Lipid Nanoparticles White Spaces Analysis

Lipid Nanoparticles in Drug Delivery: Intellectual Property Landscape (Featuring Historical and Contemporary Patent Filing Trends, Prior Art Search Expressions, Patent Valuation Analysis, Patentability, Freedom to Operate, Pockets of Innovation, Existing White Spaces, and Claim Analysis)

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Lipid Nanoparticles Overview

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.

Historical Trend of IP-related Publications in lipid nanoparticles from the research report of Roots Analysis Analysis of Simple Patent Families of lipid nanoparticles, prepared by Roots Analysis Popular / Relevant Prior Art Search Expressions of lipid nanoparticles, from Roots Analysis report

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 Areas of Innovation in lipid nanoparticles This image provides information on Patentability and Freedom to Operate in lipid nanoparticles This image provides information on Patent Valuation Analysis of lipid nanoparticles

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.

This image highlights the summary of patent claims related to lipid nanoparticles, as highlighted in Roots Analysis report This infographic informs about pockets of innovation in lipid nanoparticles, as identified in Roots Analysis report This image presents white spaces in lipid nanoparticles, as identified in Roots Analysis report

 

  • 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).

Frequently Asked Questions

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.

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