In recent years, our understanding of the human microbiome has reached an exciting momentum. It is no longer seen as a bunch of foreign invaders of the body, but rather more as a pseudo-organ that acts as a significant influencer of human health and disease. Focus has expanded from the gut microbiome to other parts of the body, and research is increasingly showing how the microorganisms we harbor can be used in the development of new treatments and diagnostics.
The food industry was the first to benefit from our increased knowledge of the microbiome. While the use of microorganisms to produce yogurt and cheese is an age-old process, the realization that human health is not only influenced by the genetic makeup of an individual, but that there is a link between microorganisms, general health and disease progression, opened new avenues for the food industry.
Consequently, the public has become familiar with terms such as “probiotic” and “prebiotic” in recent years. They are now commonly used to describe functional foods and food supplements aimed at modifying the gut microbiome.
“This was the point at which we saw the development of novel yogurt drinks and food supplements that contained bacteria and were said to strengthen the gut,” explains Craig Thomson, Partner at the intellectual property specialist firm HGF.
Evolution from supplements to medicine
The food supplement market has been a great success. However, Craig explains that without a clinical marketing authorization for their products, companies cannot clearly market any therapeutic benefits associated with their products.
“This also means that food supplements that have good evidence of a health benefit cannot distinguish themselves from other products on the market that have no such demonstrable benefits,” Craig continues.
Being able to clearly market products on the basis of a therapeutic benefit would help people in need to identify the appropriate product for them. These products would also be expected to sustain a higher profit margin than products merely sold as food supplements.
The latter point is of course important. Without such higher margins, it would be difficult to fund the significant investment required to get a therapeutic product to market.
But switching from food supplement to therapeutically approved product is not as straightforward as it may seem. As Craig comments, “The interesting thing is, when these supplement products came out, they were being developed by universities and food manufacturers that had no experience of getting drugs into clinical trials, or indeed the money to do so.”
Nevertheless, as the science in this field developed, investments grew exponentially. Food companies have been gaining the relevant experience, and therapeutically focused SMEs have been formed with the sole focus of getting a clinically approved product to market.
As a result, competition is growing. And although no therapeutic microbiome product has reached the market so far, a handful of companies already have their therapies in Phase II and III clinical trials.
Protecting that investment
With growing competition and increasing values of innovations, patent filings in the microbiome field have grown fast. As with most emerging fields, the path to patent protection is not straightforward. Even patent offices are still learning what form of protection for this technology should be granted as a patent.
“The nature of live bacterial therapeutics is very different to many conventional ‘small molecule’ products, and standard patent prosecution strategies for conventional therapeutics are therefore not always suitable for products in the microbiome field,” Craig explains. Working with a patent attorney who has experience in this field is therefore a major advantage.
There are many motivations for seeking patent protection. “First, and most obvious, a patent allows you to get a monopoly for your innovation for a period of twenty years, though this period may be extended by five years. And the monopoly allows you to get your invention to market,” Craig says.
He continues, “The other principle motivation in a field predominated by SMEs and which requires substantial funds to progress, is to be able to demonstrate to investors that they would be investing in – or buying – a business that has a monopoly. To investors, patents can represent a reduced risk.”
Patents may therefore be a vital part of the business plan of a food company or SME developing a therapeutic microbiome product. It would encourage VC investment or even sale to large Pharma.
Getting ready for Big Pharma
Large pharmaceutical companies are increasingly showing significant interest in the microbiome field and most of the large companies are now represented at any significant microbiome conference. One example of this interest is the well publicized acquisition of the biotechnology company and microbiome pioneer Rebiotix by Ferring in April 2018.
“Big Pharma are of course experts at getting therapeutic products to market,” Craig says. “So as their involvement grows, we will likely see many more therapeutic products seeking and ultimately obtaining marketing authorisation. A well-trodden path to approval is one that should be easier for all to take in the future.”
Building an IP strategy
“As companies develop their technology, it is likely that they will generate new inventions, many of which will be patentable and could provide significant additional protection for a microbiome- based product,” explains Mike Nelson, Partner at HGF. “These additional patents could add significantly to the exclusivity period, and therefore the commercial value of a product.”
Mike points out that in order to achieve this, companies will need a solid intellectual property (IP) strategy. An IP strategy needs to identify new inventions that arise as a product goes through discovery and development, and before they are published or disclosed publicly.
The identified inventions need to be considered carefully. Furthermore, companies need to decide on which inventions to invest patent protection in. “It is also important to choose those inventions that will not be patented, instead retaining them as confidential know-how within the company,” Mike says.
Working communication between the patent attorney and the technical, clinical, regulatory functions within a company is essential for the delivery of a robust patent portfolio. It is particularly important to recognise that an IP strategy is not stagnant, but needs to evolve with the product.
“As with any pharmaceutical, microbiome products will inevitably face technical challenges,” Mike explains. “But solving these problems, although challenging, can result in a generation of significant new IP opportunities.
“Moreover, the IP opportunities in the microbiome field are not limited to the companies developing the products. In future, there may be significant opportunities for companies providing platform technologies that could be used by more than one microbiome product.”
In this respect, the development of drug delivery systems that allow oral administration of microbiome products and the targeted delivery of the product to specific regions of the GI tract are particularly interesting. One day, they could lead to significant income streams for companies developing these technologies.
Are you working on a new therapy in the microbiome field? Make sure to get your experts around the table as soon as possible. Get in touch with HGF and allow your innovation to be protected and supported in the best possible way. Click here for more information!
Images via GiroScience, Phunkod, Anatomy Insider, Olivier Le Moal /Shutterstock
Author: Larissa Warneck, Science Journalist at Labiotech.eu