中國Court CasesInvalidationInventionsPharma
2018年11月19日

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

Breaking News: China passes Fourth Amendment to the Chinese Patent Law

2020年10月19日
After 12 years, the Fourth Amendment to the Chinese Patent Law has passed and will be in effect on 1 Jun 2021. After years of multiple draft amendments that moved in various directions, we FINALLY have some clarity on what patent protection is going to look like in China in the coming future. Many of […]

First ever Invalidation decision on an RNAi Invention patent in China

2023年12月4日
Decision on Examination of Request for Invalidation (No. 58530) In one of China’s Top 10 Patent Re-examination / Invalidation cases of 2022, an invalidation decision on a patent claiming Hepatitis B Virus (HBV) RNAi compositions (No. 58530) by the Patent Re-examination Board (the “Board”) sheds light on the standard for post filing data for rejections […]

Major and Exciting Changes to China’s Patent Law [Fourth Amendment to China's Patent Law]

2019年2月20日
Major changes are on the horizon for China’s Patent Law, which will see an overhaul in many areas as early as this year (2019). On January 4, 2019, the National People’s Congress in China published the latest draft of the Fourth Amendment to China’s Patent Law. Several draft amendments have been released for public comment […]

China Hands Down First Batch of Patent Linkage “Paragraph IV” Litigation Results

2022年6月30日
China has been implementing a plethora of new laws and measures that are particularly favorable to drug companies, such as patent term extension and patent linkage. Details of the new implementation measures for patent linkage (technically “early dispute resolution mechanisms for drug patents”) came into effect on July 4, 2021. At around the same time, […]

我們過去活動

Top crossarrow-right