Key points
- I missed this case when it was published in Feb. 2020.
- “The respondents [patentees] concur with the opposition division in the definition of the problem, namely the provision of imatinib tablets improving patients compliance, i.e incorporating the entire daily dosage of 400 mg imatinib in a single tablet of acceptable dimensions, or reducing the dimensions of a tablet comprising a 100 mg dose, wherein the tablets have acceptable properties, as regards hardness, and a disintegration time of 20 minutes or less.”
- “It has to be investigated whether there is sufficient evidence supporting the alleged effects. For this purpose, documents C76 and C70 were mentioned by the respondents [patentees] and discussed during oral proceedings in support of the existence of an effect.”
- “The use of document C76 was contested by [opponent] appellant 02. According to appellant 02, this document related to experiments on desired tablet properties which were carried out after the filing date and which referred to effects not plausibly shown to be achieved by the claimed tablets in the original application. There was no mention or evidence in the original application that an effect as regards hardness, abrasion resistance, friability or disintegration time had been plausibly achieved by the claimed tablets.”
- “The Board cannot share this view. This line of argumentation appears to be incompatible with the assessment of inventive step according to the problem-solution approach, ... Said technical effect or problem must either be explicitly mentioned in the application as filed or at least be derivable therefrom, but not necessarily originally supported by experimental evidence. It can indeed not be expected from a patent applicant to include an extensive number of experimental evidences corresponding to all technical features which can possibly be claimed in the application as filed and which can possibly constitute a future distinguishing feature over the closest prior art, since said closest prior art and its technical disclosure may not be known to the applicant at the filing date of the application.”
- “C76 has been filed with the intention to proof the [advantageous properties stated in the patent] reached by tablets [...] comprising cross-linked PVP in the claimed amount over the tablets obtained by wet granulation and comprising cross-linked PVP in an amount lower than 10% by weight. Hence, disregarding the tests of C76 which intend to demonstrate an improvement in the tablet properties over the closest prior art would be incompatible with the problem-solution approach.”
- However, C76 is not a clear comparison with example 8 of the prior art document D7. “Accordingly, the experiment C76 cannot constitute evidence supporting the alleged effects.”
- This implies that the above remarks regarding the plausibility requirement being incompatible with the problem-solution approach is obiter, i.e. is also a point that Board 3.3.07 wanted to express in this decision.
- The difference was using wet granulation vs. dry compression to make the tablets, document C76A and C76B purportedly showing the same advantages but using direct compression, as in C7. However, these documents were not admitted as being late filed.
- “Since it is not possible to establish the existence of an improvement over the prior art as regards the amount of cross-linked PVP, the technical problem must be formulated as proposed by [opponent] appellant 02, namely the provision of an alternative tablet comprising a high amount of compound I [imatinib].”
- After detailed analysis, “Accordingly, the claimed solution as regards the amount of 10-35% by weight of cross-linked PVP is obvious.”
- The patent is revoked.
- It was the 2nd appeal, after T 0571/11. The patent was granted in 2007, with PCT application filed in 2003. So the patentee managed to keep something pending for about 18 years, with the EPO needing 14 years to finally dispose of the opposition.
- Let me be clear: I think such a length of proceedings is generally unacceptable for the general public, not only but in particular for patents for medicaments.
- The Board, regarding partial problems: “The Board can however not follow this argument [of patentee, that the partial problem approach must not be used because the two distinguishing features are interrelated], since the application as filed is silent as regards this alleged interrelation or interdependence, which is also not implicitly derivable from the disclosure of the application as filed.” “the alleged interrelation between the amount of compound I of 30-80% by weight and of cross-linked PVP of 10-35% by weight does not find any basis in the application as filed and is also not implicitly derivable therefrom. The effect of each distinguishing technical feature has therefore to be considered separately.”
T 0031/18 -
https://www.epo.org/law-practice/case-law-appeals/recent/t180031eu1.html
2.4 The respondents concur with the opposition division in the definition of the problem, namely the provision of imatinib tablets improving patients compliance, i.e incorporating the entire daily dosage of 400 mg imatinib in a single tablet of acceptable dimensions, or reducing the dimensions of a tablet comprising a 100 mg dose, wherein the tablets have acceptable properties, as regards hardness, and a disintegration time of 20 minutes or less.
Appellant 09 defines the problem as the provision of a tablet comprising a high drug load, that disintegrates within a certain amount of time and that employs a compound other than microcrystalline cellulose as a binder.
source http://justpatentlaw.blogspot.com/2021/11/t-003118-imatinib-and-no-plausibility.html
