Judgment of China’s First Drug Patent Linking Litigation Case
On April 15, Beijing Intellectual Property Court publicly announced that the plaintiff Zhongwai Pharmaceutical Co., Ltd. sued the defendant Wenzhou Haihe Pharmaceutical Co., Ltd. to confirm whether In the first-instance case of a dispute over the scope of patent protection, the court held that the generic drug involved did not fall within the scope of protection of the patent in question, and ruled to reject the plaintiff’s claim.
It is reported that this case is the first drug patent link litigation case in China since the implementation of the new patent law.
Introduction
The plaintiff Zhongwai Pharmaceutical Co., Ltd. is No. 200580009877.6, with the name “ED- 71 Preparations” (referred to as the patent involved), and the holder of the marketing license of the related marketed patented drug “Aidicalcidol Soft Capsule”, which is mainly used for the treatment of osteoporosis. The plaintiff 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 State Food and Drug 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 Listed Drug Patent Information Registration Platform. A declaration of category 4.2 was made, that is, its generic drug did not fall within the scope of protection of the relevant patent rights.
Therefore, the plaintiff filed a dispute with the Beijing Intellectual Property Court in accordance with Article 76 of the new “Patent Law” to confirm whether it falls within the scope of patent protection, requesting confirmation of the generic drug “Aidi ossification” that the defendant applied for registration. “Alcohol soft capsule” falls within the protection scope of the patent involved.
Beijing Intellectual Property Court held that:
Technical solutions and cases involved in the use of generic drugs The technical solution of the patent claim 1 is neither the same nor equivalent, so the technical solution does not fall within the protection scope of the patent claim 1 involved. Since claims 2-6 are dependent claims of claim 1, if the technical solution of the generic drug involved does not fall within 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 involved generic drug falls within the scope of protection of claims 1-6 of the involved patent cannot be established, and the court will not support it.
The plaintiff indicated in court that he would appeal, and the defendant indicated that he would obey the first-instance judgment.
The judge’s statement
We know that if pharmaceutical companies do not make profits from selling drugs, there will be no research and development motivation, no new drugs will be developed, and ordinary people will have no good medicinal use. However, if the price of the developed drugs is too high, people cannot afford to use them when they get sick, while high-quality generic drugs are often affordable for ordinary people due to their low R&D costs and low prices. Therefore, it is necessary to balance the interests of original drug companies and generic drug companies, so that ordinary people can take good medicines and affordable medicines. The “pharmaceutical patent linkage system” is the “legal prescription” proposed by the “Patent Law” to solve the above problems.
On June 1, 2021, Article 76 of the new “Patent Law” added a “mechanism for resolving disputes arising from patent rights related to drugs that apply for registration”, formally establishing China’s “drugs”. Patent Linkage 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, and determined that the Beijing Intellectual Property Court would have centralized jurisdiction The above-mentioned drug patent link litigation case.
The judge in charge of the case said that the important significance of the drug patent link system is not only to enhance the certainty of the drug market for the original drug companies It is also to confirm the risk of generic drug listing in advance for generic drug companies, avoid blind listing and lead to high litigation compensation, and then promote the high-quality development of generic drugs. By balancing the interests of original drug companies and generic drug companies, we will maximize the availability of drugs, so that Chinese people can enjoy good medicines and cheap medicines.
Source: Beijing Law Network Affairs