Patenting Methods Of Producing Transgenic Mice

The EPO Board of Appeal and UK High Court have recently issued conflicting decisions on the validity of Regeneron Pharmaceuticals' European Patent for the VelocImmune therapeutic antibody development platform.

The Regeneron patent ( EP 1360287) relates to methods of producing transgenic mice possessing human antibody genes that produce complete human antibodies and respond naturally to antigenic challenge. Preserving these natural responses enables concurrent production of a large number of diverse human antibodies within the same mouse against the same target. Therapeutic antibody development previously required cloning of a specific human antibody gene into the mouse, or relied on chimeric antibodies containing both mouse and human components. The Regeneron approach therefore significantly increases the efficiency of therapeutic antibody development and reduces the potential toxicity of the resultant antibodies. The VelocImmune platform has proved to be one of the most effective strategies available for the development of novel antibody therapeutics.

During Opposition proceedings before the EPO brought by Kymab and Merus, the Regeneron VelocImmune patent was revoked for lacking...