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More than 10,000 unique species of microorganisms make up the human microbiome; in fact, the total number of microbial cells in the human body is known to vastly outnumber the indigenous cellular population. Of late, many studies have demonstrated the importance of microbiome and its profound influence on multiple biological functions. Moreover, it has been shown that the diversity of the microbial community residing in a host body varies based on both intrinsic (gender, genetics, and immunity) and extrinsic factors (diet and geographical location). Modern bioanalytical techniques have enabled researchers to delve deeper into microbiome research, in terms of species identity and the influence of specific genera on various tissues and organs in the human body. Leveraging this information, advanced genome sequencing technologies and meta-analyses have allowed scientists to build unique profiles of human subjects (including both healthy individuals and patients) based on the microbial flora residing in their respective bodies. Further, imbalances in the microbiota, also known as dysbiosis, have been proven to be associated with several known diseases, including (but not limited to) cancer, diabetes, inflammatory bowel diseases, autism, anxiety and obesity. This data is presently being used in the diagnosis and treatment of more than 25 clinical conditions, by restoring key bacterial populations in the body. Experts also believe it possible that there are additional microbial species within the human microbiome, which are yet to be discovered.
In the above context, several microbiome drugs based on replenishing / restoring the microbiota in specific anatomical locations, have been developed (such as fecal microbiota transplant) and many such therapy candidates are under development. Such targeted manipulations of the microbiome represent a rapidly advancing area of clinical research. An analysis of published scientific research revealed that the count of articles focused on the therapeutic manipulation of the human microbiome has grown at a rate of over 2,000%, since 2005. However, there is still a lot, such as the functional links (at a mechanistic level) between the gut bacteria and disease, to be understood in this direction. It is worth noting that the intellectual capital, including compositions of live biotherapeutic products and associated methods of use, related to this upcoming class of therapeutics has also grown. Researchers believe that, in the future, the microbiome can be engineered for use as a controlled delivery system for conventional drugs / therapies. Transgene modified bacteria can even be used to trigger internal molecular circuits in order to regulate the production of therapeutic proteins, based on the expression of specific disease biomarkers, thereby, enabling on-demand release (or expression) of therapeutic secondary metabolites / biomolecules. 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 “Microbiome Therapeutics: 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 various types of microbiome-based interventions intended to treat a growing range of clinical conditions. Fundamentally, these are live biotherapeutic products, which have recently been proven to have the potential to aid in the amelioration of several diseases, primarily via the gut-brain axis. 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 activity 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-based therapies 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, but rapidly evolving segment of the pharmaceutical industry.
An examination of IP literature, shortlisting key words and phrases used to describe microbiome-based therapies (and affiliated products) that are either already available in the market, or under development. 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 identifying 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 specific 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.
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 product markets.
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 CPC symbols) 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), type of claim (open ended claim or closed ended claim) and key elements of a claim (individual aspects of an innovation that are covered in a singular claim).