The Intellectual Property Court of the Supreme People’s Court issued Judgment (2019) Zui Gao Fa Zhi Xing Zhong No. 127 (the judgment) on December 6 2019, maintaining the first instance decision made by the Beijing IP Court, which rescinds the Reexamination Decision No. 129924 (the decision) made by the China National Intellectual Property Administration (CNIPA). The judgment, which relates to an invention of monoclonal antibodies, could serve as a point of reference in the examination of biomedical inventions for both examiners and applicants.
Erasmus University Medical Center Rotterdam and Roger Kingdon Craig (the applicants) filed an application entitled “Binding Molecules” before the CNIPA. The application was rejected by the examiner, citing lack of inventiveness. The applicants filed a petition for reexamination, yet the CNIPA still concluded that the application is devoid of inventive step and should not be granted a patent. The applicants later filed an administrative lawsuit before the Beijing IP Court, which corrected certain findings of the CNIPA and withdrew the decision. The CNIPA appealed to the Intellectual Property Court of the Supreme People’s Court.
A major dispute in this case focuses on whether the prior art provides the technical suggestion. Reference document 1 (D1) and the application share almost identical research direction. The most important defining distinction lies in the V gene segments comprised in the heavy chain-only antibody, with D1 adopting camelid V gene segments and the application natural V gene segments derived from a human. The CNIPA found that since minifying the antibody and developing a human heavy chain-only antibody have been a research direction in the development of engineered antibodies, stemming from the knowledge of such research direction and safety considerations, those skilled in the art would have the motivation to replace the camelid VH exons of D1 with human natural V gene segments.
The Supreme People’s Court asserts that when confronted with the objective problem to be solved, in principle, the suggestion those skilled in the art acquire from the prior art should be specific and clear technical means, rather than abstract ideas or general research directions. The technical suggestion of the prior art, if identified merely based on the consistency of the research direction and the abstract and universal needs in the art, risks hindsight, which could lead to the underestimation of inventiveness. To avoid hindsight, assessment should be made of the possibility of whether those skilled in the art could readily obtain the technical solution of the application in view of all the prior arts they have known, in order to solve the technical problem.
In this case, it is known that a human natural VH heavy chain-only antibody is inclined to accumulate or adhere, while the heavy chain-only antibody produced from camelid V gene segments has better water solubility. Therefore, those skilled in the art could hardly be motivated to replace “camelid V gene segments” with “natural V gene segments derived from a human”. The application is not limited by the cognition that a human natural VH heavy chain-only antibody tends to accumulate or adhere. Instead it arrives at a novel antibody having improved water solubility via replacement. The application thereby involves an inventive step.
The problem-solution analysis is conducted in the assessment of inventiveness of a patent. The third step of this approach involves the determination over technical suggestion in the prior art, the finding of which will lead to the conclusion that the invention is obvious and does not have inventiveness. In practice, the determination of technical suggestion is usually subjective. To assess the inventiveness of an invention, the overall technical concept of the reference documents and the invention should be examined as a whole, and the motivation for solving the technical problem should be objectively evaluated. The obviousness of the solution should not rest upon the mere fact that solving the technical problem is the universal pursuit of the field. The motivation for applying the distinguishing technical feature should be evaluated on the basis of the technical solution per se, by taking into account the application environments for the reference documents and the invention. Otherwise, it will only lead to hindsight assessment of inventiveness.
The SPC judgment states that the technical suggestion those skilled in the art acquire from the prior art should be specific and clear technical means, rather than abstract ideas or general research directions, which is expected to shed some light on clarifying the criteria for obviousness assessment.
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