From:
http://www.cukier.com/writings/opensourcebiotech.html
Note: This article is the complete text, including references, of a shorter, edited version that appeared in The Acumen Journal of Life Sciences, Vol. I, Issue 3. September/October 2003. Online at: http://acumenjournal.com
Can a non-proprietary approach to intellectual property work in the life sciences?
In early 1999, as labs around
the world raced to decode the human genome, Tim Hubbard, the head of human
genome analysis group at the Sanger Institute in Britain, was becoming more and
more interested in something father afield: Open-source software. On the Sanger
strategy group's internal email list, he drew parallels between the open source
movement's philosophy and what the six-nation project was trying to achieve by
making the genome sequence publicly available. While surfing the Net in his
office late one evening in January 2000, he stumbled upon something called
"open content licenses." It offered a way to apply open-source
principles to information, not just computer code. "I realized that there
might be ways to adapt [open source licenses] to something appropriate to the
genome that had legal weight," he recalled. [1]
With six months to go before
the draft of the genome would be completed - helped along, controversially, by
the private-sector company Celera Genomics - Dr. Hubbard knew he had to act
fast. A flurry of emails ensued, teleconferences hastily called, and lawyers
set in motion. The team even contacted the scraggily father of the free
software movement, Richard Stallman, to get advice. Soon, draft license
agreements and implementation plans were circulated, followed by a round of
legal reviews. A "click-wrap contract" was drawn up so that if a
party refined a sequence by mixing the Human Genome Project's public draft version
with extra sequence data, they would be obliged to release it. "Protecting
the sequence from someone taking it, refining it and then licensing it in a way
that locked everyone in, was the primary objective," says Dr. Hubbard.
The result? At the end of
February, a little over a month after the crash initiative began, the Sanger
Institute opted not to pursue the open-source strategy. Genomic data had
historically been placed in the public domain with unrestricted use. Imposing
any sort of restriction on it, even in the form of an open-source license that
ensured its non-proprietary nature, would run counter to that tradition, the
group decided. [2] Yet far from a set-back, the voluminous work of Dr. Hubbard
and others represented a secret triumph. Crucial groundwork had been laid; and
a precedent established, if only ideologically. The issue of applying
intellectual property law to the life sciences would never be the same again.
Dr. Hubbard is a far cry from
a cyberpunk. Rather, the staid scientist may well represent the future of the
life sciences. As the industry advances, there is a growing call among
researchers to redraw the lines of intellectual property. [3] Instead of simply
learning to live with the current system, they want to upend it. In addition to
graduate degrees, they're armed with moral arguments, evidence of economic
efficiency and a nascent spirit of solidarity that exceeds the traditional
ethos of cooperation found in the sciences and the academy. And the approach
that is gaining momentum comes from the neighboring industry of information
technology: open-source. Its underlying principles are the communal development
of a technology, complete transparency in how it works, and the ability to use
and improve it freely provided improvements are shared openly. [4] Where
proprietary software's underlying code is forbidden to be modified (and
normally even inspected) by customers, open source products encourage users to
develop it further. The parallel in life sciences are things like the Human
Genome Project that represent a "common good," says Sir John Sulston,
co-recipient of the 2002 Nobel Prize. "Progress is best in open
source," he concludes. [5]
To be sure, it's still
business as usual for today's university tech-transfer offices, patent lawyers,
venture capitalists and entrepreneurs. They don't oppose open source as much as
feel skeptical about it. Whatever the apparent virtues, the approach is fraught
with serious obstacles - from the professional credentials of scientists and
cost of research, to the rarity of success among projects and uncertain
incentive structure. No biotechnology company currently fears its prized
intellectual property will be rendered worthless by a band of teenagers with a
wet lab in their garage. But that belies a major shift in the industry. The
current intellectual property system for the life sciences has created a lot of
losers, who are bound by increasingly onerous licensing obligations. [6] On the
one hand, these underdogs have an interest in joining forces. On the other
hand, as they develop intellectual property of their own, some are looking to
make it publicly available in ways that benefit the entire community. The
question isn't whether open source biotech will happen - it is happening now,
says Janet Hope, a lawyer examining the feasibility of open source
biotechnology as a PhD candidate at the Australian National University in
Canberra. "There are lots of areas in the biotech and pharma industries
where people are already doing things that are analogous to open source."
[7]
* * *
One thing is for certain: the
current system of biotechnology patent law is the subject of fierce
controversy. Patents - essentially government-granted temporary monopolies for
inventions that are novel, useful and man-made - reward innovation and act as
incentives for investment. But at times, the system can become a serious
encumbrance. A study published last year in the Journal of the American Medical
Association found that 47 percent of geneticists who requested information of
findings from other researchers were rejected at least once. Ten percent of all
requests for information in genetics were denied, leaving a quarter of
researchers unable to replicate published results and forced to delay their own
publications. [8] The current patent law system is a major culprit. Critics say
that categories of research that is currently patentable shouldn't be
encumbered by intellectual property law because it's a matter of discovery not
invention, and thwarts new innovation. Also, opponents argue that patent awards
are overbroad, or simply so extensive that it makes research for everyone more
difficult for the sake of protecting the financial interests of a single
player. The process, they say, becomes self-perpetuating which masks its true
evil: Researchers are forced to patent new discoveries if only as a means to
use that intellectual property as a negotiating tool to gain access to other's
intellectual property. Some observers go so far as to state that this
"patent thicket" leads to an "anti-commons," whereby the
biotech industry is forced to combine a large number of separately patentable
elements to form a single product, which is cumbersome to achieve, and once the
license fees are stacked up, overwhelms the value of the ultimate product. [9]
At the same time, even the
much hailed 1980 Bayh-Dole Act that has done so much to commercialize
federally-funded research has come under its share of criticism, by
transforming academic institutions into ersatz commercial entities. [10] In
July 2003, a number of biotechnology companies including Amgen, Genetech and
Biogen sued Columbia University alleging that the school improperly obtained a
new patent on an earlier invention whose patent expired in 2000. Universities
adopting the hardball tactics of the private sector is seen in the 1994 patent
infringement lawsuit by Johns Hopkins University against CellPro, over a
process of isolating stem cells from bone marrow, which bankrupt the start-up.
[11] Meanwhile, as materials transfer agreements, a means of free-yet- formal
sharing among institutions, gains ground in academe, it's not clear whether
they solve the problems or symbolize them.
Strikingly, a study in 2002 commissioned
by a National Academy of Science's panel on intellectual property that is used
by proponents of the status quo to refute charges that the current system is
broken actually identifies so many problem areas that its main point gets
overshadowed. [12] The study found that despite an appreciable increase in
patents on research tools, drug discovery and university research hasn't been
substantially impeded. However, it acknowledged that patents have caused delays
in access to tools and genetic diagnostics, as well as restricted access to
foundational discoveries. Ultimately it reports that in certain cases
"research is redirected to areas with more intellectual property
freedom" - the harshest indictment that exists in the sciences. Far from a
model of efficiency, the current intellectual property system is a testament to
the lengths researchers go to circumvent it, mainly by infringement. Making
criminals out of scientists seems a short-sighted strategy, and where a
"research exemption" once existed, it's been whittled away by the
courts. [13]
The result is that a third of
private firms and all university or government labs in the NAS study admitted
to using patented research tools without a license. What is more, commercial
patent holders say they tolerate the academic research infringement
"partly because it can increase the value of the patented
technology." [14] Ironically, this admission - that building upon a
technology without constraints increases rather than diminishes its value - is
precisely the underlying precept of the open source movement. [15]
* * *
The life sciences of course
isn't the only place where patent law has become overbearing. Similar concerns,
and open source reactions, are cropping up in the physical sciences and biology
generally. But the huge rush of investment in biotechnology companies has
raised the sector's profile as well as led to an increase in patent
applications, which deepens the magnitude of the problem. Strikingly, the
situation seems to follow a classic pattern of intellectual property for new
technologies, whether it's the railroad, the airplane, broadcast radio or
computer software. Reactions to overcome the problems varied. In the case of
technologies like the pumping engine and iron industry, "collective
invention" took place, akin to today's open source movement. [16] For the
airplane, the US government threatened to expropriate the patents held by the
Wright Brothers and the rival airplane manufacturer Herring-Curtiss Co. on the
grounds of eminent domain since the companies refused to cross-license; the
resulting patent pool ultimately freed the technology. [17] With radio,
squabbles among the patent holders (AT&T, Westinghouse, GE and, of all things, United Fruit)
restrained the technology so much that in 1919 the government stepped in and
created a patent pool called the Radio Corporation of America, or RCA. In a
historical echo, likeminded patent pools have been suggested for biotechnology.
[18]
In the information technology
sector, the method of commercializing intellectual property has occasionally
been to open it up rather than lock it up. But it took the industry a long time
to get to there, a trail littered by tears before triumphs. For instance,
Sony's Betamax technology for home videotape recording was superior to the VHS
system, but by refusing to open up its intellectual property to the home
entertainment industry, including potential competitors, the Japanese firm
shrunk its overall market and allowed the VHS system to acquire more users,
thus becoming the dominant standard. A similar history applies to Apple
Computer, which in the 1980s and 90s lurched between licensing its technology
and keeping it in-house, only to watch its market share shrivel. That is not to
say that dismissing intellectual property rights is the recipe for success.
Xerox's Palo Alto Research Center (PARC) is widely acknowledged to have
"fumbled the future" by failing to strategically license its patent
portfolio, which included inventions like the graphical user interface and mouse
that are staples of personal computing, to the ubiquitous data-networking
protocol Ethernet. [19]
Today, the technology sector
has a fairly well-defined mental algorithm over what sort of intellectual
property to make openly available to the benefit of all and what to keep
proprietary and monetize. [20] For instance, for consumer software, the model
is to make client-side, or end-user, products free so as to achieve a large
user base and influence standards, while selling the server-side software and
document authoring tools. The browser wars between Netscape and Microsoft in
the 1990s was based upon just this premise. Meanwhile, Adobe Systems' Acrobat
software has successfully embodied that business model - and as a result, the
US government electronically published its official documents on that format.
The cost to firms that don't
develop dexterous intellectual property policies can be death by Lilliputians.
Consider the genesis of the most prominent open source movement: The Internet.
[21] In the mid 1980s there were a number of competing data communication
protocols that had larger users bases and were superior in performance - but
not in price - to the Internet Protocol. The technologies, including IBM's
Simple Network Architecture, AT&T's Token Ring and the International
Telecommunication Union's X.25 standard (upon which France Telecom's Minitel
system was based), were closed and did not allow for modification by users. By
contrast, the Internet's technology, shepherded by a group of decentralized but
highly-organized computer engineers from outside of the major technology
vendors, was open in its design process and free to use. Over time, it
supplanted the rival proprietary technologies.
Today, a similar form of
battle is being waged for the operating system of person computers, pitting
Microsoft Windows against the open-source Linux system. Moreover, the means by
which the open source movement is fighting isn't by eliminating intellectual
property. [22] Rather, it is by a form of legal jujitsu that turns the
opponent's strength against itself. The movement uses radical intellectual
property licenses, sometimes called "copyleft" (an antidote to
"copyright"), to ensure that the open-source technology remains
non-proprietary and free. For software, things like the GNU General Public
License [23] enables code to be shared but not corralled; for written material,
user-designed licenses via the Creative Commons ensures the text is openly
available but without the risk of being misappropriated.
The lesson for the life
sciences is that just as the information technology sector had to go through a
rough period of transition to figure out workable models of sharing
intellectual property - an evolution that is still ongoing - so too must
biotechnology. The process is incremental, and probably inevitable. There are
powerful economic arguments in its favor. [24] The open source movement
encompasses the classical economists' spirit of decentralization that is
considered essential to progress, with a relatively new conception of
enlightened community-interest, championed by the New York University legal
theorist Yochai Benkler, who considers open source processes as a peer-based,
non-capitalist modes of production that is likely to expand well beyond
software design. [25] There are even moral imperatives facing the biotechnology
industry that propel it in this direction, namely, the aim to improve and
preserve life, which doesn't exist in information technology. At the same time,
the professional culture of the life sciences and information technology share
an acknowledged desire to change the world. Perhaps fittingly, then, the first
seedlings of an open-source biotech movement are beginning to emerge in the
field that melds both molecular biology and computing: Bioinformatics.
* * *
The duality of wet biology
and hot transistors is personified in Tom Knight at the Massachusetts Institute
of Technology. On the ninth floor of the fabled computer science building at
200 Technology Square in Cambridge, past a maze of antechambers teeming with
dismembered robots and stray wires and sleek electronics, are doors to his
laboratory, emblazoned with the familiar orange and black BIOHAZARD stickers.
It seems incongruous that DNA synthesizers and freezers filled with test tubes
and Petri dishes should sit comfortably beside hardcore circuit boards, and Dr.
Knight, a computer scientist by background, admits it's not an ordinary comp
lab. It's the epicenter of BioBricks, an attempt to establish standardized,
non-proprietary terms, tools and processes for DNA work. This, as much as
anything, can free the biotech industry from an ungainly reliance on patented
technologies. It's a matter of interoperability; the life sciences' equivalent
of software Application Programming Interfaces.
BioBricks will make it more
reliable and less expensive for researchers to assemble genetic sequences, by
using standardized process and non-proprietary tools that are forever being
improved upon by the community. "The idea of copying one gene from one place
to another - that goes away," Dr. Knight says. "It is a computer
science problem." [26] In such a world, the base pairs that comprise
strands of DNA are akin to digital bits, and just as computers modify those
bits from scanner (the input) to printer (the output), so too will we be able
to sequence and synthesize DNA.
The central tool in both cases is the same - a computer - so it only makes
sense that the same approach to the technology, via open source methods and
practices, emerges in the life sciences as it did in computing.
BioBricks is only one of a
number of initiatives that have adopted open source practices. [27] For
instance, there are other bioinformatics projects, such as those overseen by
the Open Bioinformatics Foundation, for tailoring numerous open-source computer
languages for life sciences research. One success in the field is BLAST, the
Basic Local Alignment Search Tool, which has for years been used to find
similarities in DNA and protein sequences. Ensembl, a joint project between the
Sanger Institute and the European Bioinformatics Institute aims to provide a
freely available genome annotation software system, starting with the whole of
the human genome sequence. An extension of this is the distributed annotation
system, or DAS, which is a nascent protocol standard coordinated by Lincoln
Stein, the celebrated champion of open source bioinformatics based at Cold
Spring Harbor Labs in New York. The movement has for years even had its own
annual conferences. [28] Then, there's the computational-heavy SNP Consortium,
a joint public/private sector initiative to create an open database of single
nucleotide polymorphisms (SNPs), the DNA sequence variations among individuals
that are key for new drug development.
Though on the surface the
projects seem rather basic, it is precisely these boring, low-level aspects of
modern biotechnology research that are costly and where cooperation could
benefit everyone. "When I'm doing an analysis, I'm not interested in
coding, I'm interested in getting the results of the analysis," says Ann
Loraine, a bioinformatics scientist. "There are certain computations that
every computational biologist does over and over and over - its great to have
open source software that you can use to execute these mundane tasks." Dr.
Loraine developed that ethos as a student sharing code at the Berkeley
Drosophila Genome Project, which she brought over with her to industry as a
researcher at Affymetrix. Christopher Dagdigian, a board member of the Open
Bioinformatics Foundation, concurs. "It's really boring, really routine,
everyone has to do it, and no one gets a competitive advantage," he says.
"Our philosophy is let everyone agree on a common foundation so we can
pursue what actually interests us."
While for the moment, most open-source
biotech initiatives spring from academia or the non-profit sector, one start-up
company has pinned its fortunes on it as a business model. Electric Genetics
Corp., based in South Africa, offers bioinformatics software, validation and
support services. For one product, it co-developed [29] a standard for gene
expression ontologies that the company placed under a free open-source license
to see it widely adopted, in order to swell the market for its commercial
software that best parses the data. "Some people think we are quite
crazy," admits Tania Broveak, the managing director, about the company's
approach. To write software, the company organized a "hackathon" in
2002 and flew a score of top-notch open-source programmers to South Africa for
a week to write code. Electric Genetics has managed to attract a slight amount
of venture capital backing (about $1.5 million) and expects to be profitable by
mid 2004.
Companies like Electric
Genetics are rare. If an open source movement in the life sciences is going to
take off, it may not come from the deep pockets of venture capitalists, who are
skittish on how to glean returns on biotech even when they own all the
intellectual property. Instead, it may be borne of the purse of federal funding
agencies, which may see open source projects as a way to ensure that public
monies result in public goods. [30] Dr. Peter Good, a program director at the
NIH's National Human Genome Research Institute, says that they are particularly
sensitive to the issue when deciding whether to fund grant applications.
"We have to deal with the concern that the software be available to people
to use to build on," he says. "We don't say it has to be, but we
encourage open source."[31] At DARPA, which sponsors an open-source
biotechnology project called BioSPICE that uses software to simulate cell life,
administrators say that although they have no formal position on open-source
they found the approach "useful" and "effective." [32]
However, officials at
government funding agencies acknowledge difficulties. They say they want to
keep their options open rather than favor one sort of method of development and
approach to intellectual property over another. What is more, supporting
open-source projects is on uncertain legal terrain. The Bayh-Dole Act lets
universities patent and profit from federally-funded research; stipulating
open-source licenses may run foul of that. In fact, in one instance a professor
at the University of California-Berkeley, Steven Brenner, had to make special
arrangements with the school before he could participate in an open-source
bioinformatics project and give away his work freely. [33] These concerns are
merely speed-bumps on an inevitable road, believes Roger Brent, the director of
the Molecular Sciences Institute in Berkeley. Putting his patents where his
principles are, Dr. Brent's institute has drafted an "Open Source
Policy" which commits to "[making] reagents and methods freely
available to the research community." [34]
On a more fundamental level,
the simplest form of open source material is the publication of research. A
number of initiatives exits to link up databases in standardized,
non-proprietary ways that would greatly increase the availability of scientific
data. [35] Also, there are moves afoot to create non-proprietary peer-reviewed
journals, such as the Public Library of Science. [36] They have an allies in
government, as politicians question why research funded by public monies go to
private publishers rather than the public domain. In the US, Representative
Martin Sabo, a Democrat from Minnesota, recently introduced legislation that
would require federally-funded research be made available to the public. A
House appropriations report requested that the National Library of Medicine
consider the same. [37] Internationally, the Organzation for Economic
Cooperation and Development issued a report in March 2003 arguing for a
"core principle" that "publicly funded research data should be
openly available to the maximum extent possible." [38]
Whether the groundswell of
open source activity that is emerging will become a potent force in the life
sciences or remains a non-threatening niche will determined by the degree to
which it is able to tackle large scale projects that would be too complex and
expensive for any company to do individually, and for which the use benefits
all. So far, these are exactly the kinds of projects where open source
approaches are taking hold. But they are so-called "pre-competitive"
areas like the Human Genome Project, the SNP Consortium and bioinformatics.
Will it be sustainable for more sophisticated and lucratively patentable things
as the industry matures?
* * *
Far geographically from Tim
Hubbard at the Sanger Institute in Britain, and far ideologically from Tom
Knight at MIT, is Lita Nelson, whose office is just down the road from Dr.
Knight's in a modern red brick building on campus. Dr. Nelson directs MIT's
patent transfer office. Rather than a law degree, hers is a PhD in organic
chemistry. Her work has earned her respect among intellectual property lawyers,
and world renowned among other universities that are keen to emulate MIT's
successes. In a ricochet Rorschach test-like conversation, she was asked three
words to start: "Open Source Biotech?" She stopped short, smiled wide
and shot back "I don't know what it means!" The term is so broad, she
says, it's meaningless. Similarly, she believes trying to adapt intellectual
property approaches for different classes of technology, such as processes
versus products, would be impossible. "One man's infrastructure is another
man's product or biotech company." she says. Patents provide an incentive
to invest; open-source negates this. Many firms won't want access to a tool if
it can't have it exclusively.
Free software and journal
articles are small change compared with the immensity of the life sciences
industry and the problem of hindered innovation. Scientists, lawyers, and
businesspeople are divided on whether open source may apply to designing
diagnostic tools and drug therapies due to a lack of economic incentive to fund
research and regulatory compliance. For instance, the venture capitalist Brook
Byers, a principle at Kleiner Perkins Caufield & Byers, which has backed a
number of important biotechnology firms, says open source processes may work
for platform technologies like the human genome project but may not be
successful for applications that spring from it, which is better suited to
proprietary, commercial models.
Moreover, the life sciences
sector doesn't resemble the information technology industry at all - there is
no single nasty incumbent with which to rally against, nor are there obvious
places where one can give away a product and make it up on services. [39]
Likewise, the open source software movement itself is new and relatively
unproven. And Linux, its champion test-case, is an operating system - as
foundational a technology as is possible, and one whose cost might legitimately
drop to nil had the market not devolved into a near monopoly situation.
Janet Hope at the Australia
National University believes many arguments against open source biotechnology
set a false standard that it shouldn't have to surmount. "Open source is a
type of business strategy but it is rarely the sole strategy," she says.
More moderate expectations are appropriate. Open source will crop up in places
where it fits, and won't elsewhere. But critics who proclaim it inherently
impossible, Ms. Hope contends, miss the point - it's already happening in small
pockets of the industry, providing a symbolic proof-of-concept that may
resonate more widely. It's gaining widespread support. In July, scores of
senior scientists and intellectual property experts wrote an open letter the
Kamil Idris, the director general of the World Intellectual Property
Organization, calling on the UN body to consider adapting its intellectual
property regulations to account for open source approaches. [40] Although WIPO
waffled, first agreeing to convene a meeting on the topic, then later declaring
the issue verboten after the US Patent and Trademark Office nixed the idea from
pressure by commercial software companies, the groundswell has clearly begun.
At its essence, the issue
centers on what a patent actually means. Awarded by governments, it is not so
much an exclusionary right as it is a preventative asset; it marks the domain
for an actionable claim for damages in cases where it is infringed, and the
patent holder exercises its protections. This point is most crucial, because if
governments set the terms under which a patent may exist, it can also modify
how its protections can be exercised. This has long been a staple of
intellectual property law. For instance, US-funded research enables the
government to use the resulting technology on a royalty free basis. In the case
of the Bayh-Dole Act, the government has "march-in" rights to take
control of a patent it does not believe it being sufficiently exploited. [41]
More broadly, the US and its contractors can't be prohibited from using
patented technology as a matter of law [42] (such as when the government
threatened to strip the Wright Brothers of their airplane patents on the eve of
World War I). That's why, for example, US defense contractors never worry about
infringing any of the thousands of patents that go into building a military
aircraft; if they do, the sole recourse is to seek damages at the Court of
Federal Claims. There, the patent holder can't get an injunction to prevent the
technology from being used, and the damages can only be reasonable, not, say,
trebled.
That approach - based on the
legal doctrines of sovereign immunity and eminent domain [43] - makes perfect sense when the
critical challenges to a nation is security. Yet the current concept of
national interest has expanded to include the realm of health as well. As such,
it would be reasonable for the National Institutes of Health to exercise the
same powers, according to Robert Blackburn, a vice president and chief patent
counsel for Chiron Corp. [44] The policy may free up patented technology
without even being called into use, since the threat of lawful infringement may
induce patent holders to license more readily. [45] Mr. Blackburn's goal isn't
to bring down the patent system as much as preserve it. "Before you go to
the length of overhauling the intellectual property system that has adopted new
technologies over and over again, you should explore all the potential remedies
that exist in the current system," he says.
It's an elegant legal hack
that may free up public-funded research, the very programs that are eyeing open
source approaches anyway. Arti Rai at Duke Law School likes it because it
applies to patents that may not be covered under the Bayh-Dole march-in rights.
"But a lot of research is in private organizations," notes Rochelle
Dreyfuss, a law professor at New York University, who believes it doesn't go
far enough. Yet the most powerful aspect of the proposal is what it symbolizes:
Even industry lawyers most in support of the current patent regime are calling
for reforms.
Such legal maneuvering may
become besides the point, and the reason is found back with Tim Hubbard at the
Sanger Institute, surfing the Net instead of peering into a microscope. His
work between 1999 and 2000 on open source licenses for the Human Genome Project,
although never used, didn't lie fallow - it supplied the critical groundwork
for researchers, lawyers and officials to directly build upon. The fruits of
Dr. Hubbard's efforts will be resurrected this fall in an unprecedented
approach for the life sciences - an open source contract for access to data on
the haplotype map of the human genome, or HapMap. Licensees agree not to use
the data in any way that will restrict the access of others, and will only
share the data obtained with others who have accepted the same license. It
serves to block "parasitic patents" by industry, which could
otherwise combine the HapMap's public data with a smidgeon of their own and
patent the haplotype, explains Mark Guyer, the director of the division of
extramural research at the National Human Genome Research Institute.
Beyond the tradition of
standing on the shoulders of giants, which has always been the staple of
scientific advancement, open source processes are emerging in the life sciences
because of a patent system that allows bad-faith players to prosper. This may
be the most important reason it will take hold, just as it did in information
technology against Microsoft. "The bottom line," says Dr. Hubbard,
"is that public domain projects are using proactive mechanisms to prevent
their generosity from being misused."
________________
1. Interview and email
correspondence; July 2003.
2. Sir John Sulston, with
Georgina Ferry. 2002. The Common Thread: A Story of Science, Politics, Ethics
and the Human Genome. Joseph Henry Press (National Academy Press). Washington,
DC. October 2002
3. Burk, Dan. 2001.
"Open Source Genomics." Boston University Journal of Science and Technology Law. Vol. 8, Issue
1. (Symposium on Bioinformatics and Intellectual Property Law. Boston, Mass.
April 27, 2001. Online at: http://www.bu.edu/law/scitech/OLJ8-1.htm
4. Bruce Perens. 1999.
"The Open Source Definition." Open Sources: Voices from the Open Source Revolution, edited by
C. DiBona, S. Ockman and M. Stone. O'Reilly. Online at:
http://www.oreilly.com/catalog/opensources/book/perens.html
5. Interview (unpublished)
with journalist Duff McDonald, July 2003.
6. The Royal Society. 2003.
"Keeping science open: the effects of intellectual property policy on the
conduct of science." The Royal Society. April 2003. Online at:
http://www.royalsoc.ac.uk/policy/
7. Interview, July 2003. For
more information, see: Janet Hope.
2003. Open Source Biotechnology Project (Online working draft of PhD
dissertation). Law Program, Research School of Social Sciences, Australian National University (Canberra). Online
at: http://rsss.anu.edu.au/~janeth/home.html
8. Eric G. Campbell, Brian R.
Clarridge, Manjusha Gokhale, Lauren Birenbaum, Stephen Hilgartner, Neil A. Holtzman, and David Blumenthal.
2002. Data Withholding in Academic
Genetics: Evidence from a National Survey. Journal of the American Medical Association 287 (4):473 - 479.
Abstract online at: http://jama.ama-assn.org/cgi/content/abstract/287/4/473
9. Heller, M. A. and R. S.
Eisenberg1998. "Can Patents Deter Innovation? The Anticommons in
Biomedical Research." Science 280 [1 May]:698-701. Online at:
http://www.sciencemag.org/cgi/content/full/280/5364/698 See also: Eisenberg, R .S. 2001.
"Bargaining over the Transfer of Proprietary Research Tools: Is This
Market Failing or Emerging?" in R. C. Dreyfuss, D. L. Zimmerman, and H.
First, eds. Expanding the Boundaries of Intellectual Property: Innovation
Policy for the Knowledge Society Oxford. Oxford University Press, pp. 223-250.
10. Berg, Pail. 2003.
"Bayh-Dole@23" (version 8). Unpublished update of remarks presented
at the conference Bayh-Dole at 23: Balancing Academic Values With Commercial
Ambition at the Howard Hughes Medical Institute on May 28, 2003. Online at:
http://www.practicingsafescience.org/conference2003/present.html
11. Avital Bar- Shalom and
Robert Cook-Deegan. 2002. "Patents and Innovation in Cancer Therapies:
Lessons from CellPro." Milbank Quarterly. December 2002. Abstract online at:
http://www.milbank.org/800402.html
12. John P. Walsh, Ashish
Arora, and Wesley M. Cohen. 2002. "Research Tool Patenting and Licensing
and Biomedical Innovation." Study paper for US National Academy of Science
(Science, Technology and Economic Policy Board). Washington, DC. December 11,
2002. Online at: http://www.heinz.cmu.edu/wpapers/download.jsp?id=2003- 2
13. See the recent US Circuit
Court decision in Madey v. Duke University; Ruling online at:
http://www.ll.georgetown.edu/federal/judicial/fed/opinions/01opinions/01-1567.html
14. John P. Walsh, Ashish
Arora, and Wesley M. Cohen. 2003. "Working Through the Patent
Problem." Science, vol. 299. 14 February 2003. Online at:
www.uic.edu/~jwalsh/WalshetalScience.pdf . The "working solutions"
include "licensing, inventing around patents, going offshore, the
development and use of public databases and research tools, court challenges,
and simply using the technology without a license (i.e., infringement)."
Essentially, a molecular biologistŐs version of a slave revolt.
15. Raymond, Eric S. 2001.
The Cathedral and the Bazaar: Musings on Linux and Open Source by an Accidental Revolutionary. O'Reilly. 2001.
(Initial version of the essay in 1999.) Online at: http://www.catb.org/~esr/writings/cathedral-bazaar/cathedral-bazaar/
16. Nuvolari, Alessandro.
2003. "Open Source Software Development: Some Historical
Perspectives." Eindhoven University of Technology; Centre for Innovation
Studies. Jan. 2003. Online at: http://opensource.mit.edu/papers/nuvolari.pdf
17. Seth Shulman. 2002.
"Unlocking The Sky: Glenn Hammond Curtiss and the Race to Invent the
Airplane." HarperCollins. 2002. See also: Joel I. Klein. 1997.
"Cross-Licensing and Antitrust Law." Address to the American
Intellectual Property Law Association. (Representing the US Department of
Justice.) San Antonio, Texas. May 2, 1997. Online at:
http://www.apeccp.org.tw/doc/USA/Policy/speech/1123.htm
18. David B. Resnik. 2003.
"A Biotechnology Patent Pool: An Idea Whose Time Has Come?" PSL
Journal. Vol 3, Jan 2003. Online at:
www.psljournal.com/archives/papers/biotechPatent.cfm
19. Douglas K. Smith, Robert
C. Alexander. 1988. "Fumbling the Future: How Xerox Invented, Then
Ignored, the First Personal Computer." New York. William Morrow & Co. 1988.
20. Joel West. 2003. "How Open Is Open Enough? Melding Proprietary And Open Source Platform Strategies." Research Policy 32. 2003. Online at: www.cob.sjsu.edu/west_j/Papers/West2003a.pdf
21. Kenneth Neil Cukier.
1999. "Internet Governance and the Ancien Regime." The Swiss Review
of Political Science. University of Zurich. Spring, 1999.
22. Henry W. Chesbrough.
2003. "The Era of Open Innovation." MIT Sloan Management Review.
Spring 2003. Apparently the publication has not heeded Professor Chesbrough's
wisdom; only the abstract is online, at:
http://smr.mit.edu/past/2003/smr4435.html
23. The GPL has never been
legally tested but will be in the case of SCO v. IBM, over alleged patents to
the Linux operating system. It is seen as a litmus test for the intellectual property
viability of open source movements in general.
24. As a model of innovation,
see: Lawrence Lessig. "The Future of Ideas: The Fate of the Commons in a
Connected World." Random House; 2001; Web site:
http://the-future-of-ideas.com On
the incentives of contributors, see: J. Lerner and J. Tirole. 2000. "The
Simple Economics of Open Source," NBER working paper No. W7600. National
Bureau of Economic Research. Cambridge, Mass. March 2000. Online at:
http://papers.nber.org/papers/w7600.
25. Yochai Benkler. 2002.
Coase's Penguin, or, Linux and The Nature of the Firm . 112 Yale Law Journal. Winter 2002-03. Available at:
http://www.law.nyu.edu/benklery/
See also: Benkler. 2000. "A Political Economy of the Public Domain:
Markets in Information Goods vs. The Marketplace of Ideas," in Expanding
the Bound of Intellectual Property: Innovation Policy for the Knowledge Society
(R. Dreyfuss, D. Zimmerman, H. First eds.). Oxford. 2000.
26. Interview, July 2003 at
MIT
27. For a list of open source-like
biotechnology initiatives, see chart along with this article in The Acumen
Journal of Life Sciences, online at: http://acumenjournal.com.
28. E.g. the 4th Annual
Bioinformatics Open Source Conference in 2003 (see: http://news.open-bio.org)
as well as the O'Reilly Life Science Informatics Conference 2004, which marks
its third year (see: www.oreilly.com).
29. Co-developed with SANBI,
the South African National Bioinformatics Institute.
30. The Wellcome Trust issued
a report after a meeting in January 2003 on the responsibility of funding
agencies, researchers and industry in sharing intellectual property of
"community resources" in the sciences. It called on agencies to
"require, as a condition for funding, free and unrestricted data
release." See: "Sharing Data from Large-Scale Biological Research
Projects: A System of Tripartite Responsibilities." 2003. Wellcome Trust.
Oneline at: www.ebi.ac.uk/microarray/General/News/
Prepubl_data_release_6986.pdf
31. Interview, August 2003.
32. Telephone and email
interview with DARPA officials, August 2003.
33. Interview with Dr.
Brenner's colleagues, August 2003. Also, see: Justin Hibbard. 2002. "The
open-source debate enters the genomics arena. Should publicly funded software
be free?" Red Herring. February 25, 2002. Online at:
www.redherring.com/insider/2002/0225/1805.htm
34. Molecular Sciences
Institute. "Open Source Policy (draft)" MSI. Berkeley, CA. Undated.
Online at: http://www.molsci.org/Dispatch?action-WebdocWidget:4866-detail=1
35. Cf: the Biomedical
Informatics Research Network BRIN, funded by the National Institute of Health.
Online at: http://www.nbirn.net
36. The Creative Commons
copyright license is already used for PubMed Central, a digital library for
research and journal publications being developed by the National Center for
Biotechnology Information at the U.S. National Library of Medicine. The group
plans to initiate a "Science Commons" program in 2003, due in part to
demands in the biotechnology community to find alternatives to traditional
intellectual property approaches. Interview with Glenn Otis Brown, executive
director of Creative Commons, July 2003.
37. US House of
Representatives (2003). Report 108-188. Departments of Labor, Health and Human
Services, and Education, and Related Agencies Appropriation Bill, 2004. Online
at: http://www.access.gpo.gov/congress/legislation/04appro.html
38. OECD. 2003.
"Promoting Access to Public Research Data for Scientific, Economic and
Social Development." Organization for Economic Cooperation and
Development. Final Report. March 2003. Online at:
http://dataaccess.ucsd.edu/FinalReport.htm.
39. James Boyle. 2001.
"The Second Enclosure Movement and the Construction of the Public
Domain." Discussion paper at the Conference on the Public Domain. Duke
University School of Law, Durham, NC. November 9-11, 2001. Online at: http://www.law.duke.edu/pd/papers/boyle.pdf
40. Declan Butler. 2003.
"Drive for patent-free innovation gathers pace." Nature. Vol. 424. 10
July 2003. Letter online at: http://www.cptech.org/ip/wipo/kamil-idris-7july2003.pdf
41. Rai, Arti Kaur and Eisenberg, Rebecca S. 2002. "Bayh-Dole Reform and the
Progress of Biomedicine." Law and Contemporary Problems, Vol. 66, No. 1;
Nov 23, 2002. Online at: http://ssrn.com/abstract=348343
42. US Code, title 28,
section 1498, which covers patents "used or manufactured by or for the
United States without license." The code is online at:
http://caselaw.lp.findlaw.com/casecode/uscodes/28/parts/iv/chapters/91/sections/se
ction_1498.html
43. Eugene Volokh. 2000.
"Sovereign Immunity and Intellectual Property." Southern California
Law Review 1161 (2000). Online at: http://www1.law.ucla.edu/~volokh/sovimm.htm
44. Telephone and email
interviews, July-August 2003. Mr. Blackburn is examining the approach in a
forthcoming paper; initial thoughts were stated at the Biotechnology Industry
Organization's annual conference BIO in June 2003.See: Ronald Bailey. 2003.
"BIO2003: Reporter's Notebook." Reason online. Washington, DC. June
25, 2003. Online at: http://reason.com/rb/rb062503.shtml
45. The idea was raised years
ago in an NIH report which quickly dismissed it. See: National Institutes of
Health. 1998. "Report of the National Institutes of Health; Working Group
on Research Tools."Presented to the Advisory Committee to the Director.
Washington, DC. June 4, 1998. Online at: http://www.nih.gov/news/researchtools/
_____________________
Copyright 2003 Kenneth Neil
Cukier.
Note: This work may be freely copied and distributed provided that the author and title is cited, as well as indicating that it is a pre-edited version of an article that appeared in The Acumen Journal of Life Sciences. If questions, please email the author at: kn@cukier.com