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| Skinny Label and Second-Medical-Use Patents: from Legal Constructure to Attribution Standard |
| Wu Kewei |
| （School of Law, Peking University, Beijing 100871, China） |
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Abstract Since the implementation of the Hatch-Waxman Act, which pioneered the pharmaceutical patent linkage system in the United States, the "cat and mouse game" between the original research drug and the generic drug manufacturer has lasted for more than 30 years. As part of this system, U.S. legislation provides a way for generic drug companies to enable them to obtain marketing approvals that are less than the number of indications for brand-name drugs through skinny labeling. In this way, the patent linkage is connected with the patent protection of the second-medical-use patents. However, this rule cannot eliminate the possibility of off-label use of second-medical-use patents. The key to balancing the interests of the three parties lies in the infringement attribution standard for the infringement of the second medical use patents. It is one of the key issues in the practice of international pharmaceutical patent affairs, and it is also a new issue emerging in China. Despite the controversy, the patentability of second-medical inventions has been gradually reached the same standard around the world. The essence of Swiss-type claims is to break through the basic doctrine of "Prohibition of granting patents monopoly on diagnosis and treatment of diseases", which is prevailing in the civil law paradigm, and provide the possibility of obtaining patent protection for medical-use inventions. From 2017, this kind of patent claim can be also protected by China's patent legislation.#br#Infringement attribution standards of Swiss-type claims is also a hit and tough matter in the UK. In Warner-Lambert v. Actavis, the British court proposed and reviewed the following three standards for the determination of infringement: subjective intention test, objective intention test, and outward presentation test. The judges of the Supreme Court of the UK showed a certain consistency in the judicial choice of infringement standards and the value judgments based on the existing facts, that is, they all tend to deny the harsh objective intention test. In Warner-Lambert v. Actavis, the outward presentation test finally prevailed and became the majority opinion, while the subjective intention test failed and became the minority opinion. How to determine the behavioral boundary between the brand drug and generics' patents related to the second-medical-use indications is also a controversial issue in the field of drug patents in the United States. In GlaxoSmithKline v. Teva, CAFC (the US Court of Appeals for the Federal Circuit) chose to support the subjective intention test standard on this issue. The majority opinion of CAFC believes that as long as an innovator company can prove that a generic company has the subjective intention to induce direct infringement, it is sufficient to complete its burden of proof, and there is no need to prove that there is a probabilistic causal relationship between generic company's labeling behavior and direct infringement. #br#The subjective intention test and objective intention test in the Warner-Lambert v. Actavis belong to the infringement attribution standard under the fault principle and correspond to the theoretical terminology of Chinese tort law: fault and presumed default respectively. The outward presentation test proposed in Warner-Lambert v. Actavis is a no-fault determination standard which means when determining whether the drug listing behavior of a generic drug manufacturer infringes the second medical use patent, only considers whether the generic drug manufacturer's behavior falls within the scope of patent rights of the brand-name drug manufacturer. This paper argues that the practice of choosing different infringement attribution standards for specific situations coincides with the British Supreme Court's conditional support for the outward presentation test, and also in line with emphasizing that subjective conditions are still important in certain situations, and it is also consistent with the dominant opinion of the Chinese patent law, which believe that the criteria for determining patent infringement should be distinguished according to the circumstances, and there is no unified standard that should not be absolutely adhered to. The results show that China needs to formulate its infringement identification standards for second-medical-use patents from the comprehensive perspectives of the balance of drug innovation, the generic drug industry and drug availability. China should adhere to the non-fault standard for the identification of direct infringement of second-medical-use patent and only consider the skinny labeling behavior's compliance with laws, then to decide whether or not it falls into the scope of protection of second-medical-use patents. In determining the indirect infringement, the fault standard should be adhered to, and causation should account.#br#
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Received: 29 December 2020
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