Intellectual Property Rights and Research Tools in Molecular Biology Summary of a Workshop Held at the National Academy of Sciences, February 15-16, 1996 (1997) / Chapter Skim
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CASE STUDIES
CASE STUDIES
Pages 40-56
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From page 40... ...
One is a process patent for making molecular chimeras and two are product patents one for proteins produced using recombinant prokaryote DNA and another for proteins from recombinant eukaryote DNA. Recombinant DNA, arguably the defining technique of modern molecular biology, is the founding technology of the biotechnology industry (Beardsley 1994~.
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From page 41... ...
By 1978, NIH decided to support the patenting of recombinant DNA inventions by universities; in December 1980, the process patent for making molecular chimeras was issued. The product patent for prokaryotic DNA was issued in 1984.
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From page 42... ...
If the technology had been licensed exclusively to one company and the entire recombinant DNA industry had been controlled by one company, the industry might never have developed. Alternatively, major pharmaceutical firms might have been motivated to commit their resources to challenging the validity of the patent.
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From page 43... ...
Tom Caskey, senior vice-president for research at Merck Research Laboratories and past-president of the Human Genome Organization, attributes much of the success of the Human Genome Project to PCR: "The fact is that, if we did not have free access to PCR as a research tool, the genome project really would be undoable.
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From page 44... ...
Licenses in the last-named category are very broad; there are no upfront fees or annual minimum royalties, and the licensees have options to obtain reagents outside Roche. Discussion about access to PCR technology centered on the costs of Taq polymerase, rather than on the distribution of intellectual property rights.
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From page 45... ...
But he also argued that the price of Taq polymerase is too high and has slowed the progress of PCR products from the research laboratory to the marketplace. Poiesz stated that the diagnostic service licenses "are some of the highest royalty rates I have personally experienced." He cited the example of highly sensitive diagnostic tests for HIV RNA, which he said are too expensive for widespread use, largely because of the licensing fees charged by Roche.1 Caskey felt that Roche should have expanded the market by licensing more companies to sell PCR-based diagnostic products and profited from the expansion of the market, rather than from the semiexclusivity that it has maintained.
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From page 46... ...
There was vigorous discussion and disagreement as to whether the licensing fees justify the value added by Roche. PROTEIN AND DNA SEQUENCING INSTRUMENTS: Research Tools to Which Strong Patent Protection Promoted Broad Access This case study was selected because it provides a clear example of how patent protection promoted the development and dissemination of research tools.
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From page 47... ...
As Hood told it, the argument that convinced Cal Tech to support the arrangement was that "if the scientific community wants these instruments, it is our moral obligation to make them commercially available." At the time of this workshop, ABI had sold more than 3,000 DNA sequencers and more than 1,000 protein sequencers worldwide (although some elements of the technology, such as peptide synthesis, were not protected by patents, most of the instrumentation was patented by ABI)
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From page 48... ...
RESEARCH TOOLS IN DRUG DISCOVERY: Intellectual Property Protection For Complex Biological Systems Research tools in drug discovery present an example of the difficulties in protecting intellectual property when technologies involve complex biological systems that lack discrete borders. The information is often broad and refers to general categories of matter, such as a class of neural receptors, rather than finite entities, such as the human genome, or specific techniques, such as PCR or recombinant DNA techniques.
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From page 49... ...
The assays were in the public domain, and many companies used them to develop new drugs. Today, Merck would patent such an assay and use its patent position to trade with other companies for access to other research tools.
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From page 50... ...
A newer biopharmaceutical strategy emerged not to discover large proteins or other large-molecule drugs, but to find other therapeutically active small molecules. These are the traditional targets of pharmaceutical research, but a biopharmaceutical company uses modern biotechnology and insights from molecular biology to get to the ultimate target product more quickly and efficiently.
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From page 51... ...
More recently a private institution, Merck, has assumed the quasigovernment task of sponsoring a university-based effort to place information into the public domain. While other private companies have provided funds for public sector research, such as in the Sandoz-Scripps agreement, these efforts have not been with the expressed purpose of putting information into the public domain.
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From page 52... ...
initially adopted an exclusivelicensing model, and Incyte adopted a broad licensing approach of offering nonexclusive licenses to its database to as many firms as would sign up. Putting information in the public domain limits opportunities to exploit it as a trade secret by controlling access to it.
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From page 53... ...
William Haseltine, CEO of HGS, noted that patent applications filed by HGS for ESTs involve considerably more than simply identification of the gene fragments and involve information about the stage of development and tissue type in which those genes are expressed. He further commented that the importance of the EST database is not simply that the fragments are identified, but that the database itself provides a high level of information.
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From page 54... ...
Many discoveries about HIV have evolved from that sequence information, and Sikella noted that it would have been a disservice to the public if the sequence information had not been available as a general research tool. The Human Genome Is Finite As of this workshop, some 27,000-35,000 human genes were represented in the database.
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From page 55... ...
The Advent of DNA Sequencing Presents Important Questions About Patentability Leon Rosenberg commented that "although the debate seems to have cooled a bit, the issues surely have not been resolved." Tom Caskey of Merck and William Haseltine of HGS both commented that they have no quarrel with the current criteria for patents, but they express different views as how those criteria should be interpreted. Since the workshop, HGS has received patents on a number of ESTs with broader claims of utility than the initial EST patent applications filed by NIH in 1974.
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From page 56... ...
1991. Complementary DNA sequencing: expressed sequence tags and human genome project.
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