Interpretation and Enlightenment of the Anti-monopoly Judicial Experience on Reverse Payment in the Pharmaceutical Industry in the United States: Focusing on the Judicial Rules

Abstract

The reverse payment agreement in the pharmaceutical field embodies the game between the innovative protection of drug R&D and the free competition in the pharmaceutical market. The anti-monopoly review carried out on this type of agreement reflects the application competition between drug patent laws and anti-monopoly laws. In American antitrust legal practice of reverse payment in the field of pharmaceuticals, in order to clarify whether the reverse payment agreement has a long-term effect that is unfavorable to competition, in the process of reviewing the illegality of reverse payment, we find that per se illegal rule, rule of reason, quick look rule and Scope of the Patent test have constituted the main rules for the antitrust review of the reverse payment agreement nowadays. However, no unanimous conclusion has been reached on this issue. On the one hand, this is due to the issue of the competing application of patent laws and anti-monopoly laws in reverse payment behaviors, which makes the value selection not easy. On the other hand, this is also based on the fact that different courts of the court, especially different federal circuit courts, enjoy greater autonomy in the choice of rules. The review of the judicial experience in the United States, in addition to providing relevant information, is more to provide useful lessons for the next step in the healthy and orderly development of China’s pharmaceutical market, especially the generic market. The selection of the judicial experience in the United States is based on the following factors. First, the selection of the U.S. experience as the object of investigation is determined by its world leading position in the application of antitrust laws, the development and application of the pharmaceutical industry, and its patent specifications. Second, the selection of the U.S. experience is related to the differences in the focus of antitrust enforcement mechanisms in the United States, and the European Union and its major countries. Third, the anti-monopoly review focused on reverse payment in the pharmaceutical field shows a competition and a value selection between the application of anti-monopoly laws and the application of patent laws of medicines essentially. It is difficult to draw on a fair and efficient judgment to rely on administrative agency alone. Strengthening a judicial supervision and review, or establishing a third-party review mechanism, may be a realistic and effective move. At present, the implementation of anti-monopoly laws in China is basically normal, and it is on the way to achieving specialization and refinement. The innovation protection and the competitive incentives in the pharmaceutical industry are an important part of the entire market competition law and its implementation system. The relevant institutional mechanisms need to be improved and the practice process must be promoted in an orderly manner. Taking the anti-monopoly review of reverse payment as a breakthrough point, combining the extraterritorial experience with our country’s reality, and ensuring and satisfying people’s drug demands as the fundamental starting point, we should pay full attention to the balance between drug innovation protection and free competition. As the basic rule of anti-monopoly review of reverse payment, the rule of rebuttable illegality presumption provides both parties with full defense opportunities and encourages innovative development and free competition in the pharmaceutical sector with a sound system. Finally, it is worth emphasizing that China and the United States have different legal environments. It is hard to say that a specific experience and practice of the United States can directly apply to China. However, while investigating the U.S. experience, it is worthwhile to take seriously the cultivation and training of ideas and methods for thinking about similar issues. Specific to the anti-monopoly review of reverse payment, the problem of the value selection between drug patent innovation protection and market free competition, it is a good idea to use third-party evaluation platforms and operational mechanisms similar to the court and its judicial review mechanisms. This is not only conducive to the substantive solution to the problem, but also conforms to the design advocacy for the establishment and development of the third-party public service platforms from the top political level, and can effectively implement the landing.