This case was among the 20 typical cases selected by the Supreme People’s Court Intellectual Property Tribunal from 3,468 technical intellectual property and monopoly cases concluded in 2022.
Case numbers: (2021) Supreme People’s Court Zhi Xing Zhong No. 451 and No. 702. Patentee: Bayer Intellectual Property GmbH. Other parties: Nanjing Hengsheng Pharmaceutical Co., Ltd. and Nanjing Life Energy Technology Development Co., Ltd.
The dispute concerned the scope of the Bolar exception for activities undertaken for regulatory approval.
[Basic Facts]
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") displayed rivaroxaban preparations and active pharmaceutical ingredients (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 challenged the administrative decision before the Nanjing Intermediate People’s Court in Jiangsu Province. The first-instance court dismissed their claims.
On appeal, the Supreme People’s Court held that the companies’ website and exhibition displays communicated an intention to sell the products to the public without authorization and constituted infringing offers for sale. The Bolar exception in Article 75(5) of the Patent Law covers manufacturing, use and importation for the purpose of obtaining regulatory approval, and manufacturing or importation specifically for the party seeking that approval. The companies did not satisfy those conditions, and their offers for sale fell outside the exception. The Court dismissed the appeal and upheld the original judgment.
Article 75(5) of the Chinese Patent Law provides that the following activities are not deemed patent infringement:
For the purpose of providing information required for administrative examination and approval, a person manufactures, uses or imports patented drugs or medical devices, or another person manufactures or imports them specifically for that person.
[Typical significance]
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 low-priced 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.
