China’s First Supreme Court Patent Linkage Decision
On 5 August 2022, the Chinese Supreme Court (the “SPC”) handed down the second instance judgment on Chugai Pharmaceutical Co.,Ltd (the “Chugai”) v Wenzhou Haihe Pharmaceutical Co., Ltd. (the “Haihe”) [(2022) Zui Gao Fa Zhi Min Zhong No.905], which is the first effective judgement for patent linkage court proceedings in China.
The SPC upheld the first instance judgment of the Beijing IP Court (the “BIPC”) and dismissed Chugai’s suit and appeal. The judgment was published on 18 August 2022.
The China patent linkage system, introduced in July 2021, provides an early mechanism for originators/generics to resolve patent disputes relating to a generic drug application (the “ANDA”). For more detail on the patent linkage mechanism and judicial practice – see our articles - News flash - Patent Linkage Implementing Measures came into force in China on 4 July 2021 and China Patent Linkage News Flash (II) - The Supreme Court finalized the Patent Linkage Judicial Interpretations on 5 July 2021.
1. Background
(1) Originator drug
The drug in dispute was Eldecalcitol Soft Capsules (specification: 0.75μg) used for the treatment of osteoporosis. Chugai was the patentee and marketing authorisation holder (the “MAH”) and the marketing authorisation (the “MA”) was approved on 11 December 2020 in China (MA number- HJ20200058).
(2) Patent in dispute
On 13 July 2021 Chugai registered and published ZL200580009877.6 (the “ZL877”, titled ‘ED-71 Preparation’) on the China Marketed Drug Patent Information Registration Platform (the “Patent Linkage Platform”) in relation to its Eldecalcitol Soft Capsules.
ZL877 was filed on 7 February 2005 and granted on 8 December 2010 in China. The granted claims include 1 independent claim and 6 dependent claims. Claims 1 and 2 are as follows (the “Granted Claims”):
“1. A preparation comprising:
(1) (5Z,7E)-(1R,2R,3R)-2-(3-hydroxypropoxy)-9,10-secocholesta-5,7,10(19)-triene-1,3,25-triol;
(2) fat and oil; and
(3) an antioxidant;
wherein the antioxidant is used for …;
2. The preparation according to claim 1, wherein the antioxidant is one member selected from dl-α-tocopherol, dibutylhydroxytoluene, butylhydroxyanisole, and propyl gallate.”
On 15 April and 10 June 2021, two Chinese companies, Sichuan Gowell Pharmaceutical Co., Ltd. and Jiangsu Chia Tai-Tianqing Pharmaceutical Co., Ltd. filed invalidation proceedings against ZL877 respectively. On 2 July and 6 August 2021, Chugai amended claims 1 and 2 as follows (the “Amended Claims”):
“1. A preparation…
