Patentability of microorganisms – the basics
Protecting new microbial inventions, whether these are newly-developed microbial compositions or newly-identified microbial species or strains, is not uncommon. Indeed, as far back as 1873, the US Patent Office granted a patent to Louis Pasteur for a yeast, free of pathogenic “germens”. In the 1930s, Yakult's founder Minoru Shirota isolated from the human gut a specific bacteria (the eponymous Lactobacillus casei Shirota) and developed the now well-known fermented milk drink containing it.
However, the act of patenting microbial inventions can pose specific challenges. Particular issues arise, and precise claim language is required, for instance, for products, including foodstuffs, which have both therapeutic and non-therapeutic effects. This is emphasised between jurisdictions which do and do not allow method of treatment claims. Additionally, patent law postulates an often unclear division between the non-patentable, pre-existing phenomena and creations of nature on the one hand, and the patentable, non-naturally occurring organisms constructed by techniques of biotechnology on the other.
Field of constant flux
The rapid development of biotechnology since the 1970s has enabled this field to emerge as one of the most innovative and promising areas of scientific research. Recently, for example, researchers have found that the presence or absence of certain gut bacteria can help to predict how the body will respond to fatty foods, which could lead to personalised supplements and/or diets for patients based on the makeup of their gut flora.
The inclination towards healthy eating and living shows no sign of slowing down and presents a wealth of opportunities for companies innovating in this domain. Although investment is invariably required in innovation, the rewards can be well worth the input when combined with the right product and the proper protection.