The case for genomic patenting

Posts, George

doi:10.1038/378534a0

Cited by 22 publications

(8 citation statements)

References 8 publications

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“…It is argued that patents have been critical to the growth and maintenance of the pharmaceutical industry. 1,2 In this industry particularly, patents are seen as necessary to enhance an inventor's ability to recoup the substantial investments of many years and hundreds of millions of dollars necessary to bring a new drug or device to market. However, it has been proposed that patents are not necessarily an effective incentive for the development of clinical genetic diagnostic tests.…”

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confidence: 99%

Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services

Cho¹,

Illangasekare²,

Weaver³

et al. 2003

The Journal of Molecular Diagnostics

145

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The growth of patents that include genetic sequences has been accompanied by concern about their impact on the ability of physicians to provide clinical genetic testing services and to perform research. Therefore, we conducted a survey of clinical laboratory directors that perform DNA-based genetic tests to examine potential effects. We performed a telephone survey between July and September in 2001 of all laboratory directors in the United States who were members of the Association for Molecular Pathology or who were listed on the GeneTests.org website. One hundred thirty-two of 211 (63%) laboratory directors were interviewed. Ten of these were excluded because they did not conduct DNA-based genetic tests. Almost all performed genetic tests for clinical purposes. Half performed tests for research purposes as well. Twenty-five percent of respondents reported that they had stopped performing a clinical genetic test because of a patent or license. Fifty-three percent of respondents reported deciding not to develop a new clinical genetic test because of a patent or license. In total, respondents were prevented from performing 12 genetic tests, and all of these tests were among those performed by a large number of laboratories. We found 22 patents that were relevant to the performance of these 12 tests. Fifteen of the 22 patents (68%) are held by universities or research institutes, and 13 of the 22 patents (59%) were based on research funded by the United States Government. Overall, respondents reported that their perceptions of the effects of patents on the cost, access, and development of genetic tests, or data sharing among researchers, were negative. In contrast, most respondents felt that patents did not have an effect on the quality of testing. We conclude that patents and li- Patents were created to provide incentives for the production of innovative products that could benefit the public. It is argued that patents have been critical to the growth and maintenance of the pharmaceutical industry.

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mentioning

confidence: 99%

Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services

Cho¹,

Illangasekare²,

Weaver³

et al. 2003

The Journal of Molecular Diagnostics

145

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“…SmithKline Beecham has formed a consortium with an American company, Human Genome Sciences, to map, sequence, and patent as much of the human genome as possible 2. The consortium has sequenced about 850000 fragments of DNA drawn from almost 85% of the human genome.…”

Section: Not In the Best Interests Of Science Or Societymentioning

confidence: 99%

“…The issue is no longer whether genes can be patented on principle, but what sort of patents on what sort of genetic information will most encourage the development of useful inventions and products for promoting human health and wellbeing. While a convincing case can be made for the value of patents in securing investment and attention from those who hold them,2 limiting access to portions of the human genome to a small set of scientists simply because they identified the sequences first is unlikely to lead to the maximal intellectual exploitation of this resource. Nor does it make moral sense.…”

Section: Not In the Best Interests Of Science Or Societymentioning

confidence: 99%

Patenting gene sequences

Caplan¹,

Merz²

1996

BMJ

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“…To cite a second example, isolated and/or purified DNA has been routinely given subject matter status since the 1980s. United States Patent 5,747,282, issued 5 May 1998, the so-called 'breast cancer gene patent', has been at least as controversial as the New Guinea cell line patent (Kass, 2000;Stewart, 1995;Poste, 1995). It claims, in 'isolated' form, the DNA sequence of a gene that can cause susceptibility to breast cancer-not just methods or processes for producing or using the DNA sequence, but the actual sequence of chemical bases by which the breast cancer gene does its work in human cells.…”

Section: Introductionmentioning

confidence: 99%

Rethinking the product of nature doctrine as a barrier to biotechnology patents in the United States—and perhaps Europe as well1

Conley¹,

Makowski

2004

Information & Communications Technology Law

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For more than a decade, gene patents have been the driving force behind the burgeoning American biotechnology industry. Many people-even otherwise sophisticated lawyers-assume that such patents cover only methods and therapeutic applications. They are shocked to learn that patents on genes themselves, as long as they are isolated from the body, are routinely allowed by the United States Patent and Trademark Office and acquiesced in by the courts. The practical consequences of this development are equally startling to the non-patent community: gene patent holders can control not only commercial applications, but virtually all research involving the subject genes. Since genes are valuable as transmitters of information, the ultimate effect can be a monopoly on the use of that information. This, we believe, takes intellectual property protection to an unprecedented level.All challenges to gene patents in the United States have thus far been dismissed almost out of hand. One possible avenue of attack that has gotten little attention involves the 'product of nature' doctrine, whose roots in American patent law go back to the nineteenth century. In its strongest form, it holds that compounds and compositions of matter that are not materially different from naturally occurring products are not patentable subject matter. In this article, we explore the history and current status of this doctrine. After reviewing some of the critical scientific elements of gene patents, we ask whether the product of nature doctrine, properly argued, might be reinvigorated as a brake on the rush to patenting the human genome. We believe that it would be particularly useful for lawyers and regulators in Europe to examine the American experience, since the European position on gene patents seems still to be more open to debate.

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The case for genomic patenting

Abstract: Opposition to the patenting of genomic inventions threatens to erode the foundation of intellectual property rights needed to convert innovative research into new drugs, vaccines and diagnostic tests.

Cited by 22 publications

References 8 publications

Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services

Effects of Patents and Licenses on the Provision of Clinical Genetic Testing Services

Patenting gene sequences

Rethinking the product of nature doctrine as a barrier to biotechnology patents in the United States—and perhaps Europe as well1

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