CAR-T Cell Therapies

Report Description

Cancer, one of the leading causes of death worldwide, claimed  close to 10 million lives annually Although there are several treatment options available to control disease progression and keep malignant cells from spreading throughout the body, lasting remission is difficult to achieve. In this context, immunotherapies, a relatively recent addition to the gamut of anticancer interventions, have demonstrated significant promise. For instance, after multiple rounds of chemotherapy, a stem cell transplant, participating in two clinical trials of experimental anticancer interventions and targeted radiation therapy, Scott McIntyre was treated with a CAR T-cell therapy at the University of Chicago Medicine, in 2016. Till date, he is in complete remission from his diffuse large B-cell lymphoma (DLBCL). This highly specific and promising form of treatment that harnesses the versatile effector machinery of the human immune system, has revolutionized cancer treatment across the world. CAR-T therapies have so far been evaluated and approved for several hematological malignancies; ABECMA® (relapsed or refractory multiple myeloma), BREYANZI® (relapsed or refractory large B-cell lymphoma), TECARTUS™ (relapsed or refractory B-cell precursor ALL), KYMRIAH™ (relapsed or refractory DLBCL and relapsed or refractory ALL), YESCARTA™ (DLBCL, primary mediastinal B-cell lymphoma, high grade B-cell lymphoma, and follicular lymphoma), are products involving the use of CAR-T cells, which have been approved by the US FDA.  

Presently, the success rate for CAR T-cell therapies is estimated to be around 30% to 40%, offering lasting remission without requiring any additional treatments. Cytokine release syndrome (CRS), a commonly reported side effect of the treatment, is typically observed within a few days to a couple of weeks after CAR T-cell infusion. In severe cases, patients with CRS may need to be transferred to intensive care and even require life-support machines to stay alive. However, over time, medical science has developed the necessary means to control / treat CRS. In addition, a successful CAR-T cell graft is known to cause certain rare types of infections, which are generally observed in severely immunodeficient patients. This is because the programmed, effector T-cells also eliminate normal immune cells, which are responsible for keeping infections at bay, in a healthy host. Other barriers to therapeutic success include inadequate anti-tumor activity (in certain cases), antigen escape, restricted trafficking, and limited tumor infiltration. As a result, there is a lot happening in terms of innovation related to this promising segment of cell-based therapies; medical researchers are developing targeted interventions for different indications and also exploring ways to make the therapy safer. It is also worth mentioning that a lot of capital has also been invested to support R&D activity in this burgeoning field of research. This report attempts to identify key trends that describe the pace and focus of innovation related to CAR-T cell therapies, and make key observations / inferences regarding the development of intellectual capital in this domain.

Scope of the Report

The “CAR-T Cell Therapies: Intellectual Property Landscape” report features an extensive study of the historical and current collection of granted patents, patent applications and affiliated documents associated with the upcoming suite of programmable, personalized anticancer therapies. The information in this report has been presented across two deliverables, namely a MS Excel sheet, featuring an interactive dashboard, and an MS PowerPoint presentation, summarizing the ongoing activity in this domain, and key insights drawn from the available data. The report features the following details:

• Overall Intellectual Property Landscape

An in-depth review of the various patents and affiliated IP documents that have been published related to technologies and methods associated with the therapeutic applications of CAR-T cells, featuring key insights on historical and recent trends.

• Popular / Relevant Prior Art Search Expressions

An examination of IP literature, including a shortlist of key words and phrases that have been used to describe innovations involving CAR-T cells that are indicated for the treatment of different types of cancers. The analysis also features historical usage trends of the aforementioned terms in IP filings, key affiliated terms (which can be used to further identify similar innovations), and other related details.

• Patent Valuation Analysis

A competitive benchmarking and valuation analysis of the IP documents published in this field of innovation, 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).

• 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 and intended applications, 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 segregates the intellectual capital in terms of area of innovation and intended applications; this offers the means to identify unique innovations that presently have marketing exclusivity, and the feasibility for innovators to enter into promising product markets. 

• Pockets of Innovation and White Spaces

An insightful analysis of the various CPC symbols mentioned 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 the prevalent white spaces (based on CPC symbols) in this area 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).

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 CAR-T cell therapies. 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 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).
    
Sheet 3 is an elaborate tabular representation of the overall IP landscape, featuring information on the various patent application- and granted patent-related documents that have been published since 2000. 

Sheet 4 includes a tabular representation of key words and phrases that are used to describe CAR-T cell therapies.

Sheet 5 is a subset of sheet 3, featuring all the patent applications, covering intellectual capital related to CAR-T cell therapies.

Sheet 6 is a subset of sheet 3, featuring all the granted patents, covering intellectual capital related to CAR-T cell therapies. 

Sheet 7 is an insightful summary of key inferences from the independent claims mentioned in the granted, active patents in the dataset. We have used a systematic segregation approach 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 (in terms of frequency of appearance in the dataset) CPC symbols and CPC families, related to CAR-T cell therapies.    

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 need for better therapeutic options in the field of cancer treatment, and the key advantages of CAR-T cell therapies. It also features an overview of the intellectual property landscape related to this upcoming class of advanced therapy medicinal products. 

Chapter 2 and 3 feature 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 CAR-T cell therapies.

Chapter 5 provides a brief overview of T-cell therapies, the concept of chimeric antigen receptors and their applicability in personalized medicine. It also features a summary of the key events and milestones associated with the development of one of the most versatile classes of immunotherapies. The chapter lists the various US FDA approved CAR-T cell therapies and their key benefits and limitations. It concludes with a brief description of the likely future of this class of biological interventions. It is worth mentioning that the inputs featured in this chapter were validated based on the opinions of key experts involved in this segment of the biopharmaceutical industry. 
 
Chapter 6 includes a review of the various patents and IP documents that have been published describing various technologies and methods associated with CAR-T cell therapies, featuring key insights on historical and recent trends.

Chapter 7 features an insightful examination of IP literature, identifying key words and phrases that have been / are being used to describe CAR-T cell therapies. The chapter includes information on historical usage of the aforementioned expressions in IP filings, key affiliated terms (which can be used to further identify similar innovations), and other related trends.

Chapter 8 offers insights generated from a competitive benchmarking and valuation analysis of the IP documents related to CAR-T cell therapies, 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 and intended applications, 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 segregation criterion, based on type of product / solution and intended applications; 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 CAR-T cell therapies market. 

Chapter 14 is a set of appendices.