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【转载】314.53 submission of patent information(1/2)

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【转载】314.53 submission of patent information(1/2) 2 {. h0 f, ~" o& M

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2014-10-16 22:40:09| 分类： FDA|举报|字号[url=]订阅[/url]

本文转载自aimerjiaer《314.53 submission of patent information(1/2)》

Sec. 314.53 Submission of patent information.递交专利信息
(a)Who must submit patent information. This section applies to any applicant who submits to FDA a new drug application or an amendment to it under section 505(b) of the act and 314.50 or a supplement to an approved application under 314.70, except as provided in paragraph (d)(2) of this section.
(a)哪些情况必须递交专利声明。按照法案505(b)和314.50递交NDA以及修订，或者按照314.70递交已批准申请的补充，本部分段落(d)(2)规定的补充除外。
(b)Patents for which information must be submitted and patents for which information must not be submitted --(1)General requirements. An applicant described in paragraph (a) of this section shall submit the required information on the declaration form set forth in paragraph (c) of this section for each patent that claims the drug or a method of using the drug that is the subject of the new drug application or amendment or supplement to it 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. For purposes of this part, such patents consist of drug substance (active ingredient) patents, drug product (formulation and composition) patents, and method-of-use patents. For patents that claim the drug substance, the applicant shall submit information only on those patents that claim the drug substance that is the subject of the pending or approved application or that claim a drug substance that is the same as the active ingredient that is the subject of the approved or pending application. For patents that claim a polymorph that is the same as the active ingredient described in the approved or pending application, the applicant shall certify in the declaration forms that the applicant has test data, as set forth in paragraph (b)(2) of this section, demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the new drug application. For patents that claim a drug product, the applicant shall submit information only on those patents that claim a drug product, as is defined in 314.3, that is described in the pending or approved application. For patents that claim a method of use, the applicant shall submit information only on those patents that claim indications or other conditions of use that are described in the pending or approved application. The applicant shall separately identify each pending or approved method of use and related patent claim. For approved applications, the applicant submitting the method-of-use patent shall identify with specificity the section of the approved labeling that corresponds to the method of use claimed by the patent submitted. Process patents, patents claiming packaging, patents claiming metabolites, and patents claiming intermediates are not covered by this section, and information on these patents must not be submitted to FDA.
(b)专利的哪些信息必须递交，哪些信息禁止递交。
(1)一般要求  NDA，及其修订和补充中涉及药品或者药品使用专利的，申请人需按照段落(c)的要求递交表格所需的信息，如果任何人未通过专利拥有人授权，参与药品的生产，使用和销售活动的，有关专利侵权的索赔将得到合理宣判。就本部分而言，这样的专利包括原料药（活性成分）专利，成品（处方和组成）专利，适应症专利。
原料药专利，申请人仅限于提供以下专利主张的信息，主张原料药是待批准或已批准申请的主体，或主张原料药与待批准或者已批准申请的主体原料药一致。
晶型专利主张与已批准或待批准申请中描述的活性成分晶型一致的专利，申请人应在报表中证明申请中的段落(b)(2)要求的数据可以证明包含多晶型的产品可以与NDA的产品发挥同样的作用。
成品专利申请人仅限于提供主张待批准或已批准申请中成品的专利信息
适应症专利申请人仅限于提供主张待批准或已批准申请中适应症或其他使用条件的专利信息。
申请人应分别确认每个待批准或已批准的适应症和相应的专利主张。对于已批准申请，递交适应症专利的，需指出已批准标签中与适应症专利一致的具体部分。

工艺专利，包括包装专利，代谢物专利，中间体专利都不包括在本部分中，这些专利的信息禁止递交给FDA。
(2)Test Data for Submission of Patent Information for Patents That Claim a Polymorph. The test data, referenced in paragraph (b)(1) of this section, must include the following:
(2)晶型专利需递交检测数据作为专利信息,检测数据必须包括以下内容：
(i) A full description of the polymorphic form of the drug substance, including its physical and chemical characteristics and stability; the method of synthesis (or isolation) and purification of the drug substance; the process controls used during manufacture and packaging; and such specifications and analytical methods as are necessary to assure the identity, strength, quality, and purity of the polymorphic form of the drug substance;
(i)对原料药多晶型做一个详细的描述，包括物理和化学的性质，稳定性，原料药合成（或分离）以及纯化的方法，生产和包装过程的工艺控制，用于确保原料晶型性质，规格，质量以及纯度的质量标准和分析方法。
(ii) The executed batch record for a drug product containing the polymorphic form of the drug substance and documentation that the batch was manufactured under current good manufacturing practice requirements;
(ii) 包含多晶型原料药的成品执行批批记录，以及能证明执行批的生产符合GMP要求的文件；
(iii) Demonstration of bioequivalence between the executed batch of the drug product that contains the polymorphic form of the drug substance and the drug product as described in the NDA;
(iii) 能证明包含多晶型原料药的执行批的成品与NDA成品具有生物等效性的文件；
(iv) A list of all components used in the manufacture of the drug product containing the polymorphic form and a statement of the composition of the drug product; a statement of the specifications and analytical methods for each component; a description of the manufacturing and packaging procedures and in-process controls for the drug product; such specifications and analytical methods as are necessary to assure the identity, strength, quality, purity, and bioavailability of the drug product, including release and stability data complying with the approved product specifications to demonstrate pharmaceutical equivalence and comparable product stability; and
(iv) 多晶型成品的组分清单，成品组成的描述，每个组分质量标准和分析方法的描述；成品生产，包装程序以及中间控制的描述；确认成品性质，规格，质量，纯度以及生物利用度的质量标准和分析方法，包括符合成品标准的放行数据和稳定性数据，以证明药品稳定性和均一性；以及
(v) Comparative in vitro dissolution testing on 12 dosage units each of the executed test batch and the new drug application product.
(v)试验药和NDA药分别做12个制剂单位的体外溶出对比试验。
(c)Reporting requirements --(1)General requirements. An applicant described in paragraph (a) of this section shall submit the required patent information described in paragraph (c)(2) of this section for each patent that meets the requirements described in paragraph (b) of this section. We will not accept the patent information unless it is complete and submitted on the appropriate forms, FDA Forms 3542 or 3542a. These forms may be obtained on the Internet at http://www.fda.gov by searching for "forms".
(c)报告要求
(1) 一般要求申请人需按照段落(c)(2)的要求递交专利信息。FDA只接受按照表格FDA3542或3542完整填写的专利信息。这些表格通过在FDA官网上输入“forms”搜索得到。
(2)Drug substance (active ingredient), drug product (formulation or composition), and method-of-use patents --(i)Original Declaration. For each patent that claims a drug substance (active ingredient), drug product (formulation and composition), or method of use, the applicant shall submit FDA Form 3542a. The following information and verification is required:
(2) 原料药（活性成分），成品（处方和组成），适应症专利--(i)最初的声明  填写FDA Form 3542 递交原料药（活性成分），成品（处方和组成），适应症专利信息，需要填写和确认以下信息：
(A) New drug application number; NDA号
(B) Name of new drug application sponsor; NDA发起人的姓名
(C) Trade name (or proposed trade name) of new drug; 新药的商标名（或者提议的商标名）
(D) Active ingredient(s) of new drug; 新药的原料药
(E) Strength(s) of new drug; 新药的规格
(F) Dosage form of new drug; 新药的剂型
(G) United States patent number, issue date, and expiration date of patent submitted;
专利的美国专利号，发布的日期以及有效期
(H) The patent owner's name, full address, phone number and, if available, fax number and e-mail address;
(H)专利拥有人的姓名，详细地址，电话以及传真和电子邮箱地址(最后两项有的话就填)
(I) The name, full address, phone number and, if available, fax number and e-mail address of an agent or representative who resides or maintains a place of business within the United States authorized to receive notice of patent certification under sections 505(b)(3) and 505(j)(2)(B) of the act and 314.52 and 314.95 (if patent owner or new drug application applicant or holder does not reside or have a place of business within the United States);
(I)（如果专利拥有人或者NDA申请人或持有人未在美国境内居住或者在美国境内没有商业场所），需要填写美国代理机构或者代理人（能够接收专利声明的通知）的姓名，详细地址，电话以及传真和电子邮箱地址（最后两项有的话就填）
(J) Information on whether the patent has been submitted previously for the new drug application;
(J) 此专利先前是否已在NDA中递交（确认项）
(K) Information on whether the expiration date is a new expiration date if the patent had been submitted previously for listing;
(K)如果专利先前已被递交上市，填写的专利有效期是否是新的有效期（确认项）
(L) Information on whether the patent is a product-by-process patent in which the product claimed is novel;
(L)是否是新产品的product-by-process专利（确认项）
(M) Information on the drug substance (active ingredient) patent including the following:
(M) 原料药专利信息需要确认的项目如下：
(1 ) Whether the patent claims the drug substance that is the active ingredient in the drug product described in the new drug application or supplement;
(1)有专利主张的原料药是否是NDA或补充中药品的活性成分
(2 ) Whether the patent claims a polymorph that is the same active ingredient that is described in the pending application or supplement;
(2)有多晶型专利的原料药是否是待批准申请或补充中的活性成分
(3 ) Whether the applicant has test data, described in paragraph (b)(2) of this section, demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the new drug application or supplement, and a description of the polymorphic form(s) claimed by the patent for which such test data exist;
(3)申请人是否有本段落(b)(2)要求的检测数据，能够证明包含多个晶型原料药的成品与NDA或补充中的药品有相同的效果（确认项），同时对该专利主张的多晶型进行描述。
(4 ) Whether the patent claims only a metabolite of the active ingredient; and
(4)专利是否仅主张原料药的代谢物；以及
(5 ) Whether the patent claims only an intermediate;
(5)专利是否仅主张中间体；
(N) Information on the drug product (composition/formulation) patent including the following:
(N)成品专利信息（组成/配方）需要确认的项目如下：
(1 ) Whether the patent claims the drug product for which approval is being sought, as defined in 314.3; and
(1)有专利主张的药品是否是314.3中定义的寻求批准的药品
(2 ) Whether the patent claims only an intermediate;
(2)专利是否仅主张中间体；
(O) Information on each method-of-use patent including the following:
(O)适应症的专利信息需要确认以下项目：
(1) Whether the patent claims one or more methods of using the drug product for which use approval is being sought and a description of each pending method of use or related indication and related patent claim of the patent being submitted; and
(1)专利是否主张一个或者多个寻求批准的药品的使用，对每个待批准的使用方法或相关的适应症，以及该递交专利的专利主张进行描述，并且
(2 ) Identification of the specific section of the proposed labeling for the drug product that corresponds to the method of use claimed by the patent submitted;
(2) 确认药品待批准的标签上适应症部分与专利主张一致；
(P) Whether there are no relevant patents that claim the drug substance (active ingredient), drug product (formulation or composition) or method(s) of use, for which the applicant is seeking 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;
(P)申请人寻求批准的申请中是否不包括任何原料药（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。（确认项）
(Q) A signed verification which states:
(Q)签字确认以声明：
"The undersigned declares that this is an accurate and complete submission of patent information for the NDA, amendment or supplement pending under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-sensitive patent information is submitted pursuant to 21 CFR 314.53. I attest that I am familiar with 21 CFR 314.53 and this submission complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is true and correct."; and
“署名人宣誓本次按照食品药品化妆品法案505部分递交的用于待批准NDA，及其修订和补充的专利信息完整无误。此时效性的专利信息是依据21 CFR 314.53递交的。我证明自己熟悉21 CFR 314.53的条款并且递交的专利信息符合该法规的要求。我宣誓没有触犯伪证罪条款，上述所有内容都属实。”
(R) Information on whether the applicant, patent owner or attorney, agent, representative or other authorized official signed the form; the name of the person; and the full address, phone number and, if available, the fax number and e-mail address.
(R)NDA申请人，专利拥有人或者其法律代理，商务代理机构，个人或其他授权的人员签字，同时提供以下信息：签字人的姓名，详细地址，电话和传真号以及电子邮件地址（最后两项如果有的话就填）。
(ii)Submission of patent information upon and after approval. Within 30 days after the date of approval of its application or supplement, the applicant shall submit FDA Form 3542 for each patent that claims the drug substance (active ingredient), drug product (formulation and composition), or approved method of use. FDA will rely only on the information submitted on this form and will not list or publish patent information if the patent declaration is incomplete or indicates the patent is not eligible for listing. Patent information must also be submitted for patents issued after the date of approval of the new drug application as required in paragraph (c)(2)(ii) of this section. As described in paragraph (d)(4) of this section, patent information must be submitted to FDA within 30 days of the date of issuance of the patent. If the applicant submits the required patent information within the 30 days, but we notify an applicant that a declaration form is incomplete or shows that the patent is not eligible for listing, the applicant must submit an acceptable declaration form within 15 days of FDA notification to be considered timely filed. The following information and verification statement is required:
(ii)批准时和批准后递交专利信息  申请或补充得到批准后30天内，申请人需递交每个专利的FDA form 3542，主张原料药（活性成分），成品（处方和组分）或已批准适应症的专利。FDA只认可表格上的专利信息，如果专利信息表的内容不完整或者表明专利没有资格列入清单，FDA不会将专利信息列入清单或者公布。NDA批准后发布的专利信息也要按照本部分段落(c)(2)(ii)的要求递交。专利信息必须在专利发布的30日内递交。如果申请人在30日内递交了专利信息，但是FDA通知申请人递交的表格不完整或者显示专利不符合在清单中列出的资格，申请人必须在接收到通知之日起15日内递交一份可接受的表格，才能被认为是及时递交专利信息。递交的表格有以下信息需要填写或者确认：
(A) New drug application number;
(A) NDA号；
(B) Name of new drug application sponsor;
(B) NDA申请人姓名；
(C) Trade name of new drug;
(C) 商品名；
(D) Active ingredient(s) of new drug;
(D) 活性成分；
(E) Strength(s) of new drug;
(E) 规格；
(F) Dosage form of new drug;
(F)剂型；
(G) Approval date of new drug application or supplement;
(E) NDA或补充的批准日期；
(H) United States patent number, issue date, and expiration date of patent submitted;
(H) 美国专利号，发布日期，以及专利的有效期
(I) The patent owner's name, full address, phone number and, if available, fax number and e-mail address;
(I) 专利拥有人的姓名，详细地址，电话，传真和电子邮件地址（后两项如果有的话就填写）；
(J) The name, full address, phone number and, if available, fax number and e-mail address of an agent or representative who resides or maintains a place of business within the United States authorized to receive notice of patent certification under sections 505(b)(3) and 505(j)(2)(B) of the act and 314.52 and 314.95 (if patent owner or new drug application applicant or holder does not reside or have a place of business within the United States);
(J) （如果专利拥有人或者NDA申请人或持有人未在美国境内居住或者在美国境内没有商业场所），需要填写美国代理机构或者代理人（能够接收专利声明的通知）的姓名，详细地址，电话以及传真和电子邮箱地址（最后两项有的话就填）
(K) Information on whether the patent has been submitted previously for the new drug application;
(K) 此专利先前是否已在NDA中递交（确认项）
(L) Information on whether the expiration date is a new expiration date if the patent had been submitted previously for listing;
(L) 如果专利先前已被递交上市，填写的专利有效期是否是新的有效期（确认项）
(M) Information on whether the patent is a product-by-process patent in which the product claimed is novel;
(M) 是否是新产品的product-by-process专利（确认项）
(N) Information on the drug substance (active ingredient) patent including the following:
(N) 原料药专利信息需要确认的项目如下：
(1 ) Whether the patent claims the drug substance that is the active ingredient in the drug product described in the approved application;
(1) 有专利主张的原料药是否是已批准申请中成品的活性成分；
(2 ) Whether the patent claims a polymorph that is the same as the active ingredient that is described in the approved application;
(2) 有多晶型专利的原料药是否是已批准申请中的活性成分；
(3 ) Whether the applicant has test data, described at paragraph (b)(2) of this section, demonstrating that a drug product containing the polymorph will perform the same as the drug product described in the approved application and a description of the polymorphic form(s) claimed by the patent for which such test data exist;
(3)申请人是否能按照本段落(b)(2)的要求，提供检测数据证明包含多个晶型原料药的成品与已批准申请的药品有相同的效果（确认项），同时对该专利主张的多晶型进行描述。
(4 ) Whether the patent claims only a metabolite of the active ingredient; and
(4)专利是否仅主张原料药的代谢物；以及
(5 ) Whether the patent claims only an intermediate;
(5)专利是否仅主张中间体；
(O) Information on the drug product (composition/formulation) patent including the following:
(O) 成品（组成/处方）专利需要确认以下信息：
(1 ) Whether the patent claims the approved drug product as defined in 314.3; and
(1) 有专利主张的药品是否是314.3中定义的已批准药品；以及
(2 ) Whether the patent claims only an intermediate;
(2)专利是否仅主张中间体；
(P) Information on each method-of-use patent including the following:
(P) 适应症的专利信息需要确认以下项目：
(1) Whether the patent claims one or more approved methods of using the approved drug product and a description of each approved method of use or indication and related patent claim of the patent being submitted;
(1) 专利是否主张一个或多个已批准的药品使用，对每个已批准的使用方法或适应症，以及该递交专利的专利主张进行描述，并且
(2 ) Identification of the specific section of the approved labeling for the drug product that corresponds to the method of use claimed by the patent submitted; and
(2) 确认药品已批准标签上使用方法部分与专利主张一致；并且
(3 ) The description of the patented method of use as required for publication;
(3) 确认标签与专利主张的使用方法的描述与印刷版的一致；
(Q) Whether there are no relevant patents that claim the approved drug substance (active ingredient), the approved drug product (formulation or composition) or approved method(s) of use 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;
(Q)是否没有相关专利，主张已批准原料药（活性成分），已批准成品（处方或组分），或已批准的使用方法，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。（确认项）
(R) A signed verification which states: "The undersigned declares that this is an accurate and complete submission of patent information for the NDA, amendment or supplement approved under section 505 of the Federal Food, Drug, and Cosmetic Act. This time-sensitive patent information is submitted pursuant to 21 CFR 314.53. I attest that I am familiar with 21 CFR 314.53 and this submission complies with the requirements of the regulation. I verify under penalty of perjury that the foregoing is true and correct."; and
(R) 签字确认以声明：“署名人宣誓本次按照食品药品化妆品法案505部分递交的用于已批准NDA，及其修订和补充的专利信息完整无误。此时效性的专利信息是依据21 CFR 314.53递交的。我证明自己熟悉21 CFR 314.53的条款并且递交的专利信息符合该法规的要求。我宣誓没有触犯伪证罪条款，上述所有内容都属实。”
(S) Information on whether the applicant, patent owner or attorney, agent, representative or other authorized official signed the form; the name of the person; and the full address, phone number and, if available, the fax number and e-mail address.
(S) NDA申请人，专利拥有人或者其法律代理，商务代理机构，个人或其他授权的人员签字，同时提供以下信息：签字人的姓名，详细地址，电话和传真号以及电子邮件地址（最后如果有的话就填）。

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