| Summary: | 碩士 === 輔仁大學 === 財經法律學系 === 98 === Pharmacogenomics is a rising field of science, which focuses on relevance between drugs and gene variety. It’s main purpose is to discover and evaluate effectiveness, side effects, toxicity of a drug dosed to different individuals, to avoid adverse reactions, and finally to develop personal medicines. However, 99.9% of human genes are the same among individuals; the only 0.1% differences are decisive. Traditional one-size-fits-all drugs may cause serious side effects because of minor difference of gene, from recoverable harm to health to death. To drug developers, application of pharmacogenomics can serve as a technology platform in drug development, to derive gene information of drugs. This can promote cost efficiency of bio-pharmaceutical industry, and raise the chances of success.
Gene is the key factor of pharmacogenomics. According to a report in 2005, however, 23688 gene sequences recorded in NCBI, 4382 gene tags are patented at least in one patent; and most patents are property of several pharmaceutical companies. Patent rights are exclusive rights; and gene has character of widely applied and rare substitution. In combination of the two factors, if patentees refuse to license their patents, may defer researches and developments greatly. These patens become patent barriers and result in anti-commons tragedy. As a result, development cost of drugs is raised, price of drugs follows, and then patients are unable to access drugs. On the other hand, as commercial revenue derives from patents serve as an incentive for developers to invest, if there is no patent granted in the field of gene related inventions, researches on genes may deferred and no more new findings on functions, defects or effect of genes. Since every system can come with pros can cons, how to balance revenue of patentees and public welfare, this thesis will discuss on how to find out the balance.
In the beginning, this thesis starts with examination process of gene patents. Substantial criteria of granting gene patents are not tailored for biotechnology, and lead to incompatibilities in examinations. Therefore, there are many controversial decisions made by US Federal Circuit. To avoid case by case standards, improper grant of patents and too wide protections, we need to strictly obey the criteria of patent – substantial criteria. We need to further develop a standard tailored for biotechnology, in order to refine the criteria as the technology progress. Next, I discuss access of patented gene inventions, in view of ease patent barriers. There are three proposed ways – experimental use exemption, licenses (including compulsory and voluntary licenses) and patent pools; and they face different challenges in practicing in biotechnology industry. At the end, I propose a solution to balance right of patentees and needs of inventors to try to solve the insufficiency of regulations.
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