The latest draft implementation guidelines for China’s Drug Administration Law (“Guidelines”) are out and open for comment. Previously, the new implementation measures for early dispute resolution mechanisms for drug patents (“Patent Linkage Measures”) came into effect on July 4, 2021. The Guidelines indicate that the final approval of generic chemical drug applications for marketing approval will be stayed pending Paragraph IV litigation results. Technical review for things like safety and efficacy will proceed regardless. Although previously published Patent Linkage Measures indicate that the maximum stay period is 9 months, these Guidelines only say “a certain period.” The regulatory approval process for generic biologics and traditional Chinese medicines will not be…
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CHINA: How Prohibiting “Illegal” Inventions Runs into Food Safety Law
Chinese Patent Law has an interesting provision that specifically prohibits patent protection on “illegal” or “immoral” inventions. What does this mean, exactly? According to Article 5.1 of the Chinese Patent Law, “no patent shall be granted for an invention that contravenes any law or social moral or that is detrimental to public interests.” On its face, this provision seems extremely broad, undefined, and potentially very subjective. Whose moral standard? And how do you define “detrimental”? Because details of litigations are not always publicly available in China, we only have limited examples by which we can understand how Chinese courts and examiners interpret and apply this language. Below we highlight one…
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China Patent Office (CNIPA) Releases More Details About Patent Term Adjustment (PTA) in the Draft Examination Guidelines
The new 4th Amendment of the Chinese Patent Law came into effect on June 1, 2021. Right before that date, the Chinese Patent Office (“CNIPA”) released some “Interim Measures” to give us a taste of what was to come, though they have yet to released the actual Implementation Rules. Two months later, CNIPA finally released Draft Patent Examination Guidelines in conjunction with the new Patent Law. We have provided a summary of the key points at this link, and for the next several posts, we will explore some of those topics in greater detail. “PTA” in the Patent Law Patent term compensation for patent office delay, which we will refer…
