Ruchika Nijhara, J Lille Tidwell, Steven Ferguson, Krishna Balakrishnan
After a heart attack, patients often undergo a procedure to open up the clogged artery and install a tiny meshlike device called a stent to keep the artery propped open. In most cases, the body reacts to this foreign object with scar-tissue formation, and the artery narrows again. To combat this re-clogging process, National Institutes of Health inventors developed paclitaxel-coated stents and later licensed it to Angiotech. Approved by the Food and Drug Administration in March 2004, these stents are expected to substantially reduce the use of coronary artery bypass surgery, an expensive operation now performed annually on 350,000-plus Americans. This and three other examples of NIH licensing success stories are described in this paper: (a) Kepivance, which improves the quality of life for cancer patients by eliminating mouth sores, (b) AIDS drug ddI, an important component of many combination drug therapies, and (c) Vitravene, the first and only antisense drug to be approved by FDA. These four examples will illustrate the success not only of the NIH licensing program, but also the innovative approaches taken by NIH inventors and the persistence of its commercial partners. This paper also highlights the business and legal lessons learned from these four cases.
心脏病发作后，患者通常会接受一个手术，打开堵塞的动脉，并安装一个微小的网状装置，称为支架，以保持动脉的畅通。在大多数情况下，身体对异物的反应是形成疤痕组织，动脉再次狭窄。为了对抗这种再堵塞过程，美国国立卫生研究院的发明者开发了紫杉醇涂层支架，并将其授权给Angiotech公司。2004年3月，美国食品和药物管理局(Food and Drug Administration)批准了这种支架，预计将大大减少冠状动脉搭桥手术的使用。目前，每年有35万多美国人接受这种昂贵的手术。本文描述了这一案例和另外三个NIH许可成功案例:(a)通过消除口腔溃疡改善癌症患者生活质量的Kepivance， (b)艾滋病药物ddI，许多联合药物治疗的重要组成部分，以及(c) FDA批准的第一种也是唯一一种反义药物Vitravene。这四个例子不仅说明了美国国立卫生研究院许可计划的成功，而且说明了美国国立卫生研究院发明者采用的创新方法及其商业伙伴的坚持不懈。本文还强调了这四个案例的商业和法律教训。
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