A comparison of data exclusivity betweem Taiwan and U.S

• Main Authors: Shih, Yun-Ting, 施昀廷
• Other Authors: Chan, Keith
• Format: Others
• Language: zh-TW
• Online Access: http://ndltd.ncl.edu.tw/handle/5z5md8

碩士 === 國立政治大學 === 科技管理與智慧財產研究所 === 105 === Drug is related to national health, therefore, manufacturers need to conduct clinical trials before NDA to prove that their products are safe and effective. However, the data from clinical trials is not only time-consuming, costly, but also the reason for the high price of drugs. Data exclusivity is to give brand name drug applicant an exclusivity by excluding generic drug applicant relying on brand name drug applicant’s clinical data without their permission. In Taiwan, data exclusivity system has not been established completely, and the system compared with the system in United States is imcompleted. The one reason is drug information is not transparency and the act of “rely on” lack of legitimacy, the other reason is whether there is the copyright infringement when generic drug’s rely on brand name drug’s label. This thesis will focus on the history of data exclusivity in U.S and how U.S court deal with above issues to complete the data exclusivity system. The difference of data exclusivity between U.S and Taiwan is there are different kinds of data exclusivity for different kinds of drugs in U.S. However, in Taiwan, the data exclusivity is only for new chemical entity drug. Moreover, the data exclusivity does not require the applicants to prove that the clinical trials were done by their own or funded by themselves, but it is contrary to the legislative purpose. The case Pfizer, Inc v. Food and Drug Administration ruled that the brand name drug applicant could not block the the generic applicant applying ANDA by registering "unapproved dosage form". In the same case, the court gives the FDA legitimacy to “rely on” the brand name drug applicant 's clinical data for examining generic drugs. Compared to the U.S, Taiwan’s disclosure regulations are not sufficient to require the brand name drug applicant to fully disclose the drug information. Due to lack of information, generic drug applicants might face the high risk of infringement. Therefore, it is suggested that the relevant provisions of disclosure should be included in the appropriate height of the law to reduce the uncertain risk of producing generic drug. Besides, it is unclear that whether there is the relgulation about the act of relying on, and therefore it forces the generic drug manufacture to face high risk of infringement as well. For the above reasons, it is suggested that the relevant provisions of relying on should be included in the appropriate height of the law to reduce the uncertain risk of lawsuit and establish a more comprehensive system. SmithKline Beecham Consumer Healthcare, LP v. Watson Pharms., Inc. ruled that HWA were prior to copyright. Therefore, generic used the same labeling as original did not infringe the copyright of originator. However, in Taiwan, the ruling that the name of the pharmaceutical company has to claim that its reproduction is in accordance with the law of the act, belong to Article 52 of the Copyright Law "necessary for other legitimate purposes" fair use. It is because the regulation about labeling, which is registration of drug registration standards is lower than the copyright law, the judge can only rule that the generic’s replicating act belongs to fair use to avoid infringement, and therefore some of the rulings are inconsistent with each other. That increase the uncertain risk when generic would like to marketing their product. As a result, it is recommended to improve the legal standard for the labeling regulation, given the corresponding legal protection of the generic drug. From TRIPS to TPP, the implementation of the data excusivity became harsh gradually, but generic has the great proportion of the pharmaceutical industry in Taiwan. The government should have supporting measures for generic before implemting the data exclusivity. The thesis suggested that the data exclusivity regulation could add the requirement of proving the R&D or clinical trial of new drug was copmplely or partially done in Taiwan.