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Microbiome refers to the diverse community of microorganisms that inhibit different environments in and on the human body (such as gut, respiratory tract, skin and urogenital tract). In fact, the human microbiome contains about 100 trillion microbes. Notably, every person has a unique microbiome composition, which is dependent on various factors such as daily routines, drug intake, eating habits and genetic makeup. This ecosystem plays a significant role in digesting food, synthesizing vitamins, regulating the immune system and protecting from pathogens, thereby maintaining gut health.
However, the imbalances in microbiota, also known as dysbiosis, often results in negative health consequences including (but not limited to) anxiety, autism, cancer, diabetes, infectious diseases, inflammatory bowel diseases and obesity. The recent advancements in the microbiome domain has transformed our understanding of human health and diseases; these include improved technologies such as high-throughput sequencing, shotgun metagenomics and bioinformatics (uncovering intricacies and functioning of microbial communities), personalized medication approaches (promoting development of more effective therapies for different health disorders conditions - gastrointestinal disorders to autoimmune diseases), exploration of gut-brain axis (highlighting the influence of microbiome on neurological and psychiatric conditions) and employing artificial intelligence and machine learning (for identify patterns and predict health outcomes based on microbial profile).
In the above context, several human microbiome therapeutics focused on replenishing / restoring the microbiota in particular areas of the body, have been developed (such as fecal microbiota transplantation) while various other potential therapies are currently being investigated in different stages of development. In addition, diagnostic tools are being developed to identify the biomarkers for early disease detection. Despite significant progress in this domain, there is an unmet need for comprehensive understanding of the microbiome’s interaction with human physiological processes. As a result, researchers and pharmaceutical companies are racing to fill these knowledge gaps and discovering next generation products that are often patented to protect intellectual property. These patents cover a wide array of innovations, including novel microbial strains, compositions of live biotherapeutic products and associated methods of use, and advanced diagnostic methods. In light of such developments, it is important to keep track of both the pockets of innovation and key areas of improvement for stakeholders to remain competitive in this upcoming field of medicine.
This report captures some of the key R&D-related trends and provides competitive intelligence on intellectual property, in the field of microbiome therapeutics and diagnostics. The leading players with the highest number of patents related to microbiome therapeutics and diagnostics include MD Healthcare, DSM, AOBiome, Rebiotix, COSMAX, Synlogic, Finch Therapeutics and Seres Therapeutics. Further, in terms of key indications, the majority of the patents were focused on gastrointestinal disorders, followed by dermatological disorders, oncological disorders, infectious diseases and metabolic disorders.
The “Microbiome Therapeutics and Diagnostics: Intellectual Property Landscape” report features an extensive study of some of the key historical and contemporary intellectual property (IP) documents (featuring granted patents, patent applications and other documents), describing the microbiome-based interventions intended to treat a growing range of clinical conditions. The insights generated in this report have been presented across two deliverables, namely a MS Excel workbook and a MS PowerPoint deck, summarizing the ongoing trend in this domain. Key inclusions are briefly described below:
An analytical perspective of the various patents and affiliated IP documents that have been published related to microbiome therapeutics and diagnostics, since 1969. An in-depth analysis of published IP documents, representing unique patent families across various global jurisdictions, featuring insightful inferences related to both historical and recent R&D trends within this niche, yet rapidly evolving applications in the biotechnology and pharmaceutical industry.
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An examination of IP literature, shortlisting key words and phrases used to describe microbiome-based therapies (and affiliated products). The analysis also includes details on the historical use of the aforementioned terms across different IP filings, key affiliated terms (which can be used to identify other relevant IP search terms and establish relationships between prior art search expressions), and other related trends.
A competitive benchmarking and valuation analysis of the key members of unique patent families captured in the report, taking into consideration important parameters, such as type of IP document, year of application, time to expiry, number of citations and jurisdiction (factoring in value associated with the gross domestic product (GDP) of a particular region).
A systematic approach to identify relevant areas of innovation by analyzing published IP documents (representative of unique patent families), by defining the uniqueness of patented / patent pending innovations, in order to assess the scope of patentability in this domain, and pinpoint jurisdictions wherein new and / or modified claims may be filed without infringing on existing IP.
A detailed summary of the various patent applications (representative of unique patent families) that were filed across different jurisdictions and their relative value in the IP ecosystem. The analysis classified the intellectual capital in terms of type of innovation and the innovation (such as a product class, enabling technologies or method of use), thereby, offering the means to identify active arenas of research and assess innovation-specific IP filing trends.
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An analysis of the granted patents (representative of unique patent families) across different global jurisdictions and their relative value in the IP ecosystem. The analysis also features a meaningful classification system, segregating granted IP into relevant categories (namely type of innovation and innovation) to help develop a detailed perspective on the diversity of intellectual capital (having marketing exclusivity) related to microbiome therapeutics and diagnostics, and the assessing likelihood for innovators to enter into promising research areas.
An insightful analysis of the various CPC codes used in published IP literature (representative of unique patent families) and their affiliated families, offering the means to identify historical and existing pockets of innovation (based on the functional area / industry described by the elaborate and systematic IP classification approach, mentioned earlier); the analysis also features a discussion on prevalent white spaces (based on type of innovation and innovation in this field of research.
One of the objectives of the report was to analyze and summarize key inferences from the independent claims mentioned in granted, active patents (representative of unique patent families) in the dataset. Using a systematic segregation approach, we have analyzed trends associated with the preamble, type of patent (product patent or method patent), and type of claim (open ended claim or closed ended claim).
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