PCR and Scientific Invention: The Trial of DuPont vs. Cetus

Mullis, Kary B.

doi:10.1007/978-1-4612-0257-8_35

Cited by 8 publications

(14 citation statements)

References 6 publications

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“…Prior publications of MIT’s Gobind Khorana were brought to the attention of the patent office, but the patent office reissued the patents after concluding that some key features of PCR, including exponential amplification, had not been disclosed in the prior art. A jury found for Cetus in February 1991 (150). As noted above, Kodak sued to block sale of PCR rights to Hoffman--La Roche in 1991 but lost.…”

Section: The Diversity Of Dna Patents: Patent Storiesmentioning

confidence: 99%

Patents in Genomics and Human Genetics

Cook-Deegan

Heaney

2010

Annu. Rev. Genom. Hum. Genet.

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Genomics and human genetics are scientifically fundamental and commercially valuable. These fields grew to prominence in an era of growth in government and nonprofit research funding, and of even greater growth of privately funded research and development in biotechnology and pharmaceuticals. Patents on DNA technologies are a central feature of this story, illustrating how patent law adapts---and sometimes fails to adapt---to emerging genomic technologies. In instrumentation and for therapeutic proteins, patents have largely played their traditional role of inducing investment in engineering and product development, including expensive postdiscovery clinical research to prove safety and efficacy. Patents on methods and DNA sequences relevant to clinical genetic testing show less evidence of benefits and more evidence of problems and impediments, largely attributable to university exclusive licensing practices. Whole-genome sequencing will confront uncertainty about infringing granted patents but jurisprudence trends away from upholding the broadest and potentially most troublesome patent claims.

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Section: The Diversity Of Dna Patents: Patent Storiesmentioning

confidence: 99%

Patents in Genomics and Human Genetics

Cook-Deegan

Heaney

2010

Annu. Rev. Genom. Hum. Genet.

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“…"The quintessential use of biotechnology in an industrial setting, because it took advantage of larger, rather than smaller teams of scientists to explore to its fruition an idea. But each member of that team had brought to that team a very different experience, really a multidisciplinary approach, so you had the creative chemistry background that Kary brought to the area...the enthusiasm and intelligence, really, of Fred Faloona...the human genetics background and the careful experimentation in molecular biology that Henry Erlich and Norm Arnheim and their colleagues brought to that [ 6 ]."…”

Section: Case Descriptionmentioning

confidence: 99%

“…The group worked throughout the summer and fall to obtain reliable results. An experiment run by Scharf and Faloona on November 14, 1984 provided them with those results [ 6 ]. With solid experimental data in hand, the group worked towards perfecting the technique.…”

Section: Case Descriptionmentioning

confidence: 99%

“…Saiki recalls Mullis and Faloona "wanted to do more elegant experiments. They didn't want to use radioactivity...So they went off and wanted to do it in a nonradioactive manner, which at the time was very difficult [ 6 ]." Mullis states that the final experiment he wanted to run, showing that PCR could be done in a single copy gene in human DNA, turned out to be much harder than he anticipated [ 3 ].…”

Section: Case Descriptionmentioning

confidence: 99%

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Fore

Wiechers

Cook-Deegan

2006

J Biomed Discov Collaboration

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Introduction: Polymerase chain reaction (PCR) was a seminal genomic technology discovered, developed, and patented in an industry setting. Since the first of its core patents expired in March, 2005, we are in a position to view the entire lifespan of the patent, examining how the intellectual property rights have impacted its use in the biomedical community. Given its essential role in the world of molecular biology and its commercial success, the technology can serve as a case study for evaluating the effects of patenting biological research tools on biomedical research.

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“…While the transcripts of the trial tell us little about how the Cetus patent attorneys and scientists worked to draft the patent documents, 46 we do have an account of how an earlier Cetus inventor worked with a Cetus patent attorney. After the Mullis patent was upheld by a jury in DuPont v. Cetus, Mullis (1994b) wrote an account of the trial. He included a discussion of the drafting of the Mullis patent, which he described as very much a joint effort between himself and the junior Cetus patent attorney, Janet Hasak, the same attorney who later wrote the Taq patent application.…”

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confidence: 99%

Biotech in Court

Swanson

2007

Soc Stud Sci

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This paper examines the American legal system's reliance upon the unity of science through a close study of the testimony presented in a biotech patent trial, explicated through the context of the legal practice of patent drafting and the history of the American biotechnology industry. In order to decide whether a key patent related to the polymerase chain reaction (PCR) was invalid, the court needed to decide whether the inventing scientists had made intentional misrepresentations in the process of drafting and prosecuting the patent. I analyze the various images of science presented to the court by scientists testifying about how scientists report their experimental results in scientific publications. By setting this testimony about scientific authorship in the context of the legal understanding of patent authorship, I explain why the court was prepared to accept a universal notion of science and of the scientist that rendered unimportant any distinctions between papers and patents, or between professors and biotech scientists. This image of universal science was opposed at trial by local and specific images of sciences which have been institutionalized in industrial science throughout the 20th century, and which I argue were adopted and adapted by the American biotech industry of the 1970s to the 1990s in ways that contributed both to the trial court's finding against the patent, and to the instability of that ruling.

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PCR and Scientific Invention: The Trial of DuPont vs. Cetus

Cited by 8 publications

References 6 publications

Patents in Genomics and Human Genetics

Patents in Genomics and Human Genetics

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Biotech in Court

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