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 Top 10 Patent Re-Examination and Invalidation Cases of 2020 CNIPA Upholds Bayer’s Rivaroxaban Patent
2021年6月9日
The development of China’s approach to patents, especially those in the pharmaceutical and biotech space, has been fascinating to watch. Those of us who have practiced in the area for a long time have been frustrated by the Chinese patent office’s overly strict rules regarding patentability (e.g., high data support standard and refusal to consider […]
閱讀更多 >
How Smart is a "Skilled Person in the Art"?
2022年4月11日
Let’s start with a riddle: can you name a person who has read every book, every journal, conducted every known experiment, and is knowledgeable about every single patent prosecution / litigation in the world? The answer? A “skilled person in the art.” This person is also known as a “person having ordinary skill in the […]
閱讀更多 >
What is the difference between an Invention Patent and a Utility Model Patent?
2021年8月13日
There are two types of patent protection in China. Invention patents (similar to a US utility patent) have a term of 20 years from the date of filing and may be granted for both methods and products. Utility model patents (similar to a petty patent) may be granted in China for technical solutions that relate […]
閱讀更多 >
RNAi Patent Success in China: Overcoming “Comprising” Claim Challenges
2025年3月10日
An Update on Sufficiency and Inventiveness of RNAi Patents in China RNAi is a fast-developing technology that has gained traction in the pharmaceutical industry as a promising therapeutic agent. It is important to follow closely RNAi patent proceedings to learn how different examination boards and courts understand and handle these new technologies. The first-ever invalidation […]
閱讀更多 >
我們過去活動
Dr. Jacqueline Lui, Ms. Pauli Wong, and Mr. Eddie Ho Named Patent Stars by ManagingIP
2025年6月13日
Eagle IP Ranked Among Top Tier Firms in IAM Patent 1000
2025年6月12日
Jennifer Che from Eagle IP to Attend BIO 2025 in Boston!
2025年6月11日
Insights from HKSTP Market Discovery - BIO Connect
2025年5月28日
HKMHDIA Medical Fair Forum
2025年5月27日
Celebrating Innovation at the Asia Summit for Global Health
