Date:15 April 2022
In the first drug patent linkage litigation case in China since the implementation of the new Patent Law, Chugai Pharmaceutical Co., Ltd ('Chugai Pharma') v. Wenzhou Haihe Pharmaceutical Co., Ltd ('Haihe Pharma'), the Beijing Intellectual Property Court held that the generic drug involved did not fall within the scope of protection of the Plaintiff's patent. (Patent linkage refers to the relationship between the market approval for a generic drug and the patent status of its branded equivalent.)
The Plaintiff, Chugai Pharma, was the owner of a patent (No. 200580009877.6 ) for the ED-71 preparation, a pharmaceutical preparation that inhibits certain activity in the Vitamin D analogue, E-71. It was also the holder of a marketing authorization for "Eldecalcitol Soft Capsules", approved for the treatment of Osteoporosis.
When it registered the above-mentioned patent and pharmaceutical product on the Chinese Marketed Drug Patent Information Record Platform, it found that the Defendant, Haihe Pharma, had applied to the national medical products administration for a marketing authorization in relation to a generic drug: "Eldecalcitol Soft Capsules" and made a Category 4.2 statement on the Chinese Marketed Drug Patent Information Record Platform to the effect that its generic drug did not fall within the protection scope of any relevant patent right. Chugai Pharma commenced proceedings in the Beijing Intellectual Property Court, requesting confirmation that the Defendant's generic drug "Eldecalcitol Soft Capsules" fell within the scope of its patent.
After trial, the Court held that the technical solution used in the generic drug involved in this case was neither the same as nor equivalent to the technical solution in Claim 1 of the Plaintiff's patent; therefore, the generic drug did not fall within the scope of Claim 1 of the patent. As Claims 2-6 are subordinate claims to Claim 1, it could not fall within the scope of those claims either. Accordingly, the Court did not support the Plaintiff's claim.
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