Roche's Biogen IDEC is the oldest independent biotech company and Fortune 500 company in the world. The disputed?patent involved has far-reaching significance for the Chinese domestic antibody pharmaceutical industry.
The case involves the patent administrative litigation on the unforeseeable technical effects of the accusation. The judgment of the First Intermediate People's Court of Beijing Municipality on the trial of first instance has decided that the part of the indicted decision on the validity of the patent in question shall continue to be maintained on the basis of claim 2. Beijing Higher People's Court upheld first instance verdict.
In the judgment of the second instance, the accused patent claim 2 claims the use of rituximab in combination with the chemotherapy regimen CHOP in the manufacture of a medicament for the treatment of diffuse large cell lymphoma in a human patient, wherein said lymphoma is accompanied by large lesions. When it is determined in judgment?of Inventive Step?that there is unforeseeable technical effect, the characteristics of the technical field to which the invention belongs, especially the predictability of the technical effect, the technical teaching?existing in the prior art and the like should be comprehensively considered. In general, the clearer the technical teaching?given in the prior art, the higher the predictability of the technical effect. In addition, it is necessary to consider whether the technical solution claiming the unforeseeable technical effect matches the technical solution claimed. In the present case in particular, the prior art has given the teaching of the combination of rituximab with the CHOP chemotherapy regimen for the treatment of diffuse large cell tumor, as a whole, can be predicted by those skilled in the art according to the prior art diffuse large cell tumor, and the treatment effect is better than just using one of the above drugs / treatment options. According to the information disclosed in the patent application, all the experimental data involved only diffuse large cell tumor, but not related to large lesions associated with diffuse large cell tumor, those skilled in the art only provided by the specification of rituximab CHOP combined treatment of moderate or high NHL to achieve 96% of the overall response rate cannot be determined for the combined treatment of large lesions associated with diffuse large cell lymphoma, that is, the disease involved in claim 2 can reach 96% of the overall response rate of the therapeutic effect. In the absence of experimental evidence, those skilled in the art cannot know the overall response rate of diffuse large cell lymphoma associated with rituximab and CHOP, and then determine whether the effect exceeds as is expected in the art. It cannot be determined that the technical solution of claim 2 of the disputed?patent has achieved unexpected technical effects. Therefore, disputed?patent claim 2 does not have inventiveness.
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