Analysis on the copyright of drug specification

Is the drug specification protected by copyright law? Does the drug manufacturer have the copyright of the drug specification? These issues have been controversial The reasons for the copyright protection of drug instructions are as follows: 1 The provisions in the regulations on the administration of drug instructions and labels may lead to the convergence of writing methods and structure styles of drug instructions, but will not lead to the loss of originality of drug instructions 2 The drug specification is not included in the scope expressly excluded by the copyright law 3 The drug experiment data itself belongs to the results of intellectual labor, especially the original toxicology experiment and pharmacokinetic part, which has the element of "creation" Therefore, the manual containing the independent intellectual achievements of the author should belong to the scope of copyright protection 4 Drugs are closely related to public health and safety When the manufacturers provide drugs to the market, they should conduct experiments on the drug properties of the drugs, so as to obtain their own data, which should be protected by copyright The reasons why the drug description is not protected by copyright are as follows: 1 The drug description is not original, and its pharmacological action and precautions are objective descriptions of drug properties 2 As an annex to the approval document for drug registration approved by the drug regulatory authority, the drug specification is an integral part of the administrative license for drug registration and belongs to the document of administrative nature 3 The main body that formulates and issues the specification has the right to revise it Combined with the relevant laws and regulations, the author thinks that drug manufacturers do not enjoy the copyright of the drug specification, the main reasons are as follows: first, the drug specification is an objective description of the drug properties in the real state, and does not have originality For example, after the research of pharmaceutical factory, material screening finds that a certain substance has activity for a certain disease Through a series of processes and methods, the substance is separated and extracted, and then through animal and human experiments, it is confirmed and proved that the substance has effect on a certain disease (i.e indication) It can be seen that it is an objective law that what composition of substances (active substances) has an effect on what disease Pharmaceutical factories only express this fact in words, which is reflected in the drug instructions, and it does not belong to words, literary creation or literary works In addition, the description of production date, composition, expiry date, specification, manufacturer, product batch number, approval number, etc in the drug manual is only a description of some objective facts, and should not be original Second, the drug specification does not have the power listed in the copyright law Article 10 of the copyright law stipulates 16 rights of copyright, including the right to publish, the right to sign, the right to modify, the right to protect the integrity of works, the right to copy and the right to distribute The determination and modification of the contents of the drug instruction manual shall be decided by the drug regulatory function department As the "creator" of the drug instruction manual, if a drug factory needs to modify an indication or drug dosage form in the drug instruction manual, it must be approved by the relevant department, and can't modify it at will, otherwise it will be subject to the corresponding administrative penalty Third, once the contents of the drug manual have been approved, they will become one of the standards to measure whether the drugs can be legally listed, just like the quality standards of drug production, with the nature of administrative documents Drug specification is one of the items that must be provided by the applicant and strictly examined by the drug regulatory department in the administrative examination and approval of drug listing It is an integral part of medicine and indispensable for sale The regulations for the implementation of the copyright law prescribes the conditions for works protected by the copyright law, one of which is originality Obviously, the drug specification does not have this characteristic Fourth, if we think that the drug manual has copyright, it will bring difficulties to the public If it is confirmed that the drug specification enjoys the copyright, the enterprises that have obtained some drug specifications may become the preconditions for the drug regulatory authorities to issue the administrative license, because the content of the specification has been occupied by the enterprises that produce the same drug, the manufacturers do not agree to use it, and the regulatory authorities do not agree with other forms of expression, which will cause the registration license of drugs not to be obtained However, only a few enterprises can produce common drugs and essential drugs, while the production capacity of some enterprises is limited, which can not meet the real needs of the public for common drugs and essential drugs The same can happen with generics In addition, drug instructions are actually written instructions for guiding doctors and patients to use drugs safely and reasonably If we confirm that the drug instructions enjoy copyright, there will also be dozens of cases of drug applicability of the same component, forming a situation of "one drug in one thousand aspects", which will cause difficulties for doctors and patients to use drugs.