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
No % homology? How to craft allowable claim scope around sequences to comply with China’s strict written description requirements
23 November 2018
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 […]
Read more >
Chinese Courts Cares More About Patent Quality Now (A Doctrine of Equivalents Story)
13 December 2022
There is no doubt that the drafting quality of a patent can be crucial in determining the success (or failure!) of the patent during litigation. However, due to various reasons, patents often fail to use the right drafting strategies that best protect the invention. Too often, inexperienced or unsophisticated patent drafters merely listen to an […]
Read more >
Beijing IP Court Reverses CNIPA Decision and Upholds Ozempic® semaglutide patent in China as VALID based on Novo Nordisk’s Post Filing Data
27 June 2024
Recently, all eyes have been on China as the fundamental patent covering semaglutide, the active ingredient in Ozempic® and Wegovy®, will expire on March 20, 2026. It goes without saying that generics are ramping up bigtime in China (and also around the world), preparing to manufacture and sell this blockbuster drug to one of the […]
Read more >
Markush claims in China - what can be arbitrarily deleted during invalidation?
4 December 2018
Since 2010, the China 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 […]
Read more >
Our Past Events
Eagle IP Celebrates 20th Anniversary, Reflecting on Two Decades of Excellence
21 May 2025
Eagle IP is Coming Back to LSPN in Boston!
24 April 2025
AIPLA Women in IP Global Networking Event in Hong Kong
3 April 2025
Talk at Hong Kong Christian Service
31 October 2024
Talk for HKUST Entrepreneurship 101 Training Program
31 October 2024
IP Training Programme on patent commercialization and technology transfer