Is it worth filing for a patent in China? What kind of damage awards can you get? Pharma companies care more about injunction than damage awards, since it’s quite unlikely that any damage award can compensate for the large amounts of money that may be lost for patent infringement. Chinese courts often issue injunctions in pharma patent litigations (both by the court and administrative enforcement bureaus), though damage awards are possible too. Although not all court cases are publicly available, there have been some recent published cases with pretty high damage awards, ranging from $750K USD to $25M USD. Keep in mind these are cases litigated under the old patent…
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China Releases Draft Implementation Guidelines for the Drug Administration Law
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…
