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一场生物科技领域罕见的专利冲突案例
2016年3月16日

这听起来像是科幻小说——借助新的基因编辑技术,科学家可以精确定位并截取细菌、动物甚至人类活体细胞中的一小段DNA。不过,CRISPR这种基因编辑技术可是货真价实的。它有可能在未来的某一天治愈细胞性贫血等与基因相关的疾病,种出更好的庄稼,或者带来大量可供移植的器官。难怪《科学》杂志将这一技术评为2015年科学“年度突破”。

但现在,谁拥有并控制着这项革命性技术也正式成为一个问题,顶尖科学家和科研机构为此争执不下。

20161月,美国专利商标局宣布,有两位科学家的专利申请存在“冲突”,从而正式抛出了一个问题,那就是谁首先发明了CRISPR技术,进而拥有这项蕴含着巨大价值的技术。本次专利纠纷不仅将决定相关名誉的归属,还将决定哪位科学家和哪所科研机构将获得这项潜在价值达数十亿美元的专利权。

加利福尼亚大学伯克利分校生物化学家詹妮弗?杜德纳于20125月就核心CRISPR技术申请专利。201212月,麻省理工-哈佛大学布罗德研究所生物学家张锋提交了类似申请。但他申请了快速授权,并在20144月正式取得专利权。现在,专利商标局正式启动了“冲突”解决程序,三名专利法官组成的小组将决定张锋是否应该继续拥有CRISPR专利以及其他与此项技术有关的专利。

对两位科学家和他们所在的科研机构来说,这牵涉到大笔财富,因为世界各地的研究者和企业都已经开始把这项技术用于新的应用之中。纽约法学院法律和技术创新中心副教授雅各布?沙尔蔻说:“所有人都试图算清楚那些应用会值多少钱。这方面有各种说法,但都达到了数十亿美元的水平。”

CRISPR被喻为基因编辑技术的“圣杯”。它能够精准地对活体组织中的基因进行编辑。这项技术利用核糖核酸(RNA)导向分子进入某些细胞中,然后把Cas9核酸内切酶附着在DNA上,Cas9会像微型剪刀一样把DNA切断。这种办法既可以只移除有缺陷的DNA,也可以用一个没有缺陷的基因序列来代替前者。

已经开始融资的公司

目前,市场上已有多家生物科技初创利用这项技术推出了新的治疗方法,并有可能治愈重大基因疾病和免疫疾病,甚至能让盲人重见光明。波士顿咨询公司提供的数据显示,包括张锋的Editas Medicine和杜德纳的Caribou Bioscience在内,这些公司在过去两年中已经吸引了逾10亿美元风险投资。沙尔蔻说:“人们的想法是,无论这些公司得到了多少投资,都只是这些专利估值的粗略体现。至少,在倍数范围内确实如此。”

在初创公司中,Editas Medicine已经和生物医药公司Juno Therapeutics联手研发抗癌药物,平均每个项目的阶段性付款为2.3亿美元。据彭博报道,杜德纳在维也纳大学的合作伙伴埃马努埃尔·夏庞蒂埃建立的Crispr Therapeutics正在和制药公司Vertex Pharmaceuticals合作,每个项目都将获得最高4.2亿美元的阶段性付款。

罕见的专利争议

从历史上看,专利冲突案例很少见。2013年美国修订专利法以来,这种情况基本上就没有再出现过。现行的专利权授予的基本原则是“先申请者得”。但在2013年之前,这个标准是“先发明者得”。也就是说,谁能证明自己首先提出了相关想法,谁就能取得专利权。由于杜德纳和张锋申请专利的时间在专利法修订之前,此案将按“先发明者得”的标准进行审理。沙尔蔻指出,以前这样的专利纠纷会在一年内结案。但鉴于此项专利价值巨大,败诉一方提起上诉的可能性很大。而上诉有可能拖上好几年。

与此同时,研究者和初创公司仍将继续借助CRISPR技术来推进自己的工作。而源于这项技术的潜在治疗手段和应用,估计仍需要几年时间才会成为现实,但愿在此期间,我们能够解决这项核心技术的归属问题。

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 namedSciences 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 inventedand 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 were 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 Zhangs Editas Medicine and Doudnas 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, its a very rough approximation of what the patents are worth, said Sherkow. Its 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 Doudnas 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 theyve 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 Doudnas and Zhangs 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 offhopefully long enough to solve who gets the final ownership on the core technology.

来源:IPRdaily
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