Beijing Intellectual Property Court’ s Typical Cases concerning Pharmaceutical Patent

Case 1: Administrative Dispute over Invalidation of the “Baloxavir Prodrug” Invention Patent 
—Determining whether a Markush compound claim is supported by the specification 

1.Basic facts 

The patent, entitled “Prodrugs of Substituted Polycyclic Carbamoylpyridone Derivatives,” is owned by a pharmaceutical company referred to here as Shio*. It contains nine claims. Independent claim 1 concerns a compound defined by a general formula, or a pharmaceutically acceptable salt thereof. 

An individual, Liu*, requested that the China National Intellectual Property Administration (“CNIPA”) invalidate the patent. CNIPA decided to maintain its validity. Liu* brought an administrative action before the Beijing Intellectual Property Court, arguing that the drug activity and preparation methods of the “tricyclic” compounds covered by claim 1 were not supported by the specification. Liu* contended that claim 1 covered numerous tricyclic compounds with substantially different core structures, whereas the specification disclosed only six examples of their preparation and one example of their effects. The claim’s generalization therefore exceeded the disclosure. 

The court held that the specification supported both the drug activity and the methods of preparing the tricyclic compounds in claim 1. The claim complied with Article 26(4) of the 2009 Patent Law of the People’s Republic of China. The court dismissed Liu*’s claims. No party appealed, and the first-instance judgment took effect. 

2. Significance 

Whether a Markush compound claim is supported by the specification is a difficult question in pharmaceutical patent grant and validity proceedings. Both Markush claim drafting and the support requirement involve generalization, but the applicable standard needs clarification. 

The invention sought to convert compounds from an earlier invention into prodrugs. Its parent compound, baloxavir, was described in the case materials as a novel anti-influenza drug pioneered by the patent owner and, at the time, the first and only single-dose oral influenza treatment approved by the National Medical Products Administration, marketed under the trade 
name Xofluza. The judgment defines the nature of a Markush claim and clarifies the support standard applicable to it. It provides drafting guidance, improves predictability concerning patent validity, and helps pharmaceutical companies build effective patent protection systems. 

Case 2: Administrative Dispute over Reexamination of the Rejected “Kuanxiong Liqi Oral Liquid” Patent Application 
—Rules for assessing the inventiveness of a TCM formulation invention 

1. Basic facts 

The applicant for the invention patent application entitled “Kuanxiong Liqi Oral Liquid” was a TCM research institute. CNIPA upheld the rejection of the application on reexamination. The institute brought an administrative action, arguing that the decision had overlooked the application’s distinctive understanding of disease mechanism, treatment principles, and “jun-chen-zuo-shi” formulation structure—the traditional roles of chief, deputy, assistant, and envoy ingredients. It argued that the formulation could not be deemed obvious solely on the basis of the effects of individual medicinal ingredients. 

The Beijing Intellectual Property Court held that the inventiveness of a TCM composition cannot be assessed by simply adding together the known effects of its individual ingredients. From the perspective of a person skilled in the art, the formulation must be considered as a whole, including its understanding of disease mechanism, treatment principles, ingredient compatibility and hierarchy, selection of ingredients, and dosage ratios. 

Although the application and the cited prior-art document shared some ingredients, their underlying understanding of disease mechanism and treatment approach differed. The compatibility structure had been reconfigured beyond the routine addition or omission of ingredients that a skilled person might derive from the prior art. The prior art gave no technical motivation to construct the claimed formulation. Claims 1 and 2 therefore met the inventiveness requirement in Article 22(3) of the Patent Law. The court revoked the reexamination decision and ordered CNIPA to make a new decision. Neither party appealed, and the judgment took effect. 

2. Significance 

This case clarifies how to assess the inventiveness of TCM formulation patents. Rather than comparing ingredients one by one, the court examined the professional framework of TCM prescription theory, including the logic of “jun-chen-zuo-shi” compatibility and treatment based on the patient’s condition and the underlying cause. It recognized that the core contribution of a TCM composition may lie in its overall compatibility relationships and structure, not merely in the collection of ingredients. 

TCM applicants should clearly document disease-mechanism analysis, treatment principles, a complete explanation of the formulation, and ingredient-compatibilitylogic. They should explain decisions concerning ingredient selection, processing specifications, and weight ratios, so that the application demonstrates its innovative contribution over the prior art. 

Case 3: “Edoxaban Tosylate Tablets” Pharmaceutical Patent Linkage Dispute 
—Identifying a generic drug’s technical solution after amendment 

1. Basic facts 

The patent, entitled “Pharmaceutical Composition,” was owned by a company referred to here as Company K. It was listed on the Patent Information Registration Platform for Drugs Marketed in China in connection with Company K’s approved edoxaban tosylate tablets, an original drug indicated for conditions including deep vein thrombosis and pulmonary embolism in adults. 

A company referred to here as Hai* used the original drug as its reference product and submitted an application to the 
National Medical Products Administration for marketing authorization for generic edoxaban tosylate tablets. The application was accepted. Hai* submitted a Category 4.1 declaration asserting that the relevant patent should be invalidated. Following a request for supplementary materials from the Center for Drug Evaluation, Hai* changed the composition of the generic drug’s film-coating premix. The Center completed its technical review on the basis of the amended application. 

Separately, in response to Company K’s request for an administrative adjudication concerning the patent, CNIPA confirmed that the generic drug’s relevant technical solution fell within the scope of claims 2 and 11. Hai* then brought an action before the Beijing Intellectual Property Court seeking confirmation that its amended solution did not fall within those claims. 

The court held that the amended solution governed. Because it was neither identical nor equivalent to the solutions protected by claims 2 and 11, the court confirmed that the generic drug did not fall within their scope. Company K appealed to the Supreme People’s Court, which upheld the judgment. 

2. Significance 

The case establishes a standard for identifying a generic drug’s technical solution after amendment. Once an amended solution has been accepted by the drug review authority, it becomes the basis for determining whether the drug falls within the patent’s scope of protection. This provides guidance to generic companies making changes during review while maintaining a balance between their interests and those of patent owners. 

Case 4: “Lurasidone Hydrochloride Tablets” Pharmaceutical Patent Linkage Dispute 
—Applying by reference the approach of “dismissing the action first, while permitting a separate action later” when patent status is unstable 

1. Basic facts 

The patent, entitled “Pharmaceutical Composition,” was owned by a company referred to here as Sumi*. It was listed on the Patent Information Registration Platform for Drugs Marketed in China in connection with the company’s approved lurasidone hydrochloride tablets, indicated for conditions including schizophrenia. 

A company referred to here as Hua* submitted an application for marketing authorization for generic lurasidone hydrochloride tablets, using the originator drug as its reference product. The application was accepted. Hua* filed a Category II declaration stating that the patent listed for the reference drug had expired or been invalidated. CNIPA had declared the patent invalid in its entirety, although that decision was under administrative judicial review. 

Sumi* brought an action seeking confirmation that the generic drug fell within the patent’s scope of protection. The Beijing Intellectual Property Court dismissed the action because CNIPA had declared the patent invalid. The Supreme People’s Court upheld that ruling on appeal. 

2. Significance 

This was one of the earliest patent linkage cases in which an action was dismissed because the patent’s status was unstable. 
Taking account of the linkage system’s purpose and the interests of both parties, the court explained why it was appropriate to apply by reference the approach used in patent infringement litigation of dismissing the current action while allowing a separate action later. The ruling provides a reference for similar cases and avoids unnecessary expenditure of judicial resources. 

Case 5: “Eldecalcitol Capsules” Pharmaceutical Patent Linkage Dispute 
—Proceeding to substantive adjudication at a generic company’s request when patent status is unstable 

1. Basic facts 

The patent, entitled “ED-71 Formulation,” was owned by a company referred to here as Chu*. It was listed on the Patent Information Registration Platform for Drugs Marketed in China in connection with the company’s approved eldecalcitol capsules, indicated for conditions including osteoporosis. 

A company referred to here as Hai* submitted an accepted marketing authorization application for a Class 4 chemical generic of the capsules, using the original drug as its reference product. Hai* filed a Category 4.2 declaration asserting that its generic drug did not fall within the protection scope of the listed patent. 

Chu* brought an action seeking confirmation that the generic drug fell within the patent’s scope. Taking account of Hai*’s express request for adjudication on the merits and other relevant circumstances, the Beijing Intellectual Property Court examined the substance of the dispute. It found that the generic drug did not fall within the patent’s scope and dismissed the 
patent owner’s claims. The Supreme People’s Court upheld the judgment on appeal. 

2. Significance 

This was the first case accepted and concluded by a court following the implementation of the pharmaceutical patent linkage system. It refines the rules for cases involving unstable patent status: where the generic company expressly requests substantive adjudication, the court may hear the merits. The decision reflects the need to balance drug accessibility with incentives for pharmaceutical innovation. 

Case 6: “Palbociclib Tablets” Pharmaceutical Patent Linkage Dispute 
—Standards for assessing Category IV declarations and Category I declarations where the originator drug has not been marketed in China 

1. Basic facts 

The patent, entitled “2-(Pyridin-2-ylamino) -pyrido[2,3-d] pyrimidin-7-one,” was owned by a company referred to here as Lang*. It was listed on the Patent Information Registration Platform for Drugs Marketed in China in connection with palbociclib capsules approved for marketing by Company C. The drug was indicated for conditions including breast cancer. 

A company referred to here as Qi* submitted an accepted application for a Class 3 chemical generic of palbociclib tablets. Its reference product was palbociclib tablets that had “not” been approved for marketing in China. Qi* filed a Category I declaration stating that the platform contained no relevant patent information for the drug it sought to copy. 

Lang* brought an action seeking confirmation that the generic tablets fell within the scope of patent claims 1–4. The Beijing Intellectual Property Court held that registration of the patent in connection with palbociclib “capsules” could not be treated as registration in connection with palbociclib “tablets”. The generic application fell within the circumstances of a Category I declaration, and the action did not meet the conditions for acceptance. The court dismissed it. The Supreme People’s Court upheld the ruling. 

2. Significance 

The case addresses how to assess the four categories of patent declarations. A Category IV declaration is one of the conditions for accepting a linkage case under Article 3 of the Supreme People’s Court’s relevant judicial provisions. Considering the purpose of the linkage system, the court explained why declarations should be assessed according to the category that “ought” to have been made, rather than solely by the label supplied by the applicant, and clarified a process of elimination for making that substantive assessment. 

The case also clarifies the Category I standard where the original drug has not been marketed in China. Patent information listed for another marketed drug cannot automatically be treated as patent information registered for the unmarketed reference drug, even if the products differ only in dosage form. This helps define the scope of the early resolution mechanism, protects generic applicants’ legitimate interests, and promotes proper use of the system. 

Case 7: “Vonoprazan Fumarate Tablets” Pharmaceutical Patent Linkage Dispute 
—The generic applicant’s burden of proof 

1. Basic facts 

The patent, entitled “Pharmaceutical Composition,” was owned by a company referred to here as Taked*. Claims 1–4 were listed on the Patent Information Registration Platform for Drugs Marketed in China in connection with the company’s approved vonoprazan fumarate tablets, indicated for acid-related disorders and other conditions. 

A company referred to here as Ying* submitted an accepted application for a Class 4 chemical generic of the tablets, using the originator drug as its reference product. It did not make a patent declaration concerning the patent when submitting its marketing authorization application. 

Taked* brought an action seeking confirmation that the generic drug fell within the scope of claims 1 and 2. Despite being duly summoned, Ying* did not appear in court. It also failed to submit the necessary technical materials or any other evidence concerning its generic drug within either the original response period or the additional period set by the court. The Beijing Intellectual Property Court found that Ying* controlled the evidence but had refused to produce it without justification. It therefore held that the generic drug’s technical solution fell within the scope of claims 1 and 2. No party appealed, and the judgment took effect. 

2. Significance 

This case concerns how to determine a generic drug’s technical solution when the applicant fails to produce evidence. It clarifies both the allocation of the burden of proof and the consequences of withholding application materials. By assigning that burden appropriately, the judgment protects the patent owner’s legitimate interests and supports fair competition in the drug market. 

Case 8: “Upadacitinib Extended-Release Tablets” Patent-Related Administrative Dispute 
—Defining the scope of protection of a Markush compound claim

1. Basic facts 

The challenged administrative adjudication was issued by CNIPA in response to a pharmaceutical patent dispute request 
made by Company A against another company. It concerned an invention patent entitled “Novel Tricyclic Compounds.” CNIPA 
found that the technical solution for generic upadacitinib extended-release tablets fell within the scope of claims 1–3. 

The generic company brought an administrative action. It argued that, because the claim specifically directed to upadacitinib had been invalidated, the compound should be treated as a “bad point” excluded from the scope of claims 1–3. It also argued that upadacitinib hemihydrate and upadacitinib were different substances and did not constitute the same technical feature. 

The Beijing Intellectual Property Court held that upadacitinib remained a technical solution falling within claim 1. The invalidation of claim 4, which specifically claimed that compound, meant only that upadacitinib could not receive protection different from that afforded to other compounds 35within claim 1. It could still receive the same protection under claim 1 as those other compounds. The court further held that the upadacitinib hemihydrate in the generic technical solution contained all the technical features of upadacitinib and therefore fell within claims 1–3. It dismissed the plaintiff’s claims. On April 30, 2026, the Supreme People’s Court dismissed the appeal and upheld the first-instance judgment. 

2. Significance 

The case addresses how to define the scope of a valid Markush compound claim when a claim to a specific compound within it has been invalidated. Invalidation of the specific-compound claim does not remove that compound’s technical solution from the scope of the valid general-formula claim. It means only that the compound cannot receive a distinct level of protection relative to other compounds covered by the general claim. 

The case also clarifies that compound-related technical solutions should be compared by their technical features, rather than by comparing substances as indivisible wholes. It provides guidance for future disputes involving Markush compounds. 

Case 9: “Upadacitinib Extended-Release Tablets” Pharmaceutical Patent Linkage Dispute Concerning Whether Acceptance Requirements 
—Determination Standard for the Acceptance Condition of Declaration in Cases of Improper Declaration 

1. Basic facts 

The patent, titled “Novel Tricyclic Compounds,” is owned by Company A. Claims 1–3, 6–8 and 15 were associated with upadacitinib extended-release tablets, and that information had been published on the China Marketed Drug Patent Information Registration Platform. 

Bei Company’s application for marketing authorization for a Class 4 chemical generic version of those tablets was accepted. 
It submitted Type II declarations concerning the patent. Company A sued in the Beijing Intellectual Property Court, seeking confirmation that the generic drug fell within Claims 1–3. 

The Beijing Intellectual Property Court, after trial, held that when Bei Company made its Type II declarations, the claims at issue had already been decided by the CNIPA to be maintained. Therefore, the generic drug company was subjectively at fault in making the aforementioned improper declarations. Where the parties were unable to reach agreement on the commitments, it 37cannot be found that it made Type III declarations. The Court inferred that the generic-drug company ought to have made Type IV declarations and held that the action met the acceptance requirements. After examining the merits, it ruled that the generic-drug technical solution fell within Claims 1–3. No party appealed, and the first-instance judgment took effect. 

2. Significance 

Judicial practice has established a substantive, or “ought-to-have-been” standard for determining whether a declaration qualifies as Category IV under Article 3 of the Supreme People’s Court’s relevant judicial provisions. This means examining the substance of the declaration recorded on the platform. The present case further refines that standard. 

In circumstances where a generic drug company improperly made a Type II declaration, even if the defendant expressed an intention to change it to a Type III declaration, where—after comprehensively considering that the generic drug company was subjectively at fault in making the improper declaration and that the parties were unable to reach agreement on the commitments—it cannot be found that the circumstances of the case fall within those of a Type III declaration. On this basis, it may be presumed that the generic drug company made a Type IV declaration, and the case meets the acceptance requirements for a drug patent linkage case. This rule is 38intended to regulate the conduct of generic drug companies in dishonestly exploiting differences among declarations to obtain improper benefits, guide generic drug companies to make declarations truthfully, and thereby ensure the full realization and effective operation of the value of the drug patent linkage system.