China Proposed Measures To Implement Its Drug Patent Linkage System

中国就药品专利链接制度实施细则征求意见

作者：陈少羽 王文佳

China has recently passed the amendment to its patent law and formally established a drug patent linkage system.  The amended patent law, to become effective on June 1, 2021, contains only three short paragraphs describing the principles of the patent linkage system without providing any details on how to implement the patent linkage system.

中国最近通过了专利法修正案，正式建立了药品专利链接制度，将于2021年6月1日生效。不过，专利法修正案对于专利链接只包含简短的三条规定，并不包含任何实施细节。

The implementation details are set out separately, under a rule recently proposed by the National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA), which jointly issued the "Implementing Measures for Drug Patent Dispute Early Resolution Mechanism (Tentative)" (the Draft Measures) on September 11, 2020, to seek public comment until October 25, 2020.

实施细节体现在最近出台的另一份征求意见稿。2020年9月11日，国家药品监督管理局和国家知识产权局发布了《药品专利纠纷早期解决机制实施办法（试行）（征求意见稿）》（下称"《征求意见》"），意见征求截止至2020年10月25日。

The Proposed Measures probably will be finalized prior to the June 1, 2021 effective date of the amended patent law, in order to implement patent linkage system set out under the amended patent law. When finalized, the Draft Measures will present significant challenges and opportunities for both innovator and generic drug companies doing business in China.

《征求意见》可能在2021年6月1日专利法修正案生效日之前完稿颁布，以便施行专利法中关于建立药品专利链接的要求。《征求意见》完稿颁布后，新的专利链接制度必将给在华经营的原研药和仿制药公司带来重大的机遇和挑战。

Patent Listing

专利信息登记

According to the Draft Measures, the NMPA will create a publicly available database, the Chinese Marketed Drug Patent Information Listing Platform (Platform), for marketing authorization holders (MAH) to list patent information for their drugs marketed in China.

根据《征求意见》，国家药监局将建立中国上市药品专利信息登记平台（下称"登记平台"），供药品上市许可持有人登记在中国境内注册上市的药品相关专利信息，并向社会公示。

The Draft Measures set time limits and procedures for submitting and updating patent listing information: (a) if a patent has already been granted, patent listing information may be submitted together with the new drug application (NDA); (b) if the patent has been newly granted and the NDA is pending, patent listing information may be submitted within 30 days of receiving the notice of patent grant, (c) if the NDA has already been approved, the Draft Measures do not specify a deadline for submitting patent information; and (d) for patents already listed, updates should be submitted within 30 days of any changes to the patent listing information.

《征求意见》规定了提交和更新专利登记信息的时限及程序：（1）如果专利权已经授予，在提交新药申请的同时自行登记专利信息；（2）如果专利权在新药申请期间授予，在公告授予专利权之日起30日内登记专利信息；（3）对已上市药品相关专利，《征求意见》未规定补充登记专利信息的最晚期限；（4）已登记的药品专利信息发生变更时，应当在变更生效后30日内进行变更登记。

The Draft Measures provide that if a drug is not in the NDA process or has not yet received marketing authorization in China, it will not be eligible for patent listing; if a patent is not listed, it will not be eligible for patent linkage protection.

根据《征求意见》，如果某个药品未处在新药上市申请过程中，或者未获得在中国的上市许可，该药品将无法进行药品专利信息登记。并且，如果一项专利未能在登记平台登记，该专利将无法受到专利链接制度的保护。

The Draft Measures also limit the types of patents that can be listed on the Platform: applicants for small molecule drugs can list compound, composition, and indication patents; and biologic product applicants can only list sequence structure patents. The patent listing information will include the drug name, patent number, patent type, patent status, patentee, MAH, patent expiry date, and contact information.

《征求意见》还限定了可以在登记平台登记的专利种类：小分子化学药的申请人可以登记药物活性成分化合物专利、含活性成分的药物组合物专利、医药用途专利；生物制品的申请人仅可登记序列结构专利。登记的专利信息包括药品名称、专利号、专利种类、专利状态、专利权人、上市许可持有人、专利保护期限届满日和通讯方式。

It appears that the NDA applicant or the MAH for the approved NDA can list and update the patent information directly on the Platform without NMPA review. The Draft Measures make the NDA applicant or the MAH responsible for the truthfulness, accuracy, and completeness of the patent listing information, and impose penalties for intentionally listing unrelated patents, or intentionally making untrue patent certifications.

提交新药申请的申请人或者已获批的新药申请的上市许可持有人似乎可以直接提交并登记有关专利信息，无需国家药监局审查。《征求意见》要求新药申请人或者药品上市许可持有人对其提交的相关专利信息的真实性、准确性和完整性负责。对故意将其他无关的专利纳入专利信息登记的，或故意提交不实声明，《征求意见》规定了处罚措施。

Patent Certification

专利声明

A generic drug applicant filing for marketing authorization will be required to make certifications regarding each related innovator drug patent listed on the Platform, and provide supporting evidence for the certifications. The certifications are classified into four categories, similar to the US Hatch-Waxman framework:

仿制药申请人提交药品上市许可申请时，应当对照已在登记平台载明的专利信息，针对原研药每一件相关的药品专利作出声明，并提供声明依据。声明分为四种类型，该分类方式近似于美国的哈奇·维克斯曼(Hatch-Waxman)体系。

Opposition Period and Waiting Period

异议期和等待期

The generic drug application and patent certification will be publicly disclosed on the information platform of the Center For Drug Evaluation (CDE). Generic drug applicants have no obligation to notify innovator drug MAHs. Therefore, innovator drug MAHs should closely monitor the CDE information disclosures in order to avoid inadvertently missing the deadline for filing opposition.

仿制药的申请和专利声明在药品审评机构信息平台进行公示，仿制药申请人不需要通知原研药上市许可持有人。因此，原研药的上市许可持有人需要密切注意药品审评机构的信息公示情况，以免因疏忽错过提交异议的期限。

For Category I and II certifications, the generic drug application can be approved immediately. For Category III certifications, the generic drug application can also be approved immediately, but must contain a notation that the generic drug applicant can launch its product only after the patent expiration date.

对于第一类、第二类声明，可以直接作出是否批准仿制药申请的决定；对于第三类声明，也可以直接作出是否批准仿制药申请的决定，但应同时注明在专利权期限届满后仿制药申请人方可上市销售。

For Category IV certifications, the innovator drug MAH can oppose the patent certification made by the generic drug applicant within 45 days from the date of the CDE public disclosure. This opposition is filed either with a People's Court or the CNIPA. For small molecule drugs, the NMPA will set a 9-month waiting period before approving the generic drug application, starting from the date the case is accepted by the People's Court or the CNIPA. Although the NMPA will wait to approve the generic drug application, the CDE will not stop its technical review during the waiting period.

对于第四类声明，原研药的上市许可持有人对仿制药申请人的专利声明存在异议的，可以自药品审评机构公示之日起45日内，向人民法院提起诉讼或者向专利行政部门申请行政裁决。自人民法院或者专利行政部门立案或者受理之日起，国家药监局对化学仿制药上市许可审批设置9个月的等待期。虽然国家药监局会延迟对仿制药申请的批准，但是，等待期内国家药品审评机构不停止技术审评。

For Category IV certifications, the NMPA will follow the judgment of the People's Court or the decision of the CNIPA in deciding whether to approve the application. If the generic drug falls within the patent protection scope, the NMPA will not approve until the patent expiration date. However, if (i) the generic drug does not fall within the patent protection scope or the parties settle the case; (ii) the patent is invalidated; or (iii) the court or the CNIPA does not issue an effective judgment, decision or mediation within the 9-month waiting period, the NMPA will approve the application immediately.

对于第四类声明，国家药监局结合人民法院判决或者专利行政部门行政裁决来决定是否批准申请。如果确认化学仿制药落入相关专利权保护范围的，暂停行政审批直至专利到期。但是，国家药监局在下列情形会直接作出批准上市的决定，包括：(1)不落入相关专利权保护范围或者双方和解的，(2)相关专利权被宣告无效的，或(3)超过9个月等待期人民法院或者国务院专利行政部门未作出生效判决或者行政裁决，或者未出具调解书的。

Biosimilars

生物类似药

For biosimilars, marketing authorization applications may be approved immediately without any waiting period; however, if (1) the innovator has opposed the patent certification within the 45 day period, and (2) the biologic patent is found to have been infringed by a court judgment or CNIPA decision before the marketing authorization is approved, the approval should contain a notation that the biosimilar applicant can launch its product only after the patent expiration date.

对生物类似药的申请，可以直接作出是否批准上市的决定，无需等待期；但如果(1)原研药的上市许可持有人对生物类似药申请人的专利声明在45日内起诉或申请行政裁决，并且(2)批准前收到判决或裁决认定侵犯原研生物类似药专利权的，那么批准文件应注明在专利权期限届满后生物类似药的申请人方可上市销售。

Effectiveness of Approval

批准效力

After a generic drug application is approved, if the innovator drug MAH believes that the generic drug infringes its patent rights, the dispute shall be resolved in accordance with the PRC Patent Law and other relevant laws and regulations, and the marketing authorization approval will not be revoked and its effectiveness will not be affected.

仿制药被批准上市后，原研药的上市许可持有人认为仿制药侵犯其相应专利权，引起纠纷的，依据《专利法》等相关法律法规的规定解决, 已经依法批准的药品上市许可决定不予撤销，不影响其效力。

Incentives to Patent Challenge

对专利挑战的鼓励

The first chemical generic drug to successfully challenge an innovator drug patent can enjoy a 12-month market exclusivity period, during which the NMPA may review but will not approve other generic drug applications. This exclusivity period will not exceed the term of the innovator drug patent being challenged.

首个挑战专利成功的化学仿制药可以享有12个月的市场独占期，国家药监局在市场独占期内会接受申请但不会批准其他相同品种的化学仿制药上市，市场独占期不能超过被挑战的原研药的专利权期限。

Patent Term Extension

专利期延长

The Amended Patent Law adds a patent term extension to compensate the time that the NMPA and its CDE (Center for Drug Evaluation) spent in the review and approval of the marketing authorization for a new drug. The maximum extension shall not exceed five years, and the total patent term after adding the extension shall not exceed 14 years at the time of receiving marketing authorization. 

专利法修正案增加了专利期延长制度，用来补偿新药上市时国家药监局审批占用的时间和药品审评中心审评占用的时间。对在中国获得上市许可的新药发明专利，国务院专利行政部门可以应专利权人的请求给予期限补偿。补偿期限不超过五年，新药上市后加上补偿期限后的总有效专利权期限不超过十四年。

Data or Marketing Exclusivity

数据或市场独占期

China does not give data or market exclusivity to an innovator or improved drug that is manufactured and imported into China. A generic drug application can be filed and approved in China as soon as the foreign innovator or improved drug is approved either in or outside China, and the generic drug can be commercially manufactured and launched if the foreign innovator drug is not protected by any patents in China.

对于在境外生产后进口到中国的原研药或改良药，中国不给予数据或市场独占期。一旦进口的原研药或改良药在中国或国外获批，仿制药可以立即在中国提交申请并获得批准。如果进口的原研药或改良药在中国没有专利保护，仿制药可以在中国进行商业化生产和上市销售。

In contrast, China gives or at least used to give market exclusivity to an innovator or improved drug that is manufactured in China. When such a drug is approved in China, it will be placed under a New Drug Monitoring Period running from three, four, or five years, during which time the NMPA will not grant approval of its generic version prior to the expiration of the new drug monitoring period.

相反，中国现在或者至少过去曾经给予在中国生产的原研药和改良药市场独占期。此类药品在中国获批后可以获得三年、四年或五年的新药监测期，在新药监测期内，国家药监局在不会批准其仿制药。

The provisions for the new drug monitoring periods were set out under the Drug Registration Regulation (DDR) amended in 2007. The provisions, however, have been removed from the DDR that was most recently amended in 2020.  A notice from the NMPA indicates the continuous validity of the 2007 DDR provisions that are not in conflict with the 2020 DDR, but it appears that the NMPA has viewed the new drug monitoring provisions as conflicting, and has stopped granting any new drug monitoring periods for domestic innovator or improved drugs approved after the July 1, 2020 effective date of the 2020 DDR. Unlike the Orange Book system in the US, China does not publicly list the starting and ending date of the new monitoring periods. Pharmaceutical companies should closely monitor whether the new drug monitoring period or some other types of data or market exclusivity will be set up in the near future. 

新药监测期的条款体现在2007年修订的《药品注册管理办法》。最新修订的2020年版《药品注册管理办法》中删除了关于新药监测期的条款。根据国家药监局的一项公告，2020年版《药品注册管理办法》及其相关文件已作出规定和要求的，从其规定；无新规定和要求的，按照现行的有关规定和要求执行。国家药监局似乎认为新药监测期条款存在冲突, 因而对于2020年7月1日（2020年版《药品注册管理办法》的生效日）后获批的国内原研药和改良药，不再给予新药监测期。与美国的橙皮书体系不同，中国不公布新药监测期的起始和终止日期。业界应该密切关注今后是否会设立新药监测期或其他方式的数据或市场独占期。

Conclusion

结语

The patent linkage system set out under the Draft Measures presents significant opportunities and challenges for both innovator and generic drug companies doing business in China. Companies should closely monitor the development of the Draft Measures, and any provisions on data or market exclusivity that may be proposed. Please contact us if you have questions on any of these topics.

《征求意见》规定的专利链接制度对在华经营的原研药企和仿制药企而言，既是重大机遇也是巨大挑战。药企应密切关注《征求意见》的发展，以及可能出台的数据或市场保护期相关制度。若您对上述话题有任何疑问，欢迎随时联系我们。