Lipid Nanoparticles in Drug Delivery: Intellectual Property Landscape (Featuring Historical & Contemporary Patent Filing Trends, Prior Art Search Expressions, Patent Valuation Analysis, Patentability, Freedom to Operate, & Claim Analysis)

INTRODUCTION

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 to enhance bioavailability 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-based 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:

Overall Intellectual Property Landscape

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.

Popular / Relevant Prior Art Search Expressions

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.

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 lipid nanoparticles in drug delivery, 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.

CHAPTER OUTLINES

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.