Dr. Jacqueline Lui, Managing Director of Eagle IP Ltd., gave a speech titled “Being a Defendant in China” at the Intellectual Property Law in China 2013 conference in Central London, UK.
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Polymorph Patents in China: What is the Standard for Inventiveness for New Crystal Forms?
14 July 2020This case is focused on polymorphs, namely what are the standards for novelty and inventiveness when it comes to new crystal forms of a known drug? A recent Supreme People’s Court decision in China is illustrative of the way Chinese courts are thinking about polymorph patents in China. Grünenthal is a German pharmaceutical company and […]
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A More Detailed Overview of China’s Patent Term Extension (PTE) System
17 June 2024Although PTE has been in the Chinese Patent Law since the 4th Amendment of the law came into effect June 1, 2021, we didn’t really know the exact details of how it operated until the Implementation Regulations and Examination Guidelines (“Implementation Regulations”) were finally released in December 2023. New Rules 77-84 in the Implementation Regulations […]
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NMPA's Releases Draft Measures for Data Protection (Data Exclusivity)
4 September 2025In March 2025, China's National Medical Products Administration (NMPA) released yet another set of draft implementation measures on data protection.1 Key highlights of these new measures include the following: A Bit of History China's journey toward a comprehensive pharmaceutical data protection framework has been ongoing for over two decades, a roller coaster ride from its […]
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China Hands Down First Batch of Patent Linkage “Paragraph IV” Litigation Results
30 June 2022China has been implementing a plethora of new laws and measures that are particularly favorable to drug companies, such as patent term extension and patent linkage. Details of the new implementation measures for patent linkage (technically “early dispute resolution mechanisms for drug patents”) came into effect on July 4, 2021. At around the same time, […]
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