GL G II 5.6.1.7 Definition by hybridoma

Antibodies may also be defined through a deposited hybridoma cell producing the antibodies. The general requirements for deposited biological materials apply, see F-III, 6.3.

GL G II 5.6.1.6 Definition by the epitope

An antibody may be defined also by its epitope, i.e.

GL G II 5.6.1.5 Definition by production process

Antibodies can be defined by the process of their production, i.e.

GL G II 5.6.1.4 Definition by functional and structural features

Antibodies can also be defined by both functional properties and structural features. It is possible to claim an antibody characterised by the sequences of both variable domains or CDRs with less than 100% sequence identity when combined with a clear functional feature.

GL G II 5.6.1.3 Definition by target antigen and further functional features

In addition to the functional definition by the antigen it binds to, claims directed to antibodies can be further characterised by functional features defining further properties of the antibodies; for example, the binding affinity, neutralising properties, induction of apoptosis, internalisation of receptors, inhibition or activation of receptors (c.f. e.g.

GL G II 5.6.1.2 Definition by reference to the target antigen

An antibody can be functionally defined by the antigen it binds to, as long as the antigen is clearly defined in the claims. If the antigen is defined by a protein sequence, no sequence variability and no open language (e.g. an antigen comprising …) can be used in the definition of the antigen.

GL G II 5.6.1.1 Definition by structure of the antibody

Since the three CDRs of each of the variable domains of the light and heavy chains are normally responsible for binding to the antigen, the conventional antibody, in order to be uniquely defined by its structure only and have its characteristic binding specificity, needs to be defined by at least these six CDRs to fulfil the requirements of Art. 84.

CDRs when not defined by their specific sequence must be defined accord

GL G II 5.6.1 General remarks

Conventional antibodies are large, Y-shaped proteins naturally produced by plasma B-cells and composed of two identical light chains and two identical heavy chains, both containing variable and constant domains.

GL G II 5.6 Antibodies

5.6.1 General remarks

5.6.2 Inventive step of antibodies

GL G II 5.5.2 Repeatability of results of microbiological processes

In the case of microbiological processes, particular regard has to be had to the requirement of repeatability referred to in F‑III, 3. As for biological material deposited under the terms of Rule 31, repeatability is assured by the possibility of taking samples (Rule 33(1)), and there is thus no need to indicate another process for the production of the biological material.[Rule 33(1); ]