Full Disclosure Criteria In The Application Of Gene Patents

Full disclosure system is the substantive condition of patent authorization,it is the patent law on the invention of technical information and protection of the right of information disclosure degree.The full disclosure system embodies the purpose of the patent system to balance private rights and public interests,and highlights the most essential value attribute of the patent system.The existing judgment criteria of full disclosure in the patent law and patent law implementation rules of China are applicable to all technical fields,and there are no special provisions for the field of gene technology.The development of gene technology cannot be separated from the protection of patent system.On the one hand,the technology research and development cost in this field is high,and the patent system can guarantee the return of investment of inventors.On the other hand,gene technology is widely used in the field of medicine.It plays an irreplaceable role in improving human body function and patients’ quality of life.Therefore,it is of great significance for both the inventor and the public to clarify the standard of full disclosure of gene patents and improve the quality of patent authorization.Genetic technology belongs to experimental science,and the presentation of technical means depends on the support of experimental data.It is difficult to provide an intuitive and accurate way for the presentation of technical effects in the specification.Moreover,gene technology for making changes in the biological haracteristics of effects is hard to predict,and technical comparison publicly,in the field of software functional limit way easily lead to rights protection scope is too broad,if this field technology still needs to pay excessive labor to complete the invention and confirm its effect,also do not conform to the requirements of the written description in the fully open.In practice,gene patents are fully open to judge some common difficulties.The first is that the technical problems of gene patents are hard to judge.Secondly,gene patents are unpredictable.Take polypeptides as an example,the sequence of polypeptides is composed of multiple amino acid residues.The way to modify polypeptides includes selecting one or more different mutation points,and selecting the specific amino acid types to be replaced by deletion,substitution or addition at the mutation points.The resulting large number of amino acid variants makes the peptide’s function difficult to predict.Finally,the broad scope of patent claims,the profit-seeking nature of capital and the unpredictability of genetic technology all make applicants tend to propose broad scope of patent protection.In order to solve the above problems,it is proposed to construct a theoretical framework that is fully disclosed and applicable in the field of genetic technology from the following three aspects.Firstly,it is the judgment of the scope of claim.Secondly,the realizable judgment.When determining whether the contents disclosed in the specification meet the realizable standard,the "possession" standard should be satisfied,so that the technical personnel in the field can expect that the inventor has "possessed" the right to be protected at the time of application.Finally,there is the judgment of the written description,which needs to confirm that the invention will not violate the objective law and the principle of "excessive experiment".Under the guidance of the above theory and in combination with the existing problems in practice,the standard of full disclosure can be perfected from the following three perspectives: clarifying the scope of common knowledge in gene patents;Gene patent can be realized with "reasonable prediction" as the criterion of judgment;To clarify the value judgment in the full disclosure identification of gene patent.