| The pharmaceutical test data protection system is stipulated in Article 39,paragraph 3,of the TRIPS Agreement.And this provision just sets the minimum protection criteria for each member.Different members set different standards for the protection of test data because of different economic developmental level and different understanding about this provision.By interpreting the provisions of paragraph 3 and the protection models of other members,this article puts forward some suggestions to promote China’s pharmaceutical test data protection system’s development in view of the problems existing in China.The first part of this paper introduces the basic situation of pharmaceutical data protection system and discuses the legal nature.By comparing the difference between pharmaceutical test data and business secrets,this paper makes an in-depth analysis from the perspective of intellectual property and regard the pharmaceutical test data as a special new form of intellectual property.The second part starting from the semantics of article 39(3)of Trips Agreement and then focuses on the two conditions of pharmaceutical test data protection:containing new chemical substance and it has to be undisclosed data.It is appropriately that we adopt the "relatively new" standard on the basis of comprehensive aspects because there is no unified definition of "new chemical substance" around the world.The third part of this paper introduces the protection mode of data exclusivity and anti-unfair competition,which are adopted by most countries.The different developmental level of different countries determines the different protection modes.What kind of protection mode of our country adopts is based on confidentiality,which is not conducive to protecting the public’s right to know.The fourth chapter analyzes the general situation of china’s current legislation and points out some problems.And then puts forward some pointed suggestions to promote china’s pharmaceutical test data system development. |
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