Study On Issues Of The Drug Patent Authorization Influenced By Pharmaceutical Efficacy

As a vital field of human life,the pharmaceutical industry has always been in conflict.Because of high drug costs and imperfect medical insurance policies,low-income and even middle-income people unable to get timely treatment and protection.For the field of pharnaceutical patents in China,we can draw lessons from the relevant provisions of the Indian patent law so as to balance the conflict between drug patents and public health.Section 3(d)of the Indian patent law has already stipulated that "Pharmaceutical Efficacy" as the condition of drug patent authorization,and the case of Gleevec is also a typical case under this provision.In view of the provision of the Indian patent law,there has been extensive discussion and thinking around the world,and a lot of countries have certain doubts and corresponding development trends.The main research content of this paper is the specific details that should be considered for how to use "Pharmaceutical Efficacy" to influence drug patent authorization.In the specific research work,firstly,putting forward the issue of "Pharmaceutical Efficacy" influences the drug patent authorization.Understanding the current legislative situation of drug patent authorization's conditions,the status of "Inventive Step" in these conditions and the issues of "Pharmaceutical Efficacy" arising,combing with the"Gleevec Case" to comprehend section 3(d)of the Indian patent law,India use"Pharmaceutical Efficacy" as a condition of patent authorization.This invites a question:"Pharmaceutical Efficacy" should be considered with in applying for a patent.Secondly,analyzing the nomological issues of "Pharmaceutical Efficacy",of which influences the patent authorization.Understanding developed countries' arguments against India's provision.And understand the legal logical relation of "Pharmaceutical Efficacy" and"Inventive Step" profoundly.In the meanwhile,if we get legislative reference on section 3(d),we should also pay attention to the technical examination of "Inventive Step" on dealing with the two words "Known Substances" and "Pharmaceutical Efficacy".How to define the range of "Known Substances",and how to delimit the parametric standard of "Pharmaceutical Efficacy" at the biomedical level.After that,considering the compatibility and value of "Pharmaceutical Efficacy" influencing the patent authorization in the international perspective.Under the regulations of TRIPS,the Doha Declaration and any other international treaties,we should make full use of the flexible regulations and take the initiative in international communication while fulfilling the minimum international obligations.By means of consulting the legal systems of developed countries such as Europe and America,as well as developing countries such as India and South Africa,we can have a comparative study on the value of emphasizing "Pharmaceutical Efficacy" influencing the patent authorization.Finally,combined with the content discussed above,this paper puts forward detailed legal suggestions to use "Pharmaceutical Efficacy" influencing the patent authorization in our country from three aspects:the definition of the scope of "Known Substances",the refinement of examination rules and the highlighting of examination of "Pharmaceutical Efficacy" in"Inventive Step".The prices of drugs are high because they are protected by patents.The aim of awarding patents is to encourage innovation,not to hold the market.Highlighting"Pharmaceutical Efficacy",influences the patent authorization,preventing incremental innovation from forming patent barriers,opening up the competition in the generic drug market will have an impact on reducing drug prices.In the process of granting patents authorization on drugs,our aim is not only to encourage the research and development of high-value drugs patents,we should also ensure the life and health of medical patients.We should pursue the maximum balance between the both.What should we grant the patent authorization is the innovative drugs having observably pharmaceutical efficacy,we must break patent evergreen and strive the greatest interests for the majority of patients.