The Beijing Intellectual Property Court recently publicly pronounced the first-instance judgment in the case of Chugai Pharmaceutical Co., Ltd. v. Wenzhou Haihe Pharmaceutical Co., Ltd., concerning a dispute over whether the patent right was infringed. After trial, the court held that the generic drug in question did not fall within the scope of protection of the patent-in-suit and dismissed Chugai Pharmaceutical's claims. This case is reported to be the first drug patent linkage litigation case nationwide since the implementation of the new Patent Law.

Chugai Pharmaceutical Co., Ltd. (hereinafter "Chugai") is the patentee of the formulation named "ED-71 Formulation" (the patent-in-suit) and is also the marketing authorization holder of the related listed patent drug "Eldecalcitol Soft Capsules," which is primarily used to treat osteoporosis. Chugai's drug and the patent-in-suit were registered in China's Listed Drug Patent Information Registration Platform. Chugai discovered that Wenzhou Haihe Pharmaceutical Co., Ltd. had filed an application with the national drug regulatory authority for marketing authorization for a generic drug named "Eldecalcitol Soft Capsules" and had made a declaration on the China Listed Drug Patent Information Registration Platform stating that its generic drug did not fall within the scope of protection of the relevant patent.

Pursuant to the provisions of the Patent Law, Chugai filed a lawsuit with the Beijing Intellectual Property Court seeking a determination of whether the patent right was infringed, requesting confirmation that the generic drug "Eldecalcitol Soft Capsules" applied for by Haihe Pharmaceutical fell within the scope of protection of the patent-in-suit.

After trial, the Beijing Intellectual Property Court held that the technical solution used by the generic drug was not identical to the technical solution of the claims of the patent-in-suit; therefore, the technical solution did not fall within the scope of protection of the claims of the patent-in-suit. Chugai's claims were thus not sustainable and were not supported by the court. The court found that the technical solution used by the generic drug was neither identical nor equivalent to the technical solution of claim 1 of the patent-in-suit, and therefore did not fall within the scope of protection of claim 1. Since claims 2 to 6 were dependent claims of claim 1, given that the technical solution of the generic drug did not fall within the scope of protection of claim 1, it also did not fall within the scope of protection of claims 2 to 6. Consequently, Chugai's claim that the generic drug fell within the scope of protection of claims 1 to 6 of the patent-in-suit was not sustained. Chugai indicated in court that it would appeal, while Haihe Pharmaceutical stated its acceptance of the first-instance judgment.

"The drug patent linkage system directly relates to the protection of the innovator drug industry and the high-quality development of the generic drug industry, and it has a significant impact on the development of the entire pharmaceutical industry. The purpose of the patent linkage system is to balance the interests of innovator and generic drug companies, ensuring the intellectual property rights of innovator companies to promote innovative development, while also enabling the public to access affordable, low-cost drugs," Zhang Suoying, a lawyer from Chengdu Ding'an Law Firm, told reporters.

On June 1, 2021, Article 76 of the new Patent Law added a mechanism for resolving disputes arising from patents related to drugs under application, formally establishing China's "drug patent linkage system." Subsequently, the Supreme People's Court issued relevant provisions, designating the Beijing Intellectual Property Court for centralized jurisdiction over such cases, commonly referred to as "drug patent linkage" cases. During the drug marketing approval and review process, if a dispute arises concerning a patent related to a drug under application between an innovator company and a generic drug company or other interested parties, the relevant parties may file a lawsuit with the people's court, requesting a judgment on whether the technical solution related to the drug under application falls within the scope of protection of another party's drug patent.

Zhang Suoying stated that in this case, the two parties disagreed on whether the technical solution fell within the scope of protection of the patent-in-suit. If the patentee believes that a generic drug falls within the scope of protection of the relevant patent, it needs to provide registered patent information, including the patent name, patent number, and relevant claims; information on the drug under application, including the drug name, drug type, registration category, and the correspondence between the drug under application and the listed drug involved; and essential technical materials submitted by the patentee to the national drug review authority that are relevant to determining whether the scope of protection is infringed.

A judge from the Beijing Intellectual Property Court indicated that the significance of the drug patent linkage system lies not only in enhancing the certainty of the drug market for innovator companies, encouraging continuous investment and promoting innovation in the industry, but also in allowing generic drug companies to ascertain the risks of marketing their generic drugs in advance, avoiding costly litigation damages from blind market entry, thereby promoting the high-quality development of generic drugs. By balancing the interests of innovator and generic drug companies, the system aims to maximize drug accessibility, ensuring that the Chinese public has access to both good and affordable medicines.