Research On Truthfulness Of Data Disclosure In Patent Specification Of Pharmaceutical & Chemical Fields

This article mainly focuses on the research on truthfulness of experimental data disclosure in patent specification,especially in pharmaceutical & chemical fields.The experimental data includes that disclosed by original patent application and that submitted after filing date.Since pharmaceutical &chemical fields seriously rely on experimental data to prove its technical effect,it is more embarrassing and important to pay attention to the truthfulness of experimental data disclosure in such fields.However,the truthfulness of the experimental data is rarely concerned.Each modification to Patent Examination Guidelines all involves how to deal with the experimental data submitted after filing date,including the latest amendment of 2017.However,both experimental data above all greatly affect patent examination results,while there is no effective regulation to its truthfulness.Just because of this,it is necessary to pay more attention to the truthfulness of experimental data thereof.Untruthful experimental data will do harm to related principles.First,the legislative purpose of patent law is “disclosure for protection”,which requires truthful disclosure without any false.Since pharmaceutical &chemical fields seriously rely on experimental data to prove its technical effect,if the experimental data disclosure is untruthful,such legislative purpose will be damaged.Second,first-to-file principle is intended to protect the completed technical scheme disclosed in the specification which is firstly filed.Such technical scheme must follow thenatural policies,while natural policies are scientific,untruthful experimental data can not reflect the true technical effects.Therefore,untruthful data disclosure would hurt the first-to-file principle.Third,untruthful data disclosure would also hurt the practical applicability of Article 22.4.Fourth,untruthful data disclosure would hurt inventive step of Article 22.3.Both “prominent substantive features” and “notable progress” all relate to technical effect,which needs to be proved by experimental data.Fifth,untruthful data disclosure would hurt the full disclosure article of Article26.3.Sixth,untruthful data disclosure would hurt Article 24.4,which recited that the claims are supported by specification.Seventh,truthfulness of experimental data is inevitable requirement as evidence.Experimental data is the basis of patent examination,similar to the documentary evidence in civil proceedings.As evidence,experiment data must have three nature of evidence,wherein truthfulness is the basis thereof.Untruthfulness thereof will hurt the evidence system.Therefore,it is necessary to pay more attention to experimental data truthfulness.However,there is no regulation to the truthfulness thereof.As new examination policies take in force,it is more urgent to regulate the truthfulness thereof.Studying from the experimental data related policies worldwide,we learned different policies related to the truthfulness of experimental data disclosure.Different policies of each country adapts to its own national condition.Considering all of the above,we set forth the suggestions below: first,perfecting formal requirement to experimental data provided by the applicant;second,establishing prompt-disclosure system of experimental data;third,examination prosecution open to public;fourth,introducing technical expert or third party assisting system;fifth,notary office prudently making notarial certificates;and finally,introducing punitive measures to willful false statement on experimental data in the long run.