Spotlight on Microbiome

It is estimated that there are more individual microorganisms living in and on the human body than there are human cells in the body. This means that – by cell count – everyone is more microbe than human. This microbial community is referred to as the ‘microbiota’ and includes many types of bacteria, viruses, fungi and other microorganisms. The term ‘microbiome’ is also used, although strictly it refers to the genomes microbiota.

Building up this microscopic community begins at birth, once the baby exits the sterile environment of the womb. It is at once a common feature of the population and completely personal: the kind and amount of microorganisms you carry is influenced by your environment, your pets – even your left and right hand host different collections.

Studies have shown that an imbalance in the microbiome is an underlying cause of many diseases, including allergies, obesity and cancer. Quite how microbial imbalances cause disease is not yet fully understood. Studies have revealed a complex network of interactions between the microbial communities and immune cells in and around the gut. These interactions appear to be necessary to prevent damaging inflammatory reactions against innocuous targets, such as constituents of the food we eat and of the human body itself. Therefore, treating the gut microbiome is increasingly seen as a way of curing or preventing inflammatory and allergic disease.

The human microbiome market is growing rapidly, projected to grow five-fold to exceed USD 1Bn by 2029. Nevertheless, a lack of expertise, inadequate research, uncertain regulatory requirements and IP challenges are factors restraining this market's growth. Companies that can solve these challenges will establish a commanding position in this important field.

An average person contains 30 trillion human cells, but even more microbes – about 39 trillion. In addition, there are possibly ten times that number of viral particles in the human virome. Understanding an individual’s microbiome is becoming increasingly important for diagnosing a broad range of diseases.

The number of patent publications related to the microbiome is growing at a huge rate. From just two patent families in 2010 to several hundred per year now. Patents that relate to the microbiome often need to be drafted differently from patents covering small molecule drugs or conventional diagnostics. For instance, some inventions lie in a way of affecting or detecting a heterogenous population of microbial cells. The cells could be defined in various ways, such as by their function or by their degree of genetic relatedness to a reference organism. Other inventions lie in a way of assessing the impact of the heterogenous population of microbes on drug metabolism, which might require functional definitions and/or specific assays to be written into the claims.

Applicants for microbiome-based patents need to be aware of legal obstacles in certain jurisdictions that would make certain claims very difficult to obtain. As with any new treatment, it is absolutely essential to establish a strong IP position before undertaking the massive cost of clinically validating a microbiome based treatment. While at first glance it might seem hard to build a strong patent portfolio in this field because the active therapeutic ingredients may be either naturally occurring or well known, this is not necessarily the case if the therapeutic use is new and innovative. With new observations indicating a link between an absence of certain gut bacteria and diverse diseases such as cancer, depression and diabetes, the potential for personalised mental health interventions, looks set to continue to drive novel discoveries.