This case is one of the 20 typical cases selected by the Intellectual Property Tribunal of the Supreme People's Court from the 3468 technical intellectual property and monopoly cases concluded in 2022.
Case No.] (2021) Supreme People Court Zhi Xing Zhong No. 451, (2021) Supreme People Court Zhi Xing Zhong No. 702
[Patentee] Bayer Intellectual Property GmbH
Nanjing Hengsheng Pharmaceutical Co., Ltd.
Nanjing Life Energy Technology Development Co., Ltd
Bayer Intellectual Property GmbH (hereinafter referred to as “Bayer”) is the holder of the invention patent "Substituted Oxazolidinones and Applications in the Field of Blood Coagulation of the Same" (Patent No. 00818966.8). Nanjing HengSheng Pharmaceutical Co., Ltd. (hereinafter referred to as "HengSheng") and Nanjing Life Energy Technology Development Co., Ltd. (a wholly-owned subsidiary of HengSheng, hereinafter referred to as "Life Energy") display Rivaroxaban preparations and APIs marked with the registered trademark of HengSheng on their official websites and relevant exhibitions. Bayer submitted a request for patent infringement dispute resolution to Nanjing Intellectual Property Office, which ruled that HengSheng and Life Energy should stop infringing
HengSheng and Life Energy refused to accept the decision and raised a lawsuit with the Intermediate People's Court of Nanjing, Jiangsu Province. The first instance court ruled to reject the lawsuit request.
HengSheng and Life Energy still refused to accept the judgment and raised an appeal. The second instance of the Supreme People's Court(SPC) held that, HengSheng and Life Energy made declaration of will to sell the products involved to unspecified objects through websites and exhibitions without permission, which constituted an infringement of offer to sell; The exception clause for administrative examination and approval of drugs or medical apparatus and instruments (i.e. Bolar exception, corresponding to Article 75 (5) of the Chinese Patent Law) only applies to the "manufacture, use, and import" behaviors implemented for their own to apply for administrative approval, as well as the "manufacture, import" behavior implemented specifically for the aforementioned subject to apply for administrative approval. HengSheng and Life Energy do not meet the subject conditions of the Bolar exception, and the offer to sell behavior does not fall within the scope of the exception, so the Bolar exception cannot be applied. The appeal was rejected and the original judgment was upheld.
Article 75 (5) of the Chinese Patent Law
None of the following shall be deemed as infringement of the patent right:
(5) where for the purposes of providing information needed for the administrative examination and approval, any person manufactures, uses, or imports patented drugs or patented medical apparatus and instruments, or any other person manufactures or imports patented drugs or patented medical apparatus and instruments especially for that person.
The judgment in this case clarified the judicial concept that the patent law takes the protection of lawful rights as the principle, with statutory non-infringement as an exception, and all exceptions must be strictly interpreted. In the legal application scenarios of the provisions of the administrative examination and approval exception (Bolar exception) for drugs or medical apparatus and instruments specified in the Patent Law, it is necessary to ensure that the public can obtain lowpriced drugs or medical apparatus and instruments in a timely manner after the expiration of the patent right, while also avoiding weakening the protection of the lawful rights and interests of patent right holders. It is necessary to prudently balance the interests of patent right holders, generic drug companies, and the public in accordance with the law. The judgment in this case has a positive guiding role in encouraging invention and creation in the pharmaceutical field and maintaining the innovative development of the pharmaceutical market.