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Fact check: Simpson misinformed on publicly funded research

Madison, Wis. - At last, we're getting to the bottom of what makes John Simpson and the California-based Foundation for Taxpayer and Consumer Rights tick - or, more accurately, ticked off.

Not only does Simpson think the historic Bayh-Dole Act has been a colossal waste of time and money, even though many experts believe it unchained the innovative potential of the nation's research universities, but he doesn't understand the basics about “technology transfer” on those same campuses.

In his Aug. 11 column published by the Wisconsin Technology Network, Simpson described the 27-year-old Bayh-Dole Act as “flawed” because, in his view, taxpayers are cut out of the deal when it comes to reaping the rewards of federally or state-funded research.

It is a misinformed position that explains why Simpson and the foundation have repeatedly claimed the University of Wisconsin-Madison, the Wisconsin Alumni Research Foundation or both have prevented other researchers in the United States or abroad from learning from their findings about human embryonic stem cells.

Faulty assumptions

Frankly, if Simpson were correct on the basics, even I would be tempted to agree with him. But he's wrong in his key assumptions.

Simpson: “Faced with dwindling federal support for research, more and more states like Wisconsin are stepping up to fill the shortfall with state money.”

Fact: The state of Wisconsin has not provided one penny to fund human embryonic stem cell research, a line of research where Simpson has focused his complaints. The state has helped to pay for basic life sciences research at the UW for more than 100 years, an academic mission few seriously question. And it has provided grants or loans to many tech-based companies. But when it comes to basic research, state government is a poor fourth behind the federal government; private, non-profit WARF; and other private sources of cash.

The Wisconsin Institutes for Discovery is a prime example of how the state gets involved. The Institute is a $150 million building funded with one-third state dollars and two-third private dollars. Once completed, the facility will encourage and establish collaborative research on the UW-Madison campus and beyond. Some stem-cell researchers may be housed on the Institute's privately funded side, but the state is not directly paying for their work.

Simpson: “Who should control, profit, and otherwise benefit from discoveries made in state-funded laboratories across Wisconsin? As states like Wisconsin have increasingly raised their contributions, appropriate policies and safeguards are essential at the state level.”

Fact: The state of Wisconsin hasn't “raised its contributions” for stem-cell research or any of research. State spending on academic research has declined in real terms for more than two decades, to the point that Wisconsin's slide in state support puts it among the top 10 percentage “losers” among the 50 states.

Simpson: “If Wisconsin has funded an invention, but the patent holder does not commercialize it, Wisconsin should be able to license the invention to someone who will.”

Fact: So what does Simpson think WARF has been doing for the past 80 years? Since 1925, WARF has held the patents generated by research on the UW-Madison campus and licensed to others the rights to use them. Any profits from those licenses are plowed back into the university - about $850 million over the years. In fact, for the past seven years, WARF has given more back to the UW than it has generated in license revenues. While few academic tech transfer organizations have been as successful as WARF, that model is standard practice at research universities across the United States.

Simpson: “The results of all Wisconsin-funded research should be available to all researchers in Wisconsin - and any other researchers designated by the state - for further research without a licensing fee. Once taxpayers pay to develop a technology, researchers in the state ought to have free access to further research.”

Fact: With stem-cell licenses as well as all WARF licenses, non-profit researchers are provided a safe harbor to use any WARF-owned technology for academic research not only in Wisconsin but all over the world. The only thing WARF declines to do is to donate its stem cells to for-profit companies or private labs.

WARF has all but given away its stem cells to 400 academic researchers in two-dozen nations, and trains those researchers in how to properly use those cells in their own labs. Because it exists to protect and commercialize UW inventions, however, WARF declines to simply hand off its intellectual property to others who might profit by their use. Private groups can buy WARF stem cells at a fair price given what those companies and labs stand to gain if their research leads to a billion-dollar cure. They just can't get stem cells for free.

Even though an academic researcher can license WARF cells for $500 - yes, $500 - and come to Madison for free training, Simpson and friends still claim WARF is blocking the schoolhouse door. Go figure.

Simpson: “Consider the California biotech company Genetech. It charged $100,000 a year for its cancer-fighting drug Avastin even though $44.6 million in federal funds from the National Cancer Institute went to develop it.”

Fact: Well, at least Simpson is wrong about California tech transfer, too. The $44.6 million from NIH was spent on basic research, which the federal government long ago concluded is done most efficiently at the academic level. The full cost of developing a newly discovered chemical entity into a marketable drug averages more than $800 million, which includes at least three stages of clinical trials and a federal approval process that devours up to half of the patent life. If it were not for patents on such new chemical entities, no company or any other institution would accept the financial risk necessary to develop a drug.

Sharing the fruits

Simpson says the public should share in the fruits of the research for which it paid. That happens every day in America, in a million unseen ways, through better and safer drugs, medical devices, and other products. To assert that Wisconsin taxpayers are paying more is wrong; to claim that federal support for basic research is wasteful is wrong-headed.


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Tom Still is president of the Wisconsin Technology Council. He is the former associate editor of the Wisconsin State Journal in Madison.

The opinions expressed herein or statements made in the above column are solely those of the author, and do not necessarily reflect the views of Wisconsin Technology Network, LLC.

WTN accepts no legal liability or responsibility for any claims made or opinions expressed herein.

Comments

Joe Boucher responded 1 year ago: #1

Tom,

Terrific rebuttal to a poorly analyzed critique by Simpson. Some people may actually have believed him to begin with, which is too bad.

John M. simpson responded 1 year ago: #2

Tom,

I'm always delighted to prompt reasoned, thoughtful discussion of public policy and thank you for engaging me in a discussion.

Frankly, though, I'm a little confused by some of your comments. Please go back and read what I said again. Why have you put much emphasis on WARF and stem cell research?

I believe I made one passing reference to stem cells, noting California's stem cell research program as an example of the sort of direct payback to the state that I advocate.

I never said the Bayh-Dole Act "has been a colossal waste of time and money." I said that it was "flawed." That means it has problems that need fixing. I also would assert that it ought not serve as the model for state funding programs without appropriate modification.

And while many support it, many are critical. Read Jennifer Washburn's excellent book, "University, Inc. the Corporate Corruption of Higher Education" for that view. The suggestion is that the Bayh-Dole Act has led to too many patents, too far "upstream" and an over commercializing of traditional basic academic research.

Part of the reason for that, some say, are unrealistic expectations about what average research universities can expect to make from their technology transfer operations. That unrealistic expectation has been fueled, ironically, by a few very successful operations such as WARF. But few universities can expect to achieve such success. Nor should they; but they do.

But I digress.

My point was about all state-funded research. Really, it has nothing to do with stem cells at all. My premise is simple. If the taxpayers put up the money, they should share directly in the fruits of the research. It's exactly the same principle as what operates for a venture capitalist. Consider the taxpayers as investors who should share the successes. And, if there isn't one, they lose their money.

Based on that broad premise, I'd suggest that any publicly funded research IP policy should have four elements:

1. If there is an invention that results in a revenue stream, the funder - in this case, the state - should get a share as a direct payback. The exact amount is open to discussion, but needs to be known up front. Arguably, it also should be a function of the amount of public investment in the project.

2. While the inventors are entitled to a fair profit, the invention should be affordable and accessible to the taxpayers who funded it. If not, the state should be able to take corrective action.

3. Any other researcher in the state should be able to use the invention for research purposes without a licensing fee. Traditionally most believed that academic researchers had a "research exemption," but the recent Madey vs. Duke decision has more or less eliminated it. If you check, you'll see that most university technology transfer operations are writing research exemptions into their licenses. I'm just saying the state should do the same thing if it funds a project.

4. Finally, if the state-funded research that resulted in an invention, but the inventor fails to commercialize it, the state should have the right to license it to someone who will. Many university technology transfer agreements have exactly such a provision when they grant exclusive licenses.

Again, I do appreciate your thoughtful and carefully reasoned analysis of my first column. I'd ask you to ponder what I've just suggested and look forward to your comments.


Best regards,
John M. Simpson

Tom Still responded 1 year ago: #3

John - Thanks for firing back.

I used human embryonic stem cell research as an example because many of your past writings have zeroed in on that technology and WARF's policies on use of its hESC intellectual property. However, my points are the same with other technologies that may be generated by UW-Madison professors and patented or licensed through WARF (or, for that matter, UW System and WiSys).

Without repeating my earlier comments on use of state taxpayer dollars for research, the return on investment is abundantly clear. It's called innovation, which in turn improves the human condition and leads to economic growth in Wisconsin.

State taxpayer support for basic research within the UW System is nothing new; it has taken place for more than a century. It has led to thousands of innovations and some 235 spin-off companies from UW-Madison alone in the past 50 or so years. That's the payback, which has been enormous given how much the state has actually invested compared to other players.

Similarly, at the federal level, Bayh-Dole was envisioned as a way to unlock innovation and speed ideas to commercialization for the greater good. Public support for basic research is essential. But it only gets good ideas into play. It takes many times that much private investment (and risk) to see the process through to completion.

Lawrence B. Ebert responded 1 year ago: #4

Of certain points made by Simpson and Still-->

Simpson: [The Bayh-Dole Act] has given ownership of any discovery to the research institution where it is made, even though taxpayers paid for the research. The institution - usually a university - patents the discovery and then licenses it to a private company and receives royalties.



LBE: Simpson's discussion of how the Bayh-Dole Act works is not entirely accurate. One can review 35 USC section 200 ff and see also



http://web.archive.org/web/20040326111707/http://www.pabar.org/membersonly/17/ipfall00.pdf



Simpson: First, when a discovery has been funded by the public, it's only fair that the public share in any profits. As an example, the recently enacted IP rules in California's landmark $6 billion stem cell research initiative provide that if there is revenue to a research institution as the result of publicly funded research, 25 percent goes back to the state.



LBE: Simpson's number of $6 billion assumes tax-exempt bonds can be issued, a reality that is far from clear. See



Problems Loom in State-Funded Stem Cell Programs, http://www.ipfrontline.com/depts/article.asp?id=9565&deptid=5



http://ipbiz.blogspot.com/2006/03/state-tax-exempt-bonds-patent.html





Still: Not only does Simpson think the historic Bayh-Dole Act has been a colossal waste of time and money, even though many experts believe it unchained the innovative potential of the nation's research universities, but he doesn't understand the basics about “technology transfer” on those same campuses.



LBE: The Bayh-Dole Act has been criticized, for example, within the magazine Fortune. There have been some issues with potential misuse of university patents, such as the infringement suit brought by the University of Rochester over COX-2 inhibitors, which suit terminated at the summary judgment stage. See also



http://ipbiz.blogspot.com/2005/09/fortune-on-bayh-dole-litigious-scrum.html



http://ipbiz.blogspot.com/2006/04/lemley-confused-on-columbias-axel.html



http://ipbiz.blogspot.com/2006/05/themes-discussed-by-cirms-ip-group-are.html




Still: Fact: With stem-cell licenses as well as all WARF licenses, non-profit researchers are provided a safe harbor to use any WARF-owned technology for academic research not only in Wisconsin but all over the world. The only thing WARF declines to do is to donate its stem cells to for-profit companies or private labs.



LBE: Neither Simpson nor Still talk about the impact of the research exemption of the Hatch-Waxman Act codified at 35 USC 271(e)(1), the relevance of which to stem cell research was discussed in 88 JPTOS 239 (2006).



Simpson rebuttal: And while many support it, many are critical. Read Jennifer Washburn's excellent book, "University, Inc. the Corporate Corruption of Higher Education" for that view. The suggestion is that the Bayh-Dole Act has led to too many patents, too far "upstream" and an over commercializing of traditional basic academic research.



LBE: On Jennifer Washburn, see Los Angeles Times Article Way Off Base on Stem Cell Issues at http://ezinearticles.com/?id=178050




Simpson rebuttal: 1. If there is an invention that results in a revenue stream, the funder - in this case, the state - should get a share as a direct payback. The exact amount is open to discussion, but needs to be known up front. Arguably, it also should be a function of the amount of public investment in the project.



LBE: One should realize that this is a sort of "deck chairs on the Titanic" concern. For example, with embryonic stem cells, the likelihood of research in the first ten years leading to a significant revenue stream is small. The more likely near-term payback is in state employment, and as to the science of stem cells, in genetic screening. See



http://ipbiz.blogspot.com/2007/08/gail-dutton-got-it-right-on-stem-cells.html




Lawrence B. Ebert is a registered patent attorney located in central New Jersey. He holds a Ph.D. from Stanford, a J.D. from the University of Chicago, maintains a blog at IPBiz.blogspot.com, and is the author of LESSONS TO BE LEARNED FROM THE HWANG MATTER: ANALYZING INNOVATION THE RIGHT WAY, published in the Journal of the Patent & Trademark Office Society [88 JPTOS 239 (March 2006)] and PATENT QUALITY AND PATENT REFORM, 88 JPTOS 1068 (December 2006),

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