On November 18, 2022, China’s Supreme People’s Court (SPC) released an announcement soliciting public opinion on on the Draft Judicial Interpretation of Anti-Monopoly Civil Procedures (关于反垄断民事诉讼司法解释稿向社会公开征求意见的公告). The Draft includes an article on reverse payments for generic pharmaceuticals and so may be of interest to foreign pharmaceutical companies facing potential competition from generics on patented pharmaceuticals. The SPC stated it is releasing this draft to “strengthen the anti-monopoly judiciary, to hear monopoly civil dispute cases in a fair and efficient manner according to law, and to maintain fair competition in the market.”
Article 23 reads,
If an agreement reached and implemented by the patentee of the generic drug and the applicant of the generic drug meets the following conditions at the same time, the people’s court may preliminarily determine that it constitutes a monopoly agreement as stipulated in Article 17 of the Anti-Monopoly Law: (1) The generic drug patent owner has given or promised to give the generic drug applicant a large amount of money or other forms of beneficial compensation; (2) The generic drug applicant promises not to challenge the validity of the patent rights of the generic drug or delay entry into the relevant market of the generic drug. If there is evidence to prove that the interest compensation referred to in the preceding paragraph is only to compensate for the cost of resolving disputes related to the patent of the generic drug or there are other legitimate reasons, the people’s court may determine that it does not constitute a monopoly agreement as stipulated in Article 17 of the Anti-Monopoly Law.