In AstraZeneca AB (Sweden) vs China National Intellectual Property Administration
(CNIPA), (Intellectual Property Tribunal of the Supreme People’s Court of China (SPC), (2019)
SPC IP Admin. Final 33), the SPC established the standard for accepting supplementary
experimental data by CNIPA in patent invalidation process.

Facts of the case
This case concerns an invention patent with patent number 200610002509.5 and
named Novel Crystalline Form and Non-crystalline Form of Triazolo [4, 5-D]
Pyrimidine Compound, and the patentee is AstraZeneca AB. Shenzhen Salubris
Pharmaceuticals Co., Ltd. submitted a request to declare the patent to be invalidated,
on the ground that claims 1-4 of the patent do not have inventiveness. To prove the
inventiveness, AstraZeneca AB submitted rebuttal evidence. CNIPA held that the
relevant rebuttal evidence cannot prove that the patent has an unexpected technical
effect, and the patent does not have inventiveness. As a result, CNIPA issued its
decision to invalidate claims 1-4 of the patent.
AstraZeneca AB was not satisfied and filed a lawsuit with Beijing Intellectual
Property Court, which held that, firstly, the experimental data in the rebuttal evidence
was completed after the filing date of the patent; secondly, only the Background
section of the specification of the patent alleged that the claimed compound high
potency for the claimed purpose and has a “surprisingly high metabolic stability and
bioavailability.” The patent specification neither mentioned nor provided any
experimental data about the technical effects, and persons skilled in the art can’t
confirm the alleged technical effect based on the specification. Thirdly, the rebuttal
evidence is an experiment completed by an attester itself who has a relationship with
AstraZeneca AB, and that the specific scenarios of experimental condition and
experimental data cannot be corroborated by other evidence. Therefore, this case
cannot rely on the technical effect described in the rebuttal evidence to determine the
technical problem actually solved by the patent. AstraZeneca AB appealed to the SPC
on the ground that the rebuttal evidence which serves as the supplementary
experimental data shall be accepted.
Legal Issues
The SPC held that it is unavoidable that patent applicants do not incorporate certain
specific experimental data into their original application documents due to the
difference in perception of prior art, the difference in understanding of the inventive
point of technical solution, and the inconsistency in the grasp of cognitive level of
those skilled in the art. As far as inventiveness is concerned, the inventiveness of a
pharmaceutical compound can be based on the structures or configurations of the
compound per se or can be based on the pharmaceutical effects. The aforesaid
pharmaceutical effects can be pharmaceutical uses, i.e. indications, or can be efficacy
of the pharmaceuticals, i.e. activity, toxicity, and stability of the pharmaceuticals as
well as velocity of controlled release. Any non-obvious technical contribution to the
aspects above can be used as a basis to determine the technical problem that is
actually solved by the technical solution such that the technical solution would meet
the standards of inventiveness for patent-granting. It is difficult for the applicant to
precisely foresee the inventive point on the filing date or the priority date.
Even if the applicant could give a precise forecast of the inventive point, there would
be possibly different facts and data required to prove the non-obvious technical
contribution due to the different understanding of prior art and the different choices of
the closest prior art in respect to the same technical problem. Taking sufficiency of
disclosure as another example, because examiners and petitioners for invalidation
may both have different understandings on patent application documents and may
both have different choices of the closest prior art to that of the patent applicants, the
former may therefore question whether the patent application meets the requirement
of sufficiency of disclosure. Under the circumstances above, the patent applicants
need to rely on supplementary experimental data submitted after the filing date or the
priority date to prove that their patent applications are eligible for granting. Therefore,
the supplementary experimental data submitted by the patent applicant after the filing
date shall be examined.
Of course, allowing patent applicants to submit supplementary experimental data after
filing date or priority date and examining them does not mean that such data must be
accepted for sure. Considering the impact on priority claims over inventions and the
need to ensure compliance to the rules on sufficiency of disclosure at the time of
patent filling, there is a need to avoid these problems when accepting supplementary
experimental data.
First, the original patent application documents shall clearly describe or implicitly
disclose the to-be-confirmed fact that is intended to be directly proved by
supplementary experimental data, and this is a positive requirement.
Second, the applicant cannot remedy the deficiencies inherently and naturally present
in the original application by the supplementary experimental data. The
supplementary experimental data shall be normally used when the to-be-confirmed
fact is to serve as a supplementary proof for the legally required fact which needs to
be eventually proved by the applicant. However, the supplementary experimental data
shall not be independently used to prove for the contents that are not disclosed in the
original application, or to overcome the deficiencies inherently present in the original
application, such as insufficiency of disclosure.
In this case, the original patent application documents described a technical effect of a
surprisingly high metabolic stability and bioavailability. But a person skilled in the art
cannot confirm the compound of Claim 1 actually has the said effect merely based on
the original patent application. The supplementary experimental data provided by
AstraZeneca AB intended to prove that the to-be-confirmed fact is authentic, i.e. the
compound of Claim 1 does have a surprisingly high metabolic stability and
bioavailability, so as to prove inventiveness in a further step. Therefore, the
supplementary experimental data was not used to overcome the deficiencies
inherently present in the original application and shall be accepted.
The court held that, in the field of pharmaceutical research and development, in
particular for the R&D of a novel pharmaceutical, the subjects of R&D are relatively
centralized. Therefore, the sources where the supplementary experimental data come
from are also relatively centralized. The fact that the provider of the relevant
supplementary experimental data and the patent applicant or the patentee has a
relationship of interest such as employment or the like is in line with the convention
or practice of R&D, and these facts shall not be the sole ground for not accepting
supplementary experimental data.
In view of the above, the original judgment for not accepting the supplementary
experimental data submitted by AstraZeneca AB was erroneous and has been
corrected by the appellant court.
Points of Significance
Courts should accept supplementary data where the original patent application
documents have clearly described or implicitly disclosed the to-be-confirmed fact that
is intended to be directly proved by the supplementary experimental data, and where
the data is not intended to remedy deficiencies present in the original patent
application.