A Study on the Regulation of Gene Therapy

• Main Authors: CHEN,YUNG-CHEN, 陳永震
• Other Authors: 黃承啟
• Format: Others
• Language: zh-TW
• Published: 2011
• Online Access: http://ndltd.ncl.edu.tw/handle/47040743005884790016

碩士 === 嶺東科技大學 === 財經法律研究所 === 100 === Abstract Gene therapy, the insertion of genes into an individual's cells and tissues to treat a disease, is notably absent from the litigations identified in the study. This is not surprising, because up until now human gene therapy has failed for the most part to progress beyond the clinical testing stage. However, there is great hope that ultimately gene therapy will prove a powerful new form of treatment, and when that occurs it could result in a new category of human gene patent litigation. It is important to bear in mind that the mere perception of a threat of litigation could alter the course of research and the commercialization of biomedical technology, so it would be a mistake to assume that litigation tells the whole story on the impact of human gene patents. But perceived threats could be overblown, and litigation does provide some a publicly accessible source data from which to objective assess the effect of these patents on innovation. The high degree of concern that has been expressed regarding the perceived detrimental impact of human gene patents on research and medicine is not reflected in the litigation history of these patents. To date, these patents do not appear to have been enforced in a manner that would warrant enactment of legislation to ban the patenting of DNA and DNA-based inventions. Many of the attacks on gene patents assume that the overall cost of these patents to society exceeds any positive benefit. However, the critics often fail to account for the positive benefits of human gene patents, particularly in the protection of therapeutic proteins, but perhaps even in incentivizing the discovery and commercialization of research tools and genetic diagnostics. Any appraisal of the patent system that focuses solely on the patents right to exclude will naturally lead to a conclusion that patents are a detriment to society, but such an analysis is flawed for failing to account for the substantial benefits to be derived from the patents ability to incentivize research and innovation. The newest and next frontier in the battle against doping in sports targets gene doping Gene therapy is a nascent medical field that refers to the insertion of a new gene - a functional one - into human cells to correct the DNA for some defective, malfunctioning, or absent gene This can be facilitated by introducing a virus into the cells through injection or delivery to the lungs by aerosol. Sometimes, cells are removed from the body, treated outside the body in a lab, and then reintroduced into the body. Gene therapy has shown promise in patients with immuno-deficiencies or hemophili Researchers are developing pharmaceuticals that can switch on the genes responsible for protein synthesis as well.