In order to carry out the spirit of Chinese leader's instruction on strengthening intellectual property protection, respond to the demands of the rapid development of economy and technology for the examination rules actively, and improve the quality and efficiency of patent examination. Thus, the CNIPA has decided to amend the Guidelines of Patent Examination, which is hereby issued and has come into force on January 15, 2021.
The amended contents mainly clarify and improve the examination criteria for supplementary experimental data, the examination criteria for compound novelty and the examination criteria for compound and biological creativity.
Amendments related to supplementary experimental data (Section 3.5 of Chapter 10 of Part II)
The "examination principles" of supplementary experimental data are added in these amendments. And it further clarifies that " the examiner shall examine the supplementary experimental data submitted by the applicant after the filing date to meet the requirements of Patent Law Article 22 Paragraph 3 and Article 26 Paragraph 3".
In addition, "supplementary experimental data for drug patent application" is added in the guidelines of patent examination, and two typical cases are included. Case 1 involves the situation that the applicant fully discloses the supplementary experimental data to prove the specification, which also clarifies that "the supplementary experimental data should also be examined when examining the creativity". Case 2 involves the situation where the applicant submits the experimental data to prove the creativity of the application. It can be seen from these two cases that the examination criteria of the supplementary experimental data for drug patent application is further clarified.
- Amendments for other limitations of the composition claims (Section 4.2.3 of Chapter 10 of Part II)
The current guidelines of patent examination stipulate that "if only one performance or use of the composition is disclosed in the specification, it shall be written as performance limited or use limited". In these amendments, "it shall" is adjusted to "generally required". And the amended standard is more conducive to safeguarding the legitimate rights and interests of the applicant.
- Amendment of the novelty of compounds (Section 5.1 of Chapter 10 of Part II)
The purpose of amendment is to clarify the relationship and boundary between "disclosure by reference" and "presumption of no novelty" and clarify the relevant burden of proof.
Regarding the situation of “disclosure by reference”, this amendment only retains the content related to the structural information, and requires the disclosure of the structural information to the extent that “makes those skilled in the art think that the claimed compound has been disclosed”. The deletion of the word "presumption" achieves the purpose of clearly distinguishing the two situations.
Regarding the situation of "presumption of no novelty" in the second and third paragraphs, first, delete related content, so that the "presumption of no novelty" situation will no longer appear as an example of the "disclosure by reference" situation; second, combine physical and chemical parameters and preparation methods and other factors, add "effect experimental data", propose that these factors should be considered comprehensively, and and the result of the consideration is to reach the extent that those skilled in the technical field have reason to presume that the claimed compound is substantially the same as the compound in the comparative document, and the burden of proof can be transferred to the applicant; third, the use of the expression "there are reasons to presume that the two are substantially the same" emphasizes that the examiner should pay attention to the reasonableness of the presumption and the reasoning of the examination opinions; fourth, modify the "but" part to "unless the applicant can provide evidence to prove that the structure is indeed different" in order to meet the proof requirements of this type of presumption.