The patent relates to long-acting formulations of insulin and has already been discussed in the present blog but under a different topic.
Brief outline of the case
The opponent appealed the decision of maintenance according to a new MR filed during OP before the OD.
In the summons to OP before the OD, the OD held that claim 1 as granted lacked N over D1=US 2004/048783, the only document of category X,A in the ISR established by the EPO.
The board confirmed the decision of maintenance according to the MR.
Claims 11-23 related to the use of the long-lasting insulin for the treatment of Diabetes Mellitus Type I or II, and defined a concentration of insulin glargine of 270-330 U/ml being equimolar to 270-330 IU human insulin, and further comprising in the range of 20 – 400 µg/ml zinc.”
The case is interesting as it deals with the topic of novelty of purpose-limited product claims pursuant to Art 54(5) relying on a dosage regimen defined by a numerical range.
Claims 11-23 – The opponent’s point of view
According to the opponent, the subject-matter of claims 11- 23 of the MR lacks novelty over D12=DE 10 2008 053048, because the insulin glargine concentration defined in said claims falls within the broad meaning of the term “dosage regimen” as used in G 2/08, OJ 2010, 456, and yet is not characterised by any technical effect that would be particular to said sub-range compared to other concentrations within the range disclosed in D12.
The opponent did not, however, object to the novelty of claim 1.
The opponent argued that in the case of purpose-limited product claims pursuant to Art 54(5) relying on a dosage regimen defined by a numerical range, a selection from the prior art must be purposive for it to be novel.
Claims 11-23 – The board’s decision
It is undebated that D12 does not disclose a concentration of insulin glargine in the composition in the claimed range of 270-330 U/ml.
The OD’s finding that this claimed range is narrow compared to the range of D12 [criterion (a)] and far removed [criterion (b)] from any specific example of this document, in which the concentration of insulin glargine is always 100 U/ml, is not contested.
In this respect, the board concurred with the most recent decisions, including T 261/15, Reasons 2.2.2, according to which the former criterion of purposive selection [criterion (c)] is relevant for the question of inventive step rather than for novelty.
This is reflected in the Guidelines for Examination in the EPO, which state since 2019 that only criteria (a) and (b) need to be fulfilled, see G-VI, 8 (ii) – November 2019 version).
For the sake of completeness in relation to this point, the board observes that already in the landmark decision T 198/84 it was affirmed that the presence of a newly discovered effect in a sub-range singled out of a larger range (purposive selection) was not a prerequisite for novelty (see point 7).
For the board, the subject-matter of claim 1 was novel over D12.
As to claims 11 and 23, the fact that the compositions of these claims are limited, in comparison with claim 1, by the feature pertaining to their specific use in a method of treatment of Type I or II Diabetes Mellitus, does not entail that the features pertaining to the concentration of insulin glargine should no longer be regarded as defining the composition, but merely its use.
Neither decision G 2/08, see points 6.1 and 6.3, which merely abstain from precisely defining the term “dosage regimen”) nor its reference to T 1074/06, where the claims related to doses, and not concentration, justify reading the word “concentration” of claims 11 and 23 as a dosage regimen.
In claims 11 and 23 just as in claim 1, the concentration feature defines the composition itself, i.e. the amount of insulin glargine in the composition, and not the use of the composition, i.e. the dose given to a patient at particular times or time intervals.
This concentration feature thus establishes novelty for the subject-matter of claims 11 and 23 for the same reasons as for claim 1.
Additionally, considering the case law in the general situation of selections from numerical ranges, the board was not convinced by the opponent’s argument that in the case of purpose-limited product claims pursuant to Art 54(5) relying on a dosage regimen defined by a numerical range, a selection from the prior art must be purposive for it to be novel.
The board added that in point 6.3 of G 2/08 the EBA stated that “the claimed definition of the dosage regime must therefore not only be verbally different from what was described in the state of the art but also reflect a different technical teaching“.
However, under the same point of the reasons the EBA explained that “for the assessment of novelty and inventive step of a claim in which the only novel feature would be the dosage regimen, the whole body of jurisprudence relating to the assessment of novelty and inventive step generally also applies“.
In the board’s view, this indicates that G 2/08 did not seek to establish different novelty criteria for numerical ranges in the case of dosage regimen.
The opponent’s objection must fail for the additional reason that, even if the concentration features of claims 11 and 23 were arguendo seen as a dosage regimen, the former criterion of a purposive selection [criterion (c)] should no longer be regarded as a requirement under G 2/08 for a dosage regimen to represent a novel selection from a broader range known in the prior art.
It is after a long series of decisions T 198/84, T 305/16 (Reasons 2.1), T 1233/05 (Reasons, 4.4), T 230/07 (Reasons, 4.1.6), T 1130/09 (Reasons, 3.2), T 1948/10 (Reasons, 3.6), T 378/12 (Reasons, 4.8 to 4.9) or T 261/15, that a new line of case law has emerged according to which the criterion of “purposive selection” is only relevant for the question of inventive step, and not for novelty.
It took a long-time for the EPO to amend the Guidelines in order to transfer the criterion (c) of “purposive selection” to inventive step.
That the criterion of purposive selection has been transferred to IS has a direct influence in presence of prior art under Art 54(3). Provided the selected range is narrow and far enough away from the boundaries or any specific value within the range, N is given. It remains nevertheless that deciding on “narrow” and “far enough away” is a case by case decision.
This is most probably the reason why it took so long to amend the Guidelines.
Once the criterion (c) of “purposive selection” being transferred to IS, there was no reason not to apply it on substances and compositions pursuant to Art 54(5) falling under the case law “dosage regimen”.
In this respect it is worth noting that in case of deleting essential features, the test still figures in the Guidelines not under the name “essentiality test”, but under the name “three points test”, cf. Guidelines H-V, 3.1. The boards have clearly stated in their case law their dislike of the three point test. See T 2311/10, T 619/18 or T 2420/18. The three point test is thus still used by ED’s or OD’s, ev en if it is summarised under G 2/10.