The tremendous advances in understanding our microbial ecology and the rise in companies looking to commercialise inventions in this area have reignited the debate around the patentability of nature-based claims, both in the UK and elsewhere.Where does this leave life sciences companies looking to protect emerging microbiome technologies which promise to protect against disease and/or positively impact a range of human biological systems including our immune system, metabolism and even our mental health?
Why do patents matter?
The patent system is a bargain between the state and inventors: inventors are rewarded with a 20 year monopoly over their innovative and useful product or process, in exchange for advancing scientific research by publishing full details of their invention.
Microbe-based patents embody a tension between promoting scientific innovation through the commercialisation of technologies, and the public interest in preventing monopolies covering naturally occurring products or biological processes.
The state has long refused to grant exclusivity for the mere discovery of elements of the human body (such as genes) on the basis that it would be unethical to grant a private monopoly on fundamental elements of living organisms which are naturally existing and essential for basic research. It is therefore a basic requirement of patentability in most jurisdictions that these inventions must have some sort of industrial application, as well as fulfilling requirements of novelty and inventiveness. Against this backdrop, companies must strike a careful balance between applying for patent protection early, with limited supporting data, or wait until later, when the body of prior art has grown along with the risk that the invention may no longer be novel or inventive over that art.
Position in Europe
To patent a microbe in Europe, the patent application must usually describe the microbe's function in order to meet the requirements of industrial applicability and inventive step. Without knowing its function, the person skilled in the art (PSA) would not know how to use the microbe or would consider trial use of the microbe as obvious. The PSA is presumed to be a skilled practitioner in the relevant field, who possesses average knowledge and ability, and is aware of what was common general knowledge in the field at the relevant date.
One difficulty of this approach is that, in reality, microbe-based patents are often filed in circumstances where function or activity remains a matter of speculation based upon the level of experimental evidence available. The question typically asked by patent offices is whether the patent application makes it plausible (or credible) that the microbe claimed by the inventors embodies the function or activity set out in the patent based on the information contained in the original application.
In terms of the level of data required to support an alleged function, the threshold is fairly low. Whilst unsupported speculation will not be enough, conclusive experimental testing is not required and even an educated guess (based on sequencing, profiling, or initial in vitro / in vivo testing) can suffice. Further clarification as to the test for determining whether a patented invention is plausible is expected from the UK Supreme Court, later this year, in Warner-Lambert v. Actavis.
Position in the US
Whilst patents claiming naturally occurring material or processes, per se, arenot allowable in the US, it is possible to obtain a patent if the application discloses a product or process that is significantly different to what is already found in nature. Isolating a naturally occurring microbe would therefore not qualify for patent protection under current US law, whereas a claim directed to a modified or engineered microbe, such a synthetic probiotic, could fair better. In each case, it is important for the patent application to show that steps have been taken to transform or modify the claimed microorganism such that it is no longer a so-called 'product of nature'.
Considerations
The different jurisdictional approaches outlined above will impact IP strategies of life science companies operating in this space. If patent exclusivity seems attractive in order to craft an early strategy against third party copying, the timing of the patent application will be critical. A lot will depend on the level of plausibility of microbial function and use as shown by key study results. Commercial considerations, such as fund raising rounds, and buy-out plans, may also be influential. In all cases, keeping research activities a secret during the pre-patent stage will be vital to preserve the option to patent later. For others, obstacles to patentability may mean that protection by means of trade secrets and confidential information is the best approach.