A Study On The Special Incentive And Regulatory Mechanism Of "Orphan Drugs"

The “orphan drugs” may fall into an uncommon category when it comes to those who major in the IP law. The legal support for the creation of “orphan drugs” shall be treated with special attention and research as human health service and social morality have advance onto a high level. “Orphan drugs”, also known as rare disease drugs, which specifically alleges drugs for the prevention, diagnosis, treatment or control the rare diseases or conditions. Generalized orphan drugs also include vaccines, diagnostics, medical equipment and so on. “Orphan drugs” target much less market scope but much more time and resources to research and development compared to common drugs. It also faces substantial legal and administrative paradox. “Orphan drug”, however, may be critical to the lives who suffer from rare diseases. The conflict between the morality and medical as well as legal support calls for attention from the society.This thesis surveys the orphan drug laws in the U.S., E.U., Japan and South Korea with a focus on both legislation and judicature experiences. For those patentable or un-patentable intellectual achievements relevant to orphan drugs, the thesis put forward 2 proposed solutions in general: 1) to establish the expectation regulations targeting “orphan drug” under the current legal framework of IP and pharmacy. 2) to create a special act for “orphan drug” following the steps of development countries.This thesis consists of 5 chapters. The first chapter surveys the background of “orphan drug” and clarify some pharmaceutical conceptions. And then it illuminates the legislative status of orphan drugs acts in developed countries.The second chapter takes us back to China. The author investigates the development of “orphan drugs” in China through various academic methods. And then the author analyses its malpractices in-depth, such as its sky high price, slow progress in R&D, poor accessibility and so on. In addition, in consideration of mentioned points above, the author clarifies the legal and social reasons.The third chapter discusses and analyses the U.S. Orphan Drugs Act, Orphan Drugs Regulations, and Hatch-Waxman Amendments and other relevant acts. The author summarizes the highlights such as incentive mechanism and regulatory mechanism to limit the unfair competition. The author also surveys other legal materials such as Baker Norton Pharmaceuticals, Inc. v. United States Food And Drug Administration,Genentech, Inc. v. Bowen,Sigma–Tau Pharmaceuticals,Incorporated, v.Bernard A. Schwetz,Intermedics.Inc. v. Ventritex.Inc.,Amgen.Inc.v. International Trade Commission. The mentioned cases will help illustrate the advantages and disadvantages of orphan drugs acts in worldwide.The forth chapter discusses the proposed solutions towards intellectual achievements of orphan drugs in China. The author proposed 2 general ideas modes: 1) to create the exception regulations for “orphan drug” within the current framework of IP and pharmaceutical laws; 2) to create a special act for “orphan drug” following the steps of development countries. Considering the fact that China is a developing county and is not suitable to copy the U.S. legislation spirit of maintenance and stimulation to capital groups’ benefits nor to follow European and Japanese way of seeking all-parties benefits balance.Therefore, the author proposed certain concept on incentive mechanism with a special attention on relevant regulation mechanism to limit potential unfair competition:(1) to improve and optimize Bolar Exemption, for instances, to establish Orange Book, Patent Linkage system, administrative review break-off mechanism, exclusive market right of generics and so on in order to encourage generic-drugs pharmaceutical industries challenge the existing patent rights.(2) If we were to create an Orphan Drug Act, we shall consider putting a cap on the orphan drug prices, eliminating any pernicious market monopoly, revoking any unreasonable abuse, reducing the ethic risks and so other potential issues. Additionally, we should try our best to balance the benefits between the pharmacy industry, the patients suffered from rare diseases and the whole society as well.The fifth chapter summarizes the highlights on reform and discovery over the special protection mechanism of “Orphan Drug”, which restates it “thereby added the fuel of interest to the fire of genius, in the discovery and production of new and useful things.” The chapter reiterates the fact that the study on the special protection and regulation mechanism of “Orphan Drug” will benefit the society in the further.