Tuesday, September 09, 2008

Missing the point on Bayh-Dole

In early September 2008, the New York Times had an article titled When Academia Puts Profit Ahead of Wonder which was negative to the Bayh-Dole Act and included text such as

The primary concern is that its original intent — to infuse the American marketplace with the fruits of academic innovation — has also distorted the fundamental mission of universities.


today’s universities function more like corporate research laboratories. Rather than freely sharing techniques and results, researchers increasingly keep new findings under wraps to maintain a competitive edge. What used to be peer-reviewed is now proprietary. “Share and share alike” has devolved into “every laboratory for itself.”

In trying to power the innovation economy, we have turned America’s universities into cutthroat business competitors, zealously guarding the very innovations we so desperately want behind a hopelessly tangled web of patents and royalty licenses.

One blog criticized the Times article, and then another blog criticized the first blog, writing:

It remains unclear what justifies Noonan's position, the very premise behind Bayh-Dole: that universities should be able to profit from government (theoretically public) funds in such a manner. To hell with the patent sovereign immunity of state universities, that can have their cake and eat it too. Equitably, state university patenting is a game of dirty pool. If the public paid for the research, put it in the public domain, and let the conglomerates run with it, if only because the government is too stupid to make money with patents, and Joe Sixpack taxpayer can't use it, but might get a job with Mega-Tech Corporation, shipping the box out that holds the patented invention.

The New York Times article was not well thought out. A better criticism of the Bayh-Dole Act appeared in Fortune in 2005 (see IPBiz post: Fortune on Bayh-Dole: a litigious scrum of data-hoarding and suspicion. The Supreme Court case Merck v. Integra could have been captioned Scripps v. Burnham. The recent case of Carnegie-Mellon v. Hoffmann-LaRoche, as well as the internally-cited University of Rochester case were marvels of university overreaching, each case lost on summary judgment. The Axel patent cases revealed the greed of Columbia.

Comments within the first blog were not well thought out:

Similarly wrong are the purported consequences of the infiltration of filthy lucre into the ivory towers of academe. The piece bemoans that "[b]lue sky" research... has largely been set aside in favor of projects considered to have more immediate market potential." Perhaps a quick perusal of the grant proposals to the National Institutes of Health or the National Science Foundation would have helped, since these are replete, even today, with exactly this kind of "blue sky" research.

In IPT in 1999, LBE wrote:

In a guest editorial in the September 6, 1999 issue of Chemical & Engineering
News n10 (at the invitation of Madeleine Jacobs), Professor Allen J. Bard
observed that there is a trend in scientific writing in which "applications are
implied to be just around the corner and, generally, the tone is more
appropriate to Madison Avenue than sober science" and "in which, all too
frequently, the obstacles to real world applications are never mentioned." Bard
further noted: "As the pressure has increased to show applications of research,
scientists who are doing sound and interesting basic research feel it is
necessary to tie these studies, however tenuously, to possible applications.

The danger here is that unfulfilled promises can lead to good programs being
canceled when practical systems aren't immediately forthcoming."

[Inherent Difficulties, p. 28, IPT (Nov. 1999)]

Also in the article was the text:

In the July, 1999 issue of IPT, we discussed issues associated with the
alliance of Novartis with the Department of Plant and Microbial Biology at the
University of California at Berkeley. n7 The present economic reality is that
less than half of the funding of research arises from the federal government,
with the bulk from private enterprise. n8 An issue that has been raised is
possible bias in the reporting of science results because of the possibly
"interested" nature of the private support. n9 Less frequently discussed is the
influence on the reporting of science results because of pressures from
government funding.

In the context of a later article about the Busch report, which investigated the propriety
of the Berkeley/Novartis interaction, LBE noted some odd-doings with some
Bayh-Dole patents, which would render nugatory some of the NYT text, such as

R. Stanley Williams, a nanotechnologist from Hewlett-Packard, testified to Congress in 2002 that much of the academic research to which H.P. has had difficulty gaining access could be licensed to several companies without eroding its intellectual property value.

***See also

Thinking negatively about Bayh-Dole

Busch report on Novartis/Berkeley research arrangement

And, of course, how could one criticize Bayh-Dole without mentioning the Metabolite case, Crichton, and Lemley?

See Michael Crichton assails Metabolite case but ignores the academic connection

And, of course, to see how some of the premises behind Bayh-Dole can become problematic, see Proposition 71 and CIRM.
QED. But, at least that won't be happening in New Jersey in the near future.

***to the Patent Hawk blog -->

Back in 2005, Fortune had an article on Bayh-Dole which used the words "litigious scrum." Noonan notes -- if there is no way to protect an invention, no one will take the risk of commercialization. --, but does not observe that allowing a federal grantee to obtain patent rights does not imply that someone will advance the money for commercialization. The University of Rochester case on COX-2 illustrates a situation in which the federal grantee sued a private entity (Searle) the day the patent issued. No money was spent by the grantee (or its agents) for commercialization. Madey v. Duke University is a case in which the Bayh-Dole Act was used to settle an academic turf war. The patent in the recent Carnegie Mellon case was invalidated on summary judgment.


I believe that the CAFC would take issue with the assertion --The Rochester patent was invalidated (properly) in part under an interpretation of written description law not developed until long after the patent was filed. -- One line of the Rochester case noted: Rochester's suggestion in its brief that Lilly "compounded Ruschig's error" by "invoking the written descrip-tion requirement in a case without priority issues" is similarly deficient. Neither Wm. Moore nor Sus, for example, involved any priority issues. Moore and Sus were decided BEFORE Rochester's patent application was filed. But let's go to the claim: A method for selectively inhibiting PGHS-2 activity in a human host, comprising administering a non-steroidal compound that selectively inhibits activity of the PGHS-2 gene product to a human host in need of such treatment. As the CAFC noted: it is undisputed that the '850 patent does not disclose any compounds that can be used in its claimed methods. A method claim that requires the use of an undisclosed and untaught compound is invalid under patent law of 2000 or or 1790. Nevertheless, the University of Rochester, who had created nothing, sued Searle, who had brought such a compound to the marketplace without the help of Rochester. What "fruits of academic research" or commerialization is Kevin Noonan thinking of? In the short time since this thread developed, the University of Iowa sued Amgen AND Forbes ran a story on the "highest yielding" Bayh-Dole universities, which showed partnerships of universities with large corporations, not small ones.

For additional information:


Of Rae-Dupree's 2008 text about Bayh-Dole --In the past, discovery for its own sake provided academic motivation, but today's universities function more like corporate research laboratories. Rather than freely sharing techniques and results, researchers increasingly keep new findings under wraps to maintain a competitive edge. What used to be peer-reviewed is now proprietary. "Share and share alike" has devolved into "every laboratory for itself."--, I had written nine years earlier about Bayh-Dole several points, including the text Further, the same alignment issue will exist when department members go to scientific meetings outside the department. Professors A, B, C aligned with Company Z will not be predisposed to talk to Professors A', B', C' aligned with Company Z'. Not only will the timing of information exchange be altered, but the extent of exchange will differ. Furthermore, the interaction with visitors to the department will change. The cross-pollination activity of traveling professors will be curbed, for proprietary activities will not be discussed. Thus, the "free information exchange" traditionally entrusted to academics might be diminished.
[Implicitly Zurko; The Need For Fact-finding As Plain As The Nose On Your Face, IPT (July 1999)]. In August 2005, I wrote: The Federal Circuit, rather than academics, may be closer to the reality that the status of universities as patent holders has trumped the status of universities as ivory towers when one sees a University of Texas official state: "This is not about getting a big win and grabbing some money. It's about keeping things fair in the business world." University of Rochester v. Searle WAS about getting a big win and grabbing money from non-academic people who actually created a product. University development of real products is one thing, but Bayh-Dole is now supporting a litigious scrum, as Fortune pointed out long before Rae Dupree.

Of the University of Texas, note US Patent 7052541 - Color compositions.
Note separately a patent case lost by UTexas:


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