Research On Intellectual Property Protection Of Drug Test Data

The drug test data is used to determine the drug safety,effectiveness and quality controllability.It obtained in different stages of drug development.As reference information,drug test data is extremely essential to entering the drug market successfully.The problem of the Protection of drug test data arises more and more attention in the international community in recent years,meanwhile it also becomes the difficulties of legislation.In addition to the "Introduction" and "Conclusion",this paper consists of four parts.The first part discusses the legitimacy of drug test data of the Intellectual Property protection.Due to drug test data has the characteristics of property and intangibility,thus it subjects to the natural of Intellectual Property.As a new form of intellectual property,it is different from the traditional types of intellectual property.Additionally,the drug test data protection forms two parallel mechanisms,which is different from the mechanism of patent protection.Patent protection aims to prevent others to register drugs,but the target of data protection delays the speed of generics to enter the market.As a result,drug patent protection cannot replace drug test data protection.Thus,Intellectual Property of test data protection is irreplaceable.The second part analyses the Intellectual Property protection of drug test data in the field of international law area.Compared with the relevant clauses among TRIPS agreement,NAFTA,TPP and some bilateral free trade agreements signed by China,including Australia,Korea and other countries.And then draw a conclusion that the Article 39 of TRIPS agreement provides a minimum standard for anti-fair competition of drug test data,but the standard of protection in NAFTA and TPP agreement is higher than that of the TRIPS agreement,because both of them all provide an exclusive right protection for test data.In addition,the stranded TPP agreement provides a patent-like protection,which is a higher standard than NAFTA.The third part compares two typical foreign countries' intellectual property protection of drug test data.It Analyses and Compares the different protections of drug test data of two typical countries,the United States and India,which represent the largest drug market and the biggest generics' market separately.And then it draws a conclusion that the Provisions on the protection of drug test data in United States is very comprehensive owing to its strong ability of Pharmaceutical innovation,which contains the higher protection of pediatric medicine,orphan drug and biological agent.As the biggest generics drug market,India tends to protect the interest of generics' market,thus the drug legislation of drug test data protection is relatively single as well as the legislation of drug.The fourth part discusses china's intellectual property protection of pharmaceutical test data.First,it analyzes the present legislative system of the drug test data protection in our country.Besides,it puts forward some legislative suggestions based on our existing problems,including the perfection of legal system,affirming the active application protection program,the establishment of the limited data publicity mechanism,the construction of "mandatory registration period" system and constructing the period of "a + b" type of protection.