Wei Yang, Partner of IP March
On December 14, 2020, the CNIPA issued an announcement about the amendments to the Guidelines for Patent Examination (Announcement No. 391), and the amended Guidelines for Patent Examination came into force on January 15, 2021.
The amendments are made to the contents in Part II, Chapter X in relation to provisions on examination of invention application in the field of chemistry and can be generalized into the following aspects.
It is stipulated that the supplementary experimental data submitted for the purpose of satisfying sufficiency-of-disclosure and inventiveness requirements shall be taken into consideration by the examiner.
We understand this amendment is made in response to the Economic and Trade Agreement between the Government of the People’s Republic of China and the Government of the United States of America (Phase One), executed on January 15, 2020, which provides in Article 1.10 that “China shall permit pharmaceutical patent applicants to rely on supplemental data to satisfy relevant requirements for patentability, including sufficiency of disclosure and inventive step, during patent examination proceedings, patent review proceedings, and judicial proceedings”.
According to the current patent practice, where there is a sufficiency-of-disclosure defect present in the application text, it would place the applicant in a dilemma: the applicant may only submit prior-art evidence to remove such defect, and if the applicant submits such evidence, the examiner generally would use the same to raise inventiveness rejection against the claimed invention. As a result, there is a little bit possibility for such an application to be granted a patent right.
In contrast, according to the new stipulation, where the description recites the preparation method of a compound, its effect(s)/function(s) and the test or assay for determining such effect(s)/function(s), but fails to provide experimental data, to overcome the sufficiency-of-disclosure and/or inventiveness defect(s), the applicant may submit post-filing/supplementary experimental data validating such effect(s)/function(s). Keep in mind that such experimental data would be accepted only when the effect(s)/function(s) to be validated could be obtained from the disclosure of the patent application.
Although it is not clear about how the future practice in this regard would be, it can be expected that there would be a greater possibility for such applications to be granted a patent right as compared with the current practice.
Another depository institution, namely Guangdong Microbial Culture Collection Center (GDMCC), is added to the listing of the depository institutions designed by the CNIPA.
By this way, the applicant may have one more option to deposit relevant biological material.
It is stipulated that the monoclonal antibodies may be defined by structural features, e.g., the CDRs of the heavy and light chains thereof, or by hybridoma producing the same.
According to the current practice, some examiners might require the applicant to define a monoclonal antibody by the full amino acid sequences of, e.g., the variable regions of the heavy and light chains of the antibody. In the future, it can be expected that all the examiners will adopt the new criterion in terms of the definition of the monoclonal antibody. Despite of this, where the description recites that the CDRs have to interact with the frame region to produce a certain effect, and such effect is related to the inventiveness, we infer that the examiner might still require the applicant to define the monoclonal antibodies not only by the CDRs, but also by the frame region thereof.
It is stipulated that the novelty of a compound is evaluated firstly based on the structural information such as the chemical name and the molecular formula (structural formula) of the compound recited in the cited reference; and where such structural information is not sufficient to determine whether the claimed compound and the compound disclosed in the cited reference are structurally different, other information such as physical/chemical parameter(s), preparation method and experimental data on effect of the compound in the cited reference may be used to evaluate the novelty of the claimed compound.
In the current version, both the structural information and such other information are also applied to determine the novelty of a compound, but it is not explicit about the exact application order of such information in novelty evaluation.
As a matter of fact, the current practice is exactly as the same as the stipulation in the new version, and we understand that this amendment is made simply for the purpose of making the provisions more accurate and definite.
This amendment further elaborates relevant provisions for evaluating inventiveness of inventions in the fields of chemistry and biotechnology, and, in our opinion, is made for the purpose of better and more accurately evaluating the inventiveness of the inventions in the two fields.
For compound inventions, it is stipulated that the criteria for inventiveness evaluation involve three steps: (1) determine the structural difference(s) between the claimed compound and the prior-art compound, (2) determine the technical problem actually solved based on the technical effect achieved by such structural modification in the claimed invention, and (3) determine whether the prior art as a whole has provided a technical hint to apply such structural modification to solve the same technical problem. It is also stipulated that the prior art would be deemed to provide a technical hint where the skilled artisan has capability to make structural modification to the compound through logical analysis, reasoning or limited experiments to solve the technical problem and to obtain the claimed compound, and the claimed compound would be deemed inventive if the change of the use or the improvement of the effect of the compound cannot be expected based on the structural modification.
In the current version, it is generally stipulated that a compound structurally different from a known compound would be deemed inventive if it has a certain use or effect, and a compound structurally similar to a known compound would be deemed inventive only when such compound possesses unexpected use or effect.
As can be seen from the above, the new criteria for inventiveness evaluation are more close to the 3-step method for evaluating inventiveness.
For the inventions in the field of biotechnology in connection with biological macromolecules, cells, microbial individuals, and the like, it is stipulated that, during inventiveness evaluation, the structural difference and phylogenetic relationship between the claimed invention and the prior art shall be taken into consideration, together with the predictability of the technical effect. In particular, for inventions related to genes, polypeptides or proteins, recombinant vectors, transformants and monoclonal antibodies, it is explicitly stipulated that, where the claimed invention is structurally different from the prior art and possesses a different type of performance or an improved performance, and the prior art does not provide any technical hint to show the relationship between the structural difference and the different type of performance or the improved performance, the claimed invention shall be deemed inventive.
From the above, it can be seen that the new Guidelines for Patent Examination are more friendly to the applicant and in the near future, more and more patent applications will be granted a patent right and the patent right will be more stable.