GREATER CHINA
China | Market Exclusivity and Data Exclusivity included in Drug Administration Law revisions
Marking a milestone in China’s drug regulatory landscape, the 2026 Revisions of China’s Drug Administration Law introduce data exclusivity and market exclusivity into the regulatory framework, establishing a multi‑dimensional...
Marking a milestone in China’s drug regulatory landscape, the 2026 Revisions of China’s Drug Administration Law introduce data exclusivity...
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GREATER CHINA
China | Amendments to Patent Examination Guidelines finalised
After six months of drafting and revisions, the China National Intellectual Property Administration (CNIPA) issued the finalised version of the Guidelines for Patent Examination on 13 November 2025. These revisions will...
After six months of drafting and revisions, the China National Intellectual Property Administration (CNIPA) issued the finalised version of...
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GREATER CHINA
China | Draft changes to dual filing in China
With double patenting prohibited in China, many applicants have utilised a dual filing strategy to secure patent rights, but this may be set to change. As noted in our article...
With double patenting prohibited in China, many applicants have utilised a dual filing strategy to secure patent rights, but...
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GREATER CHINA
How divisional patent applications work in China
Chinese divisional practice is known for its unique timing requirements, prerequisites for filing a divisional, and strict procedural deadlines. For patent holders looking to secure their rights in China,...
Chinese divisional practice is known for its unique timing requirements, prerequisites for filing a divisional, and strict procedural deadlines....
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GREATER CHINA
China | Establishing Inventive Step in Swiss-Type Use Claims – A Case Study on Disease Subtypes and Known APIs
As pharmaceutical innovation increasingly targets specific disease subtypes and personalised therapies, patent protection strategies must evolve accordingly—especially in jurisdictions like China, where method of treatment claims are not patentable. This...
As pharmaceutical innovation increasingly targets specific disease subtypes and personalised therapies, patent protection strategies must evolve accordingly—especially in jurisdictions...
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GREATER CHINA
China | Good faith principle for patent applications
The principle of ‘good faith’ plays a crucial role in ensuring the integrity and reliability of patent applications. This principle is particularly emphasised in China's patent law, where adherence...
The principle of ‘good faith’ plays a crucial role in ensuring the integrity and reliability of patent applications. This...
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GREATER CHINA
China | Recent updates on post-filing data for patent applications
In China's patent examination practice, the technical effects demonstrated by experimental data are a crucial factor for patent applications, especially for biotech and chemical inventions. In order to address objections...
In China's patent examination practice, the technical effects demonstrated by experimental data are a crucial factor for patent applications,...
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GREATER CHINA
China | Patent examination shift for siRNA drugs in China
With the rapid expansion of siRNA research and application worldwide, the number of patent applications has also surged. An analysis of prosecution history of various siRNA patent applications in...
With the rapid expansion of siRNA research and application worldwide, the number of patent applications has also surged. An...
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GREATER CHINA
China | Post-filing data in addressing non-support issues
Since 2021, it has become common practice in China to use post-filing data to address issues related to inventiveness and sufficient disclosure. However, there is a general perception that...
Since 2021, it has become common practice in China to use post-filing data to address issues related to inventiveness...
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GREATER CHINA
China and New Zealand – Patent Prosecution Highway (PPH)
On 1 November 2024, the China National Intellectual Property Administration (CNIPA) announced the launch of the Patent Prosecution Highway (PPH) with the Intellectual Property Office of New Zealand (IPONZ)....
On 1 November 2024, the China National Intellectual Property Administration (CNIPA) announced the launch of the Patent Prosecution Highway...
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GREATER CHINA
Pharmaceutical Patent disputes in China | The nuances of “offer to sell”
The application of Bolar exceptions and the definition of "offer to sell" have long been contentious issues in the pharmaceutical industry in China. Article 11 of the Chinese Patent Law...
The application of Bolar exceptions and the definition of "offer to sell" have long been contentious issues in the pharmaceutical...
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