If an applicant or a patentee of a drug patent submits supplementary experimental data after the filing date, claiming that the data can prove that the patent application or the patent has inventiveness and that the claims can be supported by the Description, the People's Court shall examine the data. If the initial patent application documents explicitly or implicitly disclose the facts to be directly proven by the supplementary experimental data, and the applicant’s overcome of the inherent defects of the initial patent application documents is not due to the supplementary experimental data, the supplementary experimental data shall be accepted and further examined by the court to determine whether it can prove the facts to be proven.
Swedish A Company is the patentee of the invention patent involved in this case (the patent).
Shenzhen B Company requested to invalidate the patent primarily due the lack of inventiveness in claims 1 to 4. In response, Swedish A Company submitted supplementary experimental data aiming to demonstrate the patent’s inventiveness based on the unexpected technical effect of “remarkably high metabolic stability” for those skilled in the art as disclosed in the Description.
The CNIPA deemed that the supplementary experimental data submitted by Swedish A Company is unacceptable and that even if such data is accepted, it cannot prove the said technical effect, so the patent does not have inventiveness. Therefore, the CNIPA made a Decision of Invalidation, declaring claims 1 to 4 of the patent invalid.
Swedish A Company was dissatisfied and instituted an administrative lawsuit. The first-instance court ruled to dismiss the litigation requests of Swedish A Company.
Swedish A Company, dissatisfied with the first-instance judgment, filed an appeal, requesting to revoke the first-instance judgment and the challenged decision. The Supreme People’s Court recognized the decision and judgment’s errors in rejecting the supplementary experimental data but deemed the determination that the patent lacked inventiveness correct. Therefore, the Supreme People’s Court dismissed the appeal and upheld the original judgment.
The court’s effective judgment stated that the circumstance where the applicant does not disclose specific experimental data in initial patent application documents is inevitable due to variances in the comprehension of prior arts, the understanding of inventive points of technical solutions, and the perception of those skilled in the art.
Take the inventiveness as an example, the inventiveness of a compound drug may be based on the structure or morphology of the compound itself, or the efficacy of the compound drug. Wherein, efficacy may refer to the application of the drug, such as its indications, or its performance, which includes drug activity, toxicity, stability, controlled release rate, and more.
Any non-obvious technical contributions in any aspect can serve as the basis for determining the technical problems actually solved by the technical solution, enabling the technical solution to meet the inventiveness requirements for patent granting. It is difficult for the applicant to accurately predict inventive points on the filing date or the priority date. Even if the applicant accurately predicted the inventive points, the facts and data required to establish the non-obviousness of technical contribution may vary. And this variation may arise from different understanding of prior arts and diverse options of the closest prior arts.
Therefore, the patent applicant needs to prove the patentability of their patent application by supplementing experimental data after the filing date or the priority date. Supplementary experimental data submitted by the patent applicant after the filing date shall be examined.
To prevent the use of supplementary experimental data by the patentee to unfairly gain advantages from the prior applications, acceptance of supplementary experimental data should focus on examining the following issues:
First, the initial patent application documents must explicitly or implicitly disclose the fact to be directly proven by the supplementary experimental data, which is a positive condition. If the fact to be directly proven by the supplementary experimental data is disclosed in the initial patent application documents explicitly or implicitly, it may be determined that the applicant has conducted relevant research, and accepting the supplementary experimental data does not violate the first-to-file rule.
However, it is inappropriate to assume that the applicant made deceptive disclosure to gain unfair advantages and consequently refuse acceptance of the relevant supplementary experimental data simply because the initial patent application documents disclosed facts to be proven without accompanying any relevant experimental data. It is also inappropriate to require that the supplementary experimental data must have been generated before the filing date or the priority date simply because the applicant may have made a false disclosure.
In this case, the initial Description of the application documents explicitly disclosed in Paragraph 0005 of the Background section the facts to be proven by the supplementary experimental data, which is “remarkably high metabolic stability and bioavailability.” The original judgment lacks a foundation in rejecting the supplementary experimental data submitted by Swedish A Company on the ground that this disclosure is found in the Background section and that the initial patent application documents did not include experimental data supporting this technical effect.
Moreover, it’s a negative condition that the applicant cannot overcome the inherent deficiencies in the initial patent application documents by supplementing experimental data. The notion that inherent deficiencies in the initial application cannot be overcome through supplementary experimental data emphasizes that such data typically should serve to authenticate facts to be proven that are explicitly or implicitly disclosed in the initial application, so as to provide additional evidence supporting the legal prerequisites that the applicant or patentee must ultimately prove. The supplementary experimental data do not function to independently prove contents that were not disclosed in the initial application, and cannot further overcome inherent deficiencies in the initial application documents, such as insufficient disclosure.
In this case, Swedish A Company proved the authenticity of facts to be proven by submitting the supplementary experimental data to further prove the ultimate legal facts to be proven, i.e. the inventiveness of claims 1. Therefore, such supplementary experimental data is not for overcoming inherent defects of the initial patent application documents and shall be accepted.
In addition, the original reasons for rejecting the supplementary experimental data also include that counter-evidence 5 was conducted by a witness affiliated with Swedish A Company, and lacks corroborative evidence. In this regard, in the field of drug research and development, especially for new drugs, R&D entities are relatively concentrated, leading to a concentration of sources of supplementary experimental data.
Providers of supplementary experimental data often have employment or other affiliation with applicant or the patentee, which aligns with research norms and practices. This relationship should not be an absolute ground for rejecting the supplementary experimental data.
Since the supplementary experimental data cannot prove that the compound in claim 1 has “remarkably high metabolic stability and bioavailability”, it cannot prove that the compound in Claim 1 has unexpected technical effects, so claim 1 does not have inventiveness. Therefore, where the laws applied in the original judgment are corrected, the appeal is dismissed and the original judgment is upheld.
(2019) Zui Gao Fa Zhi Xing Zhong No. 33
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