Crystalline forms are critical to pharmaceutical patents, offering extended protection for improved stability, bioavailability, or manufacturability. However, securing such patents in China has grown increasingly difficult due to the China National Intellectual Property Administration (CNIPA)'s strict patentability criteria.
ChinaIntellectual Property
Crystalline forms are critical to pharmaceutical patents,
offering extended protection for improved stability,
bioavailability, or manufacturability. However, securing such
patents in China has grown increasingly difficult due to the China
National Intellectual Property Administration (CNIPA)'s strict
patentability criteria. Unlike the U.S. or Europe, where structural
novelty or problem-solving utility may suffice, China demands
quantifiable evidence of superiority over prior art forms
and rejects patents based on routine screening alone. Recent
decisions, like the invalidation of fruquintinib Crystal Form I,
highlight common pitfalls: insufficient comparative data,
incremental technical effects, and failures to preempt obviousness
challenges. With China's pharmaceutical market surging and
secondary patents under heightened scrutiny, companies must
strategically align their IP strategies with CNIPA's exacting
standards to have best chances of success.
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