The complex collection of microorganisms that colonise the human body and their genetic material (the human microbiome) is a rapidly developing area of research. As we discuss below, changes in the human microbiome have been linked with various diseases and although important challenges remain, the research is resulting in an interesting range of new technologies.
Detailed investigations into the human microbiome have been made possible by advances in technology, such as high-throughput sequencing and bioinformatics, which enable in situ study of the complex communities of microorganisms that colonise the human body. Research has begun to associate changes in the composition and function of the microbiome with numerous conditions such as inflammatory bowel disease, multiple sclerosis, diabetes, obesity, muscular skeletal conditions and even cancer. For example, studies suggest that microbes can influence cancer initiation and development and affect how a patient responds to cancer therapies.
While these developments are exciting, there are numerous challenges in the field, such as distinguishing between cause and effect; are changes in the microbiome contributing to disease or are they a consequence of that disease? Furthermore, challenges remain in the analysis and interpretation of data generated by the research; for example, many environmental factors can confound associations between a particular condition and a change in the microbiome.
Despite the challenges, many developments are being made that have important implications for improving human health. These include the development of probiotic products (live microorganisms) that can be introduced to individuals as a means to influence their microbiome and to provide health benefits. Probiotics can consist of a single type of microorganism or a collection of different types. Prebiotics (the substrates for particular microbes) are also being investigated as a way to promote the growth of beneficial microbes. In addition, the detection of specific microbes or particular microbial compositions in an individual may be used to identify individuals at risk of disease and to promote early diagnosis. For example, microbiome data has been used to predict the presence of colorectal cancer and has the potential for the development of new and non-invasive screening methods.
IP protection is important for the commercialisation and continued development of these new technologies. There are currently a wide range of patent filings in the microbiome field and a search through the published applications in this field highlights the diversity of research and development that is being undertaken. Analysis of published European applications in the microbiome field suggests a large increase in patent filings; over the two year period from 2014 to 2016, the number of published applications in this field increased by over 200%! With further research, it is hoped that the observed associations between the microbiome and human disease can be better understood and used to improve human health.
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