中国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

Burden Shift: CNIPA Requires Applicant to “Prove” that Post-Filing Data is not Fake Data

2025年4月1日
“Good Faith” is a challenging concept that brings with it the nuances of a particular jurisdiction’s ideas about honesty, moral values, and societal expectations. Most patent laws around the world include good faith requirements – especially in matters involving the legal and the medical profession – and China is no exception. So what’s the standard? […]

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 […]

Foreigners Beware: China Proposes Requiring IP Made Using Exported Chinese Genetic Resources to be Co-Owned by Chinese Collaborators

2023年3月22日
Proposed Examination Guidelines for the New Chinese Patent Law – Topic 2: Genetic Resource Restriction How Will the Tightened Genetic Resource Restrictions Affect Your IP In 2019-2021, China’s Ministry of Science and Technology (“MOST”, or the Science Ministry) established several laws and regulations with respect to biosafety1 and human genetic resources management2 (collectively referred as […]

Introducing the New USPTO Cancer Moonshot Expedited Examination Pilot Program

2023年1月10日
Starting from February 1, 2023, the USPTO will begin the new Cancer Moonshot Expedited Examination Pilot Program that advances out-of-turn applications that are directed to oncology or smoking cessation. This new program will replace the Cancer Immunotherapy Pilot Program that has been in place since 2016, and covers more technologies than only cancer immunotherapies. Applications […]

我们的过去活动

Top crossarrow-right