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Report Description
Low drug solubility and its corresponding impact on bioavailability have remained a primary cause of concern with several marketed as well as clinical stage drugs. According to the Journal of Analytical and Pharmaceutical Research, 70% of the 50 drugs approved by the USFDA in 2021 were poorly soluble. Moreover, approximately 40% of marketed pharmacological products and close to 90% of drug candidates under development, have been associated with solubility and / or permeability issues, resulting in poor bioavailability. It is worth noting that, every year, a large number of drugs fail to reach the market due to poor bioavailability and issues associated with aqueous solubility. As a result, the industry is actively seeking various tools / methods to mitigate this challenge. Amongst the various approaches for bioavailability enhancement of therapeutic interventions, lipid nanoparticles (LNPs) and other lipidic excipients have gained sufficient attention from drug developers owing to their ability to act as drug carriers for complex, albeit highly promising therapeutics. Many studies have indicated that lipid-based formulations are capable of solving the complex drug delivery challenges currently faced by this industry. This can be attributed to the versatility of such molecules in terms of structure and functionality, as well as their ability to enhance the solubility and bioavailability of poorly water-soluble (hydrophobic) drugs.
It is worth highlighting that, currently, lipid nanoparticles / lipids are the most commonly used drug delivery systems, specifically for mRNA therapeutics and vaccines. In fact, LNPs have been used in several mRNA-based COVID-19 vaccines to encapsulate and deliver genetic material to the target cells. As a result, the demand for lipid nanoparticles as drug delivery systems has grown considerably over the years. Presently, several studies are underway to evaluate the potential of next-generation lipid nanoparticles as effective drug delivery systems, aiming to enable the development of therapies with high efficacy and bioavailability. Given the extensive research activity, the intellectual capital related to the use of LNPs in drug delivery has also grown over time. Therefore, 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 trends and provides competitive intelligence on intellectual property related to lipid nanoparticles and their applications in drug delivery.
Scope of the Report
The Lipid Nanoparticles in Drug Delivery: 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 applications of lipid nanoparticles in drug delivery. 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:
An analytical perspective of the various patents and affiliated IP documents that have been published related to lipid nanoparticles in drug delivery, since 1977. 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 segment of the biotechnology and pharmaceutical industry.
An examination of IP literature, shortlisting key words and phrases used to describe lipid nanoparticles in drug delivery. 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.
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).
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.
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.
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 lipid nanoparticles in drug delivery, and the assessing likelihood for innovators to enter into promising research areas.
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.
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).
Question 1: What are lipid nanoparticles?
Answer: Lipid nanoparticles are nanostructured spherical vesicles composed of ionizable lipids with particle size of approximately 100 nm.
Question 2: Why are lipid nanoparticles used for drug delivery?
Answer: Due to their unique physical and chemical properties, lipid nanoparticles have emerged as the principal excipient for the delivery of various types of therapeutics, including small molecules, gene therapies, proteins, peptides and DNA / RNA.
Question 3: What are the advantages of lipid nanoparticles in drug delivery?
Answer: Owing to their numerous advantages, including the ability to control and modify drug release, their biocompatible and biodegradable nature, low toxicity, and ease of production, lipid nanoparticles have become a preferred drug delivery system. Further, they exhibit high drug payload, enable targeted drug delivery and can cross biological barriers such as the blood-brain barrier.
Question 4: What are applications of lipid nanoparticles in the pharmaceutical industry beyond drug delivery?
Answer: Beyond drug delivery, lipid nanoparticles have potential applications in treatment of cancer and genetic diseases. Further, they are also used in gene editing and medical imaging.
Question 5: What is the current intellectual property landscape of lipid nanoparticles in drug delivery?
Answer: Given the surge in development of LNP-based drug delivery systems in recent years, there has been increase in patent filings trend related to LNP technology, with numerous patents already been filed by various companies and academic / research institutions. As per our research, more than 5,500 patents focused on LNPs and their applications in drug delivery have been filed / granted till date. Of these, 20% of the patents are granted patents.
Question 6: Which are the major innovation categories in the intellectual property domain of lipid nanoparticles in drug delivery?
Answer: The intellectual property domain of lipid nanoparticles in drug delivery encompasses a wide range of innovations, such as compositions of lipid nanoparticles, types of lipid nanoparticles used in drug delivery and formulation methods for lipid nanoparticles.
Contents
Excel Deliverable
Sheet 1 features details on 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 lipid nanoparticles in drug delivery. It includes pictorial representations of the overall patent landscape, IP documents representing patent families that describe unique innovations related to lipid nanoparticles in drug delivery, 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 lipid nanoparticles in drug delivery, which have been published since 1977.
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 lipid nanoparticles in drug delivery and affiliated intellectual capital.
Sheet 6 is a subset of sheet 4, featuring all the patent applications, covering innovations related to lipid nanoparticles in drug delivery.
Sheet 7 is a subset of sheet 4, featuring all the granted patents, covering innovations related to lipid nanoparticles in drug delivery.
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 lipid nanoparticles in drug delivery.
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 applications of lipid nanoparticles in drug delivery and its key advantages. Further, it provides an overview of the intellectual property landscape related to lipid nanoparticles in drug delivery.
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 lipid nanoparticles in drug delivery.
Chapter 5 offers a general overview of the lipid nanoparticles and various methods of preparation of lipid nanoparticles. Further, it provides a summary of the important milestones in this field of lipid nanoparticles and their applications in drug delivery. Additionally, the chapter highlights the advantages, as well as application areas of lipid nanoparticles as drug delivery systems and the 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 lipid nanoparticles in drug delivery, since the year 1977. 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 lipid nanoparticles in drug delivery, 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 lipid nanoparticles in drug delivery 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 initiatives undertaken in the area of lipid nanoparticles and its use in drug delivery, 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 type of innovation and innovation) 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 lipid nanoparticles in drug delivery.
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.
Excel Deliverable
1. Research Notes
2. Summary Dashboard
A. Overall Intellectual Property Landscape
B. Intellectual Property Landscape (Grouped by Simple Families)
C. Key Prior Art Search Expressions
D. Key Trends related to Patent Applications (featuring Patentability and Freedom to-Operate)
E. Key Trends related to Granted Patents (featuring Patentability and Freedom-to-Operate)
F. Claims Analysis
G. Key CPC Symbols
H. Key Applicants
3. Overall Intellectual Property Landscape Dataset
4. Prior Art Search Expressions (Keyword Analysis)
5. Patent Applications Dataset
6. Granted Patents Dataset
7. Claims Analysis
8. Key Applicants Analysis
9. CPC Analysis
10. Appendix I: Pivot Tables
11. Appendix II: Country / Geography Codes
12. Appendix III: Innovation Categories
PowerPoint Deliverable
1. Context
2. Project Approach
3. Project Objectives
4. Executive Summary
5. Lipid Nanoparticles in Drug Delivery
5.1. Overview
5.2. Introduction to Lipid Nanoparticles
5.3. Advantages and Applications of Lipid Nanoparticles in Pharmaceutical Industry
5.4. Future Perspectives
6. Overall Intellectual Property Landscape
6.1. Overview
6.2. Analysis of Simple Patent Families
6.3. Key Innovation Categories
6.4. Insights from Patent Applications
6.5. Insights from Granted Patents
7. Key Prior Art Search Expressions
7.1. Overview
7.2. Analysis of Prior Art Search Expressions
8. Intellectual Property Valuation Analysis
8.1. Valuation Overview
8.2. Analysis of Individual Value Ranks
8.2.1. Rank 1 IP Documents
8.2.2. Rank 2 IP Documents
8.2.3. Rank 3 IP Documents
8.2.4. Rank 4 IP Documents
8.2.5. Rank 5 IP Documents
8.3. Concluding Remarks
8.4. List of Rank 1 IP Documents
9. Analysis of Patent Applications
9.1. Overview
9.2. Relative Valuation of Patent Applications
9.3. Patentability and Freedom-to-Operate
10. Analysis of Granted Patents
10.1. Overview
10.2. Relative Valuation of Grated Patents
10.3. Patentability and Freedom-to-Operate
10.4. Analysis of Patent Claims (Granted Active Patents)
11. Key Applicants
11.1. Overview
11.2. Analysis of Key Applicants
11.2.1. Company A
11.2.2. Company B
11.2.3. Company C
11.2.4. Company D
11.2.5. Company E
11.2.6. Company F
11.2.7. Company G
11.2.8. Company H
11.2.9. Company I
11.2.10. Company J
12. Pockets of Innovation and White Spaces
12.1. Overview
12.2. Pockets of Innovation
12.3. White Spaces
12.4. Concluding Remarks
13. Future Outlook
13.1. Lipid Nanoparticles in Drug Delivery: IP Filing Growth Trends
13.2. Relevance of IP for Business Development and Growth
13.3. Contemporary Sentiments and Predictions
13.4 Anticipated Future Developments and Trends
14. Appendices
The following companies / institutes / government bodies and organizations have been mentioned in this report:
Source 1: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3399483/
Source 2: https://themedicinemaker.com/manufacture/the-rise-of-lipid-nanoparticles
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