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China National Intellectual Property Administration (CNIPA) vs Jiangsu Targetpharma Laboratories (Jiangsu) Co., Ltd. and High-tech Research Institute of Nanjing University, Changzhou

Release time:2022-03-10 16:58:36 source:ipc.court.gov.cn

China National Intellectual Property Administration (CNIPA) vs Jiangsu Targetpharma Laboratories (Jiangsu) Co., Ltd. and High-tech Research Institute of Nanjing University, Changzhou:

Administrative Dispute over Reexamination of Invention Patent Application

(Intellectual Property Court of PRC Supreme People's Court (SPC), (2020) SPC IP Admin. Final 35)

Prepared by the Intellectual Property Court of SPC

Summary of the case

In this case, the SPC established an adjudicative standard for identifying common general knowledge (CGK) and its evidence in the relevant technical field. The identification of CGK as well as evidence of CGK may determine the technical knowledge and cognitive capability that so-called persons skilled in the art shall possess, and hence is of significant influence on inventiveness assessment at issue. Therefore, the identification of CGK shall be conducted with an incontrovertible standard and supported by sufficient evidence or grounds without being arbitrary.

Facts

Under Chinese patent law an ordinary person skilled in the art is presumed to be aware of all the common general knowledge (CGK) in the in the technical field covered by a patent application. In determining inventiveness, a patent examiner first identifies the closest prior art, then identify the distinguishing features of the claimed invention and the technical problem that is solves, then assess if a person skilled in the art (presumed to possess GSK) could be motivated to apply the invention when confronted with the technical problem. Hence, identifying the GSK becomes an important element of the examination of inventiveness.

This case concerns an invention patent application named "A Tumor-Targeting Tumor Necrosis Factor (TNF) Related Apoptotic Ligand Variants and Application Thereof". The applicants are Jiangsu Targetpharma Laboratories, Inc. (the Target Company) and High-tech Research Institute of Nanjing University, Changzhou. The technical problem to be solved by the invention was to construct a tumor-targeting TNF-related apoptotic ligand variant fusion protein with a linker peptide. After substantive examination, the original examining division of China National Intellectual Property Administration (CNIPA) rejected the application on the ground that the application lacks non-obviousness and hence does not meet the inventiveness requirement under the patent law.  The applicants requested for re-examination, and CNIPA, upon re-examination, upheld its original decision of rejection. The applicants then filed an administrative lawsuit with Beijing Intellectual Property Court which revoked CNIPA's re-examination decision.

CNIPA appealed to the Intellectual Property Court of the SPC on the following grounds: (1) Before the decision was made, the two applicants have been notified about the Evidence of the 8th Volume of Frontier of Cancer Research via the Notice of Re-examination and were given opportunities to state their opinions. When responding to the Notice of Re-examination with the statement of opinions, the applicants raised no objection against the reference to the 8th Volume of Frontier of Cancer Research as CGK in the Notice of Re-examination. (2) The law application in the original judgment was erroneous. The 8th Volume of Frontier of Cancer Research is not a journal but a book. Medical science is a field where knowledge update is relatively quick. The technical knowledge in relation to the NGR in the 8th Volume of Frontier of Cancer Research as cited in CNIPA's decision is not notable progress compared to the prior art, but a piece of CGK existed for a long time in the art. Even if the 8th Volume of Frontier of Cancer Research shall not be considered as evidence of CGK, there are also many books and literatures in the prior art to verify that the relevant technical knowledge in relation to the polypeptide of NGR sequence as disputed in this case constitutes CGK.

The legal issues

The SPC held that the identification of CGK in the relevant technical field directly determines the technical knowledge and the cognitive capability that the so-called persons skilled in the art shall possess and hence is of a significant influence on the assessment of inventiveness. Therefore, the identification of CGK shall be conducted with an incontrovertible standard and supported by sufficient evidence or grounds without being arbitrary.

In principle, CGK can be verified by such evidence as technical dictionaries, technical manuals, textbooks, etc., in failure of which, multiple evidence of other kinds in the relevant art such as patent documents and journals can also be referred to if such evidence are corroborative to one another and thereby suffice to establish CGK. Nevertheless, it's also noteworthy that the latter proving pattern shall follow a stricter standard of proof. In order to assess whether technical materials other than dictionaries, manuals and textbooks can prove CGK, it is necessary to look into such factors as their genre, content, characteristic, target readers, scope of dissemination, etc. and then make the assessment on a case-by-case basis. In this case, the 8th Volume of Frontier of Cancer Research belongs to the category of book publication, but it's not a textbook in a conventional sense, and hence does not suffice to amount to CGK evidence. Therefore, it is not convincing for CNIPA to use the 8th Volume of Frontier of Cancer Research solely as the evidence of CGK in its decision as identified by the applicants.

The related questions concerns whether the additional evidences including the books and journals dated before the publication date of the application submitted by CNIPA in the second instance proceeding shall be accepted by the court as new evidence., The SPC pointed out that CNIPA had already identified the relevant technical knowledge concerning polypeptide of NGR sequence as CGK solely on the basis of the 8th Volume of Frontier of Cancer Research in its decision. The additional evidences were presented to prove the existence of CGK only during the judicial proceeding, and hence such additional evidences are of no substantive pertinence to the basis for issuing CNIPA’s decision in the first place. CNIPA had fundamentally altered its reasoning and logics by submitting and presenting such evidences only when confronted during the judicial proceedings, and therefore these evidences should not be accepted by the court.

In view of the above, the SPC rejected CNIPA's appeal and upheld the original judgment.

Points of Significance

      1. Identification of CGK shall be conducted with an incontrovertible standard and supported by sufficient evidence or grounds without being arbitrary.

      2. In principle, CGK can be verified by such evidence as technical dictionaries, technical manuals, textbooks, etc., or multiple evidence of other kinds in the relevant technical field such as patent documents and journals. Nevertheless it's noteworthy that the latter proving pattern shall follow a stricter standard of proof.

      3. In order to assess whether technical materials other than dictionaries, manuals and textbooks can prove CGK, it is necessary to look into such factors as their genre, content, characteristic, target readers, scope of dissemination, etc. and then make the assessment on a case-by-case basis.

Key Words

Invention patent application; inventiveness; common general knowledge (CGK); person skilled in the art


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