3D Bioprinting: Intellectual Property Landscape

3D Bioprinting: Intellectual Property Landscape

Tissue injury and dysfunctioning commonly occurs in humans; however, not in all cases, the tissue regeneration capability of a human body is able to cope up with the damage caused. The conventional approach used to deal with this type of trauma involves transplantation of damaged tissues or organs; this is further associated with several limitations, including non-availability of compatible organ donor, risk of graft rejection (due to the body’s immunological reaction) and post-surgical infection / complication. Another tissue engineering approach involves the amalgamation of cells, biomolecules and growth factors with scaffolds, in order to develop a three-dimensional (3D) functional tissue that mimics the human tissue. However, this technique is less effective, time consuming and can lead to non-homogenous distribution of cells in the matrix, making it logistically and financially non-feasible for clinical applications. To improve on this aspect, additive manufacturing, specifically 3D bioprinting, is being explored in the tissue engineering domain. The 3D bioprinting technique employs bioinks (consisting of living cells and biomaterials) to fabricate complex anatomical structures (tissues, cartilages and organs), in a layer-by-layer pattern, with the help of computer-aided printers. Further, 3D bioprinting offers a range of benefits over the conventional tissue engineering techniques, including high accuracy, enhanced resolution, fast processing time and low cost. Owing to the layer-wise construction, bioprinted tissues consist of pores, which promote easy perfusion of gas and nutrients, as well as enable intercellular and intracellular communication. , It is worth mentioning that Organovo was the first company to enter the 3D bioprinting space by printing functional blood vessels in 2010.

Despite the various advantages associated with 3D bioprinting, the technology is associated with certain challenges. One of the key challenges is the stringent requirement to maintain the quality across each step (designing the model, selection of the bioink, printing validation and post-printing) executed before the transplantation. Further, the lack of a robust design software might hamper the manufacturing of a mechanically stable 3D construct. In this regard, various industry stakeholders and academicians have undertaken initiatives in order to further develop / improve this technology for use across a variety of applications, including fabrication of bone, cartilage, organ and skin (for transplantation), drug testing, toxicology screening, and cancer research, by using diseased tissue models. As a result, the intellectual capital related to different 3D bioprinting techniques, such as extrusion bioprinting, inkjet printing, laser assisted bioprinting and stereolithography, has also grown. , In light of such developments, it is important to keep track of both pockets of innovation and key areas of improvement for stakeholders to remain competitive in this upcoming field of the healthcare domain. This report captures some of the key R&D-related trends and provides competitive intelligence on the intellectual property in the field of 3D bioprinting.

SCOPE OF THE REPORT

The “3D Bioprinting: 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 3D bioprinting. 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:

Overall Intellectual Property Landscape

An analytical perspective of the various patents and affiliated IP documents that have been published related to 3D bioprinting, since 2000. 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.

Popular / Relevant Prior Art Search Expressions

An examination of IP literature, shortlisting key words and phrases used to describe 3D bioprinting. 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 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.

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 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 3D bioprinting, and the assessing likelihood for innovators to enter into promising research areas.

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 type of innovation and innovation in this field of research.

Claim 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 related to how the input data for this project was collated, including the search strings used to query a popular patent database (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 3D bioprinting. It includes pictorial representations of the overall patent landscape, IP documents representing patent families that describe unique innovations related to 3D bioprinting, trends related to patent applications (including insights on patentability and freedom to operate), trends related to granted patents (including insights on patentability and freedom to operate), key inferences from a proprietary claim analysis, list of popular CPC symbols (featuring key pockets of innovation) and list of popular applicants (shortlisted based on number of published IP documents).

Sheet 3 is an elaborate tabular representation of the overall IP landscape, featuring information on the various types of IP documents, related to 3D bioprinting, which have been published since 2000.

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 3D bioprinting and affiliated intellectual capital.

Sheet 6 is a subset of sheet 4, featuring all the patent applications, covering innovations related to 3D bioprinting.

Sheet 7 is a subset of sheet 4, featuring all the granted patents, covering innovations related to 3D bioprinting.

Sheet 8 is an insightful summary of the 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 3D bioprinting.

Sheet 11 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 12 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 rising demand of compatible organs for transplantation and the key advantages 3D bioprinting. Further, it provides an overview of the intellectual property landscape related to 3D bioprinting.

Chapters 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 3D bioprinting.

Chapter 5 offers a brief description on 3D bioprinting and its associated technologies. Further, it provides a summary of the important milestones in this field of research, highlighting some of the distinguishing features of both early research and modern variants of such interventions. The chapter highlights the advantages of 3D bioprinting, as well as discusses the application areas and future perspectives associated with this domain.

Chapter 6 includes a review of the various patents and affiliated IP documents that have been published related to 3D bioprinting, since the year 2000. 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, yet rapidly evolving applications the healthcare segment.

Chapter 7 features an insightful examination of IP literature, highlighting key words and phrases that are used to describe 3D bioprinting, 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) in order to help develop a detailed perspective on the diversity of intellectual capital (having marketing exclusivity) related to 3D bioprinting and assessing the 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 on its 3D bioprinting 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 innovation and innovation types) 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 3D bioprinting.

Chapter 14 is a set of appendices, entailing an overview of the excel research report, a list of IP documents featuring the identified white spaces, table of contents, list of figures, list of tables, glossary, and list of all the applicant companies and organizations.