UPC Local Division: Interpretation, Infringement (Pharmaceutical Formulation)

The independent product claim protects a pharmaceutical formulation of the anti-IgE antibody rhuMAb E25, characterized by the formulation comprising approximately 150 g/L of the anti-IgE antibody in 0.02 M histidine, 0.2 M arginine-HCl, 0.04% polysorbate 20, at pH 6. A person skilled in the art understands that 0.02 M histidine also implies the presence of its protonated form with a counterion. The wording of the claim is limited to the specific components because there is no indication that “is” has a meaning other than “consists of,” nor is there any indication in the description that other components are included. However, the skilled person does not stop at the purely philological interpretation and instead always considers the technical function of the feature and the features in their context. Therefore, the skilled person will not interpret every feature in isolation but will understand that the feature of 0.02 M histidine must be viewed in conjunction with the claimed pH of 6. Histidine functions as a buffer to protect a solution from changes, and has its optimal buffering capacity at around pH 6. The skilled person is generally aware of which chemical structures the components must have to achieve a specific pH. This means that for the claimed pH of 6, histidine must be present in approximately a 1:1 mixture of its neutral form and its protonated (1+) form with a counterion (Local Division Düsseldorf, 6 September 2024, Court of First Instance 165/2024).