Patent Protection Strategies In New Anti-tumor Drug Development

Malignant tumor is a major disease that seriously endangers human life and health.It is still one of the main causes of high morbidity and mortality worldwide.With the acceleration of people's pace of life,increased work pressure,irregular work and rest,unhealthy living habits,coupled with the aging of the population,the intensification of the industrialization process,the impact of environmental pollution and other factors,the proportion of people suffering from tumor diseases is increasing year by year.Cancer as a worldwide problem has received great attention from major medical institutions,and anti-tumor drugs have become the focus of drug development.The R & D of new drugs has the characteristics of large investment,high risk,difficulty,long cycle and rich returns.How to protect the intellectual property rights of new drug inventions has become the key to affecting the revenue of new drug R & D.It can even be said that the competition in the new drug R & D market is essentially a competition of intellectual property rights based on patents.Therefore,patent protection strategies have become a required course for new drug R & D.In recent years,there is still a certain gap between the R & D level of anti-tumor innovative drugs in Chinese pharmaceutical institutions and the international pharmaceutical giants.In addition to the technical backwardness,it also lies in the poor patent protection level of Chinese pharmaceutical R & D companies.Many good R & D results are often forced to stagnate because of the patent protection loopholes.And many multinational pharmaceutical companies,their professional teams tailored a full range of patent barriers for each research result,which not only effectively prevents the sniper of imitation companies but also greatly extends the life cycle of market exclusivity.The investment in patent protection is far less than the investment in new drug R & D,but the return it can create can achieve the extraordinary effect.On the other hand,for generic drug companies,patent research is equally important.Scientific progress is on the shoulders of giants.Generic drugs only need to pinpoint the entry point,which can also create great results.This also requires detailed patent investigation and analysis to find a breakthrough,which can do more with less.However,the application and research of patent protection strategies are exactly the shortcomings that China's generic drug companies and new drug R & D enterprises are seriously lacking.Therefore,it is imperative that patent protection protect the development of new drugs.This article reviews the literature on patent protection and finds that the current research mainly analyzes the patents of anti-tumor drugs to understand the development status and trend of new anti-tumor drug development,and provides some references and directions for the development of new anti-tumor drugs;Or some research combined with typical case analysis and summarized some patent protection strategies for new drug development.But no one has formulated a tailored patent protection strategies for the development of new anti-tumor drugs.This article uses an example method,an analysis and induction method to start from the typical case analysis of antitumor drugs of Sino-foreign original drug companies,and combines the characteristics of drug development and patent protection to summarize the patent protection strategies of the original research organization's anti-tumor drugs,focusing on the patent application and layout stages.And analyze how patent protection strategies can play a role in new drug development,marketing,and litigation.In the field of medicine,whether the original research institute can successfully apply a good patent protection strategies to apply for and distribute a patent on its original research drug has a direct impact on the company's product lifeline.The patent protection strategies introduced in this article mainly include space layout strategies,time layout strategies,and technology layout strategies for patent application.Patent application space layout strategies: Generally,original research institutes will apply for patents of original research drugs in time in China(CN),World Intellectual Property Organization(WO),European Patent Office(EP),United States(US)and other countries / regions.According to the original research drug production,sales,import and export situation,the original research institution should be deployed in as many countries / regions in the world as possible.While the drug goes global,the original research institution should use legal means to strengthen protection of its own scientific research results.Patent application time layout strategies: In terms of time layout,we must first carefully choose the timing of the first patent application.Once the core patent application is completed,the original research institution should immediately start subsequent improvement studies.Within the 20-year patent protection period from the filing date after the core patent is granted,it should continue to apply for peripheral patents surrounding the core patent in a timely manner to extend the drug's life cycle.Patent application technology layout strategies: Divided into core patent strategies and peripheral patent strategies.Core patent strategies: The original research institute must apply for a core patent in time for the basic,original and pioneering inventions obtained during the new original research drug development process.The core patent is the "foundation" of the entire patent protection system,and it is important to apply for a core patent.First of all,we should carefully choose the timing of applying for a core patent for the first time;Secondly,we must circle the appropriate scope of patent protection;Finally,we must pay attention to the quality of the core patent's text to ensure that it is fully in line with patent law provisions such as novelty,creativity,practicality and full disclosure of specifications and so on.The core patents of drugs include patents of general formula compounds,specific compounds,and stereoisomeric compounds that cover drug compounds,as well as patents of drug crystal forms,preparations,and uses.Peripheral patent strategies: It is a supplement and improvement of drug patent protection based on core patents.While applying for core patent protection,the original research institution may consider applying for a comprehensive range of peripheral patents in a timely manner,such as patents for analogs around drug compounds,patents for prodrugs or drug metabolites,patents for new drug crystals or salts,drugs composition patents,and so on,in order to build a strict and sound patent protection system around core patents.Core patents and peripheral patents are the foundation and barrier to each other.By using both of them to make a reasonable layout,patents can exert their maximum effect.Systematic and comprehensive patent analysis and review can provide strong supports for the R & D projects.Continuous patent follow-up can provide early warning and inspiration for R & D,and correct errors in a timely manner.High-quality patents writing and mining can firmly grasp the scientific research results.These are the significance of patent protection strategies to the R & D stage.Comprehensive patent protection strategies in the marketing process of the original research drug can play a positive role in promoting it,allow the original research organization to take the lead,effectively combat competitors,and always maintain a favorable position in market competition.High-quality core patents combined with diversified peripheral patents can form strong patent protection barriers,allow the original research institute to resist the attack of patent invalidation lawsuits of competitors,protect them from attack of patent infringement lawsuits by others,and further enhance corporate product credibility and corporate reputation,and finally achieve a double harvest of economic and social benefits.