循環腫瘤細胞 (CTC) :分離 & 檢測的專利形勢
Circulating Tumor Cells: Isolation & Detection Patent Landscape
本報告提供循環腫瘤細胞 (CTC)的分離 & 檢測相關專利形勢的相關調查，IP趨勢，每應用的專利市場區隔，主要專利受讓人的排行榜，主要企業的IP地位和專利組合的優勢，主要的專利和其詳細，及主要企業簡介等，分析。
Cancer is the second leading cause of death worldwide and was responsible for an estimated 9.6 million deaths in 2018. Globally, about 1 in 6 deaths is due to cancer (source: WHO). One defining feature of cancer is the rapid creation of abnormal cells that grow beyond their usual boundaries, and which can then invade adjoining parts of the body and spread to other organs. The latter process is referred to as metastasizing. Metastasis is a major cause of death from cancer. Preventing or detecting metastasis outbreak has therefore become a main issue in cancer prognostic (to predict the development and the outcome of the cancer) and in personalized treatment. The discovery of circulating tumor cells (CTC) was a milestone in understanding tumoral progression, and their presence in the blood enables a less invasive biopsy (liquid biopsy) which is beneficial for the patient. Then, the development of devices to intercept and analyze these rare cells steeply increased in the last 10 years, as did the number of companies supplying them (e.g. Menarini Silicon Biosystems, GPB Scientific, Gilupi, Epic Sciences). However, this development seems to be slower than in other sectors, like the free circulating DNA area, and certain key facts could explain this lower progression. First, CTC are hard to transport and store, because cell integrity is difficult to maintain. To counteract this issue, most companies develop instruments which can be directly sold to end users, but they are expensive and complex to manufacture. Then, the transfer from laboratories to clinical practice is full of obstacles, like the complexity of clinical trials or the difficulty in getting authorization from administrative bodies (e.g. the FDA). However, understanding of CTC and technology to isolate them are advancing quickly. Monitoring these rare cells as a prognostic tool among patients is an increasingly confirmed practice, as is the significance of fully characterizing a cell to enable personalized treatment. CTC isolation & detection interests big companies and start-ups alike, and 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 one's market position.
The analysis of the time evolution of patent publications shows that CTC isolation and detection started to be investigated in the late 1990s with a first patent filed in 1995 by Dendreon (company acquired by San Power in 2017). Until 2009, there is a latent period, even if big pharmaceutical companies and some academics begin to take interest in CTC. From 2010 to 2016, an acceleration is observed with big newcomers (Nestlé, Samsung, Siemens or Hitachi Chemicals). In 2016-2017, publications stagnated despite the arrival of new players. The main patent assignees are US industrial players that develop an international intellectual property strategy. Europe and China are the main countries of protection, which appear to be strategic territories for these applicants.
CTC could be isolated and detected using various methods. Therefore, a technological segmentation was made in this IP landscape, as follows:
For each segment, the patent publication timeline and the patent portfolios of main players were analyzed. If the technology results in a clinical trial, the corresponding patent, the clinical trial and the scientific publication are described.
Among the players that have filed patents related to CTC isolation and detection, over 60 newcomers were identified. These companies are established companies and startup firms developing their first products in the CTC area. These technologies are mainly related to CTC positive enrichment, size-based isolation or nucleic acid detection. Numerous IP newcomers are based in Asia and in the US 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.
This IP study includes selection and description of key patents. The key patent analysis includes the legal state 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 the fact that the patent family was involved in a patent litigation in the USA.
Moreover, the report also includes an Excel database with the >1,680 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 to which it belongs.
ABBOTT, ABBVIE, ARKRAY, ASTELLAS, AVIVA BIOSCIENCES, BECTON DICKINSON, BIOCEPT, CELSEE, CREATV MICROTECH, CYTOGEN, CYTTEL BIOSCIENCES, DECIPHER BIOSCIENCE, EPIC SCIENCES, EUTROPICS PHARMACEUTICALS, GENCURIX, GENOBIO, GILUPI, GPB SCIENTIFIC, HITACHI CHEMICAL, ILLUMINA, JANSSEN DIAGNOSTICS, JUSBIO SCIENCES, KONICA MINOLTA, LUNG LIFE AI, MENARINI SILICON BIOSYSTEMS, NESTLE, RARECYTE, ROCHE, GENENTECH, SUMITOMO, SUREXAM, TOSOH