【进展】新英格兰医学——谁拥有联邦政府资助的基金

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Who Owns Federally Funded Research? The Supreme Court and the Bayh–Dole Act

Aaron S. Kesselheim, M.D., J.D., M.P.H., and Rahul Rajkumar, M.D., J.D.

N Engl J Med 2011; 365:1167-1169September 29, 2011

Collaboration between academic researchers and private companies has long been essential to medical innovation and development because it brings together parties with different expertise, data, or technologies. Such cooperative efforts usually begin with a contract that outlines the parties' expectations and ownership of any output. A recent Supreme Court decision shines a bright light on these contracts and addresses the question of whether the public has any formal interest in agreements made involving federally funded research.
The case related to a long-simmering dispute between Stanford University and Roche Molecular Systems regarding ownership of a widely used and profitable diagnostic assay for human immunodeficiency virus (HIV). The dispute dates back to 1988, when a scientist, Mark Holodniy, joined a Stanford University laboratory to measure the effectiveness of HIV treatment. His projects involved two federally funded grants. To aid his university work, in 1989 he visited Cetus, a small privately held biotechnology company that had pioneered polymerase-chain-reaction (PCR) techniques, to learn about using PCR in quantifying HIV levels. Nine months later, Holodniy returned to Stanford to develop the technique with university colleagues — work that led to three patents on processes for HIV measurement that they assigned to Stanford. Meanwhile, Roche Molecular Systems acquired Cetus's PCR-related assets and commercialized the diagnostic assay, which has become central to the care of patients with HIV.
Stanford approached Roche for a share of the proceeds from the assay, but talks broke down and Stanford initiated a patent-infringement lawsuit against Roche. In Holodniy's employment contract with Stanford, he “agree[d] to assign” to Stanford his “right, title and interest in” inventions. However, to gain access to Cetus, he also signed a confidentiality agreement in which he asserted that he “hereby do[es] assign” to Cetus his right to “ideas, inventions and improvements” made during his time there. The District Court found that Holodniy's contract with Cetus had superior rights over the Stanford contract. However, it also found that a federal law — the University and Small Business Patent Procedures (Bayh–Dole) Act of 1980 — superseded both contracts, vesting rights to federally funded work in the institution receiving the funds.

Before Bayh–Dole, the U.S. government was a default owner of intellectual property rights to inventions deriving from the research it funded. Congress passed Bayh–Dole to address the (probably exaggerated1) perception that the government often ended up with the rights to useful inventions that languished without ever being brought to market. The statute permitted universities, businesses, or nonprofit organizations that receive federal funds to retain the title to the inventions their employees developed while using those funds. The government, in turn, was given “march-in” rights to take over the intellectual property if the owner did not take reasonable steps to commercialize an invention or to use that invention to “alleviate health or safety needs.”

Stanford argued that Bayh–Dole created a hierarchy of ownership rights that placed the organization receiving federal funds (in this case the university) at the top, followed by the government, and only then — if the organization and the government did not exercise their rights — the individual inventor. But in its June decision, the Supreme Court disagreed with this interpretation of Bayh–Dole, finding that it does not give universities primary claim to federally funded inventions patented by members of their faculties.2 Rather, writing for a seven-to-two majority, Chief Justice John Roberts noted that since the original Patent Act of 1790, the inventor has always held the primary position. Since Holodniy's contract with Cetus was found to have superior rights over his contract with Stanford, the university's lawsuit was blocked.

The Court's ruling highlights the importance of the intellectual-property–related language in agreements signed by academic scientists. Universities vary in their attention to the research contracts signed by their employees, and disputes over intellectual-property provisions in sponsored research contracts are common.3 If a university's rights to an invention or discovery are only as good as the assignments it has received from its employees, a government-grantee organization must be especially careful to ensure that it actually owns the title to an invention that it might want to license out. In the wake of the Court's ruling, at least one university, the Massachusetts Institute of Technology, has already taken preventive action by changing the wording of the Inventions and Proprietary Information Agreements it asks faculty members to sign.4 Contractual wrangling is likely to increase, impeding collaboration between private companies and universities — an effect that would run directly counter to Bayh–Dole's intention.

The case also threatens to exacerbate some of the more troubling consequences of the original 1980 legislation. Bayh–Dole's supporters argue that it has led to a dramatic increase in patenting activity by federal grantees: universities were issued 264 patents in 1979 and 3278 patents 2005. However, this trend has also been criticized as a socially inefficient privatization of academic research.5 A more complex web of licensing agreements may threaten the open nature of academic inquiry.

Finally, the decision raises questions about how to ensure equitable returns on federal research funding. In the Stanford case, the development of the widely used HIV diagnostic test occurred primarily in the private sector, and the Supreme Court's decision may have been influenced by the tenuous relationship between the federal funding and the product at issue. In many other cases, though, important new drugs and medical technologies are developed in university or nonprofit settings supported by federal funding and are later commercialized with little return to these development sources. In such situations, there is a strong public-policy rationale for giving universities the first rights to the fruits of publicly funded research. This outcome now requires a legislative amendment to Bayh–Dole. To make such an amendment more politically palatable, universities should reexamine and perhaps revamp their licensing practices to ensure that they are indeed acting as stewards of the public good, rather than simply seeking to maximize their own licensing revenues. They can do this, in part, by including access provisions in their licensing agreements to ensure that the products of their research are available to the neediest patients (for example, those in low-income countries) and by ensuring that their research agenda prioritizes the public interest over potential profit.

Disclosure forms provided by the authors are available with the full text of this article at NEJM.org.

This article (10.1056/NEJMp1109168) was published on August 31, 2011, at NEJM.org.
Source InformationFrom the Division of Pharmacoepidemiology and Pharmacoeconomics (A.S.K.) and the Department of Medicine (A.S.K., R.R.), Brigham and Women's Hospital; Harvard Medical School (A.S.K.); and McKinsey and Co. (R.R.) — all in Boston.

蓝鱼o_0

学术研究人员和私营公司之间的合作早已医疗创新和发展至关重要，因为它汇集了各方与不同的专业知识，数据，或技术。这种合作努力通常首先，概述了各方的期望和任何输出的所有权的合同。最近最高法院的决定，闪耀着明亮的光线对这些合同和地址的公众是否有任何正式协议，涉及联邦政府资助的研究兴趣问题。 之间的斯坦福大学和罗氏分子系统一种广泛使用的和盈利的诊断检测人类免疫缺陷病毒（艾滋病毒）的所有权有关的长期酝酿的争端有关的案件。争端的历史可以追溯到1988年，当一名科学家，马克Holodniy，加入了斯坦福大学的实验室来衡量的艾滋病毒治疗的有效性。他的项目涉及两个联邦政府资助的助学金。为了帮助他的大学工作，在1989年，他参观了一家私人持有的小型生物技术公司，开创了聚合酶链反应（PCR）技术，Cetus，了解使用量化艾滋病毒水平的PCR。九个月后，Holodniy回到了斯坦福大学的发展与大学的同事们的工作，导致他们分配到斯坦福的艾滋病毒测量过程的三项专利技术 - 。与此同时，罗氏分子系统收购Cetus的PCR相关的资产和商业化的诊断方法，这已成为艾滋病患者的护理。

蓝鱼o_0

最后，决定提高联邦科研经费如何确保公平的回报的问题。在斯坦福案中，广泛使用的艾滋病毒诊断测试的发展主要发生在私营部门，和最高法院的决定可能已经由联邦资金和产品的问题之间的微妙关系的影响。不过，在很多情况下，重要的新的药物和医疗技术在大学或联邦资金支持的非营利性设置和后来很少返回到这些发展的源商品化。在这种情况下，有一个强大的公共政策给大学公共资助的研究成果的第一权利的理由。这样的结果，现在需要一个贝赫 - 多尔的立法修订。为了使这项修正案政治上更加认可，高校应重新审视和可能重整他们的许可做法，以确保他们是作为公众利益的董事局，而不是简单地寻求最大限度地发挥自己的授权收入。他们可以做到这一点，部分，包括在其许可协议，以确保他们的研究产品是提供给最需要帮助的患者（例如，在那些低收入国家）的准入规定，并确保他们的研究议程优先公共利益超过潜在利润。

蓝鱼o_0

关于这个法案我也找到了解释，感兴趣的人可以看下：

http://www.autm.net/Bayh_Dole_Act.htmBayh-Dole Act
Enacted on December 12, 1980, the Bayh-Dole Act (P.L. 96-517, Patent and Trademark Act Amendments of 1980) created a uniform patent policy among the many federal agencies that fund research, enabling small businesses and non-profit organizations, including universities, to retain title to inventions made under federally-funded research programs. This legislation was co-sponsored by Senators Birch Bayh of Indiana and Robert Dole of Kansas.The Bayh-Dole Act was especially instrumental in encouraging universities to participate in technology transfer activities.

The Act is "perhaps the most inspired piece of legislation to be enacted in America over the past half-century," according to The Economist. "Innovation's Golden Goose," an opinion piece published in the Dec. 12, 2002, edition the respected publication, states: "Together with amendments in 1984 and augmentation in 1986, this unlocked all the inventions and discoveries that had been made in laboratories throughout the United States with the help of taxpayers' money. More than anything, this single policy measure helped to reverse America's precipitous slide into industrial irrelevance."

Major provisions of the Act include:

Non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programs
Universities are encouraged to collaborate with commercial concerns to promote the utilization of inventions arising from federal funding
Universities are expected to file patents on inventions they elect to own
Universities are expected to give licensing preference to small businesses
The government retains a non-exclusive license to practice the patent throughout the world
The government retains march-in rights.
AUTM Celebrates 30th Anniversary of Bayh-Dole


December 12, 2010 marked the 30th anniversary of the Bayh-Dole Act. This legislation changed fundamentally the way America develops technologies from federally funded university research and effectively secured the country’s leadership position in innovation. AUTM joined forces with the Association of American Universities, BIO, the Association of Public and Land-grant Universities and the American Council on Education to celebrate the Act and communicate its value. The Bayh-Dole Act 30th Anniversary Event was held Dec. 1 at the Washington Convention Center.

The first half of the event included remarks from original congressional sponsor of the Act, Sen. Birch Bayh. Other notable speakers included Sharon Barner, Deputy Director, USPTO and William Kirwan, Chancellor of the University System of Maryland. Patient advocate Betsy de Parry spoke of her diagnosis of an incurable form of follicular non-Hodgkin’s lymphoma in 2002, de Parry talked about the life saving treatment, radioimmunotherapy (RIT), that was co-developed at the University of Michigan. “It was the Bayh-Dole Act that enabled them to turn their discovery into a life-saving treatment that has given many lymphoma patients back their futures,” said de Parry.

de Parry presented awards for Outstanding Contributions to American Innovation to Senators Bayh and Dole. Michael Connor, partner, Alston & Bird, accepted the award for Sen. Dole, who wasn’t able to attend the event.

Sen. Bayh presented The Driving Innovation Award to Howard Bremer, Ralph Davis and Norm Latker for their work in drafting the Bayh-Dole Act. The Bayh-Dole 30th Anniversary Award was presented to Joseph Allen for his work over the past 30 years as a champion for the Bayh-Dole Act.

“Without Senator Bayh’s and Senator Dole’s foresight and commitment to this great nation, not only would the technology transfer profession exist as it does, but countless companies and products like Flumist, the nicotine patch, once-a-day HIV medication and the HPV vaccine might also not be here to help countless lives in our nation and around the world,” said AUTM President Ashley Stevens, D. Phil. (Oxon), CLP.

Former Rep. Jim Greenwood, CEO of BIO (Biotechnology Industry Organization) moderated the second half of the event, a panel discussion among business, university and policy leaders which included Sharon Barner, Deputy Director, USPTO; Sen. Bayh; Betsy de Parry, Patient Advocate; William E. Kirwan, Chancellor of the University System of Maryland; and Bart Newland, Biogen.

AUTM also launched a Web site, www.B-D30.org. The site provides links to articles and videos on the Act, its history, current news and more. The site includes examples of technologies and products that originated from federally funded university discoveries. Read more.

A celebration of the 30th Anniversary of the Bayh-Dole Act was held Dec. 9 at the United States Patent and Trademark Office. Read the remarks of USPTO Director David Kappos here.

Bayh-Dole Talking Points
Over the years, various groups have expressed support or questions about the Bayh-Dole Act. The AUTM Public Policy Committee has tried to compile some of that information into one document of talking points that you may wish to use when speaking with senior university management, legislators, the media, and the general public. We recommend adding another page that highlights the specific successes generated by your organization and have provided some ideas on what you could include.

Bayh-Dole Talking Points (Adobe PDF File)
Customize This Template for Your Institution (Microsoft Word Document)
AUTM Letter to Department of Commerce (PDF File)
Kaufmann Letter to Department of Commerce (PDF File)
Case Western Response to Harvard Business Review (PDF File)
Learn more about Bayh-Dole
Senate Committee on the Judiciary for the October 24, 2007 hearing “The Role of Federally-Funded University Research in the Patent System”

Statement submitted by the Association of University Technology Managers

Testimony presented by Charles F. Louis, Vice Chancellor for Research, University of California, Riverside

Testimony presented by Elizabeth Hoffman, Executive Vice President and Provost, Professor of Economics, Iowa State University

House Committee on Science and Technology, Subcommittee on Technology and Innovation, for July 17, 2007 Hearing on “Bayh-Dole – The Next 25 Years”

Testimony presented by Arundeep S. Pradhan, Director, Oregon Health & Science University, and President-Elect, AUTM

House Committee on the Judiciary, Subcommittee on Courts and Intellectual Property for July 13, 2000 Oversight Hearing on “Gene Patents and Other Genomic Inventions”

Testimony presented by James A. Severson, President, Cornell Research Foundation, and Past-President, AUTM

The Bayh-Dole Act: Important to the Nation, Important to Vermont

toto

只要最后为大众谋福利就行，管它给谁呢！

天天，天蓝

老外的一些作法还是有些复杂呵！