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

Abstract

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.

Evidence and anecdotes: an analysis of human gene patenting controversies

“…Here, there are more instances of researchers and firms claiming that the patent owner is asserting exclusivity or license terms that are widely viewed as inappropriate [18,30] [30] find that 25% of labs had abandoned one or more genetic test due to patents, with Myriad's patents among the most frequently mentioned. Such unlicensed lab testing, from the perspective of the patent owner, competes with its commercial activity and hence, it is not surprising to find owners asserting their rights.…”

Reflections on the Gene Patent War: The Myriad Battle, Sputnik and Beyond

“…Indeed, he seems to accept conclusions about "the chilling effect of gene patents on the advancement of both genetic research and clinical testing." In support of these kinds of social concerns, Judge Sweet references a handful of studies, including the often-cited survey of laboratory directors by Cho et al, (4 ). That study found that 53% of the respondents agreed that the existence of a patent had led them to decide "not to develop or perform a test/service for clinical or research purposes.…”

Navigating the molecular diagnostic patent landscape

“…Although the justification for patents is that they promote innovation, there is growing concern that gene and related patents may be used in ways that could have a significant negative impact on molecular diagnostics in both the clinical and research contexts [51].…”

“…One of the reasons why there is more evidence of patent enforcement against clinical molecular diagnostic laboratories in the US than elsewhere might well be because that jurisdiction tends to have a higher ratio of private to public laboratories [51], [56] (recognising that patent holders might also be strategically targeting testing facilities in that jurisdiction because of the higher volume of testing than elsewhere, and hence the greater opportunity for remuneration). Assessment of the impact of patents in the molecular diagnostic landscape requires scrutiny of the changing nature of the landscape, particularly focusing on the increasing commercialisation of this sector.…”