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
China Forges Ahead with Draft Measures for New Patent Linkage System
2020年10月19日
Update! The finalized Implementation Measures are now out. You can read the details here: Breaking: China Released New Implementation Measures for the New Patent Linkage System Last month September 11, 2020, China’s National Medical Products Administration (NMPA) and the China National Intellectual Property Administration (CNIPA) jointly issued a draft set of measures for public opinion […]
阅读更多 >
Is it Sufficient to Claim an Antibody only by Describing its Antigen?
2018年11月12日
Things may be brewing with respect to antibody inventions. Just how much description is sufficient? After losing in the Federal Circuit, Amgen has decided to ask the US Supreme Court to weigh in on a standard that could vastly influence the pharmaceutical and biotech industry. The story relates to Repatha™, an LDL-lowering drug from Amgen […]
阅读更多 >
China’s Newest Examination Guidelines: Inventive Step for Biological / Life Science Inventions (Part III)
2021年4月30日
This is Part III of a three-part series summarizing the Examination Guidelines that were released by the CNIPA on January 15, 2021, one year to the date of Phase 1 of the US and China Economic and Trade Agreement. That agreement included specific provisions where China "shall permit pharmaceutical patent applicants to rely on supplemental […]
阅读更多 >
BREAKING NEWS: New Pilot Program for Hong Kong Applicants to get Accelerated Patent Examination in the Chinese Patent Office Starting January 1, 2023
2023年1月4日
New year, new resolutions! The CNIPA has recently announced a pilot program that provides Hong Kong applicants the opportunity to expedite their patent applications filed in China. Starting 1 Jan 2023, Hong Kong permanent residents and entities legally registered in Hong Kong can request prioritized examination for their invention patent applications before the CNIPA. To […]
阅读更多 >
我们的过去活动
Pauli Wong, joined HKSTP Global Connect Market Discovery: Your Cross-Border Playbook as a panel speaker
2026年11月4日
Jennifer Che and Pauli Wong Co-Teach Advanced Patent Skills Seminar at HKU-TEC
2026年10月15日
Pauli Wong gave a talk at Hong Kong Life Sciences Society (HKLSS)
2026年10月10日
BioHK2026 | Biotech IP in practice
2026年9月16日
Jennifer Che Once Again Named to the IAM Strategy 300
2026年8月21日
Yolanda Wang attended the 1st China Pharmaceutical Innovation Conference
