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.
Other Articles
Amendments to the China Patent Examination Guidelines in 2022 - Part 1: New rules for designs in view of China signing onto the Hague Agreement
2 December 2022
This year, China stepped further onto the international scene by signing on as a member of the Hague Agreement. The Hague Agreement is an international registration system allowing applicants to file a single international design application in a single language to obtain protection in over 100 designated member countries. The US has been a member […]
Read more >
CHINA DIVISIONAL PATENT STRATEGY: Recent Judgment Narrows What Constitutes “Different Inventions” for Divisionals
6 December 2021
In China, patents applicants take advantage of a commonly-used divisional filing strategy to achieve a fine-tuned balance between protection scope and protection period (if used properly). Patent applicants (especially foreign applicants) widely welcome this well-established strategy, and up until now, have used it with much success. In fact, we recommend this strategy and have even […]
Read more >
NMPA's Releases Draft Measures for Data Protection (Data Exclusivity)
4 September 2025
In 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 […]
Read more >
China’s Newest Examination Guidelines: Inventive Step for Biological / Life Science Inventions (Part III)
30 April 2021
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 […]
Read more >
Our Past Events
Dr. Jacqueline Lui, Ms. Pauli Wong, and Mr. Eddie Ho Named Patent Stars by ManagingIP
13 June 2025
Eagle IP Ranked Among Top Tier Firms in IAM Patent 1000
12 June 2025
Jennifer Che from Eagle IP to Attend BIO 2025 in Boston!
11 June 2025
Insights from HKSTP Market Discovery - BIO Connect
28 May 2025
HKMHDIA Medical Fair Forum
27 May 2025
Celebrating Innovation at the Asia Summit for Global Health
