Patent opportunities for monoclonal antibody inventions
A recent paper in Nature Biotechnology presents general patenting guidelines for therapeutic monoclonal antibodies in Europe.
Antibodies offer a wide range of applications, particularly in diagnostics, protein purification and forensic medicine. And recently, many monoclonal antibodies (mAbs) have been developed for use as therapeutic agents for diseases including cancer, immune deficiencies and autoimmune diseases. They can also be used to stimulate or repress the immune system and as carriers in drug delivery and drug-targeting strategies.
But obtaining patent protection for inventions involving an antibody can prove challenging for researchers and patent experts. To help those working in the field, a new paper (Germinario et. al) provides a helpful discussion of the legal provisions and relevant case law in Europe, along with examples of their application in everyday practice.
The protection by patent of an antibody, especially of a mAb designed for therapeutic use, represents the point of overlap of four aspects of the patent protection of biotech inventions:
1. The patentability of proteins
2. The structural or functional characterisation of the object to be patented
3. Selection interventions
4. Inventions of therapeutic applications
The researchers highlight that patentability is highly dependent on the antibody’s selective ability to bind with a given epitope on the surface of an antigen. Any claim must focus on the specificity of this interaction, and on whether the target has already been described in the prior art or not. The characteristics of the target can be a crucial factor for whether that antibody fulfills the set of patentability requirements.
Like any other invention, an application will have to meet the disclosure requirement by providing a full description of how the antibody is produced and selected. In the case of hybridomas, this must also be deposited in a suitable repository with microorganism storage facilities. And, if the antibody is to be used for therapeutic purposes, it must include experimental evidence to support the claimed pharmacological effect.
The authors set out a guidance table to help scientists to understand whether their research results may be suitable for patent protection.
And they say: “We conclude that an antibody can be considered as an innovation subject to patent protection whenever its interaction with a target antigen results in a new and unexpected technical effect, regardless of whether it is being described for the first time or is the result of a selection from a larger group of antibodies.
The function performed by the antibody is a determining factor with respect to its patentability and derives from its specific characteristics. Such a function may be a useful therapeutic action. Finally, a known antibody can nevertheless be patented if it is intended for a therapeutic application that is novel and inventive.”
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- Germinario C., et al., Patentability of antibodies for therapeutic use in Europe. Nature Biotechnology, 36(5), p402-405 https://www.nature.com/articles/nbt.4134