On April 15, the Beijing Intellectual Property Court publicly sentenced the case of first instance in which the plaintiff Chugai Pharmaceutical Co., Ltd. sued the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. to confirm whether it fell into the scope of patent protection. According to the trial of the court, the generic drugs involved in the case were not in the protection scope of the patent right, the plaintiff's claim was rejected.

It is learned that this case is the first drug patent link litigation case in China since the implementation of the new Patent Law. 

Case Introduction

The plaintiff, Chugai Pharmaceutical Co., Ltd., is the patentee of "ED-71 preparation" (referred to as the patent in question) with No. 200580009877.6, and the holder of the marketing license of the related marketed patent drug "Aidecalcidol Soft Capsule". The medicine is mainly for the treatment of osteoporosis. The plaintiff has registered the above-mentioned drugs and the patents involved on the China Marketed Drugs Patent Information Registration Platform. The plaintiff found that the defendant, Wenzhou Haihe Pharmaceutical Co., Ltd., applied to the department of National Medical Products Administration for registration of a generic drug named "Aidecalcidol Soft Capsule" for a marketing license, and also filed an application for the above-mentioned generic drug on the China Marketed Drugs Patent Information Registration Platform. And it made the declaration of category 4.2 on the platform that its generic drug did not fall within the protection scope of the relevant patent rights.

Therefore, the plaintiff, in accordance with Article 76 of the new Patent Law, filed a dispute with the Beijing Intellectual Property Court to confirm whether it falls within the scope of patent protection, requesting for confirming whether the generic drug "Aidecalcidol Soft Capsule", which the defendant applied for registration, fell into the protection scope of the involved patent.

The Beijing Intellectual Property Court held that:

The technical solution used by the generic drug involved is neither the same nor equivalent to that of claim 1 of the involved patent, so it does not fall within the protection scope of claim 1 of the involved patent. In view of claims 2-6 are subordinative claims of claim 1, if the technical solution of the generic drug involved does not fall into the protection scope of claim 1, it also does not fall within the protection scope of claims 2-6. Accordingly, the plaintiff's claim that the generic drug involved falls into the protection scope of claims 1-6 of the involved patent cannot be untenable, and it is unassisted by the court. 

The plaintiff showed the purposiveness to appeal again in court, and the defendant accepted the first-instance judgment. 

Judge's statement

It is known that pharmaceutical companies will lack R&D motivation if they do not make profits through drugs sale, and new drugs will not be developed for people’s medication use. However, people also cannot afford high-price drugs, and the generic drugs of high-quality are on the contrary due to low cost of R&D and inexpensive price. Therefore, it needs to balance original medicines-developing enterprises and generic drugs companies. The “drug patent link system” is the very “law golden prescription” proposed by Patent Law to solve the above-mentioned problem. 

On June 1, 2021, Article 76 of the new Patent Law added a "mechanism for resolving disputes arising from patent rights related to drugs applied for registration", formally establishing China's "pharmaceutical patent link system". Subsequently, the Supreme People's Court issued the "Regulations of the Supreme People's Court on Several Issues Concerning the Application of Law in the Trial of Civil Cases of Patent Disputes Related to Drugs Applied for Registration", which specified specific provisions on the dispute resolution mechanism, determining that the above-mentioned drug patent link litigation cases are centrally administered by the Beijing Intellectual Property Court.

The judge in charge of the case said that the significance of the drug patent link system is to strengthen the judgment of the original drug-developing companies on the certainty of the drug market, continue to invest, and promote the innovation and development of the industry, and also to confirm the risks of generic drug listing in advance for generic drug companies to avoid high litigation compensation caused by blind listing, thereby promoting the high-quality development of generic drugs. The accessibility of medicine can be maximized access to by balancing the interests of originator companies and generic companies.

From Beijing Intellectual Property Court

April 18th, 2022