On The Protection Of The Copyright Law Of The Drug Specification

The drug specification is a product description document written by the pharmaceutical research and development company that is circulated together with the drug.It mainly contains information describing the drug's attributes,how to use the drug,and what risks it has.Because of the peculiarities of the drug product,if it is not strictly limited,it may lead to a public safety crisis.Therefore,the national drug administrative department has issued a series of laws and regulations to regulate the format of the drug instruction,making it standardized.In the referee's judgment,there is a diametrically opposite view as to whether the drug instruction belongs to the object of copyright protection: The opposing view is that the drug description is a description of the objective properties of drugs and must strictly comply with the requirements of the national drug administrative regulations.And the prescriptive nature of the format determines that the core requirement in the communicability of the expression is not originality,and therefore it is not a work in the sense of copyright law;on the contrary,some people think that there is an essential difference between the drug description and the administrative document.Its content includes the experimental process of the drug,experimental data,etc.It belongs to the original intellectual achievement and should be protected by the Copyright Law.The case of North Mann Welman Company v.Suzhou Erye Company's drug inscriptions copyright infringement epitomizes this problem.From the first instance and the second instance,the drug description was considered to be a work protected by copyright law.Three years later,the Hunan Higher People's Court re-examined the previous verdict.It is controversial to prove whether the drug label can be protected by the copyright law in the judicial community.The reality is that the original market exclusive advantages of patent expired drugs no longer exist,generic drugs can apply for imitation of these drugs,quickly occupy the invented drug market at its low price,in order to make up for the short period of patent protection,the original research The drug manufacturer claims that the drug product specification can be protected by copyright,so as to achieve the ultimate goal of extendingits monopoly period in the pharmaceutical market.However,the development of China's generic pharmaceutical industry cannot be hindered.Therefore,it is necessary to discuss the issue theoretically and propose ideas for solving the problem.According to the theory of originality in our country,combining with the Welman Company v.Su Zhou Er Ye copyright infringement,analyses the original leaflet,defining the drug test data and the relationship between the drug specifications,and to determine the overall protection principle.To achieve original standard of original drug instruction of copyright protection and build instructions copyright right limit system,prevent the unlimited expansion of leaflet copyright harm public interests.