls section of the review copy, to the Central Document Room, Center for Drug Evaluation and Research, Food and Drug Administration, 5901-B Ammendale Rd., Beltsville, MD 20705-1266. The applicant shall submit the patent information by letter separate from, but at the same time as, submission of the supplement.
(4) 复印件 每一份专利信息都应递交两份复印件，一份复印件放在归档申请中，一份放在审核件的CMC部分，复印件提供给FDA，CDER的中心档案室，地址是5901-B Ammendale Rd., Beltsville, MD 20705-1266。申请人递交专利信息表应按字母分开递交，但同时以补充形式递交。
+ i/ A, K* N8 h2 F(5)Submission date. Patent information shall be considered to be submitted to FDA as of the date the information is received by the Central Document Room.
(5) 递交日期 专利信息被中心档案室接收的日期作为专利信息递交日期
(6)Identification. Each submission of patent information, except information submitted with an original application, and its mailing cover shall bear prominent identification as to its contents,i.e. , "Patent Information," or, if submitted after approval of an application, "Time Sensitive Patent Information."
$ b  d& N9 E/ B9 _(6)  除了原始申请中递交的专利信息，其他每个专利信息的递交需要在邮件封面上突出识别邮件的内容，例如写上“Patent Information”或者，如果专利信息是在申请被批准后递交的，标明“Time Sensitive Patent Information”。
' H& w: {! u+ B( `! [" E" K(e)Public disclosure of patent information. FDA will publish in the list the patent number and expiration date of each patent that is required to be, and is, submitted to FDA by an applicant, and for each use patent, the approved indications or other conditions of use covered by a patent. FDA will publish such patent information upon approval of the application, or, if the patent information is submitted by the applicant after approval of an application as provided under paragraph (d)(2) of this section, as soon as possible after the submission to the agency of the patent information. Patent information submitted by the last working day of a month will be published in that month's supplement to the list. Patent information received by the Agency between monthly publication of supplements to the list will be placed on public display in FDA's Division of Freedom of Information. A request for copies of the file shall be sent in writing to the Division of Freedom of Information (ELEM-1029), Food and Drug Administration, 12420 Parklawn Dr., Element Bldg., Rockville, MD 20857.
& p- h8 Z6 ?# c(e) 专利信息的公布  FDA将在专利清单中公布专利号，专利有效期，以及每个使用专利已批准的适应症或者其他专利保护范围内的使用条件。FDA一旦批准申请就将公布上述专利信息，或者如果专利信息是在申请批准后递交的，FDA将在收到递交信息后及时公布。每个月工作日最后一天递交的专利信息，将作为这个月专利清单补充的形式公布。如果当局在每月对清单补充的时间段接收到专利信息，专利信息将放在FDA's Division of Freedom of Information进行公示
" }1 M  s4 l+ e5 _; t% J! @8 w(f)Correction of patent information errors. If any person disputes the accuracy or relevance of patent information submitted to the agency under this section and published by FDA in the list, or believes that an applicant has failed to submit required patent information, that person must first notify the agency in writing stating the grounds for disagreement. Such notification should be directed to the Office of Generic Drugs, OGD Document Room, Attention: Orange Book Staff, 7500 Standish Pl., Rockville, MD 20855. The agency will then request of the applicable new drug application holder that the correctness of the patent information or omission of patent information be confirmed. Unless the application holder withdraws or amends its patent information in response to FDA's request, the agency will not change the patent information in the list. If the new drug application holder does not change the patent information submitted to FDA, a 505(b)(2) application or an abbreviated new drug application under section 505(j) of the act submitted for a drug that is claimed by a patent for which information has been submitted must, despite any disagreement as to the correctness of the patent information, contain an appropriate certification for each listed patent.
(f) 专利信息纠正 任何人对递交给FDA并在清单上公布的专利信息的正确性和关联性存在异议的，或者认为申请人没有递交需要的专利信息的，争议人应第一时间以书面形式联系FDA，声明争议的理由。上述信息应直接递交给仿制药办公室档案室，备注：Orange Book Staff, 7500 Standish Pl., Rockville, MD 20855。FDA将会要求NDA持有人改正专利信息。除非申请人回复FDA撤销或者修订专利信息，否则FDA不会变更清单上的信息。如果NDA持有人没有变更递交给FDA的专利信息，505(b)(2)申请或者仿制药申请人尽管对专利信息的正确性存在异议，仍需要在申请中包含对清单中每个专利的声明。
[59 FR 50363, Oct. 3, 1994, as amended at 68 FR 36703, June 18, 2003; 69 FR 13473, Mar. 23, 2004; 74 FR 9766, Mar. 6, 2009; 74 FR 36605, July 24, 2009; 76 FR 31470, June 1, 2011]
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