| Under the background of the "Healthy China Strategy",the newly introduced "Drug Patent Linkage System" has become a very important intellectual property policy for the pharmaceutical industry.From the perspective of the government,the "Drug Patent Linkage System" links the drug marketing approval process with the patent dispute resolution process,aiming to promote the R&D of innovative drugs and at the same time encourage patent invalidation requests activities to facilitate the timely approval of generic drugs for marketing.From the perspective of pharmaceutical enterprises,patent invalidation requests can not only be used to clear the obstacles to their own technological development or defend against infringement suits,but also help to strive for the first generic drug and market exclusivity period,which is a way for pharmaceutical companies to gain competition advantage and an important strategy for sustainable development.However,many pharmaceutical companies currently face the dilemma of lack of awareness of patent invalidation request activities,which seriously restricts the level of intellectual property management.The previous domestic studies mostly focus on discussing the functional optimization measures of the patent invalidation system from the legal level,but seldom carry out econometric analysis on the patent invalidation requests activities from the perspective of management,so the above dilemma has not been clearly solved.Aiming at the theme of how to correctly understand the characteristics of patent invalidation requests activities of pharmaceutical industry,in this paper we put forward four core questions in turn: First,what are the general characteristics of patent invalidation requests activities of pharmaceutical companies? Second,what are the determinants of the probability of requests for invalidation of patent rights of pharmaceutical companies? Third,what are the determinants of the examination outcome for invalidation of patent rights of pharmaceutical companies? Fourth,what is the impact of the invalidation of patent rights of pharmaceutical companies on followon innovation by other innovators? To answer the above questions,firstly,we use the statistical analysis path to present the overall key features such as the frequency and outcomes of patent invalidation requests of pharmaceutical industry.Secondly,starting from the Transaction Cost Theory,and based on cost-benefit principle and the economic analysis of legal dispute litigation,we employ Logistic regression to examine,for the first time,the effects of factors such as patent value,patent legal quality and information asymmetry on the probability of patent invalidation requests.Thirdly,starting from the Contract Theory of Patents,and based on the principle of disclosure for protection,we exploit Probit regression to analyze the effects of factors such as the review of the disclosure obligation of inventions at the national level and the fulfillment of the disclosure obligations of inventions at the inventor level on the outcome of patent invalidation requests.Fourthly,starting from the Cumulative Innovation Theory,and based on cost-benefit principle,we introduce variation in the invalidity propensity of the first examiner from the perspective of national level invention disclosure obligation review to construct an instrumental variable for the core independent variable "patent invalidation" to address the potential endogeneity of invalidity decisions,and we apply standard Two-stage Least Squares(2SLS)instrumental variable method regression analysis to investigate the causal effect of patent invalidation on follow-on innovation by other innovators.The main conclusions are as follows:(1)The frequency and incidence of invalidation requests for drug invention patent rights of pharmaceutical industry in the Chinese market is low overall,but the key feature is that the proportion of patent rights invalidated in the examination outcome is relatively high;due to the distance in innovation ability,patentees with higher frequency of invalidation requests are mainly foreign pharmaceutical companies,and the most active petitioners for invalidation are mainly domestic pharmaceutical companies.(2)Among the determinants of the probability of requests for invalidation of patent rights,we show empirically that the risk of drug patent invalidation requests for pharmaceutical companies increases with patent value,asymmetric information(diverging expectations of invalidation outcomes)and low legal quality.In contrast to theoretical predictions,the empirical findings suggest that Formulation patent is challenged more frequently than Composition of matter patent.(3)Among the determinants of the invalidation outcomes of patent rights,we find empirically that the probability of patent invalidation of pharmaceutical companies increases with invalidity propensity of the first examiner who is responsible for the comprehensive review of the invalidation requests case,the scope of claims,and the insufficient disclosure of inventions in description.(4)In terms of the effect of the drug patent invalidation of pharmaceutical companies on follow-on innovation by other innovators,it is clear from our data that patent invalidation leads to a 50% decrease of forward citations to the focal patent from other innovators,on average,which is not in line with previous studies based on the developed countries such as the United States and Europe,which means that patent rights of innovative drug companies in the Chinese market can stimulate follow-on innovation by other innovative entities in the pharmaceutical industry.The innovation of this paper is expected to include:(1)To the best of our knowledge,our paper is the first study to clarify the general characteristics of the drug patent invalidation requests activity in the Chinese market,moderately develops the measurement and interpretation methods of the pharmaceutical industry’s competitive environment,and reveals that the main feature of competing is that local companies which focus on generic drug R&D actively files patent invalidation requests of foreign pharmaceutical companies.(2)It clarifies the determinants of drug patent invalidation requests behavior in the Chinese market,builds a more targeted patent invalidation requests risk prediction model for pharmaceutical companies,in addition,expands and supplements the previous study on legal dispute selection strategies which are mainly based on the United States and Europe data.(3)It clarifies the determinants of the outcomes of invalidation of drug invention patent rights in the Chinese market and from the comprehensive perspective of the performance and examination of the disclosure obligation of inventions,it responds to the research call for providing an accurate method for evaluating the stability of drug patent rights of pharmaceutical companies.(4)It is revealed that in the emerging market environment,under the circumstance that follow-on innovators have low ability to innovate and tend to adopt a defensive-oriented patent application strategy,the causal effect of a patent’s invalidation of pharmaceutical companies on follow-on inventions is so different.The different influence effects on innovation behaviors enrich the theoretical understanding of the relationship between patent rights and innovation activities. |
PDF Full Text Request