Research On The Authorization Standards Of Drug Polymorphism Patent In China

In recent years,as domestic pharmaceutical companies frequently challenge large multinational pharmaceutical companies to challenge polymorphism patents and achieve success,the layout and protection of drug polymorphism patents have once again become a focus of attention in the pharmaceutical industry.In fact,due to the particularity of the polymorphic invention itself,the discussion on the patent authorization standard for drug polymorphism has never ceased.The methods of literature research and comparative research were adopted in this paper.At the same time,it combines the relevant domestic academic literature and patent review practices to sort out and analyze the main problems existing in the patent authorization of polymorphism in China in recent years.By comparing the main ideas and standards in the examination of polymorphism patents in Europe and the United States in judicial practice,suggestions are made for the clarification and improvement of drug polymorphism patent authorization standards in China.From the perspective of novelty,drug polymorphism invention is a typical type of invention that must be limited by physical-chemical parameters or preparation methods,but this does not mean that the "deduction of novelty" can be applied naturally and arbitrarily,and the presumption is used as evidence to prove there should be strict applicable prerequisites and procedural requirements,especially when the selection of polymorphism characterization method is less arbitrary and the specificity of it is obvious,the " deduction of novelty" must be used cautiously.At the same time,this paper proposes to improve the " Guidelines for Patent Examination" where the prerequisites and procedures for application are not clear.From the perspective of inventive step,the dispute over whether the "a compound that is similar in structure" clause applies to the polymorphic invention was once very fierce.Although the Supreme People’s Court finally determined that the patent in question applies the "compounds with similar structure" clause in the "Tetropamine Bromide Crystalline Monohydrate Invalidation Case",and because the patent does not have "unexpected technical effects",the patent was invalidated,the verdict does not mean that the polymorphic invention can be all classified as "a compound that is similar in structure" without discussion.In fact,regardless of the nature of the invention,the classification of patents,or the legislative purpose of the "a compound that is similar in structure" clause,this clause should not be applied to polymorphic inventions,and"unexpected technical effects" should not be regarded as the necessary conditions for inventive step of the drug polymorphic inventions.Based on the above,this paper further discusses the relationship between the"three-step method" and the evaluation of "unexpected technical effects" in the judgment of polymorphism’s inventive step.It is very difficult to evaluate "unexpected technical effects" in isolation and the results obtained are likely to be unreasonable and unstable.Polymorphic inventions belong to the typical types of inventions that need to pay attention to the evaluation of technical effects.It is very important to balance the relationship between technical problems,technical solutions and technical effects in the judgment of inventive step.Using the "three-step method" to achieve a comprehensive evaluation of the technical fields of inventions,technical problems,technical solutions,and technical effects is a more operable and reasonable idea.In addition,this article also discusses the difficulty of novelty determination and the determination of "sufficient disclosure" and other elements that may be involved in the authorization of polymorphism patents.The relevant opinions and suggestions in this paper are aimed at clarifying the authorization standards of polymorphism patents in China,but at the same time,they can also provide references for patent authorization in similar fields and provide reference for the improvement of relevant regulations.In addition,the attitudes and authorization standards of drug crystal form patents in various countries and regions in the world are different.The review and analysis of European and American polymorphism patent examination ideas and authorization standards will also help Chinese pharmaceutical companies to authorize European and American polymorphism patents.The standard has formed a preliminary understanding to help it develop a global patent layout of polymorphism patents.