A big news to all who are into high throughput sequencing (HTS) and has collaboration with BGI
About a week ago, Mayo clinic won the Prometheus's patent war [1].
Briefly, medical test that rely on correlation alone is not eligible for patent. Only those with go beyond reciting the law of nature but also to apply such law can be patented.
Dennis Lo firstly found fetal DNA could be detected from maternal blood. His team published high throughput sequencing based test on Trisomy 21 in STM in 2010 and validated on a large cohort in 2011 [2] [3]. Subsequently they patented the method.
Today, CUHK has declared war on BGI, claiming they infringe their the patent on using HTS based method to diagnose trisomy 21.
CUHK claimed they possess the exclusive right on using HTS to diagnose Trisomy 21 (The patent was hold by Dennis Lo and in part by Sequenom, where Dennis Lo is in its scientific advisory board).
CUHK currently holds the patent in Hong Kong. CUHK has also filed patent in China, but that is still under review. BGI claimed CUHK will never get the patent in China (why? you guess it). BGI further claims they also contributed to the research. But note that BGI only has a name on the second BMJ paper. It is elusive how much the director of BGI could contribute to this project. 2 speculations, (1) BGI actually contributed a lot to this project but they did not get a lot of authorship, or (2) BGI has a name on it simply because of the CUHK-BGI collaboration that started several years ago.
This war raise the question again on what can be patented. Obviously on trisomy 21 subject, you got more sequence reads because of the extra chromosome. Using clinical cases to establish the normal boundary would not be that difficult. Is this HTS based method just demonstrating correlation alone? Does it hold sufficient innovation beyond reciting the law of nature?
No matter what, I am worry about the grim future collaboration between CUHK and BGI, especially the Institute of Trans-Omic?
The news about "CUHK versus BGI" is in traditional Chinese, as attached below.
無創驗唐氏症 中大稱被假冒
中大醫學院研發透過抽血驗DNA的無創驗唐氏綜合症技術，去年只在港、美推出，卻在內地廣泛臨床應用。
研發者盧煜明教授昨指有人假冒其技術；但正為內地及香港醫生提供有關化驗服務的「華大基因」否認假冒，並指中大不可能在內地取得專利保護。
盧煜明：中大唯一有權測試
在華大基因的網頁可見，「無創性產前基因檢測」已在內地多個省市，包括深圳和天津廣泛推行，總理溫家寶亦曾表示支持華大的研究成果，能助天津市成為第一個世界上沒有「唐娃娃」 （唐氏綜合症）城市的目標，甚至推至全國各地。
華大基因執行總監王立志承認，華大所用的核心技術與中大的一樣，且承認他們曾參與中大的有關研究，稱只是最後的學術文章由中大醫學院化學病理學系系主任盧煜明發表。
但盧煜明指現時市面有假冒測試，而中大是唯一有權做此測試的機構。他說，中大已在99年成功獲批本地專利，並在07年於內地提交申請，惟仍在審批當中。
不過，王立志指內地衞生部門的指引訂明，臨床的檢測是不會獲得批專利權，因此中大的申請是不會獲批。
華大基因：參與研究非假冒
王又承認，華大有與本港婦產科私家醫生合作，但不肯透露數目，強調所提供的報告都有ISO認證及內地認證。他稱，內地人接受檢查的費用較香港便宜，但他不肯透露實際收費。
他又說，由於他們有參與中大的研究，在美國應擁有部分專利權，相信若與中大打官司也有足夠理據，但他表示不會這樣做。
本報記者以顧客身份致電本港其中一間有提供「胎兒染色體異常的無創性產前診斷」（下稱NIFTY）服務的領峰醫務中心查詢，職員表示收費僅6,000元，更說較中大的便宜，兩星期便有結果。
職員又稱，孕婦的血液樣本會被送到深圳「華大基因」檢驗，該公司與負責婦產科的專科醫生劉子建合作已久，並稱有關技術在其他國家都有使用，只是香港未普及。
早年有份參與研發有關技術的劉子建，原為中大醫學院榮譽教授，但已被中大除名。本報向中大醫學院婦產科主任鍾國衡查詢，他否認劉子建的除名與使用技術的爭議有關。
消息稱，中大懷疑本港有醫生向病人解釋華大的報告，已屬侵犯本港的專利權，正徵詢法律意見，保留追究權利。本報昨日向劉子建查詢，但至截稿前未有回應。
References
[1] Justices Back Mayo Clinic Argument on Patents
[2] Maternal Plasma DNA Sequencing Reveals the Genome-Wide Genetic and Mutational Profile of the Fetus
[3] Non-invasive prenatal assessment of trisomy 21 by multiplexed maternal plasma DNA sequencing: large scale validity study
No comments:
Post a Comment