China: China's First Pharmaceutical Patent Linkage Case
In China, the amended Patent Law came into effect on June 1, 2021, and Article 76 newly established provisions for so-called patent linkage in the pharmaceutical marketing authorization process. In conjunction with this, the National Medical Products Administration and the China National Intellectual Property Administration promulgated the "Measures for the Implementation of the Early Resolution Mechanism for Pharmaceutical Patent Disputes (Trial)," and the Supreme People's Court promulgated the "Provisions of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases Involving Patent Disputes Related to Drug Registration Applications (Fa Shi [2021] No. 13)." Consequently, the specific procedural responses for the dispute resolution mechanism have been largely completed, and jurisdiction is concentrated in the Beijing Intellectual Property Court. On November 10, presumably, the Beijing Intellectual Property Court accepted this patent linkage case for the first time since the amended Patent Law came into effect. This text has been revised and supplemented based on the judgment that took effect at the end of 2022.
The plaintiff is Chugai Pharmaceutical Co., Ltd., and the subject patent is ZL2005800098777.6 (CN1938034B, registration date: Dec. 8, 2010, PCT/JP2005/001749, JP2004-030702), titled: ED-71 preparation. The plaintiff is the marketing authorization holder for the patented drug "Eldecalcitol Soft Capsules" in China. The plaintiff discovered that Wenzhou Hahe Pharmaceutical Co., Ltd. had applied to the national drug regulatory department for marketing authorization for a generic drug named "Eldecalcitol Soft Capsules." According to the public information on the Drug Patent Information Registration Platform, the defendant has filed a Category 4.2 statement regarding the generic drug. Therefore, based on Article 76 of the Patent Law, the plaintiff requested the Beijing Intellectual Property Court to confirm that the generic drug falls within the scope of protection of the patent in question. The Beijing Intellectual Property Court accepted the case, finding that the plaintiff's lawsuit met the conditions for filing a pharmaceutical patent linkage lawsuit.
The Japanese translation of the drug name refers to the Chugai Pharmaceutical website. The company is also involved in a dispute in Japan regarding generic versions of its osteoporosis treatment (active vitamin D3 preparation) Edirol® Capsules 0.5μg and 0.75μg (generic name: eldecalcitol).
https://www.chugai-pharm.co.jp/news/detail/20210217163000_1081.html
On April 15, 2022, the Beijing Intellectual Property Court held a public hearing and determined that the technical solution used by the relevant generic drug was neither identical nor equivalent to the technical solution of claim 1 of the patent in dispute, and therefore did not fall within the scope of protection. Since claims 2-6 are dependent claims of claim 1, it was determined that they also did not fall within the scope of protection, and the plaintiff's claims were dismissed. The plaintiff appealed, but on August 5, 2022, the Supreme People's Court upheld the original judgment and dismissed the appeal. Notably, one of the focuses of the second instance was whether the defendant violated the provisions of the Measures for the Implementation of Pharmaceutical Patent Disputes, which resulted in a judgment on procedural issues.
Source of information: Beijing Intellectual Property Court SNS site
■ Copyright Notice Copyright (2021, 2022) Y.Aizawa. Reproduction and use prohibited, permission required.