On June 13, , in the case of the Association for Molecular Pathology v. Myriad Genetics, Inc. Prior to this ruling, more than 4, human genes were patented. The Supreme Court's decision invalidated those gene patents, making the genes accessible for research and for commercial genetic testing. The Supreme Court's ruling did allow that DNA manipulated in a lab is eligible to be patented because DNA sequences altered by humans are not found in nature. This synthetic DNA is produced from the molecule that serves as the instructions for making proteins called messenger RNA.
Other chapters in Help Me Understand Genetics. Genetics Home Reference has merged with MedlinePlus. Myriad Genetics, a company that specializes in molecular diagnostics, holds the rights to those two genes. Anyone conducting an experiment on them without a license can be sued for infringement of patent rights.
This means that Myriad can decide what research is carried out on those genes, who can do that research, and how much any resulting therapy or diagnostic test will cost. The same holds true for other genes and for any pharmaceutical company, scientist, or university that holds patents similar to those held by Myriad.
On April 15th, after several years of appeals and reversals, the Supreme Court will hear arguments on the essential issue: Should human genes be patented? Traditionally, patents have applied solely to inventions, granted as a reward for ingenuity and to encourage innovation.
Naturally occurring substances, like DNA, were exempt from such laws. Then, in , Ananda Mohan Chakrabarty, a scientist working for General Electric, filed an application for a patent on a bacterium that he had modified genetically so that it could consume oil.
Chakrabarty sued, arguing that, by altering the organism, it was his ingenuity that made the bacterium valuable. The case ended up before the Supreme Court, which, by a vote of five to four, ruled in favor of the engineer. The first such patents were issued for DNA that had been altered to produce specific proteins, such as the insulin used daily by millions of diabetics. Those patents were rarely controversial.
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The scope of patent protection for gene technology in China. Nat Biotechnol. China Knowledge Resources Integrated Database. Database introduction. Peking University Library. The measurement of observer agreement for categorical data. Vogel J. Patenting DNA: balancing the need to incentivize innovation in biotechnology with the need to make high-quality genetic testing accessible to patients.
U Kan L Rev. Privacy and biobanking in China: a case of policy in transition. Download references. I am thankful for Dr. Mei Yang for her assistance in coding the data for calculating inter-coder agreement, and the University of Macau throughout the manuscript preparation and submission process. You can also search for this author in PubMed Google Scholar.
Correspondence to Li Du. Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations. Reprints and Permissions. Du, L. BMC Med Ethics 19, 29 Download citation. Received : 12 October Accepted : 12 April Published : 24 April Anyone you share the following link with will be able to read this content:. Sorry, a shareable link is not currently available for this article. Provided by the Springer Nature SharedIt content-sharing initiative.
Skip to main content. Search all BMC articles Search. Download PDF. Abstract Background The patenting of human genes has been the subject of debate for decades.
Yue was pivotal in crafting a surprise early court decision in favour of the ACLU. Readers are also treated to the inside story of the schism in the US government, with some agencies, most notably the patent office, in favour of gene patents, and the National Institutes of Health, among others, against them. It fell to acting solicitor general Neal Katyal to walk a tightrope between arguing parties, eventually developing a federal government stance: namely, whole-gene sequences as they are found in genomes should not be patentable, but the assembled protein-coding regions of a gene — minus intervening bits of non-coding DNA often scattered throughout — should.
The compromise satisfied no one completely. By , when the Supreme Court issued its unanimous decision in favour of the ACLU, gene patents and Myriad-style testing of single genes were already falling out of fashion. Medical diagnostics had moved on to multi-gene testing, and now, increasingly, the emphasis is on whole-genome sequencing. But this story stands as a guide to the forces that shape an increasingly important industry — and to the vexed influence of patents.
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