The instrument and equipment industry (including medical devices, laboratory equipment, etc.) is a technology-intensive field. Intellectual property protection directly affects enterprises' innovation drive and market competitiveness. As global technological competition grows fiercer, building systematic intellectual property protection strategies has become a core issue for the industry's development. Below, we will discuss key protection strategies and supporting data based on the industry's current status and cutting-edge practices.  

Current Industry Status and Challenges  

1. Surge in patent applications and fierce competition in high-end fields  

In the current environment, the number of global medical device patent applications exceeded 400,000 as early as 2019. Cardiovascular, orthopedic, and diagnostic equipment accounted for over 60% of these. In recent years, China's annual growth rate of patent applications has reached double digits. However, invention patents make up less than 30%, leaving a gap with Europe and the United States. Competition in high-end fields—such as AI-assisted diagnosis and surgical robot technology—has intensified. The density of patent layouts in these areas has increased by more than 40%.  

2. High infringement risks and costs  

According to online data, the average cost of medical device patent litigation exceeds $1 million. Small and medium-sized enterprises struggle to defend their rights due to insufficient funds. In cross-border infringement cases, 30% involve leaks of technical secrets. These leaks mainly stem from internal management loopholes.  

Core Protection Strategies  

1. Three-dimensional patent layout model  

Technical dimension

Adopt a "basic patents + application patents" combination. Simultaneously apply for utility model patents for data collection devices to cover both core technologies and supporting applications.  

Market dimension

Implement a "localization + internationalization" dual-track system. Use the PCT route to layout core patents in Europe and the United States. Develop market-specific patents for Southeast Asia.  

Time dimension

Adopt a phased application strategy. First, apply for utility model patents (authorized within 6-8 months) to seize market share. Then, refine invention patents to extend the protection period.  

2. Classified management system for trade secrets  

Classification of technical information

he core layer uses double protection—code obfuscation and physical isolation. The ordinary layer restricts employees through non-compete agreements.  

International Layout and Risk Avoidance  

Priority to PCT route

Use the Patent Cooperation Treaty to file simultaneous applications in target countries, reducing layout costs. For Chinese enterprises, the patent authorization rate in Europe and the United States rose from 15% to 28% (2020-2025).  

Patent pool strategy

Enterprises jointly establish patent pools to share technologies. For example, the patent pool in the cardiovascular intervention field covers 80% of core patents, reducing litigation risks by 40%.  

Building Enterprise Capabilities  

1. Full-cycle intellectual property management  

Embed patent searches and FTO (Freedom to Operate) analysis in the R&D stage to avoid infringement. Establish an infringement early warning mechanism during production.  

2. Professional teams and compliance training  

Set up an independent intellectual property department, with staff accounting for no less than 5% of the total workforce. Annual compliance training should cover all employees. The internal handling rate of infringement disputes should reach 70%.  

Policy Coordination and International Cooperation  

Domestic policy adaptation

Shanghai has implemented rapid approval for innovative medical devices. This has shortened the registration cycle by 30% while strengthening judicial protection.