Research On Legal Issues In The Pharmaceutical Patent

In the area of patent, it is a common viewpoint that patent is a balance system. However, when the attention is payed excessively to the conflict between the public interest and the private interest and the conflict between the patent holders and the patent users, an important fact is always ignored that there is disharmonious with different levels of the public interest . In fact, it is just a means that the government confers to innovators exclusive right of certain term to protect the private interest, the ultimate goal of patent system is to achieve the maximization of public interest. The pharmaceutical patent which relates to the area of survival rights of human is very important to the protection and realization for the public interest. This essay , therefore, is based on trying to figure out the relationships among pharmaceuticals, patent and public interest.This essay is divided into seven chapters. The contents go as follows:Chapter 1, survey of pharmaceutical patent system. Firstly, this chapter summarizes the history of development in the pharmaceutical patent which experienced two different phases of pre-TRIPS and TRIPS. Secondly, it analyses the current character of pharmaceutical patent from economic, political, ethical and social angles. Finally, it discusses the rationality of pharmaceutical patent. The author thinks that the actual effect of incentive mechanism has always been questioned in different degrees since the patent system emerged. In some areas, actually, the powerful monopoly of patent doesn't create the innovation. In the area of pharmacy, however, it is showed by many evidences that the patent system is the lifeline that promotes the technology of research and innovation in pharmacy, which means that although the efficiency of incentive mechanism varies with different fields, the relationship between the pharmaceuticals and the patent is most close.Chapter 2, review of the public interest in the pharmaceutical patent. Firstly, it discusses the theoretic origin of public interest and defines the public interest to confirm the meaning from the legal angle: it is unpractical to line out a clear bound as the public interest is a value judgment in nature which varies with ages. In a legal sense, it stands not on the protection of private interest but on the ultimate satisfaction with social demand which accepts more widely the development in the want, need of human and social interest. At the same time, based on the public domain and the intellectual products, the author analyses theoretically the public interest in the pharmaceutical patent: With the spread of private right in the intellectual property, the public domain is ignored to have a negative effect on the realization of public interest. The attention to the public domain, therefore, is actually to show a fact that the intellectual property law has already departed from justice , so the protection on the public domain is actually a remedy for the unbalance between the private interest and the public interest. Additionally, with the extreme spread of private right, the pharmaceuticals, which is a combination with the utilization of public resources and the effort of individual workers, is a remedy for the unbalance between the private interest and the public interest in the pharmaceutical patent as a materialization of public interest. Secondly, it discusses the value of public interest. The public interest is not only involved with economic order and social morality in content, but involved with the legal idea of justice. The public interest is just the embodiment of ethic value which is essence of justice. Justice is not a nonobjective interest which ignores the life, and it should be connected tightly with the welfare or suffering of human, so it must change from ensuring the welfare to individuals to protecting a certain interset which is accepted by society. This certain interest is the public interest. Otherwise, the public interest is involved with several levels of value which are restricted respectively by many factors of nation, society and otherwise, so it accordingly takes on high uncertainty and a state of multi-level. However, it is not absolute to confirm the order of values which lacks the certainty. The value choice as a relatively feasible standard, therefore, is used to confirm the order of values. Finally, with analysing the function, character and actual effect of certain articles concerning the public interest in the patent law and rebuilding the status of public interest articles, the author designs logically the public interest in the pharmaceutical patent law.Chapter 3, subject matters in the pharmaceutical patent. The legal range of subject matters is considered foremost when deciding whether a invention is patentable. In a broad sense, the pharmaceuticals in patent comprise mainly chemical compounds, biologic compounds and their processes of manufacture. However, the pharmaceuticals have a close relation with natural substances such as animals and plants, chemical substances and chinese traditional medicines, so we must make clear their relationships. On the other hand, as the subject matter in patent, the pharmaceuticals not only present the coherence of certain patent claims, but most importantly take on a ethic thought, which promotes the system design in the pharmaceutical patent more logically, especially on the subject matters. At the same time, the establishment of public interest standard means the degree whether a technological method in pharmaceuticals is patenable, which depends on two social values of the technological method, the promotion to the social economy and the benefit to the public.Chapter 4, essential conditions in the pharmaceutical patent. To apply a patent, an inventor must show that the invention is novel, manifests an inventive step and is industrially applicable. Firstly, in a modern sociaty, the criteria used to define what is new are crucial to the scope of possible limitations to the free access and use of technical knowledge in the public domain. For the pharmaceutical inventions which have very long process in research and use a great deal of resources, it is necessary to establish the high standard of novelty. Secondly, creativity means a invention should have corrected defects in respective technology of the prior art, be alternative technological method or representing the trend of technological development. At present, the technical claims in creativity are so low that most pharmaceuticals which lack of innovation are patentable, which means the lost in the protection on public interest that the public benefit less while afford more. Finally, in recent years, there is a huge change in industrial applicability that the scope is so broad that some inventions short of industrial applicability in the past are patentable under new standard. However, in order to avoid the spread of patents that may unduly jeopardize innovation in the health field, patent laws may provide as precise a concept of industrial applicability as possible and intensify the standard in the pharmaceutical patent field.Chapter 5, basic legal systems in the pharmaceutical patent. The modern patent system abandons the legislative idea of individal standard and state standard and adopts the idea of both that the law limits properly the exclusive rights for the public interest while protects the interest of innovators and inspires them for more better intellectual products. The establishment of basic legal systems in the pharmaceutical patent is just based on the remedy and limitation to the spread of private right to show deep concern for the public interest. As a substitution for withdrawing the patent and a remedy for the spread of private interest, the compulsory licensing system gives the pharmaceutical patent owner an incentive to protect their own interests, and most importantly aims to harmonize the private interest with the social interest for avoiding the expansion of social losses. Otherwise, the parallel importation system provides an important means to increase the accession to affordable medicines to protect the public health, especially for the developing countries, it is a practicable measure to solve the domestic public health problems.Chapter 6, exception system of exclusive rights in the pharmaceutical patent. The patent law contains the exclusive rights of the patent and the exceptions to such rights in most countries. Such exceptions are broad in content and in extent, some of which are particularly relevant to the health area. On the basis of analysis, the thesis has held that the experimental use and early working may be extremely important in fostering the innovation, promoting the diffusion of technologies or facilitating the reduction of the health-related pharmaceutical prices.Chapter 7, Problems and solutions in chinese pharmaceutical patent system. With the change in patent law in the course of chinese accession to WTO, the emphasis of this chapter is to analyse the concerned commitments and actual performances on chinese pharmaceutical patent, discuss the latest development in the pharmaceutical patent legislation and design a best mode of solving the public health problems. At the same time, with the analysis on current development of pharmaceutical patent, the author brings forward a reasonable forecast on the future of chinese pharmaceutical patent and designs some optional solutions.