Key points
- The bonus effect rule can be used to hold a claim obvious despite the claimed subject matter providing a surprising technical effect.
- "in the Board's view, the case law on bonus effects cannot be applied to all situations where a given differentiating feature [...] two separable technical effects [...], one of which may be expected. For an additional, unexpected effect to be disqualified as a mere bonus effect, it must be shown either that the situation is characterised by a lack of alternatives as regards the means for achieving the first, expected improvement (i.e. a "one-way-street" situation as explained in T 192/82), or that, considering the relative technical and practical importance of the effects in the circumstances of the case, the additional unexpected effect is merely accidental (following T 227/89 and T 1147/16) [effect was no bonus effect]. In situations which do not qualify as a "one-way street", the Board does not consider it appropriate that a /crucial and unexpected technical advantage be disregarded in the assessment of inventive step as soon as any additional obvious effect is mentioned in the patent."
- T227/89: "In determining which effect is crucial and which is merely accidental (so-called "bonus effect"), a realistic approach has to be taken, considering the relative technical and practical importance of those effects in the circumstances of a given case. In the present case, tensile strength, elongation at break and thermal stability are at least as important as the blooming properties for the overall value of the compositions in question, and any improvements thereof cannot therefore be disqualified as being merely accidental."
- "The Board is aware of the view expressed in T 1317/13 (see point 24 of the reasons) that a "one-way-street" situation is not a mandatory prerequisite for the application of the principle established in T 21/81 (see above). However, neither T 1317/13 nor T 21/81 offer a basis for an unqualified application of the bonus effect case law to any situation of plurality of technical effects without regard to their respective technical and practical importance. The Board's view in this regard is in agreement with the statement in decision T 192/82 (see point 16 of the reasons) that the use of means leading to some expected improvements might well be patentable if relying on an additional effect, provided this involves a choice from a multiplicity of possibilities."
- Note that the cited decisions are either old or relatively new.
- In the case at hand, the two effects are reduced discomfort/injection volume (unsurprising); and flatter PK/PD profile/longer duration of action (surprising) as a result of a concentration increase of an injected medicament.
- "The present case does not qualify as a "one-way-street" situation. As argued by the respondent, the skilled person could have addressed the issue of discomfort caused by the injection of larger volumes of the formulation by other means than an increased concentration, such as dividing the injection into several smaller volumes, adding further substances that facilitates diffusion at the injection site avoiding the formation of a large depot, heating the injection site to increase diffusion, including an analgesic, ..."
- "the effects of flatter PK/PD profiles and longer duration of action cannot be regarded as merely accidental, but instead represent crucial advantages in the context of basal insulins. "
- "this PK/PD effect was discovered only after arriving at the higher concentration formulation [to reduce injection volume], and would thus be nothing but an additional bonus effect [according to the opponent]. However, in the Board's opinion, it would also not be appropriate to disqualify the effect of flatter PK/PD profiles and longer duration of action as accidental, i.e. as being of lesser technical and practical importance, on account that these effects may be the result of a serendipitous discovery. What matters when deciding if the pK/PD profile effect is to be taken into account is not in what circumstances the inventors realised the invention, but what the invention achieves."
- "Similarly, the Board is not convinced that the effect of reduced discomfort and injection volume should be regarded as a bonus effect either. For the reasons given above (see 3.4.3), the fact that two technical effects arise from the same distinguishing feature does not mean that one of the two effects must necessarily be regarded as a bonus effect. However, considering that the effect on PK/PD profile and duration of action must be taken into account and already leads to the acknowledgement of an inventive step (see below), the question whether the reduced discomfort and injection volume should be additionally considered may be left unanswered."
- " the subject-matter of the main request involves an inventive step."
EPO
The link to the decision is provided after the jump, as well as (an extract of) the decision text.
source http://justpatentlaw.blogspot.com/2024/01/t-135621-limits-on-bonus-effect-rule.html
