表紙:循環遊離DNA/RNA:特許情勢の分析 (2021年)
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循環遊離DNA/RNA:特許情勢の分析 (2021年)

Circulating DNA/RNA Patent Landscape Analysis 2021

出版日: | 発行: KnowMade | ページ情報: 英文 PDF > 130 Slides, Excel file > 2440 Patent Families | 納期: 即日から翌営業日

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循環遊離DNA/RNA:特許情勢の分析 (2021年)
出版日: 2021年06月24日
発行: KnowMade
ページ情報: 英文 PDF > 130 Slides, Excel file > 2440 Patent Families
納期: 即日から翌営業日
  • 全表示
  • 概要
  • 目次
概要

今日の臨床診療において、最も待望されている技術の1つはリキッドバイオプシーであり、より具体的には、固体生検のより安全な代替手段である循環遊離DNAの分析です。それは個別化医療を達成するための有用で不可欠な要素です。また、血液・尿・唾液・脳脊髄液・胸水などの体液中のマーカー(突然変異など)を介して疾患を診断・予測するための低侵襲アプローチでもあります。循環遊離DNA/RNA分析の用途は腫瘍に限定されませんが、この分野での調査とニーズが特に大きくなっています。また、出生前診断や心血管・神経系疾患、または移植にも適用できます。特にがん分野では、3つの製品がFDAの承認を受けて以来、過去5年間で大きな進歩が見られました。同時に、循環核酸を観察する臨床研究の数は増加し続けており、このトピックへの関心の高まりと企業の経済的利害を反映しています。

知的財産(IP)の観点から、循環DNA/RNAは大企業と新興企業の両方にとって興味深いものであり、各種企業のIPの位置と戦略を理解することが重要です。実際、最近、かなりの数の訴訟や異議申し立てが行われ、この分野における知財の戦略的役割が示されています。このような知識は、ビジネスのリスクと機会を検出し、新しいテクノロジーを予測し、市場での地位を強化するための戦略的決定を可能にするのに役立ちます。

当レポートでは、循環遊離DNA/RNAの関連特許の動向について分析し、現在の主要技術の概要や、将来有望な技術の一覧、世界全体の関連特許の出願・認証・活用状況、主な訴訟の動き、主要企業の知的所有権 (IP) のポートフォリオ、主要特許のプロファイル (全2440件以上) といった情報を取りまとめてお届けいたします。

当レポートで言及されている企業 (一部)

  • ANNOROAD、AVIIR、BGI、BLUESTAR GENOMICS、CARDIFF ONCOLOGY、CAREDX、CARIS LIFE SCIENCES、CLEVELAND HEARTLAB、EISAI、GRAIL、GUARDANT HEALTH、ILLUMINA、INTEGRATED GENETICS (SEQUENOM)、NATERA、ONCOMEDX、PERSONAL GENOME DIAGNOSTICS、PREANALYTIX、QIAGEN、RAVGEN、ROCHE、STRECK

目次

イントロダクション

  • 循環遊離DNA/RNA
  • 分析範囲
  • 当レポートの概略
  • 分析目的

分析手法

当レポートで言及された主な特許出願人

エグゼクティブサマリー

特許情勢:概要

  • 特許公開件数の推移
  • 特許公開件数の推移:出願国別
  • 最も出願件数の多い特許出願人のランキング
  • 主要企業の現在の法的地位
  • 特許法的地位
  • 現在の主なIP保有者のマッピング
  • 大手IP企業の特許活動
  • 主な特許出願人の推移

新規参入企業

  • スタートアップ企業
  • 既存企業

事業協力

主な特許出願人のIPポジション

  • 特許出願人のIPリーダーシップ
  • 特許出願人のIPブロッキングの可能性
  • 特許ポートフォリオの強度指数

主な特許

  • 特許引用の分析
  • 主要な特許ファミリー

主な反対訴訟

  • EP特許に関する主な反対意見
  • 米国国内の主な訴訟

特許の分類

  • 定義
  • 主な譲受人:技術別
  • 用途別:がん
  • 用途別:出生前検査
  • 用途別:感染症
  • 用途別:移植
  • 用途別:神経系
  • 用途別:心血管系
  • 技術検出分析
  • 技術抽出の準備

主要企業のIPプロファイル (10社)

結論

KnowMadeについて

目次
Product Code: KM21003

Report's Key Features:

  • PDF with > 130 slides
  • Excel file > 2440 patent families + hyperlink to updated online database (legal status, documents etc.)
  • IP trends, including time-evolution of published patents, and countries of patent filings
  • Patents' legal status
  • Ranking of main patent assignees
  • Key players' IP position and relative strength of their patent portfolios
  • Summary of the IP related to the applications: infectious diseases, cancer, cardiovascular, nervous system or prenatal.
  • Summary of the IP related to the technologies: extraction or detection and isolation.
  • Analysis of patent litigations and review of key patents.

Circulating nucleic acids tests, an essential step in prognosis and personalized treatment

In clinical practice today, one of the most eagerly awaited technologies is the liquid biopsy, and, more specifically, the analysis of circulating DNA, which is a safer alternative to solid biopsy. It is a useful and essential element for achieving personalized medicine. It is also a minimally invasive approach for diagnosing or prognosing a disease through markers (e.g. mutations) in body fluids such as blood, urine, saliva, cerebrospinal fluid or pleural fluid. Circulating DNA/RNA analysis is not restricted to oncology, though the research and needs in this area are immense and eagerly awaited. This technology is also applicable to prenatal diagnostics, cardiovascular and nervous system diseases or transplantation. In addition, the development of technologies to intercept and analyze these circulating nucleic acids steeply increased in the last 10 years, as did the number of companies supplying them (e.g. Grail, Guardant Health, Roche, Illumina). In the cancer area, great progress has been made in the last 5 years, since 3 medical devices have arrived on the market and have been FDA approved: the cobas® EGFR Mutation Test and FoundationOne® Liquid CDx by Roche; and the Guardant360® CDx by Guardant Health. The FDA has also granted three Breakthrough Device Designations for a Natera test. At the same time, the number of clinical studies observing circulating nucleic acids continues to increase, reflecting the growing interest in this topic as well as the economic stakes for companies. Despite this, multiple issues are delaying the widespread incorporation of ctDNA into routine patient care. Future focus should be on establishing optimal techniques for sample collection, cfDNA isolation and analysis. In addition, further studies are required to better understand the biological characteristics of cfDNA.

In terms of intellectual property (IP), circulating DNA/RNA is of interest to big companies and start-ups alike, and it is crucial to understand the IP position and strategy of these different players. Indeed, significant numbers of litigations and oppositions have been filed recently, showing the strategic role of IP in this area. Such knowledge can help detect business risks and opportunities, anticipate emerging technologies, and enable strategic decisions to strengthen one's market position.

The analysis of the time evolution of patent publications shows that Circulating DNA/RNA started to be investigated in the late 1980s with a first patent published in 1987 by a French Academic player, Inserm. Until 2009, there was a latent period, although highly specialized companies in the field started to emerge, such as CLS Therapeutics, Sequenom (acquired by Integrated Genetics) and OncoMEDx. Some academics also started to take an interest in this field of research, such as American universities (Pennsylvania and John Hopkins) and Chinese universities. Since 2010, an acceleration in patenting activity has been observed, with the arrival of big newcomers such as Roche, Natera, Illumina and BGI.

Analysis by segment

Circulating DNA/RNA has been investigated and the selected patent families labeled according to applications or technologies to which they relate. This IP landscape features the following 2 types of segmentation:

  • Applications: This segmentation includes oncology, prenatal diagnostics, infectious diseases, transplantation, nervous system and cardiovascular system. cfDNA was mainly explored as a diagnostic or prognostic marker and for monitoring treatment efficacy or residual disease.
  • Technologies: This segmentation includes Extraction & Preparation of circulating DNA/RNA and the Detection & Analysis of these cfDNA/RNA.

Oppositions and litigations

There is a significant number of EP oppositions (>30) and US litigations for patent infringement (>20), which reflects the strategic issues of circulating DNA/RNA for companies. Most of the proceedings are recent, filed in the past 3 years, and are still pending.

Identifying the companies that have recently emerged in the IP landscape

Among the players owning patent families related to circulating DNA/RNA, over 100 newcomers were identified. These companies are either established companies or start-up firms developing their first methods and/or products in the cell-free DNA/RNA field. These technologies are mainly related to cancer or prenatal diagnostics. Numerous IP newcomers are based in the US and in Asia while some are based in Europe. It is possible that one of these innovative companies could become one of the next healthcare unicorns that the big corporations will be tempted to acquire.

Key patent analysis

This IP study includes a selection and description of key patents. The key patent analysis includes the legal status of the family for each of the main territories, the number of received citations, the review of the main claim(s), the description of interesting features about the innovation disclosures and relevant figures illustrating how the innovation works. The description also contains information about litigation over the patent family in the USA.

Useful Excel patent database

Moreover, the report also includes an Excel database with the >2,240 patents analyzed in this study. This useful patent database allows for multi-criteria searches and includes patent publication numbers, hyperlinks to the original documents, priority dates, titles, abstracts, patent assignees, each patent's current legal status and segmentation.

Companies mentioned in this report (non-exhaustive list)

ANNOROAD, AVIIR, BGI, BLUESTAR GENOMICS, CARDIFF ONCOLOGY, CAREDX, CARIS LIFE SCIENCES, CLEVELAND HEARTLAB, EISAI, GRAIL, GUARDANT HEALTH, ILLUMINA, INTEGRATED GENETICS (SEQUENOM), NATERA, ONCOMEDX, PERSONAL GENOME DIAGNOSTICS, PREANALYTIX, QIAGEN, RAVGEN, ROCHE, STRECK.

TABLE OF CONTENTS

INTRODUCTION

  • Circulating DNA/RNA
  • Scope of the report
  • Key features of the report
  • Objectives of the report

METHODOLOGY

  • Patent search, selection and analysis
  • Search strategy
  • Terminologies for patent analysis
  • Strength and blocking potential

MAIN ASSIGNEES MENTIONED

EXECUTIVE SUMMARY

PATENT LANDSCAPE OVERVIEW

  • Time evolution of patent publications
  • Time evolution by country of filing
  • Ranking of most prolific patent applicants
  • Current legal status of the main players
  • Patent legal status of the corpus
  • Mapping of main current IP holders
  • Patenting activity of IP leading companies
  • Time evolution of main patent assignees

NEWCOMERS

  • Start up companies
  • Established companies

COLLABORATIONS

IP POSITION OF MAIN APPLICANTS

  • IP leadership of patent applicants
  • IP blocking potential of patent applicants
  • Strength index of patent portfolios

KEY PATENTS

  • Patent citation analysis
  • Key patent families

MAIN OPPOSITIONS LITIGATIONS

  • Main oppositions on EP patents
  • Main litigations in the USA

PATENT SEGMENTATION

  • Definition
  • Main assignees by technology
  • Application cancer
  • Application prenatal
  • Application infectious diseases
  • Application transplantation
  • Application nervous system
  • Application cardiovascular system
  • Technology detection analysis
  • Technology extraction preparation

IP PROFILE OF KEY PLAYERS 10 companies)

CONCLUSION

KNOWMADE PRESENTATION