mRNA癌症治疗的专利格局分析（2022）

目前正在进行 600 多项 mRNA 临床试验，而且这个数字还在继续增长，这反映了公司日益增长的兴趣和经济利益。然而，迄今为止，市场上还没有产品，儘管已经针对主要专利发起了几项专利挑战。这里已经确定了大约 20 项异议程序，其中大部分是在过去五年中提出的，并且仍在等待中。

了解其他公司的知识产权地位和战略在不断变化的环境中至关重要。这些知识使我们能够感知业务风险和机遇，预测新技术并做出战略决策以加强我们的市场地位。

本报告调查了癌症 mRNA 疗法的专利格局，并提供了诸如已公布专利的时间变化、专利申请国家、专利法律状态等知识产权趋势以及主要公司概况等信息。

本报告中提到的公司

BioNTech、Cellectis、CoImmune、CureVac、eTheRNA immunotherapies、Factor Bioscience、Gritstone bio、ImmunityBio、Moderna、Myeloid Therapeutics、诺华、RIKEN、赛诺菲、上海泰利生物、Tricision Biotechnology、Nutcracker Therapeutics、Orna Therapeutics等

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内容

简介

• mRNA，癌症治疗的新领域
• 调查范围
• 主要专利申请人

调查方法

• 搜索、选择和分析专利
• 搜索策略
• 专利分析术语
• 强度和阻断潜力

执行摘要

专利格局概览

• 发布时间转换
• 申请国家/地区的时间变化
• 最多专利申请人的排名
• 主要公司的当前法律地位
• 语料库专利法律地位
• 当前主要 IP 所有者的映射
• 一家领先的知识产权公司的专利活动
• 主要专利申请人随时间的变化

新进入者

• 创业公司
• 成立公司

合作

主申请人IP位置

• 专利申请人的知识产权领导力
• 知识产权现有技术阻止专利申请人
• 专利组合实力指数
• 主要专利

对 EP 的主要反对意见

专利细分

• 定义
• 按技术：专利家族数量
• 主要申请人技术
• 跨矩阵段
• 特定的 RNA 类型：circRNA
• 特定的 RNA 类型：saRNA
• RNA 修饰和稳定化
• 载体：聚合物
• 载体：脂质
• 给药途径：肿瘤
• 给药途径：肠胃外
• 治疗：抗体
• 疗法：免疫调节剂
• 治疗：AG 直流负载
• 疗法：直接注射AG
• 治疗：修饰抗原受体

主要公司的知识产权概况

• BioNTech
• TRON
• CureVac
• Moderna
• Novartis
• University of Pennsylvania

结论

已知的演示文稿

联繫方式

Report's Key Features:

• PDF > 100 slides

• Excel database containing all patents analyzed in the report (>570 patent families), including patent segmentations and hyperlinks to an updated online database.

• IP trends, including time evolution of published patents, countries of patent filings and 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 RNAs and carriers: specific RNA type (circRNA, saRNA), RNA modification & stabilization, carriers (vesicle, virus, peptide, polymer, lipid).

• Summary of the IP related to treatment: antibody, immuno-modulator, antigen (direct or via DC), modified antigen receptor.

• Analysis of collaboration and EP patent oppositions.

Context of the report

For nearly three decades, extensive efforts have been made to increase RNA intracellular stability, translational efficiency and uptake of mRNA. Several players have taken an interest in this issue, such as mRNA technology leaders CureVac, Moderna and BioNTech. These optimizations were achieved by modifying RNA non-coding elements (5' cap, 5'- and 3'- UTRs, 3' poly-A tail) and RNA coding region, and through the development of formulation technologies with specific carriers. In cancer immunotherapy, the most advanced application of mRNA is therapeutic vaccination with mRNA encoding antigens, i.e., direct cancer vaccines or dendritic cell vaccines. Moreover, for more than a decade, industrialists and academics have been developing personalized cancer vaccines, based on the specific molecular features of patients' tumors, to elicit an immune response against neoantigens produced by cancer cells. Other applications of mRNA in cancer immunotherapy include engineering T cells with modified antigen receptors such as CAR-T, immunomodulator production such as cytokines, co-stimulatory ligands and receptors, and antibody delivery. Currently, there are more than 600 clinical trials in progress, and this number continues to increase, reflecting the growing interest in this topic as well as the economic stakes for companies. However, to date, there is still no product on the market, but several patent oppositions have already been initiated against key patents. Around 20 opposition proceedings have been identified herein, most of which were filed in the past five years and still pending. By winning the race for the Covid-19 vaccine, mRNA vaccines have proven their worth, and demonstrated that RNA-based therapies can deliver on their promises. Additionally, it highlighted the advantages of mRNA over conventional therapies: active at a relatively low dose range, can be developed rapidly, and GMP-compliant manufacturing processes easily upscaled for rapid availability of large numbers of doses. All progress made in the development of Covid-19 vaccines will certainly help advance the development of mRNA-based cancer therapies. In this evolving context, it is crucial to understand the intellectual property position and strategy of these different players. Such knowledge can help detect business risks and opportunities, anticipate emerging technologies, and enable strategic decisions to strengthen market position.

Analysis of the time evolution of patent publications shows that mRNA cancer therapies started to be investigated in 1992, but the technology emerged in the early 2000s with European companies such as CureVac and BioNTech, and American Universities such as Johns Hopkins University, Duke University and Texas University. In 2015 and 2017, two peaks are observed, resulting in an increase in the number of patent applicants. Moreover, in 2017, Moderna published 11 patent families and CureVac 7 patent families. As of 2019, this trend continues. Indeed, the increase in patent publications mainly corresponds to an increase in the number of assignees rather than an increase in the number of patent families for a player, even if BioNTech published 15 then 11 patent families in 2020 and 2021 respectively.

Analysis by segment

mRNA cancer therapies have been investigated and the selected patent families labeled according to the technologies to which they relate. This IP landscape features the following five types of segmentation: specific RNA type (circRNA, saRNA), RNA modification & stabilization, carriers (vesicle, virus, peptide, polymer, lipid), delivery route (tumoral, parenteral, other) and therapy (mRNA encoded antibody, immunomodulator, antigen via DC loading, antigen via direct injection, modified antigen receptor).

EP oppositions

There is a significant number of EP oppositions, which reflects the strategic issues of mRNA cancer therapies for companies. Most of the proceedings are recent, filed in the past five years, and are still pending. For each opposed patent, the application date, assignee, opponent, opposition year and results are detailed.

Identifying the companies that have recently emerged in the IP landscape

Among the players owning patent families related to mRNA cancer therapies, 50 newcomers were identified. These companies are either start-up firms (20) or established companies (30) developing their first technology in the mRNA field. These technologies are mainly related to carriers or to mRNA encoded specific proteins. 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.

IP profile of key players

This IP study includes a selection and description of the key players. The patent portfolio analysis of key players includes a description of the assignee, key numbers in terms of patents, time evolution of patent publication, main geographical coverage and live patents by technical segment. This IP profile overview is followed by the description of all the assignee's key patents and by a table with its clinical trials.

Moreover, the report also includes an Excel database with the 574 patent families 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)

BioNTech, Cellectis, CoImmune, CureVac, eTheRNA immunotherapies, Factor Bioscience, Gritstone bio, ImmunityBio, Moderna, Myeloid Therapeutics, Novartis, RIKEN, Sanofi, Shanghai Telebio Biomedical, Tricision Biotechnology, Nutcracker Therapeutics, Orna Therapeutics, etc.

TABLE OF CONTENTS

INTRODUCTION

• mRNA, a new therapeutic area in cancer treatment
• Scope of the report
• Main patent assignees

METHODOLOGY

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

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 prior art blocking potential of patent applicants
• Strength index of patent portfolios
• Key patents

MAIN EP OPPOSITIONS

PATENT SEGMENTATION

• Definition
• Number of patent families by technology
• Main assignees by technology
• Cross matrix segments
• Specific RNA type: circRNA
• Specific RNA type: saRNA
• RNA modification & stabilization
• Carrier: polymer
• Carrier: lipid
• Route of administration: tumoral
• Route of administration: parenteral
• Therapy: antibody
• Therapy: immunomodulator
• Therapy: AG via DC loading
• Therapy: AG via direct injection
• Therapy: modified antigen receptor

IP PROFILE OF KEY PLAYERS

• BioNTech
• TRON
• CureVac
• Moderna
• Novartis
• University of Pennsylvania

CONCLUSION

KNOWMADE PRESENTATION

CONTACT