EP 3 528 847 B1 relates to relates to a pharmaceutical preparation of thyroid hormone T4 in an alcohol-free water-glycerol solution.
Brief outline of the case
The opposition was rejected and the opponent appealed.
The board decided that claim 1 as granted lacked IS.
As AR1 was not admitted under Art 12(3+4) RPBA, the patent was revoked.
Claim 1 of AR1 consisted of claims 1+6 as granted.
The opponent’s point of view
The product according to claim 1 as granted differed from the product disclosed in D1 only by its packaging. The OTP was seen in the provision of an alternative pharmaceutical preparation that provided the T4 solution in suitable alternative packaging.
The skilled person seeking to solve the OTP by providing alternative packaging would have found a solution in document D2, which disclosed LDPE containers in PET/Al/PE sachets as a suitable packaging option for similar T4 solutions.
D2 also disclosed that T4 solutions stored in this packaging system had good storage stability, including with regard to T4/T3 conversion, if that aspect of stability were to be taken into account.
Composition of the OD
When filing its opposition, The opponent also requested that none of the examiners having participated in examination should be member of the OD as this “reflects the general wish of the users of the European Patent System as discussed by SACEPO”.
The proprietor’s point of view
It was not correct to use D1 as the starting point for the assessment of IS because D2 was in fact the CPA. Any conclusion on IS reached on the basis of D1 as the starting point would, therefore, not be meaningful.
If D1 were nevertheless to be used as the starting point, the proprietor acknowledged that the product of claim 1 as granted differed only by its packaging from the product disclosed in D1.
The experimental data reported in the patent in suit, and in further experimental data, showed that, in terms of storage stability, the claimed product provided high protection against unwanted premature conversion of T4 to T3.
If the OTP were to focus, instead, on a change in packaging, this would constitute ex post facto reasoning, since the skilled person was not selectively guided to work only on the packaging.
The skilled person would in any case have had reservations about changing the packaging of a successful product with regulatory and marketing approval, such as the product of D1. Furthermore, it had to be assumed that the packaging in D1 was critical to product stability.
The skilled person would not have had the expectation that any type of packaging, and specifically the packaging system defined in claim 1 as granted, would be equally suitable and, moreover, would ensure high protection against the conversion of T4 to T3.
The packaging system disclosed in D2 was not known in the art as a conventional system, and it would not have been chosen for similarity to the system in D1, either.
The inventors found that stability against premature T4/T3 conversion was improved if alcohol was omitted from the solutions.
The case law of the boards considering any potential starting point in the prior art was not correct, and in the case at hand it was thus not correct to select D1 as the starting point.
The board’s decision
Choice of the CPA
The proprietor’s argument that D1 is not a permissible starting point for assessing IS because another document is the “closest” prior art is flawed since it is based on a misconception regarding the role of the so-called “CPA” in the application of the problem-and-solution approach.
Any prior disclosure may be used as the starting point for the assessment of IS, and also as supplementary prior art in alternative scenarios with different starting points.
The selection of a starting point serves the purpose of assessing IS and is performed by the deciding body, which makes its selection from the cited prior-art disclosures that are eligible under Art 56.
Depending on the circumstances of the individual case, either only one starting point or several alternative starting points will have to be considered.
Comparative remoteness does not prohibit the consideration of any prior disclosure as a starting point in a detailed step-by-step assessment according to the problem-and-solution approach. If a chosen starting point is “too remote” from the claimed subject-matter in terms of structural features and purpose, the problem-and-solution approach will simply not result in a finding of obviousness.
The concept of the “CPA” is not relevant in a situation where an inventive step cannot ultimately be acknowledged.
Since, in the case at hand, the assessment with D1 as the starting point resulted in a finding of lack of IS, it is not relevant whether another piece of prior art might be even closer to the claimed subject-matter.
For the board it was meaningless to assert that D2 is “closer” to the claimed invention than D1, or vice versa.
Lack of IS
The immediately apparent technical effect of the difference with D1 is that the same T4 solution is presented in different packaging. The claimed product is an alternative to that of D1 in the sense that its shelf life is adequate, as is the shelf life of 18 months reported in D1.
The OTP is to provide an alternative pharmaceutical preparation that provides the T4 solution in suitable alternative packaging.
It was not shown in the patent in suit or by the post-filed data that the claimed product provides improved stability against T4/T3 conversion in comparison to the product of D1, which differs from the claimed product only by its packaging.
The board was of the view that the skilled person seeking to solve the OTP would have consulted D2, since it relates to the same type of medicament, T4 solutions, and describes possible packaging options under the aspect of product stability.
Comments
The present decision makes clear that the choice of the CPA is not so relevant in a situation where IS cannot ultimately be acknowledged.
If one piece of prior art is taken as CPA and allows to show a lack of IS, on its own or in combination of other pieces of prior art, it is moot to decide whether there could be another prior to be used as CPA.
Composition of the OD
It is somehow surprising that wishes expressed in SACEPO should become procedural rules at the EPO. The SACEPO has no competence to amend, even indirectly, the EPC. The proprietor resisted this move, and the OD made clear in the annex to the summons, that the composition of the OD was in conformity with Art 19(2).
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