The final post in our gut microbiome series examines the technological growth and development in the gut microbiome through the lens of recent patent filings, which is a strong indicator for where the market is headed in the future.
Health-conscious consumers are becoming increasingly mindful of foods and beverages they consume, and the impact those have on their health and well-being. According to a survey by L.E.K. Consulting, consumers want a diverse array of benefits from their food and beverage consumption, and 73% to 86% are willing to pay extra for food products with health and wellness benefits that resonate.1 Digestive health solutions are among many products that fall into that category, and as evidenced by the volume of microbiome-related food and beverage patent activity, companies and academic institutions are heeding the call.
Microbiome Patent Filing Trends and Legal Status
Patent filing activity has grown dramatically over the last 10 years, with the number of published patent applications almost doubling each year from 2008 to 2017. A search of worldwide patents and patent applications related to the gut microbiome in the food and beverage space identified more than 600 patent documents to date.2 This rapid expansion in the gut microbiome patent landscape suggests:
- Significant research and development (R&D) investments are being made in this area.
- A surge in innovation in 2006 corresponded with increase in patent application filings.
- A potential increase in competition and acquisition activity as more patent applications are approved and issued.
An analysis of 246 granted patents and 423 published patent applications revealed several trends related to major technologies, geographical distribution and top patent owners.
Microbiome Patent Trends by Technology Area
Based on the Cooperative Patent Classification (CPC) system, which was jointly developed by the European Patent Office (EPO) and the United States Patent and Trademark Office (USPTO), the key technology areas of microbiome-related patent are classified as medicinal preparations. The vast majority of technologies (43%) are classified as “medicinal preparations containing materials or reaction products thereof with undetermined constitution.” This includes inventions containing various microorganisms, compositions, prebiotics, probiotics, or reaction products thereof if the therapeutic effect is clearly attributed to the active substance of the medicinal preparation and is an essential part of the disclosure.3
Patents in the food and beverage space include formulations using prebiotics and probiotics (such as Lactobacillus sp. and Bifidobacterium sp.) alone or in combination for nutritional and medical applications for a variety of health outcomes, including modulation of the immune system, weight management, improved digestion, and regulation of fat storage.
Microbiome Patent Trends by Geography
Looking at the filing of microbiome-related patents by geography, the United States is leading the way with nearly half of the patent fillings identified (307 out of 669). This is indicative of the increased interest in gut health coupled with research and development efforts to understand the interaction between diet, gut microbiome, and health. Other significant filings include the Patent Cooperation Treaty, which assists applicants in seeking patent protection internationally for their inventions, and the European Patent Office, with 222 and 61 filings, respectively. On the other hand, a remarkably low number of microbiome-related patents were filed in China, reflecting consumer preferences in that region.
Market Analysis, Development Strategies, and Top Assignees
When it comes to the major players in this space, a small number of assignees possess a relatively large number of patents, and the remaining patent owners are relatively dispersed. In total, 209 assignees hold the 669 patent documents identified. Among the top 15 assignees, 12 were companies and 3 were academic institutions (University of California, University of Tokyo, and University of Minnesota). The top assignee, uBiome, Inc., owns only 31 patents, followed by Crestovo Holdings LLC (21 patents), 4D Pharma PLC (20 patents), and Nestle SA (19 patents). This indicates that the ownership of patent documents is widespread, and one might surmise it will continue to expand as more companies and institutions move into this arena.
What the Future Holds
Judging by the rapid growth in patent filings over the last decade and the growing consumer demand for digestive health solutions, the gut microbiome patent landscape is expected to evolve for the foreseeable future.
Today, the technology classes of microbiome patent documents differ substantially in volume and growth—suggesting a preference to invest R&D dollars in one technology class over another (e.g. “medicinal preparations containing peptides (peptides containing beta-lactam ring) over “modifying nutritive qualities of foods dietetic products”). As research efforts continue and consumer demands for food and beverage products that benefit gut health increase, it will be interesting to see if patent activity expands into more technology classes and if more players get involved. Maintaining a view on the patent landscape will be an important mechanism to stay abreast of developments in this field.
1 Steingoltz, M., Picciola, M., Wilson, R. October 15, 2018. Consumer Health Claims 3.0: The Next Generation of Mindful Food Consumption. L.E.K. Consulting. https://www.lek.com/insights/ei/next-generation-mindful-food-consumption
2 Turoski, Christopher. and Sharma, Anil. 2019. “The Patent Landscape: The Gut Microbiome”. IFT19, Institute of Food Technologists, New Orleans, June 3.
3 European Patent Office and United States Patent and Trademark Office. August 2019. Cooperative Patent Classification: A61K. European Patent Office and United States Patent and Trademark Office. http://www.cooperativepatentclassification.org/cpc/definition/A/definition-A61K.pdf
About the Authors
Dr. Anil K. Sharma, PhD is a highly motivated scientist with more than 17 years of multidisciplinary research experience and expertise in intellectual property (IP) law. During his research career, Dr. Sharma has published over 50 research articles/reviews/book chapters related to the field of microbiology, microbiome, immunology, personalized medicine, drug and biomarker discovery, genomics, cardiology, nano-medicine, and patents.
Professor Christopher M. Turoski is the director of Patent Law Programs at the University of Minnesota Law School, bringing two decades of progressive, real-world experience to lead the J.D., MS.C. and LL.M in Patent Law programs. In this role, he makes certain both the programs and students are prepared to excel in the modern business environment.