FREQUENTLY ASKED QUESTIONS ON PATENTS AND EXCLUSIVITY
关于专利和独占性的常见问题解答

关于专利和独占性的常见问题解答

1. What is the difference between patents and exclusivity?
1. 专利权和独占权有什么区别？

Patents and exclusivity work in a similar fashion but are distinct from one another and governed by different statutes. Patents are a property right granted by the United States Patent and Trademark Office anytime during the development of a drug and can encompass a wide range of claims. Exclusivity refers to certain delays and prohibitions on approval of competitor drugs available under the statute that attach upon approval of a drug or of certain supplements. A new drug application (NDA) or abbreviated new drug application (ANDA) holder is eligible for exclusivity if statutory requirements are met. See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, and 505(j)(5)(B)(iv) of the FD&C Act. Periods of exclusivity and patent terms may or may not run concurrently. Exclusivity was designed to promote a balance between new drug innovation and greater public access to drugs that result from generic drug competition.
专利和排他性以类似的方式运作，但彼此不同，并受不同法规的约束。专利是美国专利商标局在药物开发过程中随时授予的财产权，可以涵盖范围广泛的权利要求。排他性是指在批准药物或某些补充剂后附加的法规对竞争药物批准的某些延迟和禁止。如果满足法定要求，新药申请 (NDA) 或简化新药申请 (ANDA) 持有人有资格获得独占权。参见 21 C.F.R. FD&C 法案的 314.108、316.31、316.34 和第 505A、505E 和 505(j)(5)(B)(iv) 节。独占期和专利期可能会或可能不会同时发生。排他性旨在促进新药创新与因仿制药竞争而使公众更容易获得药物之间的平衡。

2. How long is a patent term?
2. 专利期限是多长？

Patent terms are set by statute. Currently, the term of a new patent is 20 years from the date on which the application for the patent was filed in the United States. Many other factors can affect the duration of a patent.
专利条款由法规规定。目前，新专利的有效期为自在美国提交专利申请之日起 20 年。许多其他因素会影响专利的期限。

3. How long does an exclusivity period last?
3.独占期持续多长时间？

It depends on what type of exclusivity is at issue.
这取决于所涉及的排他性类型。

Orphan Drug Exclusivity (ODE) – 7 years
孤儿药独占权 (ODE) – 7 年
New Chemical Entity Exclusivity (NCE) – 5 years
新化学实体独占权 (NCE) – 5 年
Generating Antibiotic Incentives Now (GAIN) Exclusivity– 5 years added to certain exclusivities
立即产生抗生素激励 (GAIN) 独占权——某些独占权增加 5 年
New Clinical Investigation Exclusivity – 3 years
新的临床研究独占权 – 3 年
Pediatric Exclusivity (PED) – 6 months added to existing Patents/Exclusivity
儿科独占权 (PED) – 现有专利/独占权增加 6 个月
Patent Challenge (PC) – 180 days (this exclusivity is for ANDAs only)
专利挑战 (PC) – 180 天（此排他性仅适用于 ANDA）
Competitive Generic Therapy (CGT) – 180 days (this exclusivity is for ANDAs only)
竞争性仿制药 (CGT) – 180 天（此排他性仅适用于 ANDA）
See 21 C.F.R. 314.108, 316.31, 316.34 and sections 505A, 505E, 505(j)(5)(B)(iv), and Section 505(j)(5)(B)(v) of the FD&C Act.
参见 21 C.F.R. FD&C 法案的 314.108、316.31、316.34 和第 505A、505E、505(j)(5)(B)(iv) 节和第 505(j)(5)(B)(v) 节。

4. Why does the exclusivity expire before the patent?
4. 为什么独占期先于专利到期？

Patent before exclusivity? 先专利后独占？
Why does a particular drug product only have patents?
为什么特定的药品只有专利？

Only have exclusivity? 只有排他性？
Have neither? 两者都没有？
Patents and exclusivity apply to drugs in different ways. Patents can be issued or expire at any time regardless of the drug’s approval status. Exclusivity attaches upon approval of a drug product if the statutory requirements are met. Some drugs have both patent and exclusivity protection while others have just one or neither. Patents and exclusivity may or may not run concurrently and may or may not cover the same aspects of the drug product. Patents and exclusivities that have expired are removed from the Orange Book.
专利和独占权以不同的方式适用于药物。无论药物的批准状态如何，专利都可以随时颁发或到期。如果满足法定要求，则药物产品获得批准后即具有排他性。有些药物同时具有专利和排他性保护，而其他药物只有一种或两者都没有。专利和独占权可能会或可能不会同时存在，并且可能会或可能不会涵盖药品的相同方面。已过期的专利和独占权将从橙皮书中删除。

5. What information related to pediatric exclusivity is listed in the Orange Book?
5.橙皮书中列出了哪些与儿科独占相关的信息？

When pediatric exclusivity is obtained, a 6-month period of exclusivity is added to all existing patents and exclusivity on all applications held by the sponsor for that active moiety. Pediatric exclusivity does not stand alone, but attaches to existing exclusivity. When pediatric exclusivity attaches, in the patent column of the Orange Book, the patent is shown twice—once with the original patent expiration date and a second time reflecting the six month period of pediatric exclusivity linked to that particular patent. Related information can be found on the web page Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act: Frequently Asked Questions on Pediatric Exclusivity (505A), The Pediatric “Rule,” and their Interaction
当获得儿科独占权时，所有现有专利和申办者对该活性部分持有的所有申请的独占期将增加 6 个月的独占期。儿科独占权并不是孤立存在的，而是依附于现有的独占权。当附加儿科独占权时，在橙皮书的专利栏中，该专利会显示两次——一次显示原始专利到期日期，第二次反映与该特定专利相关的六个月儿科独占期。相关信息可在根据《联邦食品、药品和化妆品法》第 505A 条获得儿科独占权资格的网页上找到：有关儿科独占权 (505A)、儿科“规则”及其相互作用的常见问题

6. Where can I find patent and exclusivity regulations in the Code of Federal Regulations (C.F.R.)?
6. 我在哪里可以找到联邦法规 (C.F.R.) 中的专利和排他性规定？

See 21 C.F.R. 314.50 Content and format of an NDA
参见 21 C.F.R. 314.50 NDA 的内容和格式

See 21 C.F.R. 314.52 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
参见 21 C.F.R. 314.52 证明专利无效、不可执行或未侵权的通知

See 21 C.F.R. 314.53 Submission of patent information
参见 21 C.F.R. 314.53 提交专利信息

See 21 C.F.R. 314.54 Procedure for submission of a 505(b)(2) application requiring investigations for approval of a new indication for, or other change from, a listed drug
参见 21 C.F.R. 314.54 提交 505(b)(2) 申请的程序，该申请需要进行调查以批准所列药物的新适应症或其他变更

See 21 C.F.R. 314.60 Amendments to an unapproved NDA, supplement, or resubmission
参见 21 C.F.R. 314.60 对未经批准的保密协议的修正、补充或重新提交

See 21 C.F.R. 314.70 Supplements and other changes to an approved NDA
参见 21 C.F.R. 314.70 对已批准的 NDA 的补充和其他更改

See 21 C.F.R. 314.94 Content and format of an ANDA
参见 21 C.F.R. 314.94 ANDA 的内容和格式

See 21 C.F.R. 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent
参见 21 C.F.R. 314.95 证明专利无效、不可执行或未侵权的通知

See 21 C.F.R. 314.96 Amendments to an unapproved ANDA
参见 21 C.F.R. 314.96 对未获批准的 ANDA 的修改

See 21 C.F.R. 314.97 Supplements and other changes to an ANDA
参见 21 C.F.R. 314.97 ANDA 的补充和其他变更

See 21 C.F.R. 314.101 Filing an NDA and receiving an ANDA
参见 21 C.F.R. 314.101 提交 NDA 和接收 ANDA

See 21 C.F.R. 314.107 Date of approval of a 505(b)(2) application or ANDA
参见 21 C.F.R. 314.107 505(b)(2) 申请或 ANDA 的批准日期

See 21 C.F.R. 314.108 New drug product exclusivity
参见 21 C.F.R. 314.108 新药产品独占权

See 21 C.F.R. 316.31 Scope of orphan-drug exclusive approval
参见 21 C.F.R. 316.31 孤儿药独家批准的范围

See 21 C.F.R. 316.34 FDA recognition of exclusive approval
参见 21 C.F.R. 316.34 FDA 承认排他性批准

Code of Federal Regulations on the Government Publishing Office web site.
政府出版办公室网站上的联邦法规。

7. How is an NDA holder notified if their application has received a period of exclusivity?
7. 如果 NDA 持有人的申请已获得独占期，如何通知他们？

No letters are sent to the application holder to indicate that a period of exclusivity has attached to their application. The posting of exclusivity information in the Orange Book is the official vehicle for dissemination of this information.
不会向申请持有人发送任何信件以表明他们的申请已附加了一段排他性期限。在橙皮书中发布独家信息是传播此信息的官方工具。

8. When should an NDA holder submit patent information?
8. NDA 持有者应何时提交专利信息？

Patent information is required to be submitted with all new drug applications (NDAs) and certain supplemental applications (sNDAs) on Form FDA 3542a at the time of submission of the NDA or sNDA. Patent information for listing in the Orange Book must be submitted on Form FDA 3542 within 30 days following approval of an NDA or supplemental application. For patents issued after approval of the NDA or supplement, the NDA holder must submit the required patent information within 30 days of the issuance of the patent for it to be considered timely filed. If the NDA holder timely submits the required patent information, but FDA notifies the NDA holder that its Form FDA 3542 is incomplete or shows that the patent is not eligible for listing, the NDA holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s notification to be considered timely filed as of the date of the original submission of patent information. New patent information may still be submitted after 30 days of the issuance of the patent, but such information is not considered timely filed.
在提交 NDA 或 sNDA 时，专利信息需要与所有新药申请 (NDA) 和某些补充申请 (sNDA) 一起通过 FDA 3542a 表格提交。列入橙皮书的专利信息必须在 NDA 或补充申请获得批准后 30 天内通过 FDA 3542 表格提交。对于在 NDA 或补充批准后发布的专利，NDA 持有人必须在专利发布后 30 天内提交所需的专利信息，才能被视为及时提交。如果 NDA 持有人及时提交了所需的专利信息，但 FDA 通知 NDA 持有人其 Form FDA 3542 不完整或表明该专利不符合上市条件，NDA 持有人必须在 FDA 批准后的 15 天内提交可接受的 Form FDA 3542自最初提交专利信息之日起视为及时提交的通知。新的专利信息在专利授权后 30 天后仍可提交，但此类信息不被视为及时提交。

9. What is a patent submission date?
9. 什么是专利提交日期？

A patent submission date is the date on which the FDA receives patent information from the new drug application (NDA) holder. See 21 C.F.R. 314.53(d)(5).
专利提交日期是 FDA 从新药申请 (NDA) 持有人处收到专利信息的日期。参见 21 C.F.R. 314.53(d)(5)。

10. Why doesn’t the Orange Book include patent submission dates for most records?
10. 为什么橙皮书不包含大多数记录的专利提交日期？

The FDA began patent submission date data collection in 2013. The October 2016 final rule “Abbreviated New Drug Applications and 505(b)(2) Applications” states, “FDA intends to list the date of submission of patents and patent information in the Orange Book on a prospective basis beginning as soon as is practicable after the effective date of this rule.” The Orange Book will now publish patent submission dates for all new records going forward.
FDA 于 2013 年开始收集专利提交日期数据。2016 年 10 月的最终规则“简化新药申请和 505(b)(2) 申请”指出，“FDA 打算在 Orange 中列出专利提交日期和专利信息在本规则生效日期后尽快开始预定。”橙皮书现在将公布所有新记录的专利提交日期。

11. How can an NDA holder request a patent submission date error correction?
11. NDA 持有人如何请求更正专利提交日期？

NDA holders should email error correction requests, including justification for the request to:
NDA 持有人应通过电子邮件发送纠错请求，包括请求的理由：

[email protected]. [email protected] 。

Requests will be considered on a case by case basis and, if accurate, will be updated in the Orange Book as soon as is practicable.
请求将根据具体情况进行考虑，如果准确，将尽快在橙皮书中更新。

12. How should an NDA holder correct or request removal of patent information?
12. NDA 持有人应如何更正或请求删除专利信息？

An NDA holder must submit a correction or change to previously submitted patent information on a new Form FDA 3542. For changes to descriptions of approved methods of use, see question 14.
NDA 持有人必须在新的 FDA 3542 表格中提交对先前提交的专利信息的更正或更改。有关已批准使用方法描述的更改，请参阅问题 14。

If an NDA holder determines that a patent or patent claim no longer meets the requirements for listing, the NDA holder must promptly notify FDA to amend the patent information or withdraw the patent or patent information and request that the patent or patent information be removed from the list. The NDA holder seeking to withdraw a patent must submit to its NDA a statement containing the NDA number to which the request applies, each product(s) approved in the NDA to which the request applies, and the patent number, and identify the submission as “Time Sensitive Patent Information.” If the NDA holder is required by court order to amend patent information or withdraw a patent from the list, it must submit an amendment to its NDA that includes a copy of the order, within 14 days of the date the order was entered. In addition, the NDA holder must submit a correction to the expiration date of the patent on Form FDA 3542 within 30 days after the grant of patent term extension.
如果 NDA 持有人确定专利或专利权利要求不再符合上市要求，NDA 持有人必须立即通知 FDA 修改专利信息或撤回专利或专利信息，并要求将专利或专利信息从上市申请中删除。列表。寻求撤回专利的 NDA 持有人必须向其 NDA 提交一份声明，其中包含申请所适用的 NDA 号、申请所适用的 NDA 中批准的每种产品以及专利号，并将提交内容标识为“时间敏感的专利信息。”如果法院命令要求 NDA 持有人修改专利信息或从列表中撤回专利，则其必须在输入命令之日起 14 天内提交对其 NDA 的修改，其中包括命令副本。此外，NDA 持有人必须在授予专利期限延长后 30 天内，在 FDA 3542 表格上提交对专利到期日期的更正。

13. Should an NDA holder submit patent information when seeking approval of a supplement?
13. NDA 持有人在寻求补充批准时是否应提交专利信息？

An NDA holder must submit patent information when it seeks approval of a supplement to add or change the dosage form or route of administration, to add or change the strength or to change the drug product from prescription use to over-the-counter use.
NDA 持有人在寻求批准补充剂以添加或更改剂型或给药途径、添加或更改强度或将药品从处方用途更改为非处方用途时，必须提交专利信息。

For supplements that seek approval for other changes (for example, to change the formulation, to add a new indication or other condition of use, or to make any other patented change regarding the drug substance, drug product, or any method of use), the requirements for submitting patent information depend on whether the existing patent information in the Orange Book for the original NDA continues to claim the changed product:
对于寻求其他变更批准的补充剂（例如，更改配方、添加新的适应症或其他使用条件，或对原料药、药品或任何使用方法进行任何其他专利变更），提交专利信息的要求取决于原NDA橙皮书中已有的专利信息是否继续要求变更后的产品：

If one or more patents, for which information was properly submitted for the product approved in the original NDA, claim the changed product, then the applicant is not required to resubmit this patent information, and FDA will continue to list the patent information.
如果原NDA批准的产品已正确提交信息的一项或多项专利要求变更产品，则申请人无需重新提交该专利信息，FDA将继续列出该专利信息。
If one or more patents, for which information was properly submitted for the product approved in the original NDA, no longer claim the changed product, the applicant must submit a request to remove the listed patent information at the time of the approval of the supplement.
如果原NDA批准的产品已正确提交信息的一项或多项专利不再要求变更后的产品，申请人必须在补充批准时提交删除所列专利信息的请求。
If one or more patents, for which information was not previously submitted, claim the changed product, the applicant must submit the patent information required under 314.53(c).The NDA holder also must submit patent information for any supplement if the description of the patented method of use in the Orange Book would change upon approval of the supplement.
如果先前未提交信息的一项或多项专利要求更改产品，则申请人必须提交 314.53(c) 要求的专利信息。NDA 持有人还必须提交专利信息以进行任何补充，如果专利的描述橙皮书中的使用方法将在补充批准后发生变化。

14. When may an NDA holder amend the description of the approved method(s) of use claimed by the patent?
14. NDA 持有人何时可以修改专利所主张的已批准使用方法的说明？

An amendment to the description of approved method(s) of use claimed by the patent will be considered timely if it is submitted within 30 days of: (1) patent issuance, (2) approval of a corresponding change to product labeling, or (3) a decision by the U.S. Patent and Trademark Office or a Federal court that is specific to the patent and alters the construction of a method-of-use claim(s) of the patent (and the amendment contains a copy of the decision). Outside of these circumstances and except as provided in the patent listing dispute regulation (21 CFR 314.53(f)(1)), an amendment to the description of the approved method(s) of use claimed by the patent will not be considered timely filed.
如果在以下情况的 30 天内提交对专利所主张的已批准使用方法的说明的修改将被视为及时：(1) 专利发布，(2) 产品标签的相应更改获得批准，或 ( 3) 美国专利商标局或联邦法院针对该专利做出的决定，该决定改变了专利的使用方法权利要求的结构（并且修正案包含该决定的副本） .在这些情况之外，除非专利清单争议条例 (21 CFR 314.53(f)(1)) 有规定，否则对专利所主张的已批准使用方法的描述的修改将不会被视为及时提交.

If the amendment to the description of the approved method(s) of use claimed by the patent is filed within an acceptable time frame but is incomplete or shows that the patent is not eligible for listing, the NDA holder must submit an acceptable Form FDA 3542 within 15 days of FDA’s notification to be considered timely filed as of the date of the submission of amended patent information.
如果对专利要求的已批准使用方法的描述的修改在可接受的时间范围内提交但不完整或表明该专利不符合上市条件，则 NDA 持有人必须提交可接受的 FDA 3542 表格在 FDA 通知被视为及时提交的 15 天内，自提交修改后的专利信息之日起。

15. What actions must a pending ANDA or 505(b)(2) applicant take if patent information is untimely filed?
15. 如果未及时提交专利信息，未决 ANDA 或 505(b)(2) 申请人必须采取什么行动？

If patent information is untimely filed, generally a previously submitted ANDA or 505(b)(2) applicant is not required to submit a patent certification or statement to address the patent or patent information that is late-listed with respect to the pending ANDA or 505(b)(2) application.
如果专利信息未及时提交，通常先前提交的 ANDA 或 505(b)(2) 申请人无需提交专利证明或声明来解决与待审 ANDA 或延迟上市的专利或专利信息505(b)(2) 申请。

16. Is there a specific format in which patent information needs to be submitted to the agency?
16.向代理机构提交专利信息是否有特定格式？

If the NDA applicant is submitting patent information with an original NDA, an amendment, or a supplement prior to approval, use Form FDA 3542a. If the NDA holder is submitting information on a patent that claims an approved drug or an approved method of using the drug after approval of an NDA or supplement, use Form FDA 3542. The agency will not list or publish patent information in the Orange Book if it is not provided on Form FDA 3542.
如果 NDA 申请人在批准前提交带有原始 NDA、修正案或补充的专利信息，请使用 FDA 3542a 表格。如果 NDA 持有人正在提交有关专利的信息，该专利要求获得批准的药物或在批准 NDA 或补充后使用该药物的批准方法，请使用 FDA 3542 表格。如果它未在 FDA 3542 表格中提供。

17. To which submissions does the final rule apply?
17. 最终规则适用于哪些提交？

The effective date of the final rule on “Abbreviated New Drug Applications and 505(b)(2) Applications” applies to any submission received by FDA on or made after December 5, 2016, the effective date of the rule, including any changes to previously submitted patent information.
“简化新药申请和 505(b)(2) 申请”最终规则的生效日期适用于 FDA 在 2016 年 12 月 5 日（规则生效日期）收到或之后提交的任何提交，包括对先前提交的专利信息。

18. Does previously submitted patent information have to be re-submitted on the new Forms FDA 3542 and 3542a?
18. 以前提交的专利信息是否必须在新的 FDA 3542 和 3542a 表格中重新提交？

No. While any patent information submitted after the effective date of the final rule must be submitted in a manner consistent with the final rule, including use of the new forms, NDA holders and applicants are not required to re-submit patent information previously submitted on a prior version of the form.
否。虽然在最终规则生效日期之后提交的任何专利信息必须以与最终规则一致的方式提交，包括使用新表格，但 NDA 持有人和申请人无需重新提交之前提交的专利信息表格的先前版本。

19. Who do I contact with specific questions regarding what patents are eligible for listing in the Orange Book?
19. 关于哪些专利有资格列入橙皮书的具体问题，我应该联系谁？

FDA’s patent listing role is ministerial. Generally, we will not respond to specific questions regarding the eligibility of patents for listing.
FDA 的专利列表角色是部长级的。一般来说，我们不会回答有关专利上市资格的具体问题。