[Basic Facts]

First instance: Shanghai Intellectual Property Court (2020) Hu 73 Zhi Min Chu No. 821

Second instance: The Supreme People’s Court (2023) Zui Gao Fa Zhi Min Zhong No. 1198

[Basic Facts]

The plaintiff A* Biotech Co., Ltd. (hereinafter referred to as “A*”) claimed in this case that it was a well-known company specializing in enzymes, dedicated to promoting the commercialization of innovative special enzymes, and was the patentee of the invention entitled “mutated enzyme for producing cephalosporine antibiotics raw material (7-ACA)”. It alleged that the products entitled “immobilized 7ACA acylase (immobilized cephalosporin C acylase)” manufactured and sold by the defendant Hebei K*L Biotech Co., Ltd. (hereinafter referred as to “K*L”), and sold by the defendant Shanghai *H Trading Co., Ltd. fell within the scope of protection of the patent right concerned. The plaintiff therefore filed a lawsuit with the court, requesting that the two defendants be ordered to cease their infringement and bear all litigation fees.

[Judgment]

Shanghai Intellectual Property Court held the view that the documents of the patent concerned only recorded the selection, preparation, and activity verification of seven variants, and that the plaintiff abandoned the possibility of other mutations than the seven mutation modes that have been verified by amending the claims during the patent authorization procedure. However, it claimed in the infringement lawsuit that the protection scope of the patent right should cover the possibility of amino acid sequence mutations at points other than the seven mutation modes, which lacked legal basis. For the comparison of technical features, a testing institution was determined upon the application of and the consensus reached through negotiation between the parties, and the court entrusted the testing institution to test the theoretical sequences respectively provided by the plaintiff and the defendants on the allegedly infringing product to determine the protein sequence of the tested products. Considering the possible impact of parameter settings on the test results, some parameter settings were adjusted based on the cross-examination opinions of the parties on the first test report, and a second test was entrusted. Based on the results of the two tests, it was finally determined that the allegedly infringing product was more similar to the amino acid sequence claimed by the defendant K*L. The evidence provided by the plaintiff A* failed to prove that the allegedly infringing product had used the patented amino acid sequence. Therefore, the plaintiff’s claim that the amino acid sequence provided by the defendant K* Lfell within the protection scope of the patent claims is not well-grounded, and accordingly the court dismissed the plaintiff’s claims. A* refused to accept the first-instance judgment and appealed. The judgment of second instance dismissed the appeal and affirmed the original judgment. 

[Significance]

The plaintiff in this case is a large professional enzyme company based in South Korea, which is renowned worldwide for promoting the commercialization of innovative special enzymes (biocatalysts) based on genetic evolution technology. The defendant K* is a national sci-tech SME that mainly produces bio-enzyme engineering products and takes a leading position especially in the field of enzyme extraction and immobilization in China. In this case, the plaintiff claimed that the technical solution it had previously abandoned through amendment to the claims in the patent authorization procedure should be re-included in the scope of protection of such patent right. Based on the patent authorization documents, Shanghai Intellectual Property Court applied the estoppel principle, and reasonably defined the scope of patent right protection. Meanwhile, this case made it clear that where the allegedly infringing product has other features in addition to the technical features clearly recorded in the closed-ended claims, such product should not be deemed to fall within the scope of protection of the patent claims. Accordingly, the court made the ruling to dismiss the plaintiff’s claim, providing solid judicial protection for the sound development of sci-tech private enterprises in the field of biomedicine.