It has been reported that humans harbour a huge number of microbes in their gastrointestinal (GI) tract. The microorganisms that live in the GI tract are collectively known as the microbiota. There has been a rapid growth in patent applications using the genetic information from the microbiota, known as the microbiome, to improve human and animal health.
An increasingly large body of life sciences research and development is directed at the health implications of the microbiota, which is the plethora of microorganisms such as bacteria, archaea, protists, fungi and viruses that live in the GI tract. It has been estimated that the number of microbes GI tract outnumber the number of human cells in the body. Indeed, there may be around ten times the number of bacterial cells than human cells. Some of these microorganisms make us ill, whereas others forge a mutually-beneficial symbiotic relationship with their hosts. In any case, evidence that the microbiota may have profound effects on human and animal health is driving an interest in patenting microbiota-related inventions.
Large research consortiums such as MetaHIT and the Human Microbiome Project have used low-cost, high-throughput sequencing technology to provide insights into the composition of the microbiota and related microbiome sequence information. This sequence information has made it possible to investigate associations between imbalanced microbiomes and disease states. The diseases thought to be associated with microbiome imbalance are certainly not limited to diseases of the enteric system, but rather may also be associated with a diverse set of diseases such as liver disease, autoimmune conditions and neurological/mental health conditions.
Such associations inform the development of inventions relating to diagnostic methods, or treatments based on rebalancing the microbiota, for example, using probiotics. Further inventions may relate to, for example, how to handle/process samples or data relating to diagnostic methods, advantageous compositions comprising probiotics , or ways to protect the microbiota balance from oral antimicrobials.
The gut is not the only environment with a microbiome forming the basis for inventions for improving health. Microbiomes of other ecosystems such as the skin and nose are also being investigated.
European Patent Office (EPO) case law specifically relating to microbiome-related inventions is relatively sparse compared with longer established life sciences technologies. However, we should assume that microbiome-related inventions at the EPO must meet the same requirements as other biotechnology inventions. Thus, we should consider existing case law on biomarkers, vaccines, biologics and other pharmaceutical treatments when prosecuting or attacking microbiome patents.
By way of example, applicants should ensure that the technical effect purported to be produced by the claimed invention is at least ‘plausible’ from the disclosure of application amongst other things. A finding of lack of plausibility could mean that no supporting experimental data obtained after the application filing date would be considered by the EPO. Thus, speculative patent applications comprising prophetical or hypothetical examples may be expected to be challenged. Additionally, applicants should manage their expectations regarding the claim scope that will be obtained in patent applications based on limited examples.
For example, the opposition division of the EPO decided to revoke EP 2211879, alleging that the patent lacked an inventive step due to a lack of contribution over the prior art. EP 2211879 relates to a probiotic comprising a bacteria selected from the genus Bacteroides, and its use for inducing or supporting weight loss. The opposition division held that the application as filed lacked experimental data confirming that the claimed compositions are capable of inducing or supporting weight loss. Furthermore, experimental data provided after the filing of the application were held to be technically unconvincing due to an alleged lack of disclosure of relevant experimental conditions and parameters, and an apparent lack of significant reduction of body weight during treatment. It seems to me that the same allegations could have been raised against a more conventional pharmaceutical composition with a similar level of experimental support. This decision is currently under appeal.
The characterisation of the microbiome provides potential for inventions that improve health. EPO case law on microbiome-related applications will emerge in the coming years. In the meantime, we should look to analogous technical fields for guidance on how to draft, prosecute, defend, and attack microbiome patent rights.