In the chemical and biotech sector, China's State Intellectual Property Office (SIPO) and courts have been extremely strict when it comes to accepting supplementation of post-filing data during prosecution, invalidation or administrative litigation proceedings. The amended Patent Examination Guideline, which took effect on April 1 2017 seemed to provide some principles for the data supplementation issue. According to this, experimental data submitted after the filing date shall be analysed by the examiners. The technical effects to be testified by the supplemented experimental data should be such that a person skilled in the art can derive from the disclosure of the patent application. However, from such wording, it is still unclear to the applicant or patentee what the technical effect derivable from the disclosure of the patent application means exactly.
Recently, an AstraZeneca CN patent related to the drug product Ticagrelor and a Novartis CN patent related to the drug product Entresto were invalidated for lack of inventive step. The decision made by the Patent Reexamination Board (PRB) of SIPO gives a clear explanation to the data supplementation issue where inventive step is involved.
Facts of AstraZeneca invalidation case (related to Ticagrelor)
The PRB issued the invalidation decision regarding the AstraZeneca patent (99815926.3) on October 10 2017 for lack of inventive step. During the invalidation proceeding, AstraZeneca submitted as evidence a statement made by the expert witness Robert J Riley who also attended the hearing. The evidence showed that the compound of claim 1 manifested significant higher metabolic stability than the compound with a chemical structure close to that of claim 1.
In the PRB decision, the panel stated the following:
i) The effect of higher metabolic stability was merely mentioned in the background part of the patent and no data was provided in the embodiments showing the compounds of claim 1 have any metabolic stability effect.
ii) One skilled in the art could not predict the compounds of the patent will have higher metabolic stability either. Therefore, the supplementary data filed by AstraZeneca after the filing date to prove the unconfirmed technical effect in the patent document was not considered acceptable.
In this case, the PRB's stance of not allowing the patentee to submit data to prove the asserted technical effect echoes several preceding court decisions, such as Boehringer Ingelheim v. PRB (2017-JingXingZhong-2470) decided by the Beijing High People's Court.
Facts of Novartis invalidation case (related to Entresto)
The PRB issued an invalidation decision regarding the Novartis patent (201110029600.7) on December 27 2017 for lack of inventive step. During the invalidation proceeding, two pieces of evidence submitted by the patentee were supplementary data to manifest the synergy effect of lowering blood pressure when using the pharmaceutical composition of claim 1. Such pieces of evidence have previously been filed during US patent prosecutions.
In the PRB decision, the panel asserted the following:
i) In order to show that a compound or composition has a certain technical effect, the patent document should provide experimental method, experimental data and result and experimental conclusion. The patent only provided experimental method and conclusion regarding the synergy effect of the pharmaceutical composition of claim 1.
ii) One skilled in the art would be unable to rely on the experimental conclusion without the data and result to ascertain the synergy effect of the pharmaceutical composition.
iii) The experimental data and result submitted by the patentee during the invalidation proceeding did not belong to the original disclosure. According to the first to file principle, the premise of accepting post filing data is that the technical effect to be proved is available from the original disclosure. Therefore, the two pieces of evidence of supplementary data could not be used to manifest the technical effect of the present invention.
From this case, we can see that the PRB sets a high standard for accepting supplementary data regarding inventive step. The PRB takes the position that the technical effect which the supplementary data intends to prove should not only be mentioned, but also be fully proved in the original disclosure with corresponding experimental method, experimental data and result and experimental conclusion.
The PRB and courts have expressed the opinion in many decisions that if the post-filing data testifying the asserted technical effects is permitted, it is detrimental to the first to file principle because it might inappropriately encourage the applicant to merely mention technical effects and file the patent application as early as possible, but hide the detailed and revealing data until later, when any dispute arises. This would destroy the founding principle of the patent system: to exchange protection with disclosure.
We believe that that the PRB/courts' attitude towards data supplementation is too rigid. Post-filing data could be used to overcome lack of inventive step or insufficient disclosure objections. Sufficient disclosure is related to enablement, thus it is reasonable to adopt a strict standard for accepting the post-filing data under the first to file principle. However, the standard cannot be higher than the enablement standard. For inventive step, if the examiner or invalidation petitioner cites a prior art about which the applicant or patentee is unaware, it would be necessary to submit the supplementary data in order to rebut the claim. If the PRB or the courts adopt a stricter rule for post-filing data regarding lack of inventive step than insufficient disclosure, a chemical or biotech patent might face a higher risk of being invalidated. This means that in order ensure a stable patent right, the applicant would have to conduct enough experimental work regarding each potential technical effect and include all the related methods, data and results when drafting the application.
In the past three years, SIPO has been prone to adopting the lack of novelty or inventive step objection for chemical or biotech patent applications, instead of resorting to the previous insufficient disclosure objection. However, from the latest cases, especially the Novartis case, it seems very hard for the applicant or patentee to meet the SIPO or PRB's standard for supplementary data. Regarding the two cases mentioned above, AstraZeneca and Novartis still have chances to appeal to the Beijing IP court. We await the court's opinion on this issue.
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