Working Through the Patent Problem
John P. Walsh,* Ashish Arora, Wesley M. Cohen*
Patents provide important incentives for biomedical innovation (1-3). There
is increasing
concern, however, that, by raising the costs of access, growing numbers of
patents on
research tools may now be retarding the pace of biomedical discovery (4-7).
Further, broad
patents on foundational discoveries may unduly limit their use in subsequent
research (8, 9).
To probe these potential challenges to biomedical research, we conducted 70
interviews with:
intellectual property (IP) attorneys, scientists, and managers from 10
pharmaceutical firms and
15 biotech firms; university researchers and technology transfer officers
from six universities;
and other IP attorneys and government and trade association personnel (10).
This purposive
sampling was designed to solicit information about the different activities
and institutions
associated with biomedical research and drug development (11).
All respondents reported that the patent landscape has indeed become more
complex, with
more patents per innovation (including patents on research tools). Also, the
patenting of
upstream discoveries (such as targets for drug intervention) has increased,
potentially limiting
access for follow-on research. Nonetheless, almost none of our respondents
reported
worthwhile projects being stopped because of issues of access to IP rights
to research tools.
Moreover, although we do not have comparably systematic evidence on projects
never undertaken, our interviews suggest that
IP on research tools, although sometimes impeding marginal projects, rarely
precluded the pursuit of worthwhile projects. Why?
Our interviews reveal that university and industrial researchers have
adopted "working solutions" that allow their research to
proceed. These 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).
Licensing is routine in the drug industry, and this suggests that the
problem of access to patented research tools or upstream
discoveries can often be settled contractually (12). Although identifying
and licensing relevant patents take time and money, the
10 industry respondents who offered concrete estimates reported that, for a
given project, usually fewer than a dozen outside
patents require serious consideration, and the number of licenses required
is much fewer, often none.
In addition, most respondents said that infringement of research tool
patents, especially by university researchers, is common. A
third of the industrial respondents (and all nine university or government
lab respondents) acknowledged occasionally using
patented research tools without a license. Infringement of research tool
patents is hard to detect, and because of the long drug
development process, the 6-year statute of limitations may expire before
infringement is discovered. However, respondents
mostly justified such infringement by invoking a "research exemption."
On the other side, all the industrial IP holders who addressed the issue
reported tolerating academic research infringing their IP
on research tools [with the exception of patents on diagnostic tests used in
clinical research (13)], partly because it can
increase the value of the patented technology. In addition, the industrial
respondents agreed that the small prospective gains
from a lawsuit were not worth the legal fees, the risk of the patent being
narrowed or invalidated, and the bad publicity from suing
a university. There is also a reluctance to upset the norms of open access
in this community of academic and industrial
researchers for fear of losing the goodwill of one's peers and the
associated access to materials and information (14). Yet, the
firms we interviewed were willing to defend against competitors'
infringement of their core patents, especially those on potential
therapeutics.
Firms also reported avoiding research tool patents by using the patented
technology offshore. Firms considering this strategy
may be emboldened by a recent court ruling that neither offshore use of a
domestically patented screening method nor domestic
sales of products discovered using that method violate the patent (15, 16).
Public and private sector responses have helped increase access to research
tools as well. For example, with substantial
public, private, and foundation support, public and quasi-public databases
(e.g., GenBank or the SNPs Consortium) have been
created, making genomic information widely available. The NIH has funded
initiatives and instituted new guidelines for grantees
to promote access to research tools (17). The NIH has also negotiated with
owners of foundational technologies, such as stem
cells or genetically altered mice, to ease publicly funded researchers'
access to important upstream discoveries (18). Scientific
journals have pushed authors to deposit sequences in publicly available
databases as a condition of publication.
Notwithstanding these "working solutions," aggressive assertions of IP can
still threaten scientific research, as recent
experience with genetically altered mice and diagnostic tests suggests (10).
Thus, we anticipate a continuing need for active
defense of open science. Moreover, the effective elimination of the research
exemption by the recent Circuit Court Madey v.
Duke University decision (19) may undermine the informal exemption that, as
our interviews suggest, is important for open
science. Thus, policy-makers should ensure an appropriate exemption for
research intended for the public domain.
References and Notes
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10.Details and more discussion are provided in J. P. Walsh, A. Arora, W.
M. Cohen, in Patents in the Knowledge-Based
Economy, W. M. Cohen, S. Merrill, Eds. (National Academy Press,
Washington, DC, in press).
11.W. F. Whyte, Learning from the Field (Sage, Beverly Hills, CA, 1984).
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15.Bayer AG v. Housey Pharmaceuticals, Inc. (D. Del. 17 October 2001).
16.S. Maebius, H. Wegner, National Law Journal, 24 December 2001, p. C3.
17.DHHS, Fed. Regist. 64, 72090 (1999).
18.E. Marshall, Science 288, 255 (2000).
19.R. Eisenberg, Science 299, 1018 (2003).
20.The Science, Technology, and Economic Policy Board of the National
Academies commissioned and supported this
research. The NSF and the Abe Fellowship Program also provided support.
We thank J. Cohen for editorial and J. Conde,
W. Hong, J. Lee, and M. Saegusa for research assistance.
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