Molecular Switches: Intellectual Property Landscape

Molecular Switches: Intellectual Property Landscape

Attempts to synthetically recreate the biological circuits in human body is a relatively new area of research within synthetic biology. Ever since the 2010s, the use of molecular “toggle” switches to mimic electronic circuits has been prevalent to understand, alter, and recreate molecular circuits within the human body. The evolution of chemistry and synthetic biology has reached an interesting point as these complex processes, including genetic regulation, expression, and replication are being understood at a molecular level. The prominent elements of these exploratory studies are molecular switches, which are responsive to internal or external stimuli and can be manipulated to create a transition between two stable states when exposed to a change in their optical, electrical, or chemical environment. During the past few years, several molecules have been identified and characterized as “switches”, which are now available for the construction of complex synthetic signaling networks with applications in both biology and nanotechnology. Of the different types of molecules, organic molecules, including proteins, nucleic acids, and cyclic organic compounds, such as crown ethers are likely to be the promising candidates in this field due to their diverse structural, electrical, and mechanical properties. In addition, synthetic molecules, such as Rotaxanes and Catenanes have emerged as potential molecular switches, as the binding sites within these mechanically interlocked molecules can be manipulated upon the application of stimuli, resulting in a shift in their structure and chemistry on cue.

One of the most important applications of molecular switches is to combat the challenges associated with anticancer therapies, like system toxicity, multidrug resistance, poor solubility, and membrane permeability. In order to overcome these drawbacks, researchers have undertaken several R&D efforts for identifying and developing effective treatment modalities. Among other alternatives, the use of Nanocarriers has emerged as a viable option. These nanomaterials encapsulate the drug, essentially warding it off from the surrounding physiological conditions and minimizing the side effects. Upon installation of molecular switches in their structure, these nanocarriers can be manipulated to gravitate towards a specific environment within the body and release the drug, when stimulated. The stimulus can further be manipulated to obtain the desired dosage strength and frequency. The extent of modification in these molecules allows for the use of minute differences in the biochemistry of different tissues as stimuli for targeted delivery of drugs. Simultaneously, with constant evolution in biomedical research and other emerging fields, such as optogenetics, molecular switches are being explored to directly switch the genes “on” and “off”, leading to control over genetic regulation and expression. The potential of gaining control over the molecular architecture and consequently, molecular function has led to a steady increase in the research and entrepreneurial activity in this domain. As a result, the intellectual capital around compositions of molecular switches, engineering techniques, and their application in gene regulation and therapeutic use, 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 medicine / drugs. This report captures some of the key R&D-related trends and provides competitive intelligence on intellectual property in the field of molecular switches.

SCOPE OF THE REPORT

The “Molecular Switches: 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 molecular switch interventions intended to treat a growing range of clinical conditions. 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 molecular switches, since 1981. 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 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 molecular switches (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 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 molecular switches, 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 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 molecular switches. It includes pictorial representations of the [A] overall patent landscape, [B] IP documents representing patent families that describe unique innovations related to molecular switches, [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 types of IP documents, related to molecular switches, which have been published since 1981.

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 molecular switches and affiliated intellectual capital.

Sheet 6 is a subset of sheet 4, featuring all the patent applications, covering innovations related to molecular switches and affiliated methods, compositions and engineering techniques.

Sheet 7 is a subset of sheet 4, featuring all the granted patents, covering innovations related to molecular switches 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 molecular switches that are either already available in the market, or under development.

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 need for molecular switches interventions and the key advantages associated with the use of such molecular switches. Further, it provides an overview of the intellectual property landscape related to this niche class of synthetic biology research.

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 molecular switches.

Chapter 5 offers an informed perspective on the core concepts of molecular switches. It also includes brief descriptions of molecular switches 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 molecular switches, highlighting the various advantages and existing limitations of molecular switches.

Chapter 6 includes a review of the various patents and affiliated IP documents that have been published related to molecular switches, since the year 1981. 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 applications the healthcare segment.

Chapter 7 features an insightful examination of IP literature, highlighting key words and phrases that are used to describe different molecular switches, 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 molecular switches, 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 molecular switch 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 molecular switches.

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.