The Shanghai Intellectual Property Administration, in partnership with the Shanghai Healthcare Security Bureau, unveiled the Implementation Opinions on Strengthening Intellectual Property Protection in Shanghai's Pharmaceutical Procurement Sector (hereafter referred to as the "Implementation Opinions") in September 2023. This groundbreaking initiative aims to enhance mechanisms for intellectual property (IP) protection in the pharmaceutical procurement sector, a cornerstone of Shanghai’s biopharmaceutical strategy.
Background and Importance
Biopharmaceuticals rank among Shanghai's three leading industries for strategic development. However, the pharmaceutical procurement sector often faces frequent and complex IP disputes, highlighting the urgent need for a robust framework that integrates IP protection with drug procurement processes.
In recent years, national policies have increasingly emphasized the protection of innovative drug IP. On Dec 5, 2022, the China National Intellectual Property Administration and the National Healthcare Security Administration jointly issued Opinions on Strengthening IP Protection in Centralized Pharmaceutical Procurement, calling for comprehensive measures to safeguard IP in procurement.
Shanghai's Implementation Opinions align with these national guidelines and represent a significant step in improving IP protection mechanisms for centralized pharmaceutical procurement. As the first normative document at the local level in China, the Implementation Opinions underscore Shanghai's leadership in fostering innovation and high-quality development in the biopharmaceutical industry.
Core Highlights of the Implementation Opinions
The document comprises three chapters and 15 articles, structured around three main objectives:
1. Establishing Coordination Mechanisms
> Setting up consultation frameworks.
> Designating liaison institutions.
> Enhancing information-sharing platforms.
> Strengthening professional IP support.
2. Improving Business Collaboration
> Instituting a self-commitment system for enterprises.
> Streamlining patent dispute resolution procedures.
> Strengthening procedural linkages and communication.
> Guiding dispute resolution and supporting enforcement.
> Aligning patent confirmation processes with pharmaceutical procurement.
> Creating a cross-regional protection mechanism within the Yangtze River Delta.
> Monitoring and assessing key pharmaceutical products.
3. Enhancing Support Measures
> Conducting joint research and training programs.
> Increasing public awareness and guidance.
Innovative Features
1. Specialized IP Support
> Establishment of the Shanghai Pharmaceutical Intellectual Property Protection Professional Committee, serving as a consultation platform.
> Formation of a professional team comprising IP experts, legal professionals, and technical specialists from academic and research institutions.
2. Self-Commitment Mechanism
> Enterprises must submit self-commitments as a prerequisite for participating in centralized procurement or sunshine platform listings.
> Links the "three declarations" mechanism for early resolution of drug patent disputes to the procurement process.
3. Expedited Patent Dispute Resolution
> Introduces fast-track procedures during procurement announcements for resolving straightforward patent disputes involving active pharmaceutical ingredients or medical use patents.
4. Aligning Patent Expiry with Procurement Cycles
> Improves coordination between the Shanghai Intellectual Property Administration and the Shanghai Healthcare Security Bureau to align generic drug procurement cycles with upcoming patent expirations.
5. Enforcing Judicial and Administrative Decisions
> Requires the Shanghai Intellectual Property Administration to share patent infringement case outcomes with the Shanghai Healthcare Security Bureau promptly.
> Allows infringing enterprises to voluntarily withdraw procurement applications through the city's pharmaceutical affairs institute.
