Case 1: Mediation Agreement and Judicial Confirmation in a Design Patent Infringement Dispute handled by the Shanghai Intellectual Property Administration (Administrative Protection of Intellectual Property Guiding Cases No. 8 by the China National Intellectual Property Administration)
Case Summary:
Mei[X] Co., Ltd. discovered that a number of products offered for sale by a Shanghai-based company were suspected of infringing multiple design patent rights it owned, and filed a request for administrative adjudication of patent infringement dispute with the Shanghai Intellectual Property Administration on May 25, 2020. On June 1, the Shanghai Intellectual Property Administration accepted the above series of cases and presided over the mediation based on the parties' mutual consent. The parties executed an Administrative Mediation Agreement for Patent Infringement Disputes on September 29.
On October 20, the parties jointly applied to the Shanghai Intellectual Property Court for judicial confirmation of the said Agreement. The Court reviewed the submitted application materials as well as the form and substance of the Mediation Agreement in accordance with statutory requirements. On the same day, the Court issued a civil ruling confirming the validity of the Agreement. The ruling further stipulates that should either party refuse to perform or fail to fully perform its obligations under the Agreement, the other party may directly petition the People's Court for enforcement.
Comprehension and Application:
1. Selection process and instructive significance
The case was submitted to the China National Intellectual Property Administration by the Shanghai Intellectual Property Administration. According to the Provisions on Guiding Intellectual Property Administrative Enforcement Cases (Interim) issued by the CNIPA, the case underwent rigorous procedures including review and selection, expert evaluation, and deliberation by the Case Guidance Committee. Recognized for its reference value in adjudicating analogous disputes—particularly regarding judicial confirmation of administrative mediation agreements in intellectual property conflicts—it was designated as a provisional guiding case. In March 2022, the case was formally adopted by the CNIPA Council Meeting and released under the second batch of guiding cases.
This guiding case clarifies that during the handling of intellectual property infringement disputes by administrative authorities, mediation may be conducted based on the established facts and the mutual consent of both parties. The parties may apply to the People's Court for judicial confirmation of the validity of the mediation agreement reached. The departments in charge of patent-related work, with governmental credibility and professional expertise, serve as neutral third parties to facilitate administrative mediation, which aids in promoting settlement agreements between the parties. However, a mediation agreement constitutes a civil contract in nature and lacks enforceability. If either party breaches the agreement, that agreement becomes invalid. This not only wastes administrative resources and undermines governmental credibility but also increases the rights holder's enforcement costs, thereby harming the good-faith market environment. The judicial confirmation procedure resolves the enforcement challenges of mediation agreements by granting them enforceability. Additionally, the single-instance final adjudication mechanism under judicial confirmation enhances efficiency and strengthens the coordination between administrative and judicial protection systems.
Currently, regions including Beijing, Shanghai, Fujian, Hunan, Sichuan, and Shaanxi have formally established judicial confirmation systems for mediation agreements concerning infringement disputes through local regulations. The Supreme People's Court has encouraged judicial confirmation practices in multiple policy documents. For example, the 2016 Opinion on Further Deepening the Reform of Diversified Dispute Resolution Mechanisms by People's Courts explicitly stipulates that agreements of a civil contractual nature mediated by administrative authorities may be submitted by the parties to the primary People's Court or People's Tribunal in the jurisdiction of the mediating organization for judicial confirmation of their validity.
Case 2: Adjudication by the Shanghai Intellectual Property Administration on the Invention Patent Infringement Dispute Concerning "Pharmaceutical Preparation Containing Dapagliflozin Propylene Glycol Hydrate" (Typical Cases of Intellectual Property Administrative Protection by the China National Intellectual Property Administration in 2023)
Case Summary:
The requester, A[X] Ltd. obtained the invention patent for "Pharmaceutical Preparation Containing Dapagliflozin Propylene Glycol Hydrate" on July 15, 2015, with the patent number ZL20********89.X. The involved patent right was legally valid at the time the requester filed the request for infringement dispute resolution.
On May 10, 2023, A[X] Ltd. submitted a request for patent infringement dispute resolution to the Shanghai Intellectual Property Administration regarding the patent infringement dispute with the respondent, Shandong Lu[X] Co., Ltd.
The requester contends that the alleged infringing drug, Dapagliflozin Tablets, for which the respondent obtained marketing authorization for a generic version, falls within the scope of protection of the involved patent. The relevant notice for centralized procurement includes the aforementioned alleged infringing drug, and certain hospitals have sold the alleged infringing drug manufactured by the respondent. Therefore, the respondent has engaged in the manufacture, sale, and offering for sale of the alleged infringing drug, which falls within the scope of the claims of the involved patent. The requester and the respondent had previously entered into a patent license agreement concerning the relevant patent for the alleged infringing drug, Dapagliflozin Tablets. However, the respondent continued to sell and offer for sale the alleged infringing drug after the termination of the license agreement, thereby infringing the involved patent right of the requester.
The respondent contends that the manufacture and sale of the alleged infringing drug by the respondent occurred within the validity period of the relevant patent license agreement, and thus should be deemed to have obtained the implied consent of the patentee. The respondent's application to the relevant administrative authorities for the centralized procurement listing of the alleged infringing drug merely indicates that the drug held by the respondent is about to undergo administrative approval by local authorities. Furthermore, the centralized procurement listing information for the alleged infringing drug does not display the drug's price or packaging details, nor has the respondent engaged in any price negotiations with relevant medical institutions. Therefore, such actions should not be construed as an offering for sale. The respondent's actions related to the centralized procurement listing all took place within the validity period of the license agreement. The respondent acknowledges that the alleged infringing drug, Dapagliflozin Tablets, falls within the scope of protection of the relevant claims asserted by the requester in the involved patent.
The Shanghai Intellectual Property Administration holds that: (1) An offering for sale refers to any public expression of intent to sell, including through means such as advertising, window displays, or trade exhibitions. The respondent's application to the Shanghai medical insurance department for centralized procurement listing constitutes an expression of intent for the subsequent sale of the alleged infringing product and should be deemed an offering for sale. (2) The patentee has the right to determine the manner and timing of the disposition of their rights. The requester and the respondent had previously entered into a patent license agreement concerning the alleged infringing drug involved in this case. The requester's claim to hold the respondent liable for infringement only after the termination of the agreement is not improper. (3) The bidding and procurement agency assisted in the investigation by providing a sales list of the alleged infringing drug. Based on the timing recorded in the list, it can be inferred that the sales and offers for sale of the alleged infringing drug occurred not only during the validity period of the agreement between the parties but also after the termination of the agreement.
Outcome:
On August 9, 2023, the Shanghai Intellectual Property Administration issued an administrative adjudication, determining that the respondent, after the termination of the agreement, continued to list and sell the alleged infringing Dapagliflozin Tablets on relevant platforms, constituting acts of offering for sale and selling. The alleged infringing drug falls within the scope of protection of the involved invention patent. The respondent is ordered to immediately cease offering for sale and selling the involved product that infringes the patent rights, and to withdraw the relevant centralized procurement listing online.
Typical Significance:
Under the overarching framework of centralized pharmaceutical procurement, whether the listing of generic drugs in centralized procurement constitutes an "offering for sale" remains a contentious issue among academia, legal practitioners, and the pharmaceutical industry. The adjudication of this case coincides with the implementation of the Guiding Opinions on Strengthening Intellectual Property Protection in the Field of Centralized Pharmaceutical Procurement jointly issued by the China National Intellectual Property Administration and the National Healthcare Security Administration, as well as the Implementing Opinions on Strengthening Intellectual Property Protection in Pharmaceutical Procurement in Shanghai formulated by the Shanghai Intellectual Property Administration and the Shanghai Municipal Healthcare Security Administration. During this process, the Shanghai Intellectual Property Administration actively collaborated with the Shanghai Municipal Healthcare Security Administration to facilitate mutual communication and information sharing regarding the respondent's submission of Dapagliflozin Tablets to the Shanghai Sunshine Drug Procurement Platform, including its intellectual property disclosures.
This case carefully balanced the legitimate interests of the public, pharmaceutical patentees, and generic drug manufacturers. It holds significant implications for enhancing intellectual property protection in pharmaceutical procurement, fostering innovation in the biopharmaceutical industry, and optimizing the business environment. Furthermore, it establishes a precedent for handling similar cases in the pharmaceutical sector. (Professor Song Xiaoting and Associate Professor Cao Lirong, Shanghai International College of Intellectual Property, Tongji University)
Case 3: Shanghai Intellectual Property Office entrusts Pudong New Area Intellectual Property Office to handle the patent Infringement Dispute over the Invention Patent "Spacer Profile and a Thermal Window Unit Using Such Profile" (Typical Cases of Intellectual Property Administrative Protection by the China National Intellectual Property Administration in 2022)
Case Summary:
The requester, Tai[X] Co., Ltd., is the patentee of the invention titled "Spacer Profile and a Thermal Window Unit Using Such Profile" (Patent Number ZL20********94.6). The patent was valid when the requester filed the infringement dispute handling request.
The requester discovered that the requested parties—Weihai Yu[X] Energy-saving Materials Ltd., Weihai Yu[X] Sealing Materials Ltd., and Yu[X] Energy-saving Materials (Huaian) Ltd.—had allegedly infringed its patent by offering products for sale during the 31st China International Glass Industry Technology Exhibition on May 7, 2021. After notarizing and obtaining evidence of the requested parties' sales activities during the exhibition, the requester filed a request for administrative adjudication of patent infringement dispute with the Shanghai Intellectual Property Administration, which accepted and filed the case on December 20, 2021. The case was suspended on the day of filing due to the COVID-19 pandemic and resumed on March 14, 2022.
During the case handling process, the Shanghai Intellectual Property Administration learned that the parties had a long-term OEM cooperation relationship, which provided a good basis for conciliation, and all parties were willing to mediate. The administration then decided to prioritize conciliation. Given that the parties were located in different regions, the panel collaborated with the organization of compromise in Weihai, Shandong Province through the cross-regional collaboration mechanism of the Pudong New Area Intellectual Property Administration, initially explained the law to the requester. After several rounds of remote video consultations, the parties reached a consensus on three related cases.
Outcome:
Under the auspices of the Shanghai Intellectual Property Administration, the parties signed a mediation agreement together via remote video on June 14, 2022, and subsequently completed judicial confirmation.
Typical Significance:
This case has high demonstrative value in terms of pre-trial mediation, remote mediation, and judicial confirmation of patent infringement disputes. It fully demonstrates the positive role of pre-trial mediation in resolving disputes and achieving a win-win outcome in patent administrative adjudication.
There are several highlights in the process of handling this case: First, it engaged local organizations of compromise to provide initial legal explanations, which helped eliminate the distance in remote mediation and increased the success rate. Second, during the remote signing of the mediation agreement, the patent management department read out the text while all parties witnessed the sealing synchronously, which ensured the expression of the parties' genuine intentions, as well as showed the department's proper act. Third, it actively guided both parties to apply for judicial confirmation of the mediation agreement, focusing more on implementation of the agreement, resolving the dispute. (Yuan Zhenfu, Professor, Vice Dean of the School of Law and Dean of the School of Intellectual Property, Shanghai University)
Case 4: Shanghai Intellectual Property Office entrusts Pudong New Area Intellectual Property Office to handle the patent Infringement Dispute over the Invention Patent "Method and Application for Lactobacillus with Enhanced Acid Resistance" (Typical Cases of Intellectual Property Administrative Protection by the China National Intellectual Property Administration in 2021)
Case Summary:
The requester, Sheng[X] Co., Ltd., is the patentee of the invention patent titled "Method and Application for Lactobacillus with Enhanced Acid Resistance". Patent number is ZL20********49.3. The patent was valid when the requester filed the infringement dispute handling request. The Shanghai Intellectual Property Administration accepted and filed the case on June 11,2021.
The requester alleged that the respondent, Shanghai Jing[X] Co., Ltd. had infringed its patent by selling the accused infringing product "Child Story Lactobacillus Reuteri Drops" without the permission of the patentee. The requester submitted several materials to support its claim, including the certificate of patent, the registration copy of patent, notarization of the respondent's sales activities, and documents supporting that DSM17938 is a specific strain. The respondent claimed that the accused infringing product was purchased from the American company Fei[X] Group Company which had a legitimate source, so that they had fulfilled their duty of care. They also argued that the DSM17938 marked on the accused infringing product was not the same strain as the DSM17938 in the patent. DSM17938 is a product batch number from the American manufacturer, not referring to the Lactobacillus Reuteri DSM17938 in the patent. The respondent also provided supporting materials, including purchase contracts, customs declarations, invoices for sales, and Fei[X] Group Company's analytical certificates, certificates of origin, free sale, health and hygiene certificates, and documents explaining that DSM17938 is a product batch number from Fei[X] Group Company.
After review, the Shanghai Intellectual Property Administration made the conclusion that according to notarization materials provided by the requester, the accused infringing product notably marked "DSM17938" in large print on the packaging and listed the name and content of the DSM17938 component in the ingredient description. Together with the analysis certificate provided by the respondent, it was sufficient to prove that the accused infringing product contained the specific strain named DSM17938 instead of representing a production batch number. Additionally, the evidence submitted by the requester and the common knowledge of the DSM standard number from the DSMZ affirmed that the DSM17938 in the accused infringing product and the DSM17938 in the patent claims referred to the same and sole specific strain. Therefore, the accused infringing product fell within the scope of the patent in question's protection.
Outcome:
On October 8, 2021, the Shanghai Intellectual Property Administration issued an administrative adjudication, finding that the respondent's behaviour of selling the accused infringing product without the permission of the patentee constituted patent infringement and ordered the respondent to cease infringing immediately.
Typical Significance:
This case is the first patent infringement case Shanghai adjudicated in the field of microbiology. In the field of microbiology, due to the need to enhance specific traits, the same bacterial strain may produce multiple variations. Therefore, confirming the identity of the specific strain in the accused product with the specific strain in the patent claims is a high priority.
In this case, the use of government approval documents related to the DSM17938 strain and the common knowledge of the DSM standard number from the DSMZ to determine the uniqueness of the strain number's reference is worth learning from. Meanwhile, in the aspect of evidence application, the respondent provided the analytical certificates from an American distribution company. Although only the foreign documents and translation were submitted without the required certification materials for foreign evidence, the content still proved unfavorable facts to the respondent and constituted self-admission. The panel accepted this self-admission and use it in determining the infringement.
This case's typicality and representativeness in both microbiology cases and evidence application can provide beneficial references. (Jiang Nan, Associate Professor, Shanghai International College of Intellectual Property, Tongji University)
Case 5: "Dipeptidyl peptidase inhibitor" Invention Patent Infringement Dispute handled by the Shanghai Intellectual Property Administration (Ten Typical cases of Intellectual Property Protection in Shanghai in 2023)
Case Summary:
The requester, Wu[X] Co., Ltd., obtained the invention patent named "Dipeptidyl peptidase inhibitor" on August 25, 2020, with the patent number ZL201110004223.1. In November 2022, Wu[X] Co., Ltd. make a request to the Shanghai Intellectual Property Administration to order the respondent, Guo[X] Ltd., to cease infringing the patent in question. The Shanghai Intellectual Property Administration filed the case on November 16, 2022.
Wu[X] Co., Ltd. argued that the respondent, Guo[X] Ltd. bid and listed the allegedly infringing product, Alogliptin Benzoate Tablets, on the "Shanghai Pharmaceutical Procurement Service and Supervision Information System" (hereinafter referred to as the "Sunshine Platform") without permission, and publicly displayed the information including the drug's name, specifications, and packaging. The allegedly infringing product fell within the scope of protection of claims 1-2 of the patent in question. The respondent's act of offering for sale the allegedly infringing product constituted an infringement.
Guo[X] Ltd. argued that it merely obtaining a complete "appear on the market" qualification through the online examination and approval, instead of constituting an intention to sell. This was an administrative examination and approval act which was not deemed to infringe patent rights. The disclosure of product information did not occur on a commercial platform, but on the official website of the administrative authority. Additionally, the product was still in the public display stage of administrative approval without any price negotiations or confirmation of pricing results with medical institutions. Therefore, it did not constitute an offering for sale.
Outcome:
On February 15, 2023, the Shanghai Intellectual Property Administration made an administrative adjudication. It concluded that while the patent in question was valid, Guo[X] Ltd. had committed an act of offering for sale Alogliptin Benzoate Tablets without permission from the patentee, Wu[X] Co., Ltd. The allegedly infringing product fell within the scope of protection of claims 1-2 of the invention patent, constituting an infringement. Guo[X] Ltd. was ordered to cease offering for sale the infringing product Alogliptin Benzoate Tablets immediately and to withdraw online listing from the Sunshine Platform.
Typical Significance:
Intellectual property is a crucial strategic resource and core competitiveness for pharmaceutical companies. It is essential for protecting pharmaceutical innovation and promoting the development of the pharmaceutical industry. This case clarified the legal attribute of the listing approval process, which is not an administrative approval for medicine marketing authorization, but a review process for regulating medicine procurement. It also makes it clear that the legal connotation of an offering for sale is a unilateral expression of the seller's intention. Although the online listing announcement for the medicine in question did not state procurement price, it would not affect the establishment of the offering for sale. On this basis, the case made an administrative adjudication in accordance with the law, and protected the patent rights of the requester.
This case is typical in strengthening patent protection: First, it emphasized strict protection during the offering for sale stage. As the first pharmaceutical online listing procurement patent infringement case Shanghai adjudicated after the issuance of the "Opinions of the China National Intellectual Property Administration and the State Medical Security Bureau on Strengthening the Protection of Intellectual Property Rights in the Field of Centralized Pharmaceutical Procurement" , it received widespread concern from the industry and society. Second, it demonstrated combined handling. During the adjudication and enforcement process, the Shanghai Intellectual Property Administration and the Shanghai Municipal Medical Security Bureau established a collaboration mechanism, making a solid foundation for the joint issuance of the "Implementation Opinions on Strengthening Intellectual Property Protection in the Field of Pharmaceutical Procurement in the City." Third, it showed exemplary adjudication. In the legal determination of medicine online listing procurement behavior, the case referred to the first major patent infringement case adjudicated by the National Intellectual Property Administration, fully demonstrating the guidance and exemplary role of major administrative adjudication cases for local authorities in substantial judgment issues. (Yuan Zhenfu, Professor, Vice Dean of the School of Law and Dean of the School of Intellectual Property, Shanghai University)
Case 6: "Prodrug of Substituted Polycyclic aminocarbamoyl pyridone Derivatives" Invention Patent Infringement Dispute Case handled by the Shanghai Intellectual Property Administration (Ten Typical cases of Intellectual Property Protection in Shanghai in 2022)
Case Summary:
The requester, Yan[X] Co., Ltd., obtained the patent for the invention titled "Prodrug of Substituted Polycyclic aminocarbamoyl pyridone Derivatives" on March 16, 2016, with the patent number ZL20********16.8. The patent was valid when the requester filed the infringement dispute handling request. In November 2021, the requester submitted an administrative adjudication request for patent infringement to the Shanghai Intellectual Property Administration, which was accepted and filed on December 1, 2021.
The requester alleged that the respondent, Shanghai Xiang[X] Co., Ltd. published the allegedly infringing product "Baloxavir Marboxil" on its official website and publicly offered for sale on the professional chemical platform ChemicalBook without the patentee's permission. A third party had notarially purchased the product from the respondent, which proved that the respondent had engaged in the sale and offering for sale of the allegedly infringing product "Baloxavir Marboxil." The product fell within the scope of claims 1-6 of the patent in question.
The respondent argued that it was unaware of the patent rights associated with the allegedly infringing product and had no subjective intention. It also had ceased the sale and display of the allegedly infringing product.
Outcome:
On April 1, 2022, the Shanghai Intellectual Property Administration issued an administrative adjudication, ordering the respondent to cease the infringement of the patent rights of the requester immediately, in the other word, to cease the offering for sale and sale of the infringing product "Baloxavir Marboxil".
Typical Significance:
This case is an administrative adjudication of a patent infringement dispute. According to the Patent Law, the patentee can either file a lawsuit in People's Court or request the departments in charge of patent-related work to handle the dispute. If the department firmly believes that infringement has been established, it may order the infringer to cease the infringing activities immediately. In this case, the Shanghai Intellectual Property Administration responded to the patentee's request and issued an administrative adjudication within four months, ordering the respondent to stop the infringement immediately. This demonstrates the speediness and convenience of administrative handling in patent infringement cases, meets the requirement for rapid protection of intellectual property, and fully protects the legitimate rights of the patentee. Meanwhile, this case is of typical significance as the patentee of this case is a multinational company, the Shanghai Intellectual Property Administration's swift and efficient administrative handling reflects the principle of equal protection of intellectual property.
Regarding the infringement comparison of chemical invention patents "Markush Claims", the department summarized the general approach for such comparisons in administrative handling of chemical patent infringement cases, providing valuable reference and guidance for similar cases. (Xu Chunming, Professor, Shanghai International College of Intellectual Property, Tongji University)
Case 7: A Design Patent Infringement Dispute of "Barrel Water Container" handled by the Shanghai Intellectual Property Administration (Ten Typical cases of Intellectual Property Protection in Shanghai in 2022)
Case Summary:
The requester, Jiangxi Heng[X] Co., Ltd., holds the design patent for the "barrel water container," which remains valid. The requester alleged that the respondent, Shanghai Yu[X] Co., Ltd., without authorization, manufactured and sold a product named "Hengda Clear Spring Packaged Drinking Water" in large quantities. This product allegedly fell within the protection scope of the design patent. The respondent's acts of manufacturing and selling the accused infringing products severely infringed the legal rights of the requester, constituting patent infringement. The requester thus filed a request with the Shanghai Intellectual Property Administration, seeking an order to stop the manufacturing and selling of the accused infringing products.
The respondent argued the following: 1. The appearance of the accused product was neither identical nor similar to the patented design and thus did not fall within the patent's protection scope. 2. The respondent had previously signed a cooperation agreement with a subsidiary of the general distributor in Shanghai of the requester. The agreement stipulated that the respondent would procure the accused barrels, fill them, and market the product. The used barrels would then be recycled by the distributor in Shanghai of the requester, Shangheng Beverage. The accused products were manufactured by an entrusted processing company, and the respondent itself did not engage in the infringing acts. Therefore, the respondent requested the rejection of the request.
Outcome:
The Shanghai Intellectual Property Administration determined that the respondent had indeed engaged in the manufacturing of the accused infringing products, and these products fell within the protection scope of the patented design, constituting patent infringement. The administration issued an administrative decision, ordering the respondent, Shanghai Yu[X] Co., Ltd., to immediately cease infringing on the "barrel water container" design patent owned by Jiangxi Heng[X] Co., Ltd. and to stop manufacturing the infringing products.
Typical Significance:
The patented design in question, a barrel water container, features novel and creative decorative patterns on its body, which also possesses aesthetic appeal. The unauthorized manufacturing and selling of such patented products could mislead consumers into mistakenly associating them with the patentee or its licensed products.
In this case, the requester used administrative complaints to safeguard its legal rights. This administrative handling of a design patent infringement case is significant in two key aspects:
1. Substantially, the case establishes fundamental rules for determining infringement involving the manufacturing and selling of packaging or container products protected by design patents. The accurate application of the law ensured the recognition of infringement and resulted in the administrative order to cease infringement, effectively protecting the patentee's rights.
2. Procedurally, the handling authority overcame challenges in evidence collection across different locations during special periods by adopting remote video investigation methods. With the assistance of the Suzhou Intellectual Property Administration, the authority conducted comprehensive online and offline investigations into the entrusted manufacturing process by the Taicang-based company. This robust evidence collection laid a solid foundation for the case's resolution and decision-making. (Shan Xiaoguang, Professor, Shanghai International College of Intellectual Property, Tongji University)
Case 8: Patent Infringement Dispute on the Invention of "1-Heterocyclic Sulfonyl, 3-Aminomethyl, 5-(Hetero)Aryl-Substituted 1-H-Pyrrole Derivatives as Gastric Acid Secretion Inhibitors" handled by the Shanghai Intellectual Property Administration (Ten Typical cases of Intellectual Property Protection in Shanghai in 2021)
Case Summary:
The requester, Wu[X] Co., Ltd., obtained an invention patent titled "1-Heterocyclic Sulfonyl, 3-Aminomethyl, 5-(Hetero)Aryl-Substituted 1-H-Pyrrole Derivatives as Gastric Acid Secretion Inhibitors" on October 5, 2011, with patent number ZL20********89.7. In June 2021, the requester filed a request with the Shanghai Intellectual Property Administration, seeking confirmation that the accused product fell within the scope of protection of Claim 12 of the patent. The requester further requested a determination that the respondent, Shanghai Mai[X] Co., Ltd., had infringed Wu[X] Co., Ltd.'s patent rights through the manufacturing, selling, and offering for sale of the accused product. Additionally, the requester requested an order requiring the respondent to immediately cease manufacturing, selling, and offering for sale products infringing upon the patent rights. The case was officially filed by the Shanghai Intellectual Property Administration on July 5, 2021.
Upon review, the Shanghai Intellectual Property Administration held that the accused infringing product was labeled with the respondent's trademark and company name in English, and the product packaging did not disclose the manufacturer information as claimed by the respondent. Therefore, it was reasonably inferred that the respondent had publicly presented itself as the manufacturer of the accused infringing product and should be legally recognized as such.
The respondent displayed information about the accused infringing products "Vonoprazan" and "Vonoprazan Fumarate," including product names, inventory, sales prices, and technical specifications, on its official website and the ChemicalBook platform. This was deemed sufficient to establish the respondent's offering-for-sale activity. The respondent provided sales quotations for the "Vonoprazan" product to third parties, sold the product, issued sales invoices, and provided delivery notices. Furthermore, during the review process, the respondent admitted to selling the accused infringing product. Therefore, the respondent's act of selling the "Vonoprazan" product was also established.
The compound protected under Claim 12 of the patent in question is "1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine or its salts." Example 8 in the patent specification describes the compound as "1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine fumarate," which is a specific embodiment of the salt of the compound protected under Claim 12. The chemical structure described in Paragraph 1483 of the specification corresponds to the general structural formula listed in Table 15 (Paragraph 1484), covering Examples 1-14. By substituting the general formula's R1b, R2b, R3b, and R4b with the specific substituents from Example 8, the chemical structure of the compound "1-[5-(2-fluorophenyl)-1-(pyridin-3-ylsulfonyl)-1H-pyrrol-3-yl]-N-methylmethanamine" protected under Claim 12 can be derived. This structure is identical to the chemical structure of the accused product "Vonoprazan." Thus, the accused product "Vonoprazan" falls within the scope of protection of Claim 12 of the patent. Furthermore, the accused product "Vonoprazan Fumarate" is also determined to fall within the protection scope of Claim 12.
Outcome:
In October 2021, the Shanghai Intellectual Property Administration issued an administrative adjudication, determining that the respondent had engaged in the manufacturing, offering for sale, and selling of the infringing product "Vonoprazan," as well as offering for sale the infringing product "Vonoprazan Fumarate." It further ruled that both "Vonoprazan" and "Vonoprazan Fumarate" fell within the scope of protection provided by Claim 12 of the involved invention patent, thereby constituting an infringement of the patent rights in question. The adjudication ordered the respondent to immediately cease the manufacturing, offering for sale, and selling of the infringing product "Vonoprazan," as well as to immediately cease offering for sale the infringing product "Vonoprazan Fumarate."
Typical Significance:
This case primarily concerns the method of infringement comparison for pharmaceutical invention patents and establishes a new model of graphic-text comparison for chemical structures in the ruling. By referencing the generic drug name and CAS registration number recorded in the information of the alleged infringing product and consulting authoritative pharmaceutical references, the chemical structure of the alleged infringing product was determined. This chemical structure was then compared with the technical features specified in the claims of the patent involved. Combining this with the content described in the patent specification, it was accurately determined that the alleged infringing product fell within the protection scope of the patent. The difficulty in this case lies in the fact that the claims of the involved patent only recorded the chemical name of the compound, making a direct comparison with the chemical structure of the alleged infringing product impossible. The Shanghai Intellectual Property Administration adopted the approach of "chemical structural general formula from examples → specific structural formula derived from examples under the claims → structural formula of the compound described in the claims" to determine the compound structure protected by the claims of the involved patent. The derivation process was clearly explained using a combination of text and structural diagrams. This graphic-text integration provided a comprehensive comparison with the chemical structure of the alleged infringing product, demonstrating high-quality drafting of legal documents.
This case, based on the characteristics of determining pharmaceutical patent infringement, further refined the method of comparing the chemical structure of the alleged infringing product with the compound structure protected by the involved patent. It innovated the presentation format of administrative adjudications, setting a precedent for handling similar pharmaceutical invention patent cases and providing significant guidance for the healthy development of China's pharmaceutical industry. This case exemplifies the rigorous, efficient, and equitable protection of intellectual property. It contributes to creating a favorable business environment in Shanghai, safeguarding the legitimate rights and interests of foreign investors, and establishing Shanghai as a preferred venue for administrative protection in biopharmaceutical patent infringement disputes. (Jiang Nan, Associate Professor, Shanghai International College of Intellectual Property, Tongji University)
Case 9: Patent Infringement Dispute on the Invention of "Dipeptidyl Peptidase Inhibitor" handled by the Shanghai Intellectual Property Administration (Typical Cases of Administrative Law Enforcement in Shanghai in 2023)
Case Summary:
In November 2022, the requester, a pharmaceutical company, submitted a request to the Shanghai Intellectual Property Administration, seeking an administrative adjudication to order the respondent, another pharmaceutical company, to cease infringing on the patent rights in question. The requester had obtained an invention patent for "Dipeptidyl Peptidase Inhibitor" on August 25, 2020, with patent number ZL20********23.1. This patent remains valid, and the Shanghai Intellectual Property Administration initiated the case on November 16, 2022. The requester claimed that the respondent, without authorization, listed the allegedly infringing product, alogliptin benzoate tablets, on the "Shanghai Pharmaceutical Procurement Service and Supervision Information System" (hereinafter referred to as the "Sunshine Platform"). The listing included the product's name, specifications, and packaging information. The requester asserted that the accused infringing product fell within the protection scope of claims 1 and 2 of the patent. The respondent had engaged in the act of offering the product for sale, constituting infringement. The respondent argued that its online listing was solely part of the approval process for obtaining market access and did not indicate a willingness to sell. It claimed that the behavior constituted an administrative approval process that should not be considered patent infringement. Furthermore, the respondent stated that the information disclosure occurred on a government website rather than a commercial platform. Since the product was still in the public announcement stage of administrative approval and had not been negotiated or confirmed with any medical institution, it did not constitute an offering for sale.
Outcome:
On February 15, 2023, the Shanghai Intellectual Property Administration issued an administrative adjudication, finding that the respondent, during the validity of the patent rights of the requester, had offered for sale alogliptin benzoate tablets without authorization. The allegedly infringing product fell within the protection scope of claims 1 and 2 of the patent, thus constituting an infringement of the patent rights. The administration ordered the respondent to immediately cease offering the product for sale and to withdraw the listing of the infringing product from the Sunshine Platform.
Subsequently, the respondent filed an administrative lawsuit with the Shanghai Intellectual Property Court. However, as the respondent explicitly refused to pay the litigation fees, the court issued an administrative adjudication treating the case as withdrawn.
Typical Significance:
I. Case Analysis
Firstly, listing drugs on government-backed provincial drug procurement platforms is a prerequisite for drugs to enter hospitals. The listing review is not an administrative approval for the drug's market authorization but a review step that standardizes the procurement model for this special category of products.
Secondly, the alleged infringing product obtained market authorization approval from the National Medical Products Administration and is qualified for market sales. After being listed on the official website of the Shanghai Centralized Drug Procurement Administration, the drug information is pushed to medical institutions through the Sunshine Platform. Medical institutions and the manufacturer of the accused infringing product can negotiate prices via the platform and ultimately complete procurement. Furthermore, the Sunshine Platform query records show that the accused infringing product's procurement status is "valid," and its procurement qualification is "normal." Therefore, the respondent's act of listing the drug on the platform constitutes a clear intent to sell the drug to medical institutions through the Sunshine Platform.
Thirdly, the nature of an offering for sale is a unilateral expression of intent by the seller and does not require agreement between the parties on contract formation terms, such as price, quantity, or delivery methods. When the content of the intent to sell is clear and specific, the act can be deemed an offering for sale. According to the "Notice on Publishing the Fifth Batch of Drugs Passing Generic Quality and Efficacy Consistency Evaluation in 2021 for Listing and Procurement" released by the Shanghai Sunshine Pharmaceutical Procurement Network, "The drug procurement price is generated through price negotiations between medical institutions and manufacturers via the Sunshine Platform, and the procurement can only proceed after both parties confirm the negotiated result." Thus, the drug listing announcement for procurement is a prerequisite for negotiations between medical institutions and manufacturers through the Sunshine Platform and does not need to include the drug procurement price. The announcement disclosed information such as the unified code, generic name, specifications, and packaging of the accused infringing product, as well as its manufacturer. The absence of procurement price, or whether the respondent and medical institutions engaged in actual price negotiations or confirmed the negotiated results, does not affect the determination of an offering for sale.
Finally, the respondent had already completed administrative approval for the market authorization of the accused infringing drug. The drug listing action involved in this case occurred after administrative approval and was not for the purpose of providing information required for administrative approval. Therefore, it does not meet the temporal conditions of the exemption from infringement stipulated in Article 75, Paragraph 5 of the Patent Law. Moreover, the provision explicitly lists permissible acts as manufacture, use, and import, excluding an offering for sale. Thus, the respondent's drug listing behavior constitutes an offering for sale and does not fall under the exemption from infringement stipulated in Article 75, Paragraph 5 of the Patent Law.
II. Legal Basis
Article 11, Paragraph 1 of the Patent Law states: "After a patent right for an invention or utility model is granted, no unit or individual shall, without the permission of the patentee, exploit the patent, that is, to manufacture, use, offer for sale, sell, or import the patented product for production or business purposes, or use the patented method, or use, offer for sale, sell, or import products directly obtained through the patented method, except as otherwise provided for in this Law." Actions such as advertising, displaying products in windows, or exhibiting them at trade fairs that express an intent to sell goods can be considered as an offering for sale. The respondent's act of listing the drug on the platform constitutes a clear expression of intent to sell the alleged infringing product to local medical institutions, thereby engaging in the act of offering for sale the accused infringing product. The alleged infringing product falls under the scope of protection of claims 1, 2, and 3 of the involved invention patent, thereby infringing upon the patent rights in question.
III. Enforcement Demonstration Points
1. Administrative adjudication of patent infringement disputes is a unique protection mechanism under the Patent Law, which facilitates timely resolution of disputes between patentees and infringers. This case was the first administrative adjudication case involving patent infringement disputes in the drug procurement field handled in Shanghai after the issuance of the "Opinions on Strengthening Intellectual Property Protection in the Field of Centralized Drug Procurement" by China National Intellectual Property Administration and the National Healthcare Security Administration. After concluding the case, the Shanghai Intellectual Property Administration promptly forwarded the case results to the Shanghai Municipal Healthcare Security Bureau. The bureau quickly took action to delist the accused infringing product from the Sunshine Platform, garnering significant public attention and demonstrating Shanghai's determination to implement "strict protection" of intellectual property rights. In the legal determination of drug listing actions for procurement, this case referenced the first significant administrative adjudication case of patent infringement disputes made by the China National Intellectual Property Administration, fully demonstrating the guiding and exemplary role of significant administrative adjudication cases in substantive issue determinations for local offices. During the adjudication and execution process, the Shanghai Intellectual Property Administration and the Shanghai Healthcare Security Bureau established a linkage mechanism, laying a solid foundation for the joint issuance of the "Implementation Opinions on Strengthening Intellectual Property Protection in the City's Drug Procurement Field."
2. The right to offer for sale is a statutory patent right. The distinction between this right and the right to sell, as well as the definition of its scope, has always been a challenging aspect of the application of patent law. The significance of this case lies in clarifying, based on administrative law theory, that the listing review is not an administrative approval for drug market authorization but a review step to standardize the procurement model for this special product category. Additionally, the case further clarified in patent law theory that an offering for sale is a unilateral expression of intent by the seller and does not require agreement between the parties on contract formation terms such as procurement price, quantity, or delivery methods. In this case, although the procurement announcement of the listed drug did not include the drug procurement price, based on the definition of a promise to sell established in the case, the absence of a procurement price does not affect the determination of a promise to sell.
Case 10: Patent Infringement Dispute Regarding the Invention Patent "Plate Heat Exchanger, Plates, and Gaskets for Plate Heat Exchanger" handled by the Shanghai Intellectual Property Administration (Typical Cases of Administrative Law Enforcement in Shanghai in 2023)
Case Summary:
The requester, a gasket manufacturing company, is the patentee of the invention patent "Plate Heat Exchanger, Plates, and Gaskets for Plate Heat Exchanger," which was publicly granted on May 4, 2011. In February 2023, the requester submitted a request to the Shanghai Intellectual Property Administration for a ruling to order the respondent, a company referred to as T Company, to cease infringing upon the patent rights in question. The patent was confirmed to be valid, and the enforcement authority filed a case on February 10, 2023.
The requester claimed that a branch of the respondent, specifically a subsidiary of a technology company, had manufactured and sold a specific model of heat exchanger gasket product without authorization. The requester asserted that this product fell within the protection scope of the patent and requested the enforcement authority to order the respondent to cease manufacturing and selling the alleged infringing product.
The respondent argued that the entity engaging in the sales activities was the company's branch and, therefore, the parent company should not be named as the respondent in this case. Furthermore, even if the parent company were treated as the respondent, the branch was merely a distributor that had procured the alleged infringing product from an upstream manufacturer, and it was not involved in manufacturing activities.
Outcome:
The enforcement authority, after review, concluded the following:
Firstly, the certificate of conformity for the alleged infringing product bore the name of T Company's branch. Although the respondent claimed that the inclusion of the company's name was merely a quality remark made during the sale, the Product Quality Law of the People's Republic of China mandates that producers provide product quality inspection certificates. Therefore, the conformity certificate should be regarded as a quality assurance provided by the producer. Furthermore, based on general principles of experience, consumers are more likely to associate the name on the conformity certificate with the product's producer rather than its seller. In the absence of contrary evidence, the respondent is deemed the producer of the accused infringing product, thus having engaged in manufacturing activities.
Secondly, according to relevant provisions of the Civil Code, branch offices conducting civil activities in their own name generate civil liabilities borne by their parent legal entities. Furthermore, under the Company Law, branches are not independent legal entities, and their civil liabilities are borne by the parent company. Therefore, the infringing activities of the branch office result in civil liabilities for the parent technology company.
Thirdly, concerning the requester's assertion about independent claim 6, which contains the introductory technical feature "for use as described in any one of claims 1–5," a comparison between the heat exchanger plate compatible with the accused infringing product and claim 1 revealed that the two are identical. Additionally, the accused infringing product also includes all distinguishing technical features of claim 6. As a result, the accused heat exchanger gasket falls within the scope of protection of independent claim 6 of the involved patent.
Accordingly, the enforcement authority issued an administrative adjudication determining that the respondent, in the state of validity of the requester's patent rights, had, without authorization, manufactured and sold the accused infringing heat exchanger gasket product. This product was found to fall within the protection scope of independent claim 6 of the invention patent, thereby constituting an infringement of the involved patent rights. The respondent was ordered to immediately cease the manufacturing and sale of the infringing heat exchanger gasket that violates the patent rights of the requester for the "Plate Heat Exchanger, Plates, and Gaskets for Plate Heat Exchanger."
Typical Significance:
I. Case Analysis
The requester, a gasket manufacturing company, holds significant influence in the industry. This case is one of a series of cases in which the requester has made a request for a ruling on thermal industrial products to the law enforcement authorities. In this case, the patentee claims that the preamble technical feature of independent claim 6 is the "adapter heat exchanger plate" for the claimed subject "a gasket," which is described as "the heat exchanger as described in any of claims 1-5." This technical feature defines an adapted heat exchanger plate, thereby limiting the scope of protection for claim 6's gasket. The law enforcement authorities conducted an on-site inspection and comparison of the heat exchanger plate adapted for the alleged infringing product and determined it to be identical to the heat exchanger plate defined in claim 1, thus laying the foundation for the infringement comparison of the accused heat exchanger gasket. This case also clarifies the status and responsibility allocation rules of the parent company and its subsidiary in patent infringement disputes, and elaborates on the general rule of determining the entity responsible for the product's quality certificate as the legal manufacturer.
II. Legal Basis
The law enforcement authorities made an administrative adjudication based on the following provisions: Article 11, Paragraph 1, Article 64, Paragraph 1, Article 65, and Article 77 of the Patent Law of the People's Republic of China; Article 74, Paragraph 2 of the Civil Code of the People's Republic of China; Article 27, Paragraph 1 of the Product Quality Law of the People's Republic of China; and Article 14, Paragraph 1 of the Company Law of the People's Republic of China. The authorities ruled that the respondent infringed upon the involved patent.
III. Enforcement Demonstration Points
This case addresses typical issues in patent infringement disputes, including the determination of the scope of protection for claims with citation relationships, the rules for infringement comparison, the identification of the subject responsible for patent infringement, and the determination of manufacturing actions in a legal context. First, regarding the determination of the scope of protection for claims with citation relationships, relevant judicial interpretations were applied. When the patentee claims to define the scope of patent protection based on a dependent claim, the additional technical features recorded in the dependent claim and the technical features recorded in the referenced claims were used to define the scope of the involved patent. Second, regarding the subsidiary's legal status, according to the Company Law, a subsidiary does not have legal person status, and its civil liabilities are borne by the parent company. Third, regarding the identification of manufacturing actions, according to the Product Quality Law, the producer is obligated to mark the product quality inspection certificate, thus determining that the parties involved in this case constituted infringing manufacturing behavior. The determination of these issues serves as important guidance for handling similar cases.
