Large-Scale Biomedical Science Exploring Strategies for Future Research (2003) / Chapter Skim
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7. Intellectual Property and Access to Research Tools and Data
7. Intellectual Property and Access to Research Tools and Data
Pages 162-191
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From page 162... ...
However, this term is not found in patent law, and no legal consequences arise from designating a particular discovery as a research tool.
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From page 163... ...
The largest portion of the increase in university patenting has been in the biomedical sciences (National Research Council, 1997~. 2 Until 1999, when Congress amended the Patent Law, U.S.
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From page 164... ...
164 LARGE-SCALE BIOMEDICAL SCIENCE Prior to 1980, the federal government sponsored primarily basic or "upstream" research, and broad, unpatented dissemination of results in the public domain was the norm for universities (Heller and Eisenberg, 1998~. Fewer than 250 U.S.
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From page 165... ...
The privatization of upstream biomedical research has led to intellectual property claims on research results that, in an earlier era, would have been made freely available in the public domain (Heller and Eisenberg, 1998~. Indeed, many biotechnology patents are considered research tools rather than traditional end products, since they are useful primarily for 5 This total, representing 2.4 percent of all utility patents issued in the year 2000, is the aggregate figure for 190 institutions.
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From page 166... ...
The term "research tool" is not found in patent law, and no legal consequences arise from designating a particular discovery as a research tool; nonetheless, some patents that fall into this category have been the most contentious with regard to their impact on the progress of science. But the key question relates to access to the research tools, rather than to whether the tools should be patented or not.
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From page 167... ...
Although the Bayh-Dole Act does not specify a preference for either exclusive or nonexclusive licenses, it does mandate a preference for licensing to small firms. But because small companies, especially start-up businesses, may depend on exclusive rights to establish a competitive advantage and ensure access to high-risk capital, the law may indirectly encourage universities to grant exclusive licenses (Henry et al., 2002~.
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From page 168... ...
Restricting the use of trans~enic mice could Neatly impede cancer - ~ - - -- - - - - -I- - -- -- - - ~ -- - J r -- - -- -research because such mice serve as basic research tools and models for human cancer and can also be used to screen for or test new therapeutics. Thus, DuPont's aggressive enforcement of the oncomouse patents could be an obstacle to achieving the goals of NCI's Mouse Models of Human Cancer Consortium (described in Chapter 3~.
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From page 169... ...
Such rights may take the form of a royalty on sales that result from use of the upstream research tool, an exclusive or nonexclusive license on future discoveries, or an option to acquire such a license. In principle, such agreements could offer advantages to both patent holders and the scientists who use the patented tools in their re6 Guidelines available at |
From page 170... ...
Unfortunately, it is difficult to define experimental use in such a way as to maintain the commercial value of research tools for the patent holder. According to Eisenberg (1997: 13~: The problem is that researchers are ordinary consumers of patented research tools, and that if these consumers were exempt from infringement liability, patent holders would have nowhere else to turn to collect 7 Congress has enacted laws for two specific research use exceptions.
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From page 171... ...
Furthermore, some industry executives have noted that although industry previously often gave university research a de facto research exemption, they are now often more reluctant to do so because in many cases, university researchers are seen as competing directly with their own research.8 As a result, companies may feel burdened by the requirement to license the results of university research that have been patented (but formerly would have been freely available) when the universities continue to expect an exemption for use of the companies' patented research tools.
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From page 172... ...
have recognized that patent pools can have significant procompetitive effects and may also improve a business' ability to survive in a time of rapid technological innovation in a global economy. In 1995, the Department of Justice and the FTC issued Antitrust Guidelines for the Licensing of Intellectual Property and set forth enforcement policies (see Box 7-5~.
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From page 173... ...
Conflicting agendas of the various patent holders and their tendency to overvalue their contribution to the pool can also make it difficult to reach mutually satisfactory agreements or to develop standard license terms. Patents on research tools are likely to include a diverse set of techniques, reagents, sequences, and instruments, making it difficult to compare the value of the various patents in a potential pool.
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From page 174... ...
A major intent of the laws that encourage universities to patent the results of federally funded
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From page 175... ...
Optimizing technology transfer to promote the commercialization of discoveries and maximizing licensing revenues may entail different strategies; thus the policies of universities regarding intellectual property rights should be considered carefully, within the context of their academic values and mission to advance knowledge. Since 1980, NIH and many universities have created technology transfer offices to patent and license their discoveries for further development.
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From page 176... ...
EXAMPLES OF INTELLECTUAL PROPERTY AND DATA SHARING ISSUES ASSOCIATED WITH LARGE-SCALE PROJECTS Genomics and DNA Patents Debates regarding patents on DNA sequences and access to sequence data have been frequent and often quite contentious in recent years. A1though raw DNA sequences are viewed as "products of nature" and are therefore not patentable, purified and isolated DNA sequences are now routinely patented.
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From page 177... ...
Most often, discovery of a disease-associated gene first leads to the development of a diagnostic test. If patent holders choose to enforce their patent rights aggressively, they can preclude scientists and physicians from testing patients in their own laboratories, which leads to increased costs.
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From page 178... ...
The Biotechnology Industry Organization opposes such legislation on the grounds that it would devastate the biotechnology industry and drive investors to other industries (Warner, 2002~. A related controversial issue regarding DNA patents hinges on the level of effort and inventiveness associated with such discoveries.
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From page 179... ...
~~: an an l ;? 02't494; W`~c Patent Holder FIGURE 7-3 Number of patents in the DNA Patent Database assigned to various entities in academia, industry, and government, 1980-1999.
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From page 180... ...
Indeed, if patent law systematically allocates stronger rights to those who identify novel DNA sequences while withholding effective patent protection from those who undertake the more difficult tasks of elucidating gene function and developing new therapies, it stands to reason that the latter two activities will be less lucrative than the business of identifying novel DNA sequences (Eisenberg, 1997~. There is currently little hard evidence that this scenario is being played out, and in fact, firms that own the sequence patents will still undoubtedly be motivated to learn the functions of those genes.
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From page 181... ...
According to the U.S. Patent and Trademark Office, researchers can make separate patent claims on these variant proteins even if the parent gene is already patented, as long as the identified changes lead to new and unclaimed functions and uses.
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From page 182... ...
At the other end of the spectrum, the "open source code" model that was used to develop free computer software was discussed as an option for the public databases containing human genome sequences, although that strategy was ultimately rejected (Sulston and Ferry, 2002~. In such a model, anyone could freely use the information in the database to conduct research, to develop products, or to redistribute the information in any form.
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From page 183... ...
Because the data collected in large-scale projects are often placed in publicly accessible databases, considerations of privacy, confidentiality, and informed consent must be taken into account before, during, and after the study. A common approach to obtaining informed consent for the use of human samples in specimen banks is to develop a very general consent form that will allow future, unspecified research to be conducted without the need to reacquire consent for every subsequent study.
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From page 184... ...
The NCI has developed guidelines for protecting the identities of tissue donors while still maintaining links to data on clinical information, but researchers and their institution are responsible for protecting human subjects in studies carried out under their purview. The tremendous concern about patient confidentiality in the United States is due in part to both hypothetical and actual lapses in the routine practice of medicine for example, the management of the medical records in the ordinary setting of day-to-day hospital business, or the misuse of patient information by health care insurers.
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From page 185... ...
The sample included 219 grantees of the Human Genome Project and 1,547 faculty members in genetics or human genetics departments. The remainder of the sample (n = 1234)
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From page 186... ...
This policy is designed to speed the pace of research and to allow the field as a whole to benefit from the large investment made to generate the data, but it clearly raises new questions regarding the data's use, analysis, and publication. The advisory committee for the International Nucleotide Sequence Databases, which includes Genbank, recently endorsed a data sharing 14Respondents estimated that they had made an average of 8.8 requests for information, data, or materials regarding published research in the previous 3 years, with 10 percent of those requests being denied.
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From page 187... ...
urges scientists, funding agencies, and publishers to adhere to a uniform policy for sharing data and reagents. Using the acronym UPSIDE (universal principle of sharing integral data expeditiously)
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From page 190... ...
Many factors contribute to these difficulties, including the time and expense of sharing data and materials, the desire to protect raw or unpublished data and intellectual property, the incentive to maintain a lead in a particular research area, and the need to protect patient confidentiality. Since a primary goal of many large-scale biomedical research projects is to produce data and research tools these issues are of great importance when planning and conducting such projects.
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From page 191... ...
Even a basic research project may require the use of several patented research tools, so it can be difficult, expensive, and time-consuming to acquire licenses for conducting such a project. Because the goal of many large-scale projects is to produce data and reagents that can be used as research tools, this issue may be especially salient for large-scale endeavors.
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