Microbial consortia and IP in Europe
Our body hosts trillions of microorganisms that live symbiotically on and within the human body. This ‘microbiome’ is essential to our health and microbial imbalance or dysbiosis increases the susceptibility to many diseases, including inflammatory bowel disease (IBD), liver disease, atherosclerosis, and other severe pathologies. Given its central role in health and disease, the microbiome has become a prominent therapeutic target.
Microbial consortia
In two early proof-of-concept studies, researchers were able to restore microbiome balance in patients with IBD and Clostridum Difficile infection using Fecal Microbiota Transplantation (FMT), essentially replacing the ‘bad’ bacteria with ‘good’ ones from healthy donors. These initial studies provided an impetus for the development of therapeutic compositions that contain microorganisms, with many targeting the gut.
One category of microbiome-targeting therapies uses groups of bacteria that cooperate within a larger community, a so-called microbial consortium. Microbial consortia are believed to result in a more durable engraftment because of the establishment of a new “micro” ecosystem, and, consequently, improved biological functionality compared with using single bacterial strains.
Following isolation from biological samples, typically stool or saliva, groups of bacterial strains are propagated in clonal cell banks and consortia are selected based on a desired biological function, such as metabolite production or outcompeting pathobionts (disease-causing or harmful microorganisms).
For example, a consortium of bacteria designed to complement missing or underrepresented functions in the imbalanced microbiome of IBD patients was found to prevent and treat chronic immune-mediated colitis in humanised mouse models by decreasing pathobionts while expanding resident protective bacteria.
IP considerations for microbial consortia at the EPO
The IP strategy for therapeutics in the microbiome field differs from the more traditional drugs because microbes, the active ingredient, present in a consortium may be well known and thus not novel, or naturally occurring and considered a discovery, which is excluded from patentability in Europe.
