CRISPR Technologies: Intellectual Property Landscape

CRISPR Technologies: Intellectual Property Landscape

Over the last two decades, genome editing concepts and genetic engineering have evolved significantly, with the development of a variety of versatile DNA modulation technologies, including clustered, regularly interspaced short palindromic repeats (CRISPR), zinc finger nucleases and transcription activator-like effector-based nucleases (TALENs). These developments have enabled several medical researchers to perform an array of gene / cell line engineering experiments for a variety of R&D applications. It is worth highlighting that owing to its ease of use, fast, accurate and cost-effective approach, CRISPR / Cas technology is currently considered to be the most popular tool of all available genome manipulation technologies. CRISPRs are the hallmark of a bacterial defense system that forms the basis for CRISPR / Cas genome editing technology. These systems allow researchers to permanently modify genes in living cells and organisms, and in the future, may make it possible to correct mutations at precise locations in the human genome, in order to treat genetic causes of various disease indications. Fundamentally, the CRISPR / Cas system involves specific palindromic DNA sequences which work in tandem with a family of caspase enzymes (Cas9, Cas12), in order to excise gene fragments with high precision. Moreover, the relatively recent discovery / development of novel accompanying nucleases, namely Cas12a, Cas13, Cas14 and dCas9, has further improved the precision of CRISPR technology. ,

CRISPR / Cas system is a powerful tool with a wide array of applications in the field of disease treatment and diagnosis, and agriculture and biotechnology. It is worth highlighting that this versatile gene editing tool has garnered significant interest in the medical community owing to its ability to act on virtually any physiological target, which has opened up numerous possibilities for precision medicines. , Despite its extensive applicability, several challenges limit the use of CRISPR, including complexities associated with delivery of CRISPR components, off-targeting, autoimmune responses and ethical concerns. To address these concerns, a number of researchers across the world are leading the development initiatives in this domain. In fact, over 3,300 patents related to CRISPR and related technologies have been filed / granted till now, highlighting the continuous pace of innovation in this field. Once existing challenges limiting its applicability are addressed, this technology is anticipated to become a mainstream gene editing solution. Currently, there is a lot happening in terms of innovation related to this promising segment of gene editing technology; therefore, it is important to identify key pockets of innovation and areas of improvement in order to truly innovate whilst maintaining a competitive edge. This report attempts to identify key trends that describe the pace and focus of innovation related to CRISPR / Cas technologies, and make key observations / inferences regarding the development of intellectual capital in this domain.

SCOPE OF THE REPORT

The “CRISPR Technologies: 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 CRISPR technologies. The insights generated in this report have been presented across two deliverables, namely a MS Excel sheet and a MS PowerPoint deck, summarizing the ongoing activity in this domain. Key inclusions are briefly described below:

Overall Intellectual Property Landscape

An in-depth review of the various patents and affiliated IP documents that have been published related to the diverse technologies, methods and compositions associated with the use of CRISPR. It features insights on both historical and recent trends in R&D within this domain.

Popular / Relevant Prior Art Search Expressions

An examination of IP literature, shortlisting key words and phrases that have been used to describe CRISPR and associated technologies. The analysis includes information on the historical use of the aforementioned terms across different types of IP filings, key affiliated terms (which can be used to further identify similar innovations) and other related trends.

Patent Valuation Analysis

A competitive benchmarking and valuation analysis of IP documents published in this field of innovation, taking into consideration important parameters, such as type of IP document, year of application, time to expiry, number of citations and jurisdiction (factoring in regional GDP).

Patentability and Freedom to Operate

A systematic approach to identify relevant areas of innovation by analyzing published IP documents, defining the uniqueness of patented / patent pending innovations, understanding the scope of patentability in this domain, and pinpointing jurisdictions where new and / or modified claims may be filed without infringing on existing IP.

Analysis of Patent Applications

A detailed summary of the patent applications that were filed across different jurisdictions and their relative value in the IP ecosystem. The analysis segregates the intellectual capital, in terms of area of innovation, thereby, offering the means to understand key areas of research and identify innovation-specific IP filing trends.

Analysis of Granted Patents

An elaborate summary of the granted patents across different jurisdictions and their relative value in the IP ecosystem. The analysis also features a meaningful classification system, segregating granted patents into relevant categories in order to develop a more detailed perspective on the diverse types of innovations in this domain and the feasibility 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 and their affiliated families, in order to identify historical and existing pockets of innovation (based on the functional area / industry described by the elaborate and systematic system of classifying IP); the analysis also features a discussion on prevalent white spaces (based on CPC symbols) in this arena 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 in the dataset. Using a systematic segregation approach, we have analyzed trends associated with [A] the preamble, [B] type of patent (technology patent or method patent), [C] type of claim (open ended claim or closed ended claim) and [D] 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 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 CRISPR technologies. Additionally, it includes pictorial representations of the [A] overall patent landscape, [B] key prior art search expressions, [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 claim 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).

Sheet 3 is an elaborate tabular representation of the overall IP landscape, featuring information on the various patent application and granted patent-related documents in the domain of CRISPR technologies which have been published since 2013.

Sheet 4 includes a tabular representation of key words and phrases that are used to describe CRISPR technologies.

Sheet 5 is a subset of sheet 3, featuring all the patent applications covering innovations related to CRISPR technologies.

Sheet 6 is a subset of sheet 3, featuring all the granted patents covering innovations related to CRISPR technologies.

Sheet 7 is an insightful summary of the key inferences from the independent claims mentioned in the granted, active patents in the dataset. We have used a systematic segregation approach in order to analyze trends associated with the preamble, type of patent (technology 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 8 provides insights related to some of the key applicants 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 9 features an analysis of the most popular CPC symbols and CPC families (in terms of frequency of appearance in the dataset) related to the diverse applications of CRISPR technologies.

Sheet 10 is an appendix which includes pivot tables that drive the charts and interactive elements for the complete IP landscape, in sheet 2.

Sheet 11 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 the current investment in the development of CRISPR therapeutics, and the key advantages of CRISPR technologies. Further, it provides an overview of the intellectual property landscape related to CRISPR technologies.

Chapter 2 and 3 features brief (pictorial) summaries of the approach used for data collection and the key objectives of the study.

Chapter 4 features an executive summary of the key insights generated from analyzing the intellectual property landscape of CRISPR technologies.

Chapter 5 features a brief description of CRISPR highlighting how this technology is, as compared to other gene editing tools. It provides an impactful summary of the important milestones related to research in this domain and details on mechanism of action of CRISPR. Further, it includes information on various challenges that inhibit the applicability of this tool and ways of overcoming these challenges. It also includes key areas of application of CRISPR technologies.

Chapter 6 includes a review of the various patents and IP documents that have been published related to technologies and methods associated with CRISPR technologies, featuring insights related to both historical and recent trends.

Chapter 7 features an insightful examination of IP literature, highlighting key words and phrases that are used to describe CRISPR technologies, including information on historical usage in IP filings, key affiliated terms (which can be used to further identify similar innovations), and other related trends.

Chapter 8 offers insights from a competitive benchmarking and valuation analysis of the IP documents published related to this field of research, taking into account important parameters, such as type of IP document, year of application, time to expiry, number of citations and jurisdiction (factoring in regional GDP).

Chapter 9 provides a detailed summary of the patent applications that were filed across different jurisdictions and their relative value in the IP ecosystem. The analysis segregates the intellectual capital, in terms of area of innovation, thereby, offering the means to understand key areas of research and identify innovation-specific IP filing trends. Based on a systematic approach, the chapter highlights relevant areas of innovation from a deeper analysis of published IP documents, defining the uniqueness of patent pending innovations, understanding the scope of patentability in this domain, and pinpointing 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 across different jurisdictions and their relative value in the IP ecosystem. The analysis uses a proprietary segregation criterion, based on type of product / solution; this offers the means to identify unique innovations that presently have marketing exclusivity and explore future opportunities to enter into promising product markets, once their patents expire. Based on a systematic approach, the chapter highlights relevant areas of innovation from a deeper analysis of published IP documents, defining the uniqueness of patented innovations, understanding the scope of patentability in this domain, and pinpointing 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 patent filing activity. Each profiles includes, a brief overview of the company, information on annual revenues (wherever available), details of its initiatives focused on the healthcare sector, names of key management team members and recent developments.

Chapter 12 includes an insightful analysis of the various CPC symbols mentioned in the published IP literature and their affiliated families, in order to identify historical and existing pockets of innovation (based on the functional area / industry described by the elaborate and systematic system of classifying IP); the analysis also features a discussion on the prevalent white spaces (based on CPC symbols) in this area of research.

Chapter 13 concludes the report by providing insights on anticipated developments in this domain (from the perspective of eminent industry representatives of stakeholders in this domain), and trends that are likely to shape the future of the CRISPR market.

Chapter 14 is a set of appendices