An International Guide to
Patent Case Management for Judges

4.5 Other patent-related civil cases

4.5.1 Dispute cases over declarations of patent non-infringement

A dispute over the declaration of patent non-infringement refers to a lawsuit filed by an actor – whose interest is affected by a specific patent right against the right holder – to request a declaration that its act does not infringe the patent right. “Affected by a specific patent right” generally means that the actor has received a patent infringement warning from a specific patentee, but the right holder has not requested a people’s court to resolve the dispute within a reasonable period, in accordance with statutory procedure. Through the (2001) Civil 3^rd Requestion for Instruction No. 4 Reply dated July 12, 2002, the Supreme People’s Court specified the non-infringement declaration system in the intellectual property field.

Further regulating and improving the non-infringement declaration litigation system, Article 18 of the Interpretation of Patent Infringement Dispute Cases stipulates the specific conditions for filing such lawsuits: where a right holder sends a patent infringement warning to others and neither withdraws the warning nor files a lawsuit within one month upon receiving a written reminder in which the warned person or interested party urges the right holder to exercise the right of action, or within two months since the issuance of the written reminder, then the people’s courts shall accept the case if the warned person or interested party files a lawsuit requesting a declaration of non-infringement. “Others,” in this provision, includes specific persons and nonspecific persons. “Interested party” is understood in a broad sense to include distributors and so on. To “file a lawsuit” means to file a lawsuit against patent infringement in a people’s court. A right holder’s request to a department in charge of patent administration work to handle the infringement dispute within a certain period after the issuance of the written reminder cannot prevent the warned person or the interested party from filing a lawsuit for a declaration of non-infringement. However, to file such a lawsuit for a declaration of non-infringement, the concerned party must also meet the conditions for filing a lawsuit stipulated in Article 108 of the Civil Procedure Law in addition to the conditions stipulated in Article 18 of the Interpretation of Patent Infringement Dispute Cases.

If a dispute between the parties over whether the relevant act constitutes patent infringement has entered a statutory dispute resolution procedure (e.g., the right holder has filed a lawsuit against infringement or has applied to a people’s court for temporary measures like pre-litigation act preservation etc.), and if the relevant procedure is ongoing, then the concerned party cannot file a lawsuit for a declaration of intellectual property non-infringement.

In an appeal of a dispute over patent non-infringement declaration, VMI Holland BV v. Safe-Run Machinery (Suzhou) Co.,¹¹⁰ the Supreme People’s Court held that, in respect of the lawsuit for a declaration of patent non-infringement, the scope of the trial was to determine whether the technical solution implemented by the plaintiff fell within the protection scope of the defendant’s patent right – thereby eliminating the plaintiff’s uncertainty as to whether the technical solution implemented thereby fell within the protection scope of others’ patent rights – to facilitate its operational decision-making. In a patent infringement dispute, the patentee can choose whether the dispute should be handled by a patent administration department or tried by a people’s court. However, in either circumstance, the key lies in determining whether the alleged infringing product or process falls within the protection scope of the involved patent right.

In an appeal of a dispute over an objection to jurisdiction over design patent infringement, Honda Motor Co. v. Shijiazhuang Shuanghuan Automobile Co.,¹¹¹ the patent non-infringement declaration held that, with respect to a lawsuit for a declaration of patent non-infringement and a patent infringement lawsuit involving the same fact, the two cases shall be subject to transfer of jurisdiction and trialed concurrently to avoid the repeated trial of cases involving the same fact by different courts. The transfer of jurisdiction is determined as per the provisions on territorial jurisdiction and on jurisdiction by court level. If territorial jurisdiction is involved, then the cases will be transferred according to the temporal sequence of case acceptance: the court accepting the case later transfers the case to the court accepting the case first. If jurisdiction by court level is involved, then, generally, the inferior court will transfer the accepted case to the superior court.

4.5.2 Dispute cases over ownership of patent rights (patent application rights)

Dispute cases over the ownership of patent rights (patent application rights) primarily involve service invention-creations, invention-creations made through cooperative development or commissioned development, and the misappropriation of technical secrets.

4.5.2.1 Service invention-creations

Article 6 of the Patent Law stipulates the following:

An invention-creation that is accomplished in the course of performing the duties of the employee, or mainly by using the material and technological conditions of an employer, is a service invention-creation. For a service invention-creation, the right to apply for a patent belongs to the employer. After the application is approved, the employer shall be the patentee. The employer may, in accordance with the law, dispose of the right to apply for a patent for its service invention-creation and the patent right, there facilitating the exploitation and utilization of relevant invention-creation.

For a non-service invention-creation, the right to apply for a patent belongs to the inventor or designer. After the application is approved, the inventor or designer shall be the patentee.

For service invention-creations, Article 847 paragraph 2 of the Civil Code also stipulates the following: “A work for hire is a technological achievement that is accomplished as a result of performing the tasks assigned by a legal person or unincorporated organization or that is accomplished mainly by using the material and technical conditions of a legal person or unincorporated organization.” It should be noted that the “work for hire” stipulated in this article has a broader meaning than the “service invention-creations” stipulated in Article 6 of the Patent Law: the former includes not only patent rights or patent application rights but also other types of intellectual property rights, like new plant varieties, computer software copyright and so on.

4.5.2.1.1 Invention-creations accomplished in the course of performing the duties of an employee

Article 12 paragraph 1 of the Rules for the Implementation of the Patent Law stipulates the following:

Invention-creations accomplished while performing the tasks assigned by employer referred to in Article 6 of the Patent Law means any invention-creation made:

1. (1) in the course of performing an employee’s own duty;
2. (2) in execution of any task, other than his own duty, which was entrusted to him by the employer; or
3. (3) within one year from his retirement, resignation or from termination of his employment or personnel relationship with the entity to which he previously belongs, where the invention-creation relates to his own duty or any other task entrusted to him by the entity to which he was previously employed.

With respect to “a technological achievement that is accomplished as a result of performing the tasks assigned by a legal person or unincorporated organization,” as mentioned in Article 847 paragraph 2 of the Civil Code, Article 2 of the Interpretation of Technology Contracts¹¹² stipulates the following two circumstances:

1. (1) performing the employee’s own duty or undertaking other technical development tasks assigned thereby;
2. (2) continuing to perform technical development work that is related to the employee’s own duty or tasks assigned by the former employer within one year after separation, unless otherwise provided for by laws or administrative regulations.

Compared with Article 12(3) of the Rules for the Implementation of the Patent Law, the second item in the above provision contains the additional phrase “unless otherwise provided for by laws or administrative regulations.”

4.5.2.1.2 Invention-creations made mainly by using the material and technical conditions of an employer

Article 6 paragraph 3 of the Patent Law states the following:

For an invention-creation that is accomplished by using the material and technical conditions of an employer, if the employer has concluded a contract with the inventor or designer providing the ownership of the right to apply for the patent or the ownership of the patent right, such provision shall prevail.

In practice, an invention-creation made by a former employee may involve performing the tasks assigned by a former employer but using the material and technical conditions of the current employer. According to Article 5 of the Interpretation of Technology Contracts, under such a circumstance, the rights and interests will be determined in accordance with an agreement reached between the former employer and the current employer. Otherwise, the rights and interests are shared between them based on their respective contributions to the technological achievement.

With respect to the phrase “material and technical conditions” in Article 6 of the Patent Law, Article 12 paragraph 2 of the Rules for the Implementation of the Patent Law stipulates that this means “the employer’s money, equipment, spare parts, raw materials or technical materials which are not available to the public, etc.” Article 3 of the Interpretation of Technology Contracts stipulates the following: “‘material and technical conditions’ as depicted in Article 847 paragraph 2 of the Civil Code include money, equipment, apparatuses, raw materials, undisclosed technical information and documents, etc.”

In a retrial of a dispute over patent ownership, Shenzhen Weibond Technology Co. v. Li Jianyi,¹¹³ the determination of “invention-creations related to” an employee’s own duty or any other task assigned to them by the former employer (as per Article 12(3) of the Rules for the Implementation of the Patent Law) was further clarified:

The interests of the employee, the former employer and the current employer shall be balanced and the following factors shall be comprehensively considered: first, the specific contents of the employee’s duty or task assigned to him; second, specific circumstances of the involved patent and its relation with the employee’s duty or task; third, whether the former employer has conducted technological development and research activities related to the involved patent or whether there is another legitimate source for the patented technology; fourth, whether the right holder or inventor of the involved patent (application) can make reasonable explanations on the development and research process or source of the patented technology.

4.5.2.1.3 Ownership and disposal of service invention-creations

According to Article 6 paragraph 1 of the Patent Law, “[f]or a service invention-creation, the right to apply for a patent belongs to the employer. After the application is approved, the employer shall be the patentee.” Article 2 paragraph 2 of the Interpretation of Technology Contracts stipulates the following: “Where a legal person or unincorporated organization has entered into an agreement with an employee, with respect to the rights and interests in and to a technological achievement accomplished by the employee when he or she was employed or after separation therefrom, the people’s courts shall consider the agreement.”

When the Patent Law was last amended in 2020, it was stipulated in Article 6 paragraph 1 that “[t]he employer may, in accordance with the law, dispose of the right to apply for a patent for its service invention-creation and the patent right, thereby facilitating the exploitation and utilization of the relevant invention-creation.” Article 847 paragraph 1 of the Civil Code stipulates the following:

Where a right to use or transfer a work for hire belongs to a legal person or unincorporated organization, the legal person or unincorporated organization may conclude a technology contract on the work for hire. Where the legal person or unincorporated organization concludes a technology contract to transfer the work for hire, the creator of the work for hire has right in priority to acquire it on equivalent conditions.

4.5.2.1.4 Remuneration, reward and authorship of the inventor or designer

Article 15 of the Patent Law stipulates the following: “The entity that is granted a patent right shall reward the inventor or designer of service invention-creation. After such patent is exploited, the entity shall pay the inventor or designer a reasonable remuneration based on the extent of spreading and application as well as the economic benefits yielded.” Articles 76–78 of the Rules for the Implementation of the Patent Law further provide for the methods and amounts of “reward and remuneration.”

According to Article 16 of the Patent Law, an inventor or designer has the right to name themselves as such in the patent documents. Article 849 of the Civil Code also stipulates the following: “An individual person who has accomplished a technological work product has the right to indicate on the relevant documents that the said person is the creator thereof and to receive certificate of honor and rewards.”

With respect to the identification of an inventor or designer, further provisions are made in Article 13 of the Rules for the Implementation of the Patent Law and Article 6 of the Interpretation of Technology Contracts.

4.5.2.2 Invention-creations made through cooperative or commissioned development

According to Article 8 of the Patent Law, for an invention-creation accomplished by two or more entities or individuals, or accomplished by an entity or individual in the execution of a commission given to them by another entity or individual, the right to apply for a patent belongs, unless otherwise agreed upon, to the entity or individual that accomplished the invention-creation, or to the entities or individuals that accomplished the invention-creation in collaboration. After the patent application is approved, the entity (or entities) or individual (or individuals) that filed the application shall be the patentee. Articles 859 and 860 of the Civil Code also provide for invention-creations accomplished through commissioned development and cooperative development, respectively.

4.5.2.3 Patent applications based on unauthorized use of others’ technical secrets

If an infringer, without the authorization of the right holder, applies for a patent for a technical secret – whether obtained legitimately from the right holder thereof or illegally through theft or other undue means – the right holder may file a civil lawsuit against trade secret misappropriation in accordance with the laws to request a judgment ordering that the infringer assume civil liabilities (e.g., cessation of misappropriation and compensation for losses) or to request the competent people’s court to declare that the right holder has the patent right over the patent unilaterally applied for by the infringer.

In an appeal of a dispute over patent ownership, Tianjin Greenpine Pharma Co. v. Huabei Pharmaceutical Hebei Huamin Pharmaceutical Co.,¹¹⁴ the Supreme People’s Court held that, where a party asserts ownership of a patent right on the ground of misappropriation of a technical secret, the people’s court shall examine whether the technical secret is disclosed in the patent documents and whether it is incorporated into the patented technical solution. If the answer to either question is in the affirmative, then the technical secret has been misappropriated. If the technical secret constitutes the substantial content of the patented technical solution, the right holder of the technical secret has lawful rights to the patent.

4.5.3 Dispute cases over patent contracts

For cases over patent contract disputes, the main provisions that apply include the relevant provisions in Book I(VI) (“Civil Juristic Acts”) and Book III (“Contracts”) of the Civil Code, in addition to relevant provisions in the Patent Law and the Rules for the Implementation of the Patent Law. Book III(XX) (“Technology Contracts”) of the Civil Code also specifically provides for technology development, transfer, licensing, consultation and service contracts.

With respect to technology contracts, the Interpretation of Technology Contracts includes 47 articles divided into six parts:

• General Provisions;
• Technology Development Contracts;
• Technology Transfer Contracts and Technology Licensing Contracts;
• Technology Consultation Contracts and Technology Service Contracts;
• Procedural Issues Related to the Trial of Technology Contract Disputes; and
• Miscellaneous.

Technological cooperation involving foreign elements is regulated by relevant provisions of the Regulations on Technology Import and Export Administration and the Regulations on the Implementation of the Law on Chinese-Foreign Equity Joint Ventures.¹¹⁵ On March 18, 2019, the State Council announced Decree No. 709, which deleted Article 43(3)–(4) of the Regulations on the Implementation of the Law on Chinese-Foreign Equity Joint Ventures and Article 24 paragraph 3, Article 27 and Article 29 of the Regulations on Technology Import and Export Administration and amended the original Article 41 thereof to Article 39, as follows: “The competent foreign trade department under the State Council shall, within three working days from the date of receipt of the documents provided for in Article 38 hereof, register the technology export contract and issue the registration certificate of technology export.” Article 22 of the Foreign Investment Law stipulates the following:¹¹⁶

The State protects the intellectual property rights of foreign investors and foreign-invested enterprises, protects the legitimate rights and interests of intellectual property rights holders and related rights holders, and strictly pursues legal liability for infringements of intellectual property rights in accordance with law.

The State encourages technical cooperation based on the voluntary principle and commercial rules in the process of foreign investment. The terms and conditions for technical cooperation are determined by the investing parties through negotiation on an equal basis in accordance with the principle of fairness. Administrative departments and their staff members shall not force the transfer of technology through administrative means.

4.5.4 Civil cases involving standard-essential patents

Civil cases involving standard-essential patents mainly involve civil disputes over patent infringement, patent contracts, royalties and abuse of market dominance involving standard-essential patents.

4.5.4.1 Patent-related cases

In July 2008, in their Letter on Chaoyang Xingnuo Company’s Act of Exploiting a Patent,¹¹⁷ the Supreme People’s Court expressed the following opinion on the request for instruction raised by the High People’s Court of Liaoning:

Given the reality that China’s standard-setting organization has not established systems with respect to the public disclosure of information and exploitation of patents incorporated in relevant standards, where a patentee has participated in the formulation of a standard or has consented to the incorporation of a patent in a national, industrial, or local standard, then the patentee shall be deemed as having licensed others to exploit the patent while implementing the standard, and the relevant acts of exploiting the patent by others do not constitute acts of patent infringement as stipulated in Article 11 of the Patent Law. The patentee may require the exploiter to pay an amount of royalties which, however, shall be significantly lower than ordinary royalties; where the patentee has undertaken to waive the patent royalties, such an undertaking shall apply.

Article 24 of the Interpretation (II) of Patent Infringement Dispute Cases specifically provides for issues concerning standard-essential patents, which primarily involve important issues such as the disclosure of patent information related to technical standards; defenses against infringement; applicable conditions for the cessation of infringement; negotiation and adjudication of exploitation licensing conditions; and fair, reasonable and nondiscriminatory licensing obligations, among other issues. Paragraphs 1–3 of this article stipulate the following:

Where a recommended national, industrial, or local standard has explicitly indicated the information of an essential patent, an alleged infringer’s non-infringement defense on the ground that such a standard may be implemented without license shall generally be rejected.

Where a recommended national, industrial, or local standard has explicitly indicated the information of an essential patent, when the patentee and an alleged infringer negotiate licensing terms for exploitation of the patent, if the patentee willfully violates the fair, reasonable, and nondiscriminatory licensing obligation undertaken thereby during the formulation of the standard, which results in failure to reach a patent exploitation licensing contract, and if the alleged infringer has no obvious fault in the negotiation, the patentee’s request for cessation of implementation of the standard shall generally be rejected.

The exploitation licensing terms referred to in the preceding paragraph 2 shall be negotiated between the patentee and the alleged infringer. If the parties fail to reach an agreement after sufficient negotiation, they can request a people’s court to determine the licensing terms. In determining the licensing terms, the people’s court shall, in accordance with the principle of fairness, reasonableness and nondiscrimination, comprehensively consider such factors as the innovation level of the patent, its contribution in the standard, the technical field which the standard falls under, the nature and the implementation scope of the standard, and relevant licensing terms.

Before this judicial interpretation was issued, the Standardization Administration of China and the CNIPA had issued the Regulatory Measures on National Standards involving Patents (Interim) in December 2013, which improved the procedure for the disclosure of patent information related to national standards and specifically stipulated that patents involved in national standards are essential patents. To maintain consistency with these interim measures, the Interpretation (II) of Patent Infringement Dispute Cases only provided for recommended standards (i.e., nonmandatory standards) and explicitly indicated their related patents but did not provide for issues such as standards without disclosure of patent information, mandatory standards, international standards and so on, which were also not mentioned in the foregoing interim measures.

With respect to technical standards related to pharmaceutical products, in a retrial of a dispute over invention patent infringement, Qilu Pharmaceutical Co. v. Beijing Sihuan Pharmaceutical Co.,¹¹⁸ the Supreme People’s Court held that the prevailing laws and administrative regulations involving pharmaceutical product administration and registration do not require right holders of pharmaceutical product patents to make “fair, reasonable and nondiscriminatory” undertakings in the licensing of such pharmaceutical product patents when cooperating in the formulation of national pharmaceutical product standards. There was no evidence in this case to prove that Beijing Sihuan Pharmaceutical had made “fair, reasonable and nondiscriminatory” undertakings in the licensing of the patent during the formulation of the national pharmaceutical product standard related to the involved patent. Therefore, the principle of “fairness, reasonableness and nondiscrimination” did not apply.

4.5.4.2 Monopoly-related cases

The Supreme People’s Court issued the Provisions on Cases of Monopoly Disputes in 2012, amending it in 2020.¹¹⁹ This judicial interpretation includes 16 articles that specify issues such as the types of cases, the filing of lawsuits, jurisdiction and trial, the burden of proof, evidence, civil liabilities and the statute of limitations with respect to monopoly-related cases. It further clarified relevant provisions of the Anti-monopoly Law.¹²⁰ Article 3 of the provisions stipulates the following:

Monopoly-related civil dispute cases of first instance shall come under the jurisdiction of intellectual property courts or intermediate people’s courts of cities where the governments of provinces, autonomous regions, or municipalities are located or of cities under separate state planning, or intermediate people’s courts designated by the Supreme People’s Court.

In addition to the above law and judicial interpretation, the Anti-monopoly Commission, under the State Council, issued the Guidelines on Anti-monopoly in the Field of Intellectual Property Rights on January 4, 2019, and the Guidelines on the Definition of Relevant Market on July 6, 2009.¹²¹

In an appeal of a dispute over an objection to jurisdiction over market dominance abuse, Ericsson v. TCL Group Corp.,¹²² the Supreme People’s Court held that Article 2 of the Anti-monopoly Law specifies that the law is applicable to monopolistic conduct outside the territory of China. At the same time, it held that Article 2 also indicates that, for jurisdiction over monopoly dispute cases, the place where the alleged monopolistic conduct led to the elimination or restriction of competition can be the connecting point of jurisdiction.

4.5.5 Patent-related civil cases involving pharmaceutical products

The protection of pharmaceutical product patents is essential to the innovative development of the pharmaceutical industry and to the health and happiness of the people. While motivation systems and judicial safeguards are provided for the independent innovation and high-quality development of the pharmaceutical industry, the accessibility of pharmaceutical products and the health of the people are also considered. In particular, given the huge costs for the development and research of new pharmaceutical products, strong intellectual property protections are critical for motivating continuous innovation in the pharmaceutical industry.

To strengthen protections for pharmaceutical product patents and realize the early resolution of pharmaceutical product patent disputes, both the Opinion on Deepening the Reform of Examination and Approval Policy, issued in October 2017, and the Opinions on Strengthening the Protection of Intellectual Property Rights issued on November 24, 2019, were proposed to “explore and establish a pharmaceutical product patent linkage system.”¹²³

4.5.5.1 Amendments to the Patent Law related to pharmaceutical product patent disputes

During the fourth amendment to the Patent Law, the legislature stipulated an early resolution mechanism for pharmaceutical product patent disputes at the suggestion of relevant competent departments and by reference to the pharmaceutical product patent linkage systems of relevant countries. Consequently, Article 76 of the Patent Law now stipulates the following:

In the review and approval process before the marketing of a pharmaceutical product, where the applicant for marketing approval of the pharmaceutical product has any disputes over the relevant patent right associated with the pharmaceutical product applied for registration with the relevant patentee or interested party, the party concerned may file a lawsuit before the people’s court and request a judgment on whether the technical solution related to the pharmaceutical product that is applied for registration falls within the protection scope of any pharmaceutical product patent right owned by others. The medical product regulatory department under the State Council may, within a prescribed time limit, make a decision on whether to suspend the marketing approval of the pharmaceutical product according to the effective judgment or written order of the people’s court.

The applicant for marketing approval of the pharmaceutical product, the relevant patentee or the interested party may also petition the patent administration department under the State Council for an administrative adjudication on the disputes over the patent right associated with the drug applied for registration.

The medical products regulatory department under the State Council shall, in conjunction with the patent administration department under the State Council, formulate specific cohesive measures for patent right dispute resolutions at the stages of pharmaceutical product marketing license approval and pharmaceutical product marketing license application, which shall be implemented after the approval of the State Council.

In Article 42 paragraph 3 of the Patent Law, a provision on patent term compensation for pharmaceutical product patents was also added.

4.5.5.2 Formulation of relevant judicial interpretations and regulatory documents

To implement Article 76 of the Patent Law and improve the early resolution mechanism of pharmaceutical product patent disputes, the National Medical Products Administration and the CNIPA, in conjunction with relevant departments, issued the Implementation Measures for Pharmaceutical Product Patent Disputes on July 4, 2021.¹²⁴ Then, on July 5, 2021, the Supreme People’s Court issued their Provisions on the Patent Rights of Drugs, and the CNIPA issued the Adjudication Measures for Pharmaceutical Product Patent Disputes.¹²⁵ Both documents came into effect on the same day.

The Provisions on the Patent Rights of Drugs focused on procedural issues to be resolved after the implementation of the pharmaceutical product patent linkage system and the connection and matching of litigation procedures with the review and approval process and administrative adjudication procedure. This thereby promoted the uniformity of administrative enforcement and judicial adjudication standards. The provisions included 14 articles to provide for jurisdiction, specific causes of action, materials required for filing a lawsuit, ways of filing such a lawsuit, the linkage between administrative and judicial procedures, defenses, the protection of trade secrets during litigation, act preservation, counterclaims for damages against the losing party, means of service and so on, thereby providing clear guidance for the fair and timely trial of such cases and promoting the implementation of the pharmaceutical product patent linkage system.

4.5.5.3 Main issues involved in the early resolution mechanism of pharmaceutical product patent disputes

4.5.5.3.1 Jurisdiction

Article 1 of the Provisions on the Patent Rights of Drugs stipulates the jurisdiction and causes of action over disputes related to pharmaceutical product patents. Civil cases of first instance involving lawsuits in relation to pharmaceutical product patents come under the concentrated jurisdiction of the Beijing Intellectual Property Court to facilitate the organization of superior judicial resources and unify the adjudication standard.

Furthermore, given that such civil cases often also involve administrative patent right confirmation cases related to the patent and administrative cases filed by the concerned parties because they disagree with administrative adjudications made by the CNIPA, centralized jurisdiction safeguards the organic linkage between different litigation procedures and facilitates work coordination with relevant administrative departments under the State Council.

With respect to jurisdiction over appeal cases, in accordance with the NPC Standing Committee’s Decision on the Litigation of Intellectual Property Cases and Article 2 of the Provisions on the Intellectual Property Court, where a party disagrees with a first-instance judgment or ruling made by the Beijing Intellectual Property Court on a pharmaceutical product patent linkage lawsuit, that party may appeal to the Supreme People’s Court.

4.5.5.3.2 Relation between pharmaceutical product patent linkage lawsuits and patent infringement lawsuits

Article 11 of the Patent Law specifically provides for acts of patent infringement. As the act of applying for review and approval before the marketing of a pharmaceutical product does not constitute an act of infringement according to Article 11 of the Patent Law, the provisions on remedies against patent infringement do not apply in such cases. For a civil lawsuit filed by a party in accordance with Article 76 of the Patent Law, the specific request is for a judgment on whether the technical solution related to the pharmaceutical product for which registration is applied “falls within the protection scope of any pharmaceutical product patent right owned by others pharmaceutical product.” The nature of such a lawsuit is a lawsuit for confirmation. However, in a pharmaceutical product patent linkage lawsuit, the applicant for pharmaceutical product marketing approval may still raise a prior art defense or a prior-use rights defense in accordance with Articles 67 and 75(2) of the Patent Law, respectively. If a defense is sustained, the competent people’s court may rule to confirm that the technical solution related to the pharmaceutical product for which registration is applied falls within the protection scope of related patent rights.

4.5.5.3.3 “Relevant patents” in Article 76 of the Patent Law

As a component of the pharmaceutical product patent linkage system, the Provisions on the Patent Rights of Drugs need to be coordinated with the specific measures for linking pharmaceutical product marketing approval with patent dispute resolution during the pharmaceutical product marketing approval application stage – as stipulated in Article 76 paragraph 3 of the Patent Law (i.e., the Implementation Measures for Pharmaceutical Product Patent Disputes) – to implement the provisions of that article.

The early resolution mechanism for pharmaceutical product patent disputes stipulated in Article 76 of the Patent Law only covers specific types of pharmaceutical product patents – “relevant patents.” With respect to the scope of “relevant patents,” Article 2 of the Implementation Measures for Pharmaceutical Product Patent Disputes stipulates the following:

The pharmaceutical product regulatory department under the State Council shall establish the Patent Information Registration Platform of Marketed Pharmaceutical Products in China, for pharmaceutical product marketing approval holders to register patent information related to pharmaceutical products registered and approved in China.

Where relevant patent information is not registered on the Patent Information Registration Platform of Marketed Pharmaceutical Products in China, the Measures shall not apply.

Article 5 of the measures stipulates the following: “Chemical pharmaceutical product marketing approval holders may register patents for compounds as active pharmaceutical ingredients, patents for pharmaceutical compositions containing active ingredient(s), and pharmaceutical use patents, on the Patent Information Registration Platform of Marketed Pharmaceutical Products in China.” Article 12 stipulates the following: “For traditional Chinese medicines, patents concerning Chinese medicine compositions, Chinese medicine extracts, and pharmaceutical use can be registered; for biological products, patents concerning sequence structure of active ingredients and pharmaceutical use can be registered.”

Without making additional provisions for “related patents” but keeping coordination with the above provisions of the implementation measures, Article 2 of the Provisions on the Patent Rights of Drugs stipulates the following: “‘Related patents’ stipulated in Article 76 of the Patent Law refer to those patents for which the measures of the relevant administration departments under the State Council for linking pharmaceutical product marketing approval and patent dispute resolution during the pharmaceutical product marking approval application stage shall apply.”

4.5.5.3.4 Parties entitled to file lawsuits referred to in Article 76 of the Patent Law

Article 76 of the Patent Law stipulates that the applicant for pharmaceutical product marketing approval and the concerned patentee or an interested party may file a lawsuit before a people’s court. Article 2 paragraph 2 of the Provisions on the Patent Rights of Drugs stipulates the following: “The ‘interested party’ in Article 76 of the Patent Law refers to licensees of the patent referred to in the preceding paragraph and marketing approval holders of the related pharmaceutical product.”

According to Article 7 of the Implementation Measures for Pharmaceutical Product Patent Disputes,

[a]ny patentee or an interested party who objects to the fourth type of patent declarations may, within 45 days from the date when the application for pharmaceutical product marketing approval is published by the national pharmaceutical product evaluation institution, may file a lawsuit before people’s court regarding whether the technical solution of the pharmaceutical product for which marketing approval is applied falls within the protection scope of relevant patent rights, or apply to the patent administration department under the State Council for an administrative adjudication.

If a patentee or interested party fails to file a lawsuit within the said 45 days, the applicant for pharmaceutical product marketing approval may, in accordance with Article 4 of the judicial interpretation, “file a lawsuit before a people’s court to request for confirmation that the pharmaceutical product for which registration is applied does not fall within the protection scope of relevant patent rights.”

4.5.5.3.5 Act preservation

Article 10 of the Provisions on the Patent Rights of Drugs stipulates that, where a patentee or an interested party

requests for prohibiting an applicant for pharmaceutical product marketing approval from implementing the acts stipulated in Article 11 of the Patent Law within the term of the relevant patent right, the people’s courts shall handle such a request as per relevant provisions of the Patent Law and the Civil Procedure Law; requests thereof for prohibiting acts of applying for pharmaceutical product marketing approval or acts of pharmaceutical product marketing review and approval shall not be supported by the people’s courts.

Provisions on act preservation are made in Chapter IX (“Preservation and Preliminary Enforcement”) of the Civil Procedure Law, Chapter 7 (“Preservation and Preliminary Enforcement”) of the Interpretation of the Civil Procedure Law, and the Provisions on Act Preservation in Intellectual Property Disputes. Additionally, Article 105 of the Civil Procedure Law stipulates the following: “If an application is made wrongfully, the applicant shall compensate the person against whom the application is made for any loss incurred as a result of the act preservation.”

4.5.5.3.6 Counterclaim for compensation against vexatious litigation

To better balance the interests of patentees and interested parties and the applicants for pharmaceutical product marketing approval, Article 12 of the Provisions on the Patent Rights of Drugs provides for a counterclaim system for compensation against vexatious litigation, in accordance with Article 132 of the Civil Code, Article 13 of the Civil Procedure Law, and Articles 20 and 47 of the Patent Law.

There are two prerequisites for counterclaiming compensation against vexatious litigation. First, the subjective prerequisite is that the patentee or interested party knows or should have known that the patent right was declared invalid or that the technical solution related to the pharmaceutical product for which marketing approval is applied does not fall within the protection scope of the patent right. Here, “knows” or “should have known” are determined following the same criteria as for general infringement cases. Second, the objective prerequisite is that the applicant for pharmaceutical product marketing approval has suffered losses caused by the litigation.

With respect to jurisdiction over counterclaims for compensation against vexatious litigation, and given the close relation of such cases with pharmaceutical product patent lawsuits, it is stipulated that such cases also come under the jurisdiction of the Beijing Intellectual Property Court.

4.5.5.3.7 Administrative adjudication

With respect to the protection of patent rights, China adopts a dual-track system whereby judicial and administrative protections work in tandem. For “disputes arising from patents related to related to the pharmaceutical product for which marketing approval is applied” (Article 76 of the Patent Law), the concerned party may either file a lawsuit before a people’s court or “petition the patent administration department under the State Council for an administrative adjudication on the disputes” as per Article 76 paragraph 2 of the Patent Law.

Article 5 of the Provisions on the Patent Rights of Drugs stipulates the following:

Where a party asserts that a lawsuit referred to in Article 76 of the Patent Law should not be accepted or requests for suspension of the lawsuit on the ground that the patent administration department under the State Council has accepted the application for administrative adjudication referred to in Article 76 of the Patent Law, such an assertion or application shall not be supported by the people’s courts.

Article 4 of the Adjudication Measures for Pharmaceutical Product Patent Disputes stipulates the following: “Where a party applies for administrative adjudication, the prerequisite to be met is that no people’s court has accepted a case over the pharmaceutical product patent dispute.” A party having first chosen to apply for administrative adjudication can still file a lawsuit before a people’s court later. However, if a party has filed a lawsuit before a people’s court, and the case has been accepted, then the party can no longer apply to the CNIPA for administrative adjudication on the same pharmaceutical product and patent.

Both Article 7 of the Implementation Measures for Pharmaceutical Product Patent Disputes and Article 19 of the Adjudication Measures for Pharmaceutical Product Patent Disputes stipulate that, where a party disagrees with an administrative adjudication made by the CNIPA on a pharmaceutical product patent dispute, the party may file an administrative lawsuit before the Beijing Intellectual Property Court. Where the party still disagrees with the judgment made thereby, it may appeal to the Supreme People’s Court.