The Binding Site Group Ltd is a specialist protein company committed to the research, development, manufacture and distribution of innovative, immunodiagnostic assays for the global laboratory market.

With specialised expertise in antibody specificity technology, the Binding Site aims to provide clinicians and laboratory staff with the tools to significantly improve diagnosis and management of those patients with specific cancers and immune disorders.

The issue

The company developed an antibody and assay that could be used to help diagnose and improve the monitoring of diseases such as multiple myeloma, a cancer that arises from plasma cells produced in bone marrow. We were asked to help gain maximum protection for the product and its research and development investments. The Binding Site developed an antibody and assay that can be used to help diagnose and improve the monitoring of diseases such as multiple myeloma, a cancer that arises from plasma cells produced in the bone marrow. The antibodies and assays developed by the Binding Site are used to identify, characterise and quantify intact immunoglobulins providing a more methodical and accurate diagnosis. Immunoglobulins have two heavy chains bound to two light chains. There are five different classes of heavy chains (G, A, M, D and E) and two different types of light chains (κ and λ).   Diseases such as multiple myeloma often produce unusual quantities or different ratios of different types of immunoglobulins. The Binding Site were able to produce antibodies which characterise the heavy chain class and light chain types bound together in the intact immunoglobulin molecules (e.g. IgGκ or IgAλ). It wanted to gain maximum protection for this product and its research and development investments.

The solution

We developed a full IP strategy for Binding Site’s product range. This included ring-fencing this new product and the assays associated with it, demonstrating the innovative nature of the antibodies developed and negotiating a broader scope of the claims to ensure wider protection for technologies used generally by Binding Site and its competitors. With this strategy, we aimed to provide a full level of protection that could prevent a future third party developing a similar method or combination. As well as patent protection, we provided trade mark protection, to ensure that competitors do not try to sell similar sounding products.

The outcome

The product and associated assays have been granted full patent protection in Europe, United States and Japan, and are now on the market under the registered trade mark Hevylite^tm. The product has also been CE marked by Binding Site and successfully FDA cleared. The full level of protection granted has helped to deter Binding Site’s competitors entering this market, which is a highly-competitive industry.