In recent years, there has been an explosion of new technologies and solutions to provide for human needs while minimising or even reversing our impact on the planet.

The biotechnology (‘biotech’) sector is increasingly providing innovative answers to fundamental challenges of global warming and sustainable living. Specifically, synthetic biology (‘synbio’), the field focused on exploitation and re-design of organisms and microbes, has been recognised as a potentially key contributor to decarbonisation.

The activities of microorganisms, either in their naturally occurring form or after genetic modification, can be harnessed in different ways, often providing sustainable solutions that tackle aspects of the environmental crisis. For example, fermentation methods that produce desirable products from microorganisms can have a significantly smaller carbon footprint than traditional industrial processes. Furthermore, microorganisms can be modified and cultured to produce food or enhance sequestration of carbon from the atmosphere.

These ‘sustainable’ (or ‘green’) biotech solutions are being applied across many sectors. In this series of articles, we will explore biotech solutions that, among other things, generate sustainable alternatives to energy intensive and environmentally damaging industrial processes. We’ll look at how agriculture and the food industry is being disrupted by exciting new products that improve food security and replace environmentally damaging farming practices. We’ll also explore how alternative waste management and carbon capture are providing new ways of protecting our environment.

This article sets out some key considerations for innovators building a patent portfolio in this area of technology.

Patents in sustainable biotech: what can be protected?

Innovation in sustainable biotech, including synbio, can be protected by patents at a variety of levels. For example, applicants can look to pursue product claims, to cells or microorganisms, or to useful isolated products of those cells. Furthermore, applicants can cover specific uses of these products. Moreover, process or method claims can be useful to capture the way in which the microorganisms or cells are modified, cultured, or used in various processes.

The options for applicants extend beyond those directed specifically to the biological entity or process – innovators could pursue device or apparatus patents to capture bioreactors, or machine learning algorithms that assist in monitoring or modelling the specific processes.

It is, however, important to bear in mind which exclusions from patentability and requirements may apply in different jurisdictions to make sure that patentable aspects are not overlooked during the patent application drafting process, and consideration is given to jurisdiction specific issues. This is particularly important with respect to the protection of naturally occurring products.

The European Patent Office (EPO) permits claims to new and inventive naturally occurring organisms and molecules that have been isolated from their natural environment, provided that they can be demonstrated to impart a technical effect. However, there are different requirements in other jurisdictions. For example, at the United States Patent and Trademark Office (USPTO), so-called ‘products of nature’ are generally excluded from patentability, and, even for modified organisms or cells, it can be challenging to overcome objections of this type. While plant-related inventions, and certain plants, can be protected by patents, plant varieties per se are excluded from patent protection in many jurisdictions. Plant varieties can instead benefit from an effective sui generis system of protection as mandated by the TRIPS agreement.

Beyond these exclusion from patentability issues, and as well as demonstrating a contribution of the invention over the state of the art, applicants must also consider the importance of ensuring any subject-matter is sufficiently disclosed in the application, enabling the skilled person to reproduce the invention. For inventions relating to a microorganism or cell line, for example, it may be necessary to supplement the written description of the application with a deposit of the relevant biological material. In many jurisdictions, the deposit should be made before the effective filing date, although, in the US, under particular circumstances, a deposit can be made during pendency of the application.

Computer-implemented methods may also be patented, and we see divergence in approaches in different jurisdictions here too. The practice of patenting machine learning algorithms is also currently evolving, as explored in our series of articles on protecting AI.

Harnessing patent office incentives for sustainable biotech

Patent offices worldwide are coming together to support the green transition and have launched a series of initiatives to help the developers of green technologies obtain patent protection (see, for example, IPO Green).

It can be strategic to prosecute ‘green’ biotech patents in the UK, given the relatively low cost of prosecution and the attractive options for accelerated grant using the UK Intellectual Property Office’s (UKIPO) Green Channel scheme. Furthermore, once patent protection is achieved in the UK, applicants can exploit the Patent Prosecution Highway, enabling accelerated prosecution in a number of global jurisdictions on the basis of the claims granted by the UKIPO.

Summary

The biotech sector holds great potential for minimising or reversing the impact of human activity on the planet, and patents continue to be instrumental in driving innovation in this area. Depending on the nature of the invention, there are a range of options for patent applicants, but patent strategy should be carefully considered to accommodate for jurisdictional idiosyncrasies to maximise the chances of success in key markets, and to exploit patent office incentives for green technology to enable accelerated global prosecution.

In the follow up articles in this series, we will take a deeper look into key sectors that are being disrupted by biotech innovations with a focus on sustainability.

As foreshadowed above, many biotech innovations in the sustainability sector exist at the boundaries of biology, with aspects that encroach on chemistry, engineering and technology. Our integrated teams at Carpmaels & Ransford are well-equipped to handle such cross-over technologies.