中国Court CasesInvalidationPharma
2018年12月4日

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
Other Top 10 Cases summarized in this blog
Can Post Filing Data Overcome Inventive Step in China? How to craft allowable claim scope around sequences to comply with China’s strict written description requirements
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]

其他文章

New Remedy in China for Fixing "Errors" in a Patent Application: Incorporation by Reference

2024年3月21日
Background As mentioned in our earlier article, the Implementation Regulations of the Chinese Patent Law (“Regulations”, similar to the CFR in the US) were approved in November, and the CNIPA finally made public the full text of the Regulations just before the arrival of the New Year. At the same time, the CNIPA also released the new […]

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 […]

SPC Upholds $2M RMB Award in China’s First Patent Case on a Biological Deposit

2022年7月4日
On 28 Feb 2022, China’s Supreme People’s Court (SPC) issued its annual “Judgment Digests”, which includes a list of “48 typical cases” highlighting representative SPC decisions in 2021. The Judgment Digests help us understand more about the SPC’s judicial ideology, trial concepts, and adjudication methods in dealing with difficult and sophisticated legal issues as well […]

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 […]

我们的过去活动

Top crossarrow-right