Two Cases of Administrative Ruling on "Rivaroxaban" Invention Patent Infringement

February 29, 2024

Case Brief

Bayer AG is the patentee of the invention patent with application No. 00818966.8 and the title of "SUBSTITUTED OXAZOLIDINONES AND THEIR USE IN THE FIELD OF BLOOD COAGULATION." Hencer company and Lifenergy company displayed the rivaroxaban preparations and bulk drugs bearing the registered trademark of Hencer company on their official websites and relevant exhibitions. Bayer AG filed a request with the Nanjing Intellectual Property Office to handle the IP infringement dispute, and the Office ruled that the two companies should stop the infringement. Hencer Company and Lifenergy company were unsatisfied and brought a lawsuit to the Intermediate People's Court of Nanjing, Jiangsu Province. The first instance dismissed the claims. Hencer company and Lifenergy company were still unsatisfied and instituted an appeal. The Supreme People's Court held in the second instance that Hencer company and Lifenergy company expressed their intention to sell the products involved to unspecified subjects through websites and exhibitions without permission, which constituted an infringement via offer for sale. The exception clause in the administrative approval of medicine and medical apparatus only applies to the "making, use and import" act conducted for their own application for administrative approval, and the "making and import" act performed exclusively for the former party's application for administrative approval. Hencer company and Lifenergy company did not satisfy the subject conditions, and the act of offering for sale did not fall within the scope of the exception mentioned above, so the relevant exception clause shall not apply. Therefore, the court rejected the appeal and upheld the original judgment.

Typical Significance

The judgment of two cases clarifies the judicial concept that patent law is based on the principle of protecting legal rights, with statutory non-infringement as an exception, and that all exceptions must be strictly interpreted. Specific to application circumstances of relevant legal provisions of medicine and medical apparatus administrative approval exception (Bolar Exemption) of the patent law, it requires to guarantee the accessibility of medicine and medical apparatus to the public after expiration of the patent right and to avoid weakening protection of patentee's legal rights and interests, that is, prudently balancing the interests among patentees, generic drug companies and the public in accordance with the law. This case also embodies the People's Court's judicial concept of equal treatment and protection of Chinese and foreign parties.

(Case source: the Supreme People's Court of the People's Republic of China)