容易误判的农药登记中的专利侵权风险——兼评（2023）最高法知民终1511号判决

作者 | 邵伟 高凡非 寇飞 北京市永新智财律师事务所

在申请农药登记的过程中，为了向行政主管部门提供产品化学、药效、残留、毒理、环境影响等试验数据，申请人不可避免地需要制造、使用农药产品。如果该产品仍处于专利保护期内，农药登记申请人即可能面临专利侵权风险。

2025年12月，最高人民法院公布了（2023）最高法知民终1511号判决，对农药登记过程中实施专利的行为性质作出了重要认定，引起了农药行业的广泛关注。为了避免农药登记申请人、中介机构、试验单位等广大从业人员出现误判，有必要对该判决的内涵和外延进行明确，以正视听。

一、农药登记行为具有“生产经营目的”

专利法第十一条规定，构成专利侵权的前提之一是相关行为具有“生产经营目的”。

长期以来，很多农药企业认为，申请农药登记仅是为了满足行政审批要求，并非直接销售产品，因此不属于“为生产经营目的”实施专利的行为。

对此，1511号判决明确指出，农药登记相关行为具有“生产经营目的”。因此，不能再以“缺乏生产经营目的”作为农药登记行为不构成侵权的抗辩理由。

二、“博拉例外”不适用于农药

《专利法》第七十五条第（五）项规定的“博拉例外”情形为：“为提供行政审批所需要的信息，制造、使用、进口专利药品或者专利医疗器械的”，不视为侵犯专利权。

在1511号判决中，最高院明确认定，博拉例外仅适用于由国务院药品监督管理部门进行上市审评审批的“药品”和“医疗器械”，而并不包括农药。因此，农药登记引发的专利侵权并不能适用博拉例外。举轻以明重，因境外农药登记引发的中国境内的专利侵权更不能适用中国的博拉例外。

三、制造并向他人提供农药产品用于登记试验，构成侵权

在1511号判决中，最高院旗帜鲜明地认定，企业制造并向他人提供农药产品用于登记试验，具有获取不正当商业利益的目的，损害了专利权人的合法权益，构成侵权。

四、“科研例外”在农药登记中的适用

“科研例外”规定于《专利法》第七十五条第（四）项：“专为科学研究和实验而使用有关专利的”，不视为侵犯专利权。

在1511号判决中，最高院认为，企业为自己申请农药登记而有限地实施制造、使用被诉侵权产品的行为，构成专利法意义上的科研例外，不视为侵权。对于这一认定，笔者认为在法理层面存在较大争议。

1、农药登记行为的本质与科研例外的制度目的并不一致

科研例外所指的“科学研究和实验”， 其核心在于“以专利技术为研究对象”，即针对专利技术方案本身，为研究、理解、验证、改进专利等目的而使用专利技术的行为。而非 “以专利技术为研究工具”，即利用专利技术的方案制造产品，然后将产品作为达到其他目的（特别是商业目的）的手段。

而农药登记试验显然属于后者，农药登记中所需的产品化学、药效、残留、毒理、环境影响等试验数据，这些试验的结论指向的是“产品是否可以上市”。除原研药之外的农药登记多数情况下仅需证明产品不劣于原研产品，并不涉及对农药专利技术本身的研究或改进。同时，农药登记的最终目的在于实现产品商业化上市，其主体和行为目的与通常意义上的科学研究并无实质关联。

2、“为自己”与“为他人”的区分缺乏充分法理依据

1511号判决一方面认定“企业制造并向他人提供农药产品用于登记试验，具有获取不正当商业利益的目的，损害了专利权人的合法权益，构成侵权”，另一方面又认定“企业为自己申请农药登记而有限地实施制造、使用被诉侵权产品的行为，构成专利法意义上的科研例外，不视为侵权”。然而，为他人登记而制造产品与为自己登记而制造产品，在行为方式（制造专利产品）、行为目的（获取农药登记证以实现商业化）和行为效果（向市场错误传达专利产品已可以合法生产销售的信号，损害专利权人的市场排他利益）上具有一致性。既然最高院已经认定“为他人”构成侵权，那么在行为方式、目的和效果均一致的情况下，“为自己”理应得出相同的侵权认定，而非被纳入科研例外予以豁免。

3、科研例外的扩张适用将架空博拉例外

博拉例外系我国为履行加入WTO后的义务，于2008年修订《专利法》时专门引入的制度，其目的在于豁免仿制药企业在专利到期前，为获得药品审批而实施的部分侵权行为。类似于农药，如果科研例外本身已经能够涵盖为人用药行政审批所需行为，则当时并无必要再单独设立博拉例外，也会导致现在的博拉例外法条冗余。换言之，博拉例外的设立，恰恰说明立法者认为科研例外并不足以覆盖为行政审批而实施专利的行为。申言之，不能因为博拉例外不适用于农药，而将科研例外强加于农药登记，由此导致与立法本意的冲突。

4、缺乏配套机制的豁免将破坏利益平衡

在农药领域中适用科研例外，还会破坏原研药企业与仿制药企业之间的利益平衡。在人用药品领域，药品专利期限补偿制度能够弥补专利权人因审批周期较长而损失的有效专利保护期，博拉例外则允许仿制药企业在专利期满前提前开展研发和审批准备，二者共同构成了相对均衡的利益平衡体系。然而，在农药领域，现行法律并未建立类似的专利期限补偿制度，农药专利权人无法获得与药品专利权人相同的期限补偿。而1511号判决却通过科研例外赋予农药仿制药企业类似于博拉例外的待遇，这在客观上可能进一步削弱农药专利权人的利益，与鼓励创新、解决仿制农药产能过剩和食品粮食安全的整体方针不符。

五、豁免适用的边界

尽管1511号判决对“为自身申请登记”情形适用了科研例外，但该豁免并非没有边界。以下几类行为不应被纳入豁免范围：

• 为他人在中国进行农药登记试验而进行的制造、使用和销售侵权农药产品，不应享有豁免【1511号案明确认定】；

• 为境外农药登记进行的制造、使用和销售侵权农药产品，不应享有豁免【1511号案的应有之义】；

• 为获得农药生产许可进行的制造、使用和销售侵权农药产品，不应享有豁免；

• 从他人处获得未经专利权人许可而制造的侵权农药产品，在中国进行农药登记试验，不应享有豁免。

六、结  语

1511号判决在农药行业引起了广泛争议，其裁判逻辑及适用边界，仍有待未来更多相关案件进一步明确。尽管本案属于终审判决，并被纳入最高院知识产权法庭裁判要旨摘要之一，但其并非指导性案例，且系由三人合议庭作出。因此，最高院在后续类似案件中是否会形成不同的裁判思路，仍值得业界持续关注并结合后续案例动态进行观察。

对于农药登记申请人、中介机构、试验单位而言，在开展或协助登记申报前，应充分识别相关专利风险，审慎评估登记试验及样品提供等行为的合规边界，以降低潜在侵权风险。

（2023）最高法知民终1511号

英文版

Patent Infringement Risks in Pesticide Registration That Are Prone to Misjudgment

— Comments on Judgment (2023) Zui Gao Fa Zhi Min Zhong No. 1511

Beijing NTD Law Office, Shao Wei, Gao Fanfei, Kou Fei

In the process of applying for pesticide registration, applicants inevitably need to manufacture and use pesticide products in order to provide the administrative authority with test data on product chemistry, efficacy, residues, toxicology, environmental impact, etc. If such products are still within the patent protection term, the pesticide registration applicant may face patent infringement risks.

In December 2025, the Supreme Court released Judgment (2023) Zui Gao Fa Zhi Min Zhong No. 1511 (hereinafter refer to "Judgment No. 1511"), which made an important determination regarding the nature of acts implementing a patent during the pesticide registration process, drawing wide attention in the pesticide industry. To avoid misjudgment by pesticide registration applicants, registration agencies, testing institutes, and other industry participants, it is necessary to clarify both the implications and the boundaries of this judgment.

I. Pesticide Registration Activities Have "Production or Business Purposes"

Article 11 of the Patent Law provides that one of the prerequisites for patent infringement is that the relevant act has "production or business purposes."

For a long time, numerous pesticide companies believed that applying for pesticide registration only served to satisfy administrative approval requirements and was not a direct sale of products, and therefore did not constitute an act of implementing a patent for "production or business purposes."

In this regard, Judgment No. 1511 explicitly held that activities related to pesticide registration do possess "production or business purposes." Therefore, the defense that pesticide registration activities lack a “production or business purpose” can no longer be used to argue non-infringement.

II. The "Bolar Exemption" Does Not Apply to Pesticides

Article 75(5) of the Patent Law provides for the "Bolar exemption": "Where, for the purpose of providing information needed for administrative approval, a patented drug or patented medical device is manufactured, used, or imported" shall not be deemed as patent infringement.

In Judgment No. 1511, the Supreme Court clearly held that the Bolar exemption applies only to the "drugs" and "medical devices subject to regulatory review and approval by the drug regulatory authority of the State Council, and does not include pesticides. Therefore, patent infringement arising from pesticide registration cannot invoke the Bolar exemption. By inference from the minor to the major, patent infringement in China arising from foreign pesticide registration cannot invoke China's Bolar exemption.

III. Manufacturing and Supplying Pesticide Products to Others for Registration Testing Constitutes Infringement

In Judgment No. 1511, the Supreme Court unequivocally held that a company that manufactures and supplies pesticide products to others for use in registration testing, with the purpose of obtaining unfair commercial benefits, thereby harming the legitimate rights and interests of the patentee, constitutes infringement.

IV. Application of the "Research Exemption" in Pesticide Registration

The "research exemption" is provided in Article 75(4) of the Patent Law: "Where a relevant patent is used solely for scientific research and experimentation" shall not be deemed as patent infringement.

In Judgment No. 1511, the Supreme Court held that where a company, for the purpose of applying for its own pesticide registration, conducts limited manufacturing and use of the accused infringing product, such conduct falls within the Research Exemption under the Patent Law and therefore does not constitute infringement. In the author’s view, this determination remains highly controversial from a jurisprudential perspective. 

1. The Nature of Pesticide Registration Activities Is Inconsistent with the Legislative Purpose of the Research Exception

The “scientific research and experimentation” referred to under the research exemption fundamentally concerns “using patented technology as the object of research,” namely, using patented technology for purposes such as studying, understanding, verifying, or improving the patented technical solution itself. It does not refer to “using patented technology as a research tool,” i.e., utilizing patented technology to manufacture products and then using those products as a means to achieve other objectives, particularly commercial objectives.

Pesticide registration testing clearly falls within the latter category. The product chemistry, efficacy, residue, toxicology, and environmental impact data required for pesticide registration are all directed toward determining whether the product may be marketed. Except for brand-name pesticide products, most pesticide registrations merely require proof that the product is not inferior to the reference product, without involving any research into or improvement of the patented pesticide technology itself. Moreover, the ultimate purpose of pesticide registration is the commercial launch of the product. Neither the entities involved nor the objectives pursued bear any substantive connection with scientific research in the ordinary sense.

2. The Distinction Between “For Oneself” and “For Others” Lacks Sufficient Jurisprudential Basis

On the one hand, Judgment No. 1511 held that “where an enterprise manufactures and supplies pesticide products to others for registration testing, such conduct is intended to obtain improper commercial benefits, harms the legitimate rights and interests of the patentee, and therefore constitutes infringement.” On the other hand, the judgment held that “where an enterprise, for the purpose of applying for its own pesticide registration, conducts limited manufacturing and use of the accused infringing product, such conduct falls within the research exemption under the Patent Law and therefore does not constitute infringement.” However, manufacturing products for another party’s registration and manufacturing products for one’s own registration are fundamentally identical in terms of: (1) the mode of the conduct (manufacturing patented products); (2) the purpose of the conduct (obtaining pesticide registration in order to commercialize the products); and (3) the effect of the conduct (misleading the market into believing that the patented products may already be lawfully manufactured and sold, thereby undermining the patentee’s exclusive market interests). Given that the Supreme Court has already determined that conduct undertaken “for others” constitutes infringement, the same conclusion should logically apply to conduct undertaken “for oneself” where the mode, purpose, and effect of the conduct are essentially identical, rather than exempting such conduct under the research exemption.

3. Expansive Application of the Research Exemption Would Render the Bolar Exemption Meaningless

The Bolar exemption was specifically introduced into China's Patent Law in 2008 to fulfill China's obligations after joining the WTO. Its purpose is to exempt generic drug companies from some infringing acts required for obtaining drug marketing approval before the expiration of a patent. For a field like pesticides, if the research exemption itself already covered acts needed for administrative approval of pharmaceuticals, then there would have been no need to separately establish the Bolar exemption at that time, and the current Bolar exemption provision would be redundant. In other words, the existence of the Bolar exemption precisely indicates that the legislature did not consider the research exemption sufficient to cover acts implementing a patent for administrative approval. To put it further, the fact that the "Bolar exemption" does not apply to pesticides cannot be the reason that the research exemption should be applied to pesticide registration, thereby creating a conflict with legislative intent.

4. Exemptions Without Supporting Mechanisms Will Disrupt the Balance of Interests

Applying the research exemption in the pesticide field would also disrupt the balance of interests between brand-name pesticide companies and generic pesticide companies. In the pharmaceutical field, the patent term extension system for pharmaceuticals compensates patentees for the loss of effective patent protection due to lengthy regulatory periods, while the Bolar exemption allows generic drug companies to carry out research and marketing approval preparation before patent expiration. Together, they form a relatively balanced interest system. However, in the pesticide field, current law does not establish a similar patent term extension system, so pesticide patentees cannot obtain the same term extension as pharmaceutical patentees. Yet Judgment No. 1511 grants generic pesticide companies benefits similar to the Bolar exemption through the research exemption. Objectively, this may further weaken the interests of pesticide patentees and runs counter to broader policy objectives of encouraging innovation, addressing overcapacity in generic pesticide production, and safeguarding food security.

V. Boundaries of the Exemption

Although Judgment No. 1511 applied the research exemption to the scenario of "applying for registration on one's own behalf", this exemption would undoubtedly have boundaries. The following types of acts should not be covered by the exemption:

• Manufacturing, using, and selling infringing pesticide product to support other’s pesticide registration testing in China shall not be exempt [expressly affirmed in Judgment No. 1511];

• Manufacturing, using, and selling infringing pesticide product to support foreign pesticide registration shall not be exempt [a necessary implication of Judgment No. 1511];

• Manufacturing, using, and selling infringing pesticide product for the purpose of obtaining a pesticide production permit shall not be exempt;

• Using infringing pesticide product obtained from others without the patentee's authorization for pesticide registration testing in China shall not be exempt.

VI. Conclusion

Judgment No. 1511 has sparked extensive controversy in the pesticide industry. Its reasoning and the boundaries of its application remain to be clarified through more future cases. Although this case is a final judgment and has been included in one of the summaries of adjudicative principles issued by the Intellectual Property Tribunal of the Supreme Court, it is not a guiding case and was rendered by a three-judge panel. Accordingly, whether the Supreme Court may adopt a different line of reasoning in future similar cases remains an issue deserving close attention from the industry.

For pesticide registration applicants, registration agencies, and testing institutes, before carrying out or assisting in registration applications, they should fully identify relevant patent risks and carefully assess the compliance boundaries of activities such as registration testing and sample supply, so as to reduce potential infringement risks.

（本文仅代表作者观点，不代表知产力立场）

封面来源 | AI生成