China opens regulatory data protection to foreign pharma, but gaps remain

Janet Xiao was quoted in MLex about China's new regulatory data protection (RDP) framework. She commented that it represents a meaningful advance for pharmaceutical companies seeking stronger intellectual property protection in the country, particularly where patent coverage may be limited.

She said, “Regulatory exclusivity comes into play when the patent protection is relatively weak, for example, if the patent term is getting towards expiration,” she said. “That’s especially relevant for overseas companies. If they focus on developing a drug in the US or Europe, by the time they go to China, their 20 years may be approaching the end. At that time, the regulatory exclusivity adds another layer of protection. Now that you can get data exclusivity, that can be a meaningful change for companies planning ahead so they have more certainty."

Xiao said the ability to obtain data exclusivity provides companies with greater certainty as they plan market entry strategies. She also highlighted the new four-year RDP term for improved drugs, such as new formulations or dosage changes, noting that "RDP may be the only protection you can get if you're going after an improved drug."

At the same time, Xiao cautioned that companies should carefully evaluate the framework's details, including application requirements, reliance standards, and incentives tied to China-first launches for new indications. While she welcomed the new regime, she concluded that its practical impact remains to be seen: "This new rule at least sets up the framework. But how exactly is it going to apply? Still, time will tell."

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