Research On The Pharmaceutical Patent Linkage

The pharmaceutical industry is a very special industry.The research and development of a new drug requires a lot of capital and time costs,and the R&D is extremely difficult.Therefore,new drug companies usually protect their legal rights through patents.New drug companies obtain patent rights for new drugs by applying for patents,and obtain high monopoly profits through the monopoly position granted by patent rights.However,high profits always come from the high price of patented drugs,and the majority of patients cannot afford high drug prices.Therefore,the high price of patented medicines will seriously impair people's access to medicines.Ensuring the availability of drugs is very important to protect citizens' right to health.The right to health is the most basic human right.If patients cannot afford high patented drug prices,even if companies develop more new drugs,they will not help protect citizens' right to health.In the pharmaceutical market,generic drugs are competitors to innovative drugs,having the same therapeutic effect as innovative drugs but much cheaper.So generic drugs can greatly ease the economic burden on patients.However,since the drug is related to public health,the safety of drugs is very important.Therefore,before the pharmaceutical technological innovation achievements being put the technology into the market,they need to be examined and approved by the national administrative departments to confirm their safety.In the process of applying for registration of a generic drug,a system that examines the relationship between the relevant patent status of the generic drug and the effective patent that has been approved for the drug is the pharmaceutical patent linkage discussed in this paper.This article is divided into five chapters.The first chapter of this article first briefly introduces the concept of pharmaceutical patent linkage.Then,based on the legislation of the United States pharmaceutical patent linkage as a clue,the paper examines the historical evolution process of the pharmaceutical patent linkage.The second chapter of this article analyzes the interests balance function of the pharmaceutical patent linkage.First of all,the paper analyzes the conflict between patent right and right to health in the pharmaceutical industry and its causes.Then,the necessity of realizing the balance between patentee's interests and public health interests is discussed in detail.Finally,the paper analyzes the role of the pharmaceutical patent linkage in balancingthe interests of all parties in the process of generic drug listing and the linkage of departmental functions needed to achieve balance.The third chapter of this article mainly introduces the practice outside the domain.Firstly,we start with the pharmaceutical patent linkage in the United States and Canada,and study in depth the pharmaceutical patent linkage in these countries and the balancing effect of the system on the main interests of the drug market.Then,we introduce the measures which EU and India which oppose the pharmaceutical patent linkage,clarifying measures taken by these regions and countries and evaluating briefly on the effectiveness of these measures.The fourth chapter of this article introduces the development status of the pharmaceutical patent linkage in China.Firstly,the historical evolution of the linkage system of pharmaceutical patents in China is introduced.Then,combined with the status quo of legislation,the latest revised drafts,relevant legislative opinions,the status quo and existing problems of the construction of the pharmaceutical patent linkage in China are discussed in detail,and a brief evaluation is made.The construction of the pharmaceutical patent linkage is not perfect,lacking many necessary elements.Finally,a brief evaluation of China's current pharmaceutical patent linkage is made.The fifth chapter of this article elaborates on the improvement of the pharmaceutical patent linkage in China from seven parts,including improving the legislative level,strengthening inter-departmental functional links,setting up a "protocol infringement" mechanism,removing the regulation that applicant's application for registration within 2 years before the expiry of the drug patent period,simplifying the generic drug application procedure and establishing special examination and approval channels for biosimilar drugs,further improving "China's Listed Drug Collection" and perfecting the patent challenge system.The author believes that China's introduction and development of the patent linkage system must be based on China's national conditions,with the principle of balance of interests and the maximization of social interests.