Outline of the Court Case
IPHC Case Number: 2020(Gyo-Ke) 10071
Case Type: Revocation Action against the JPO Decision of Invalidation Trial
Judgement Date: February 2, 2022
Plaintiff: Sawai Pharmaceutical Co., Ltd. (Petitioner of Invalidation Trial)
Defendant: Asahi Kasei Pharma (Patentee)
Japanese Patent No.: 6150846 (Present patent)
Title of Invention: PTH-containing therapeutic/prophylactic agent for osteoporosis, characterized in that PTH is administered once a week in a unit dose of 100-200 units.
Summary of the Judgement:
- The IPHC dismisses the JPO Decision of Invalidation Trial that found inventive step in the present invention. (JPO Invalidation Trial Number: 2018-800080)
- The IPHC orders the Defendant to shoulder litigation costs relating to this court case.
Main Issue:
Whether or not the present invention has inventive step in that whether Differences 1 and 2 could have easily been conceived of.
Introduction
Determination of inventive step proceeds with the following steps in Japan.
- Determination of identical feature and differences between the claimed invention and its closest prior invention (main cited invention).
- Determination of whether a person skilled in art could have easily conceived of the differences in the claimed invention with the main cited invention
- Consideration of whether there are circumstances which prevent a sub-cited invention from being applied to the main cited invention [obstructive factors]
- Consideration of whether the claimed invention has an unexpected advantageous effect
This articles introduces “unexpected advantageous effects” in determining inventive step, as addressed in the main issue of this IPHC case.
Case History and Overview
Defendant is a patentee who holds a patent that has a title of invention of “PTH-containing therapeutic/prophylactic agent for osteoporosis, characterized in that PTH is administered once a week in a unit dose of 100-200 units.” The Plaintiff filed a request for invalidation trial for the present patent at the JPO in 2018. On the invalidation trial, the JPO issued a trial decision that dismissed the Plaintiff's request. The JPO states in the decision that “For corrected Claim 2, the JPO permits the corrections of the claims of Japanese patent No. 6150846 as recited in the corrected claims attached to the written request for correction. The request for the invalidation trial against Claim 1 and Claim 2 of the present patent does not stand.” In response to this JPO trial decision, Plaintiff brought the above litigation to the IPHC, seeking revocation of the present JPO trial decision.
Now, the following parts of the article pick up the effects of the present invention in this IPHC case.
Ground for judgement: unexpected advantageous effects
Firstly, with reference to the case law, the IPHC states how to judge unexpected advantageous effects as follows.
“It should be considered whether effects of the present invention are unexpected advantageous effects from the perspective of whether the effects of the present invention could have not been expected by the person skilled in the art based on the constitution of the present invention as of the base date for determining the patentability of the present invention; and whether the effects of the present invention are remarkable beyond the scope of effects which the person skilled in the art could have expected based on the constitution of the present invention.
Understandably, it is difficult to judge whether the effects are unexpected advantageous effects only based on the constitution of the present invention. Therefore, it is understood that it is permitted to refer to effects of the cited invention which is chosen as the close prior art to the constitution of the present invention, or similar effects that have achieved in the technical level of that time. To be clear, it is the patentee who is responsible for the burden of proof of unexpected advantageous effects. Thus, it cannot be said that the present invention has unexpected advantageous effects only for the reason that effects derived by the constitution of the present invention is unknown.”
Secondly, the IPHC considered the Defendant's arguments that the person skilled in the art could not expect the following Effects 1, 2, and 3 of the present invention.
- It is common knowledge that the effects for inhibiting an exacerbated vertebral body fracture being less than the effects for inhibiting a new vertebral body fracture is expected. However, it has been proven that the constitution of the present invention has effects for inhibiting an exacerbated vertebral body fracture which are the same as or greater than the effects for inhibiting a new vertebral body fracture. [Effect 1]
- Relative risk reduction rate (RRR) of an exacerbated vertebral body fracture by the constitution of the present invention is unexpectedly higher than the RRR of continuous daily administration of Forteo. [Effect 2]
- The effects for inhibiting an exacerbated vertebral body fracture cannot be expected by the increase rate of bone mineral density (BMD) that is anticipated by continuous daily PTH administration, or are higher than the BMD increase rate that is anticipated based on the constitution of the present invention. [Effect 3]
[Regarding Effect 1]
The IPHC states as follows.
“As of the base date for the present case, relative risk reduction rate (RRR) was commonly known as an index for therapeutic effects while absolute risk reduction rate (ARR) and number need to treat (NNT) were commonly known as indices for benefits of therapy. If only RRR is considered, a subtle difference in clinical trial data may be replaced with a huge number. Therefore, the technical common knowledge of that date was that it is necessary to consider not only RRR but also ARR and NNT in order to precisely evaluate therapeutic effects.
In addition, with regard to the incidence rates of an exacerbated vertebral body fracture and new fracture, Tables 20 and 34 in the present specification also describe “difference between the incidence rate of bone fracture among a test drug administration group and the control drug administration group in 72 weeks after the drugs administration,“ which is equivalent to ARR.
…The value of ARR for an exacerbated vertebral body fracture in Table 20 is similar to the value of ARR for an exacerbated vertebral body fracture shown in the plaintiff's documents 57 and 98. The value of ARR of a new vertebral body fracture in Table 34 is also similar to the value of ARR for a new vertebral body fracture shown in the plaintiff's document 57. Considering these facts, it cannot be instantly judged that the effect for inhibiting an exacerbated vertebral body fracture in the present invention is equivalent to or more than the effect for inhibiting new fracture of vertebral body, only from the fact that the RRR of the new vertebral body fracture and the RRR of exacerbated vertebral body fracture of the group of administration of 200 units of PTH per week in comparison with the placebo group, can be calculated to be 79% and 83%, respectively, from Tables 20 and 34. Moreover, even reading through the whole of the present specification, there is no description that specifies that the effect for inhibiting an exacerbated vertebral body fracture is equivalent to or more than the effect of a new vertebral body fracture, and no technical explanation on any action mechanism that describes the above effect.
Consequently, Effect 1 cannot be deemed an unexpected advantageous effect for an exacerbated vertebral body fracture.”
[Regarding Effect 2]
In light of the above discussion on Effect 1, the IPHC finds that “comparison with RRR of Forteo (Teriparatide) of continuous daily PTH administration shown in the plaintiff's documents 57 and 98 cannot support the unexpected advantageous effect of the present invention” for the inhibition of an exacerbated vertebral body fracture. Hence, the IPHC judges that Effect 2 cannot be deemed to be an unexpected advantageous effect.”
[Regarding Effect 3]
The IPHC states as follows.
“The Defendant argues that “the present invention has an unexpected advantageous effect in that the invention further mitigates relative risk of bone fracture in spite of low increase rate of BMD, in contrast to the relative risk of bone fracture in relation to the BMD increase rate which is anticipated based on continuous daily PTH administration.” This Defendant's argument was submitted as a counter argument against the Plaintiff's argument based on the Defendant's arbitrary prediction by combining clinical trial results described in the document different from the present specification with the description in the present specification. Obviously, there is no description in the present specification regarding correlation between the BMD increase rate anticipated from continuous daily PTH administration and the relative risk of bone fracture. Therefore, the Defendant merely argues effects which are not described in the present specification, and there is no other way to say but the Defendant's argument is unreasonable.
With the above discussion, the IPHC made conclusion as follows.
“It is recognized that the constitution of the present inventions 1 and 2 in the present invention pertaining to Differences 1 and 2 could have easily been conceived of. Moreover, it is not recognized that the effects of the present inventions 1 and 2 are advantageous effects which could not be expected by the person skilled in art. After all, the person skilled in art could have easily conceived of Differences 1 and 2. Thus, the JPO made an erroneous trial decision that Differences 1 and 2 could not have easily been conceived of.”
Our Analysis
The JPO Examination Standards stipulate that “an advantageous effect compared to a cited invention is a factor in support of the existence of the inventive step. If such an effect is explicitly understood from the description of a specification, claims, or drawings, an examiner takes it into consideration as a circumstance in support of the existence of an inventive step.”
Particularly, the Examination Standards also stipulate that regarding an advantageous effect which an applicant asserts or proves in Remarks, etc., an examiner has to take the effect into consideration for judging the inventive step “in case where the effect is described in the specification” or “in case where the effect is not described in the specification but the person skilled in art could deduce the effect from the specification or the drawings.” On the other hand, the Examination Standards stipulate “in case where the effect which is asserted or proved in Remarks, etc. is not described in the specification or cannot be deduced from the specification or the drawings by the person skilled in art, the examiner should not take the effect into consideration.”
The present judgement concluded that the present invention does not have unexpected advantageous effect on the ground that the effects of the present invention which the patentee argues are not sufficiently supported by the description of the specification by detailed consideration of the explanation and the clinical trial data in the specification from technical and statistical perspectives.
From the standpoint of an applicant or patentee, it is important, in order to argue unexpected advantageous effects, that the effects can be at least deduced from the specification or the drawings. Therefore, it is desirable to describe at least qualitative effects of the present invention or an action mechanism in an original specification. In addition, you should carefully check whether the effects of the invention are supported in a scientific or statistic manner by experimental examples in the original specification during the preparation of the specification.
From the standpoint of a Demandant of an invalidation trial, it may be effective, in order to deny unexpected advantageous effects, to establish common technical knowledge with specific evidence to argue that the effects are not sufficiently supported by the experimental examples. Especially in the pharmaceutical field, you should also carefully check whether interpretation of the clinical trial data in a specification is statistically appropriate.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
