Microbiome Therapeutics and Diagnostics: Intellectual Property Landscape

Microbiome Therapeutics and Diagnostics: Intellectual Property Landscape

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

SCOPE OF THE REPORT

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:

Overall Intellectual Property Landscape

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.

Popular / Relevant Prior Art Search Expressions

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.

Patent Valuation Analysis

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).

Patentability and Freedom to Operate

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.

Analysis of Patent Applications

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.

Analysis of Granted Patents

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.

Pockets of Innovation and White Spaces

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.

Claims Analysis

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).

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary research and analyzed via proprietary methods / tools to develop a detailed perspective on the current status of the innovative advances in this domain and affiliated developer landscape that is spread across different global regions. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

Company websites

Annual reports

Patent information aggregator portals

Industry databases

Press releases

Industry analysts’ views

The insights presented are solely based on our knowledge, research and understanding of the relevant market, as gathered from various secondary sources of information.

DELIVERABLE OUTLINES

Excel Deliverable

Sheet 1 features details regarding how the input data for this project was collated, including the search strings used to query a popular, public patent database (namely lens.org), and data segregation notes.

Sheet 2 is a summary MS Excel dashboard, offering a detailed, graphical perspective of the intellectual property landscape of microbiome therapeutics. It includes pictorial representations of the [A] overall patent landscape, [B] IP documents representing patent families that describe unique innovations related to microbiome therapeutics and diagnostics, [C] trends related to patent applications (including insights on patentability and freedom to operate), [D] trends related to granted patents (including insights on patentability and freedom to operate), [E] key inferences from a proprietary claims analysis, [F] list of popular CPC symbols (featuring key pockets of innovation), [G] list of popular applicants (shortlisted based on number of published IP documents), [H] list of non-English patents (IP documents with undecipherable language and script as downloaded from lens.org)

Sheet 3 is an elaborate tabular representation of the overall IP landscape, featuring information on the various types of IP documents, related to microbiome-based therapies, which have been published since 1969.

Sheet 4 is an excerpt of the data presented in the previous sheet, featuring published IP documents, that represent unique patent families across various global jurisdictions. This dataset has been analyzed in detail, in the report.

Sheet 5 includes a tabular representation of the key words and phrases (prior art search expressions) that are used to describe microbiome-based therapies and affiliated intellectual capital.

Sheet 6 is a subset of sheet 4, featuring all the patent applications, covering innovations related to microbiome-based therapies and affiliated methods / products.

Sheet 7 is a subset of sheet 4, featuring all the granted patents, covering innovations related to microbiome-based therapies and affiliated methods / products.

Sheet 8 is an insightful summary of key inferences from the independent claims of the granted, active patents in the dataset. It involves the use of a systematic segregation approach to analyze key 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).

Sheet 9 provides insights related to some of the key applicants that are active in this field of research, featuring company-specific details (such as year of establishment, and location of headquarters), and inputs on their respective IP publication trends.

Sheet 10 features an analysis of the most popular CPC symbols and CPC families (in terms of frequency of appearance in the dataset), related to microbiome therapies that are either already available in the market, or under development.

Sheet 11 is a subset of Sheet 4 and features a list of IP documents with non-English patent literature, with the contents of the documents filed in the native language of the applicants’ country and have not been analyzed in the research report.

Sheet 12 is an appendix, which includes pivot tables that drive the charts and interactive elements for the complete IP landscape depicted in sheet 2 of the deliverable.

Sheet 13 is an appendix, featuring details related to the categorization done in the report, and important abbreviations used in reference to the data categories mentioned in the document.

PowerPoint Deliverable

Chapter 1 briefly describes of the need for microbiome-based therapeutic interventions and the key advantages associated with the use of such live biotherapeutic products. Further, it provides an overview of the intellectual property landscape related to this niche class of medical products.

Chapter 2 and 3 feature brief (pictorial) summaries of the approach used during data collection for this project, and the key objectives of the study.

Chapter 4 is an executive summary of the important insights and key takeaways, generated from analyzing the IP landscape of microbiome-based therapies.

Chapter 5 offers an informed perspective on the core concepts of live biotherapeutics. It also includes brief descriptions of microbiome therapeutics that are available and under development, elaborating on the contemporary need for such therapeutic and diagnostic solutions. Further, it provides a summary of the important milestones in this field of research, highlighting some of the distinguishing features of both early generation and modern variants of such interventions. The chapter also includes a description of important application areas of microbiome-based diagnostic solutions, and the key applicants within this domain. Finally, the chapter describes the various advantages and highlighting existing limitations of live biotherapeutics.

Chapter 6 includes a review of the various patents and affiliated IP documents that have been published related to microbiome-based therapies and diagnostics, since the year 1969. It also features an in-depth analysis of published IP documents, representing unique patent families across various global jurisdictions, and includes insightful inferences related to both historical and recent R&D trends within this niche, but rapidly evolving segment of the pharmaceutical industry.

Chapter 7 features an insightful examination of IP literature, highlighting key words and phrases that are used to describe different microbiome-based therapies and diagnostics, including information on historical usage in 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.

Chapter 8 offers insights from a competitive benchmarking and valuation analysis of the key members of unique patent families that have been captured in the report. It takes 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).

Chapter 9 provides a detailed summary of the patent applications (representative of unique patent families) that were filed across different jurisdictions and their relative value in the IP ecosystem. The analysis segregates the captured intellectual capital in terms of type of innovation and the specific innovation (different product classes, enabling technologies or methods of use), thereby, offering the means to identify active arenas of research and assess innovation-specific IP filing trends. Further, it features an analysis that helps identify relevant areas of innovation by analyzing published IP documents (representative of unique patent families), defining the uniqueness of patent pending innovations, in order to assess the scope of patentability in this domain, and pinpoint jurisdictions where new and / or modified claims may be filed without infringing on existing IP.

Chapter 10 is an elaborate summary 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 gene therapies and associated vectors, and the assessing likelihood for innovators to enter into promising product markets, once active patents expire. Further, it features an analysis that helps identify relevant areas of innovation by analyzing published IP documents (representative of unique patent families), defining the uniqueness of patented innovations, in order to assess the scope of patentability in this domain, and pinpoint jurisdictions where new and / or modified claims may be filed without infringing on existing IP.

Chapter 11 features profiles of some of the most popular applicant companies, which were shortlisted based on their respective patent filing activities. Each profiles includes a brief overview of the company, information on annual revenues (wherever available), details of its microbiome therapies related initiatives, names of key management team members and recent developments.

Chapter 12 includes an insightful analysis of the various CPC symbols mentioned 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.

Chapter 13 concludes the report by summarizing publicly available insights on the anticipated developments in this domain (taking into consideration the perspectives of eminent representatives of stakeholder companies in this industry), and trends that are likely to shape the future of microbiome-based therapies.

Chapter 14 is a set of appendices, entailing [A] an overview of the excel research report, [B] a list of IP documents featuring the identified white spaces, [C] table of contents, [D] list of figures, [E] list of tables, [F] glossary, and [G] list of all the applicant companies and organizations.