Markush claims in China - what can be arbitrarily deleted during invalidation?
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 discusses post filing data in China patents.
This case (Beijing Winsunny Harmony Science & Technology Co., Ltd. v. Daiichi Sankyo Co., Ltd) describes an invalidation request of Daiichi Sankyo’s Chinese invention patent 97126347.7 related to processes of preparing pharmaceutical compositions for treating or preventing hypertension. The patent covered the marketed hypertension drug Olmesartan medoxomil.
During the invalidation, the patentee made select amendments to multiple Markush groups, deleting particular individual components from several different R groups of a molecule. The issue at hand is whether these amendments are allowable during an invalidation proceeding, which typically has very strict rules regarding amendments.
Courts Differ on Markush Claims in China
In short, it boils down to how the courts interpret a Markush claim. Does it refers to a general technical solution or parallel embodiments of several technical solutions? If it is one general solution, should you really be able to pick and carve away at its scope? Does doing so create a new scope that has a different technical effect than the original invention? If so, is that allowable?
The Patent Re-examination Board (PRB) and the Beijing High People’s Court (BHPC) disagreed on how to interpret Markush claims in China. The PRB felt that arbitrary amendments should not be allowed because a Markush claim is directed towards a general technical solution. Arbitrarily deleting elements during invalidation would thus create new scopes of protection that could have different technical solutions.
The BHPC thought that Markush groups represented alternate parallel technical solutions, and thus deleting one or more options just narrowed the scope of the claim. The Supreme People’s Court (SPC) ruled that the amendments were allowable. Additionally, the SPC indicated that such types of amendments may be allowed during invalidation as long as the amendments did not generate a scope that possessed a new function or technical effect.
Markush Claims in China Drafting Tips
Applicants should be aware that amendments which carve out a new scope with improved technical effect (as compared to the original scope) may not be allowable. During an invalidation proceeding, it will be difficult to amend claims to a narrower scope with improved technical results to overcome inventive step. Instead, at the time of drafting, applicants should draft several dependent claims directed towards alternate scopes with varying qualities of efficacy, including very narrow claims covering the best, most efficacious compounds. It is risky to rely on being able to carve out scope from broader claims during an invalidation challenge.
A side note on inventive step . . .
Interestingly, this case also briefly discussed inventive step. The petitioners argued that the patent lacked inventive step because a specific embodiment in the patent had equivalent technical effect as a prior art compound. The PRB disagreed and emphasized that inventiveness is actually a three-step determination, and it is inappropriate to directly apply just the “unexpected technical effect” test to see if claims are inventive or not.
Sources: Lexology, Sanyou IP Group
China Releases Draft Examination Guidelines for the new Patent Law
2020年12月4日
The Chinese Patent Office (CNIPA) is moving forward at breakneck speeds aiming to get all the necessary pieces in place for the June 1, 2021 date when the new 4th Amendment of the Patent Law will come into effect. Most recently, this means a flurry of drafts coming out from CNIPA, including, but not limited […]
阅读更多 >
NMPA's Releases Draft Measures for Data Protection (Data Exclusivity)
2025年9月4日
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 […]
阅读更多 >
Can Post Filing Data Overcome Inventive Step in China?
2018年11月19日
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 […]
阅读更多 >
China’s Newest Examination Guidelines: Post-Filing Supplemental Data for Compounds (Part I)
2021年4月28日
Post-filing data in China has been a constant issue for many patent practitioners around the world. Examiners seem to require it often, and yet the rules regarding when it is acceptable have seemed much stricter than other jurisdictions worldwide. In fact, we tried to summarize the latest state of the law in an earlier blog […]
阅读更多 >
我们的过去活动
Jennifer Che has been Recognized in IAM Strategy 300 Global Leaders 2026
2025年11月26日
Jennifer Che has been Recognized as IAM Global Leaders 2026
2025年11月4日
Eagle IP is Coming to San Francisco and Washington DC!
2025年10月15日
Jennifer Che has been listed on the IAM Strategy 300
2025年8月15日
Eagle IP Recognized as Top Tier Firm (Tier 1) for Patent Prosecution in IP Stars 2025 Patent Firms Ranking List
2025年7月3日
Dr. Jacqueline Lui, Ms. Pauli Wong, and Mr. Eddie Ho Named Patent Stars by ManagingIP