8.1. Neuheitskriterien für Ansprüche auf eine nicht medizinische Verwendung und Verfahrensansprüche, die ein Verwendungsmerkmal enthalten
Übersicht
8.1. Neuheitskriterien für Ansprüche auf eine nicht medizinische Verwendung und Verfahrensansprüche, die ein Verwendungsmerkmal enthalten
- T 2387/22
In T 2387/22 claim 1 according to auxiliary requests 9 to 11 defined the use of a Vacuum Metallised Pigment (VMP) in a flexographic ink formulation for providing the following technical effects: "fewer print defects, higher hiding and stronger colour and allowing a lower volume anilox". The respondent (patent proprietor) submitted that according to G 2/88, when a use claim defined technical purposes or effects, these were to be interpreted as functional features restricting the scope of protection.
According to the appellant (opponent) these functional features did not meet the requirement of clarity under Art. 84 EPC, since they were defined using relative terms as well as diffusely defined concepts. The respondent replied that it was a well-established practice of the boards to allow the definition of effects or purposes in non-medical use claims using broad and/or relative terms.
The board observed that there was no basis – be it in the case law or in the EPC – for concluding that the limiting functional features of a use claim are exempt from the clarity requirement under Art. 84 EPC or somehow exposed to lower standards in this respect. It however emphasised that – irrespective of whether a claim was directed to a use or to any other category of subject-matter – the mere breadth of protection did not in itself imply a lack of clarity. The decisive consideration was whether the feature(s) in question gave(s) rise, or could plausibly give rise, to legal uncertainty when assessing whether a particular subject-matter falls within or outside the scope of protection conferred by the claim.
Moreover, the board stated that, where the invention was based on the discovery of a new technical effect of a known entity (as in G 2/88 and G 6/88), it was generally accepted in practice to define that effect in correspondingly broad terms, provided the effect was sufficiently distinct to clearly delimit the scope of protection with respect to the prior art. The situation in the present case was, however, fundamentally different. The use claim did not seek to define distinct technical effects, but rather relative improvements in the achievement of such effects..
The board held that where a claimed invention is defined by the use of a known entity to achieve a known technical effect or purpose, and the alleged technical contribution lies in a relative improvement or enhancement of that effect or purpose, the requirement of clarity under Art. 84 EPC generally demands that the feature defining such relative improvement or enhancement be expressed in objectively verifiable terms, thereby ensuring legal certainty regarding the scope of protection. In these "relative-improvement" scenarios, any imprecise functional language could blur the distinction between claimed and known uses, giving rise to the very legal uncertainty that the clarity requirement is intended to prevent.
In the present case, the board concluded that no objective criteria were available for determining when the number of print defects, the degree of hiding, the colour intensity or the anilox volume could be regarded as sufficiently low or high for other uses to fall within or outside the scope of the claim. As a result, the subject-matter of claim 1 could not be assessed objectively in relation to the prior art, which gave rise to legal uncertainty and therefore failed to meet the clarity requirement of Art. 84 EPC.
- T 2192/22
In T 2192/22, the claims related to improved processes for purifying polypeptides of interest, by increasing the amount of a polypeptide of interest bound to a cation-exchange matrix relative to the amount of one or more impurities bound to the ion-exchange matrix..
The patent proprietor was of the view that the claim was such that its subject-matter should be recognised as novel under G 2/88 since it related to the use of a known compound for a new purpose not made available in the prior art – i.e. "the reduction of host cell proteins (HCPs) in the purification of a polypeptide of interest by cation-exchange chromatography".
The board however, concurred with the findings in T 892/94, that applying the concept of novelty developed in G 2/88 to claims for processes of producing a product, even when drafted as use for achieving a technical effect that results in an improved product could potentially result in a permanent monopoly of the use of a known substance for a known purpose. Such a permanent monopoly would arise from the repeated drafting of claims for a process of production including a new, possibly only subtly different, technical effect associated with this known process (T 1179/07).
In the present case, drafting the claim as a "use" of a chemical compound could not mask the fact that the claim defined a production/purification process and the new technical effect could only take place in the context of this process. The mere formatting of the claim to give the appearance that its subject-matter falls under the principles established by G 2/88 could not circumvent the fact that on analysis, the claim was directed to a use or process for the production of a product, here one having the "improved" property of having "reduction of host cell proteins".
Moreover, the alleged new technical effect of reduction of host cell proteins pertained to the product (the polypeptide) and could not be considered a technical limiting feature of the "use" according to G 2/88. Indeed, where an invention relates to a new technical effect of a physical entity that can only occur as part of a process for the production or manufacture of a product, such that this effect is inextricably linked to and cannot occur in isolation from the production process, a claim directed to that "use" of the physical entity to achieve that effect must be regarded as directed to the production process per se (T 1913/21).
The assessment of novelty in the present case was therefore done by answering the question of whether or not there was a disclosure forming part of the state of the art of a process having the same physical steps as the claimed process, i.e. purifying a polypeptide of interest by CEX chromatography, wherein at least one of the equilibration, loading and/or washing fluids contained a chemical structure with amino groups and/or cationic amino acid polymers, in a concentration of at least 7 mM. No other features were explicitly or implicitly implied by the wording of the claim. The board found that the prior art anticipated the claimed subject-matter and denied novelty.