As we move towards marketing approval for microbiome therapeutics, the "value" of the microbiome industry is increasing exponentially. This will inevitably result in disputes between the leading competitors seeking to protect their key intellectual property (IP) rights, including patent monopoly rights. Whilst some may regret the ramping up of competitive behaviours, this should be seen as part of the healthy development of an increasingly commercially relevant industry.
Despite the increasing commercial value of patents in this area, Patent offices are relatively inexperienced at examining patent applications relating to therapeutic microbiome compositions. A granted patent provides a 20-year monopoly and to be valid, the invention must be new, inventive and sufficiently disclosed. Some early patents granted in this field may prove to have broader claims than is justified by their technical contribution or disclosure. Legal challenges are likely to narrow or knockout such patents but at present, it is difficult for third-parties to be certain about their freedom to operate position.
A subtler benefit of such challenges is the effect they have on the way patents are examined. For example, when one strain of bacteria is demonstrated to treat IBD, examiners may have to consider if it is acceptable to claim the use of any member of the genus of that strain for treating any form of autoimmune disease? Decisions issued by the courts and patent offices in response to challenges from third parties will guide such considerations of examiners, leading to more consistent examination. Indeed, it is vital for the industry's progress that we see consistently good decisions being made so that the microbiome patent landscape develops in a fair and commercially relevant manner.
The most significant challenge to patent rights in the therapeutic microbiome field to-date is the recently issued decision in the "Vedanta Opposition". The patent (European Patent No. 2575835) was granted to the University of Tokyo (UoT) in October 2016. It relates to work derived from the Honda lab and was exclusively licensed to Vedanta Biosciences, Inc. The CEO of Vedanta was quoted in October 2016 as saying
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