一場生物科技領域罕見的專利沖突案例

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一場生物科技領域罕見的專利沖突案例

從歷史上看，專利沖突案例很少見。2013年美國修訂專利法以來，這種情況基本上就沒有再出現(xiàn)過。現(xiàn)行的專利權授予的基本原則是“先申請者得”。但在2013年之前，這個標準是“先發(fā)明者得”。

一場生物科技領域罕見的專利沖突案例

這聽起來像是科幻小說——借助新的基因編輯技術，科學家可以精確定位并截取細菌、動物甚至人類活體細胞中的一小段DNA。不過，CRISPR這種基因編輯技術可是貨真價實的。它有可能在未來的某一天治愈細胞性貧血等與基因相關的疾病，種出更好的莊稼，或者帶來大量可供移植的器官。難怪《科學》雜志將這一技術評為2015年科學“年度突破”。

但現(xiàn)在，誰擁有并控制著這項革命性技術也正式成為一個問題，頂尖科學家和科研機構為此爭執(zhí)不下。

2016年1月，美國專利商標局宣布，有兩位科學家的專利申請存在“沖突”，從而正式拋出了一個問題，那就是誰首先發(fā)明了CRISPR技術，進而擁有這項蘊含著巨大價值的技術。本次專利糾紛不僅將決定相關名譽的歸屬，還將決定哪位科學家和哪所科研機構將獲得這項潛在價值達數(shù)十億美元的專利權。

加利福尼亞大學伯克利分校生物化學家詹妮弗?杜德納于2012年5月就核心CRISPR技術申請專利。2012年12月，麻省理工-哈佛大學布羅德研究所生物學家張鋒提交了類似申請。但他申請了快速授權，并在2014年4月正式取得專利權?，F(xiàn)在，專利商標局正式啟動了“沖突”解決程序，三名專利法官組成的小組將決定張鋒是否應該繼續(xù)擁有CRISPR專利以及其他與此項技術有關的專利。

對兩位科學家和他們所在的科研機構來說，這牽涉到大筆財富，因為世界各地的研究者和企業(yè)都已經開始把這項技術用于新的應用之中。紐約法學院法律和技術創(chuàng)新中心副教授雅各布?沙爾蔻說：“所有人都試圖算清楚那些應用會值多少錢。這方面有各種說法，但都達到了數(shù)十億美元的水平。”

CRISPR被喻為基因編輯技術的“圣杯”。它能夠精準地對活體組織中的基因進行編輯。這項技術利用核糖核酸（RNA）導向分子進入某些細胞中，然后把Cas9核酸內切酶附著在DNA上，Cas9會像微型剪刀一樣把DNA切斷。這種辦法既可以只移除有缺陷的DNA，也可以用一個沒有缺陷的基因序列來代替前者。

已經開始融資的公司

目前，市場上已有多家生物科技初創(chuàng)利用這項技術推出了新的治療方法，并有可能治愈重大基因疾病和免疫疾病，甚至能讓盲人重見光明。波士頓咨詢公司提供的數(shù)據顯示，包括張鋒的Editas Medicine和杜德納的Caribou Bioscience在內，這些公司在過去兩年中已經吸引了逾10億美元風險投資。沙爾蔻說：“人們的想法是，無論這些公司得到了多少投資，都只是這些專利估值的粗略體現(xiàn)。至少，在倍數(shù)范圍內確實如此?！?/p>

在初創(chuàng)公司中，Editas Medicine已經和生物醫(yī)藥公司Juno Therapeutics聯(lián)手研發(fā)抗癌藥物，平均每個項目的階段性付款為2.3億美元。據彭博報道，杜德納在維也納大學的合作伙伴埃馬努埃爾?夏龐蒂埃建立的Crispr Therapeutics正在和制藥公司Vertex Pharmaceuticals合作，每個項目都將獲得最高4.2億美元的階段性付款。

罕見的專利爭議

從歷史上看，專利沖突案例很少見。2013年美國修訂專利法以來，這種情況基本上就沒有再出現(xiàn)過?，F(xiàn)行的專利權授予的基本原則是“先申請者得”。但在2013年之前，這個標準是“先發(fā)明者得”。也就是說，誰能證明自己首先提出了相關想法，誰就能取得專利權。由于杜德納和張鋒申請專利的時間在專利法修訂之前，此案將按“先發(fā)明者得”的標準進行審理。沙爾蔻指出，以前這樣的專利糾紛會在一年內結案。但鑒于此項專利價值巨大，敗訴一方提起上訴的可能性很大。而上訴有可能拖上好幾年。

與此同時，研究者和初創(chuàng)公司仍將繼續(xù)借助CRISPR技術來推進自己的工作。而源于這項技術的潛在治療手段和應用，估計仍需要幾年時間才會成為現(xiàn)實，但愿在此期間，我們能夠解決這項核心技術的歸屬問題。

英文版：

It sounds like the stuff of science fiction: A new gene-editing technology allows scientists to precisely locate and cut out bits of DNA from live cells in bacteria, animals, and even humans. But CRISPR is very real, with the potential, one day, to cure genetically-linked diseases like sickle cell anemia, produce better crops, and create a huge supply of organs for transplant. No wonder it was namedScience’s 2015 Breakthrough of the Year.

But who owns and controls this revolutionary technology also is now officially in question, pitting leading scientists and research institutions against each other.

In January 2016, the U.S. Patent and Trademark Office declared an “interference” between two scientists’ patent applications, which officially opens up the question of who first invented–and thus owns the lucrative rights to the foundational CRISPR technology, which stands for Clustered Regularly-Interspaced Short Palindromic Repeats. The patent dispute will determine not only who gets credit but who lays claim to the royalties, which could be worth “billions” of dollars for the scientist and research institution.

Biochemist Jennifer Doudna from the University of California, Berkeley submitted her patent application for the core CRISPR technology in May 2012. Biologist Feng Zheng from the Broad Institute of Harvard and MIT submitted a similar patent application in December 2012, but he requested a fast-track process and received the official patent in April 2014. Now, with an official “interference” proceeding underway, a panel of three patent judges will determine whether Zhang should hold onto the rights to the foundational CRISPR patent, as well as other patents related to the technology.

There is a lot of money at stake for both the creators and their institutions, as researchers and companies around the world start using the technology for new applications. “Everyone is trying to figure out how much those applications are going to be worth,” said Jacob Sherkow, an associate professor at the Innovation Center for Law and Technology at the New York Law School. “Numbers have been bandied about, but we’re talking billions with a ‘B’.”

CRISPR is considered to be the “holy grail” of gene-editing technology. It is able to edit genes accurately and precisely within a living organism by leveraging an RNA “guide” molecule to enter in specific cells; a specific protein, called Cas9, attaches to the DNA and cuts it like a pair of tiny scissors. That process can either simply remove a faulty gene or replace a gene with a good strand of DNA.

Companies already raising money

A number of biotechnology startups have been leveraging the technology to bring new treatments to market that could solve devastating genetic diseases, autoimmune illnesses, and even blindness. These companies, including Zhang’s Editas Medicine and Doudna’s Caribou Bioscience, have attracted more than $1 billion in venture investment over the past two years, according to the Boston Consulting Group. “The thinking is that however much money these companies are getting, it’s a very rough approximation of what the patents are worth,” said Sherkow. “It’s at least true within a couple of multiples.”

For starters, Editas has teamed up with Juno Therapeuticsto help create cancer treatments with milestone payments of $230 million per program. Crispr Therapeutics, which was created by Doudna’s partner Emmanuelle Charpentier at the University of Vienna, stands to make up to $420 million in milestone payments per program in partnership with Vertex Pharmaceuticals, reported Bloomberg.

A rare kind of patent dispute

Patent interference cases are historically rare; but they’ve become basically non-existent since a change in the patent law in 2013. Today, patents are awarded on a “first to file” basis. However, prior to 2013, patents were granted on a “first to invent” basis, meaning whoever could prove they invented the idea first would have rights to the patent. Since Doudna’s and Zhang’s patents were filed before the switch went into effect, the case falls under the “first to invent” standard. In the past, patent interference cases like this were concluded within a year, Sherkow said, but given the value of this patent, it seems more than likely that the losing party will appeal the decision. That process could stretch out for years.

In the meantime, researchers and startups are moving ahead, working on advancements using the CRISPR technology. The potential treatments and uses that may stem from the CRISPR method still remain a few years off–hopefully long enough to solve who gets the final ownership on the core technology.

來源：財富中文網

譯者：Charlie

校對：詹妮

編輯：IPRdaily王夢婷