(Translation for Reference Only)
To implement the directives of the Central Committee of the Party and the State Council on comprehensively strengthening intellectual property (IP) protection, and in accordance with the State Council's call to enhance IP protection mechanisms in pharmaceutical procurement, the Implementation Opinions on Strengthening Intellectual Property Protection in Shanghai's Pharmaceutical Procurement Sector aims to establish a unified and coordinated information-sharing system to prevent infringements at their source. The document strictly adheres to the Opinions on Strengthening IP Protection in Centralized Pharmaceutical Procurement issued by the China National Intellectual Property Administration (CNIPA) and the National Healthcare Security Administration (NHSA). It supports innovation in Shanghai's biopharmaceutical industry while optimizing the business environment, leveraging the collaboration between Shanghai's IP and healthcare systems.
I. Establishing a Coordination Mechanism
1. Consultation Mechanism: The Shanghai Intellectual Property Administration (SIPA) and the Shanghai Healthcare Security Bureau (SHSB) establish a coordination mechanism for IP protection in the pharmaceutical sector. This mechanism expands communication channels and establishes a normalized, diversified communication framework to jointly implement related tasks.
2. Designated Contact Agencies: SIPA and SHSB designate specific departments as liaison bodies responsible for daily communication. Each agency appoints contact persons to handle routine coordination and communication tasks.
3. Information Sharing: SIPA and SHSB share information related to pharmaceuticals and medical supplies involved in centralized volume-based procurement and IP disputes. This information exchange ensures the protection of public interests and the legal rights of IP holders.
4. Expert Support: SIPA guides the establishment of a Pharmaceutical IP Protection Committee, comprising experts from IP departments, universities, and research institutions. The committee provides consultation on patent infringement determinations, regularly organizes discussions between the IP and healthcare systems, and offers recommendations on key issues in pharmaceutical IP protection.
II. Enhancing Operational Collaboration
5. Enterprise Self-Commitment System: SHSB will guide the Shanghai Pharmaceutical Centralized Bidding and Procurement Office (hereinafter referred to as the "Pharmaceutical Office") in establishing and improving a self-commitment system for companies. Firms participating in centralized volume-based procurement or submitting products for online listing on the Shanghai Pharmaceutical Procurement Service and Supervision Information System (hereinafter referred to as the "Sunshine Platform") must make the following commitments:
(1) Their products do not violate the Patent Law of the People's Republic of China or other relevant laws and regulations.
(2) Their products have not been determined by legally effective court rulings or administrative decisions of IP management departments to fall within the scope of protection of another party's patent rights.
(3) When applying for marketing authorization for the related drugs, they did not
make a "Category 3 Patent Declaration" on the China Listed Drug Patent Information Registration Platform (indicating that a generic drug application is made for a patented drug but will not be marketed before the patent expires), or if such a declaration was made, the corresponding patent rights have expired.
(4) The company will assume full responsibility for any patent infringement disputes arising after the procurement results or online listing transactions are completed.
Enterprises must ensure the authenticity and accuracy of their commitments. False commitments or any falsified information will result in the company bearing corresponding legal liabilities.
6. Patent Infringement Objection Process: Patent holders or stakeholders may file objections during the public notice period for drugs being listed on the Sunshine Platform. These objections must include supporting materials such as patent
documentation, evidence of potential infringement, and comparative analysis of the alleged infringement. If administrative rulings, court judgments confirming infringement, or Category 3 declarations on the China Listed Drug Patent Information Registration Platform exist, these should also be submitted.
Upon receiving an objection, the Pharmaceutical Office notifies the applicant to respond within three days and requires the objector to complete the necessary documentation within the same timeframe.
If the objection is deemed valid, the Pharmaceutical Office may consult with SIPA for a joint review. If SIPA determines the objection lacks sufficient evidence to suggest infringement, the Pharmaceutical Office will promptly remove any associated risk alerts. Conversely, if the objection is valid, SIPA will issue a patent infringement determination, which is shared with the Pharmaceutical Office. The Pharmaceutical Office will then notify both the applicant and the objector.
If an infringement risk is identified, the Pharmaceutical Office recommends that the applicant voluntarily delist the product. The objector is also informed of available administrative or legal remedies, such as filing for an administrative ruling or initiating a civil lawsuit. If no infringement risk is determined, the Pharmaceutical Office promptly removes any risk alerts.
For objections not meeting these specific criteria, involved parties are informed about their options for pursuing administrative or legal action.
7. Coordination on Patent Expiry: For generic drugs with patents expiring within one month, the Pharmaceutical Office requires applicants to submit relevant materials during the preparation phase for centralized procurement or online listing. The Pharmaceutical Office will not initiate the procurement process or online listing for these drugs until the patent has expired.
SIPA and SHSB strengthen information sharing by exchanging updates on the legal status of related patents and coordinating procurement cycles with patent expiry timelines. This collaboration aims to streamline the alignment between patent expiration and the city's centralized procurement or online listing schedules.
8. Dispute Resolution Guidance: In cases of patent disputes arising during centralized
procurement or online listing processes, the Pharmaceutical Office may guide parties to seek resolution through administrative rulings, civil lawsuits, or mediation with organizations such as the Shanghai Intellectual Property Civil Dispute Mediation Committee.
SIPA handles requests for administrative rulings efficiently, resolving straightforward cases with minimal disputes within three months of acceptance.
9. Judgment and Ruling Enforcement: Once patent infringement cases involving pharmaceuticals or medical supplies are concluded, SIPA forwards the results to SHSB. The SHSB directs the Pharmaceutical Office to assist in enforcing decisions based on administrative rulings or court judgments, including delisting products
found to infringe patents.
If companies involved in administrative or civil patent infringement cases reach mediation or settlement agreements to voluntarily delist their products, or choose to delist during the legal proceedings, they may apply to the Pharmaceutical Office to withdraw the products from the Sunshine Platform. Such applications must include relevant legal documents issued by SIPA or the courts.
10. Patent and Procurement Alignment: When a product is delisted or disqualified due to patent infringement, and the relevant patent is later invalidated or subject to subsequent judicial proceedings, the company may apply to reinstate the product's listing or selection status. The Pharmaceutical Office may seek SIPA's guidance on the relationship between the invalidation decision or ruling and the product in question.
11. Yangtze River Delta Cooperation: SIPA actively promotes collaboration among Shanghai, Jiangsu, Zhejiang, and Anhui to strengthen IP protection in pharmaceutical procurement. This initiative includes information sharing, joint enforcement efforts, interactive supervision, and experience sharing to advance coordinated development in the Yangtze River Delta region.
12. Key Product Analysis: SIPA and SHSB focus on products with significant procurement volumes or high IP risks during centralized procurement or online listing. Both agencies conduct preliminary analysis of procurement demands and relevant IP information to identify potential risks. This analysis serves as a reference during procurement to prevent major IP infringement issues or public relations challenges.
III. Strengthening Support Measures
13. Joint Research: SIPA and SHSB guide the Pharmaceutical IP Protection Committee in conducting research on widespread and emerging IP issues identified during pharmaceutical procurement and IP administrative protection. This joint effort aims to address common and trending challenges, strengthen IP protection, and promote innovation in the pharmaceutical sector.
14. Professional Training: SIPA and SHSB collaborate to establish joint training programs for internal teams and external stakeholders. These programs include system-wide training sessions and workshops targeting pharmaceutical companies and medical institutions to enhance IP protection capabilities in the healthcare and pharmaceutical fields.
15. Public Awareness Campaigns: SIPA and SHSB jointly promote pharmaceutical IP protection and innovation through diverse media and outreach efforts. These include press conferences, white paper publications, and case study presentations to highlight achievements and best practices. These initiatives aim to foster a social environment that respects innovation and values IP rights.
These opinions are effective from Oct 21, 2023, to Oct 20, 2028.
