Can Post Filing Data Overcome Inventive Step in China?
Since 2010, the Patent Re-examination Board (PRB) has published the top 10 patent invalidation cases of the year in April of each year. The selection criteria are high social concern, significant impact on the related industry, or involve difficult legal issues and important examination criteria. Below is one of the top 10 cases that discusses post filing data in China patents.
Post Filing Data in China
Can post-filing data showing unexpected technical effect be used to overcome inventive step if the specification contains no data but asserts the unexpected technical effect?
In short, the answer is no, post-filing data cannot be used to overcome inventive step even if the idea was asserted if the original data was not in the application.
Novartis’s Chinese patent (201110029600.7) claimed the combination of AT 1-antagonist valsartan and NEP inhibitor Sacubitril. The specification asserted that the combination of the two drugs had synergistic effect, yet provided no data at the time of filing.
The PRB sided with petitioner Dai Jinliang and argued that one of skill in the art could not predict that the combination would be synergistic without experimental data. In other words, applicants had not solved the technical problem of providing a pharmaceutical combination with synergistic effects. At most, applicants had provided a pharmaceutical composition for treating hypertension. In January of 2018, the PRB declared that the Novartis patent was invalid.
In our experience, if experimental data is in the application as filed but another piece of prior art is cited during prosecution, the applicant may submit post-filing data showing results of comparison studies with the newly discovered art, provided that the original data for applicant’s invention was already disclosed in the application as filed.
About the Author
Jennifer Che, J.D. is a US Patent Attorney and Vice President and Partner at Eagle IP, a Boutique Patent Firm with offices in Hong Kong, Shenzhen, and Macau.[email protected]This article is for general informational purposes only and should not be considered legal advice or a legal opinion on a specific set of facts.
其他文章
IP Strategies for the Newly Released Implementation Regulations of the 4th Amendment of the Chinese Patent Law: Part 2: Grace Period without Loss of Novelty
2024年2月7日
Background As mentioned in our earlier article, the Implementation Regulations of the Chinese Patent Law (“Regulations”, similar to the CFR in the US) were approved in November, and the CNIPA finally made public the full text of the Regulations just before the arrival of the New Year. At the same time, the CNIPA also released […]
閱讀更多 >
Miss the 12-month Filing Deadline? China Finally Allows Patent Applicants to Restore, Add, or Correct a Priority Claim
2024年4月15日
Three major 'remedial’ systems taken from the PCT Regulations have been introduced in the third revision of the Implementation Regulations of the Chinese Patent Law in 2023 (hereinafter referred to as the "Implementation Regulations"). We previously discussed one of these remedial systems, Incorporation by Reference based on Rule 45 of the Implementation Regulations, which allows […]
閱讀更多 >
CHINA: New Patent Examination Guidelines Now Available for Public Comment
2021年8月4日
Two months after the new Chinese Patent law came into effect, the CNIPA has released a new set of Patent Examination Guidelines (proposed version) for public comments on Aug 3, 2021. Here are the explanation of the amendments (Chinese only). Here is the full set of proposed amendments (Chinese only). Briefly, the new amendment focuses […]
閱讀更多 >
China Announcing More Proposed Amendments to the Examination Guidelines in 2022
2022年11月17日
It’s been a year and a half since the new Chinese Patent Law came into effect (1 June 2021). Although various versions of draft Examination Guidelines have been released, thus far no official finalized versions have been confirmed. On October 31, 2022, yet another new list of proposed amendments was published1, this time consolidating the […]
閱讀更多 >
我們過去活動
Jennifer Che has been Recognized in IAM Strategy 300 Global Leaders 2026
2025年11月26日
Jennifer Che has been Recognized as IAM Global Leaders 2026
2025年11月4日
Eagle IP is Coming to San Francisco and Washington DC!
2025年10月15日
Jennifer Che has been listed on the IAM Strategy 300
2025年8月15日
Eagle IP Recognized as Top Tier Firm (Tier 1) for Patent Prosecution in IP Stars 2025 Patent Firms Ranking List
2025年7月3日
Dr. Jacqueline Lui, Ms. Pauli Wong, and Mr. Eddie Ho Named Patent Stars by ManagingIP