We asked Andrew Hogan, a historian of science and medicine whose work focuses on the observational approaches of postwar human genetics and biomedicine, what the sort of questions he asks might reveal about contemporary science. He sent us the following guest post; you can find out more about his work here.
Excellent coverage of the BRCA gene patenting case by Lukas on this blog (and elsewhere) over the past few months has recently gotten me thinking about the ways that various analogies shape the arguments and decisions made by lawyers, jurists, and government officials. Comparisons to more tangible objects seem to be particularly influential in cases that consider scientific concepts and entities, like genes, which cannot be directly seen.
After the case Association for Molecular Pathology v. Myriad Genetics, Inc. was heard before the US Supreme Court last month, I read through the oral arguments, previous Court decisions for this case, and the 2001 US Patent and Trademark Office (USPTO) justification for allowing gene patents. I wanted to get a sense of what gene analogies seemed to be most influential, and how this shaped the framing of the BRCA case.
In his recent post, Lukas did an excellent job of probing the implications of framing genes as molecules versus information. Today, I want to examine two related sets of analogies that may also shape the outcome of this case: those that equate human genes with (1) other chemicals that have been isolated and/or purified from the human body, like the hormone adrenaline, and (2) macroscopic anatomical entities, such as a kidney, liver, or tree leaf.
In its 2001 ruling, the USPTO pointed back to Federal Court cases from earlier in the 20th century, which upheld patents on chemicals that had been taken from the human body and put to new uses. The jurists in these cases had found that the hormones adrenaline and prostaglandin were substantially different when isolated and purified, than when found in the body.
Lawyers for Myriad offered a similar argument about the isolation of human genes, suggesting that DNA segments making up the BRCA genes, when excised from their respective human chromosomes, were chemically distinct molecules (in this case, not just purified, but different). As Myriad sees it, when they were first isolated from the body, the BRCA genes were entirely new compositions of matter, directly resulting from human ingenuity, and were thus patentable.
To briefly review some of what was covered in Lukas’ post: US Circuit Court Judge Alan Lourie agreed with this characterization of human genes in his opinion upholding the BRCA gene patents. Lourie argued that the breaking of chemical bonds necessary to isolate the BRCA genes from their normal position among the human chromosomes made them chemically distinct, and thus patentable, molecules. In his decision, Judge Lourie set aside an argument previously made by US District Court Judge Robert Sweet, who suggested that DNA’s role in embodying biological information made it ineligible for patenting. Judge Lourie was not persuaded by the significance of analogies equating DNA with information, and instead found that isolated DNA was like any other molecule that had been chemically altered from its natural form.
As arguments got underway on April 15 at the US Supreme Court however, it quickly became clear that many of the Justices were more taken with anatomical analogies for human genes than chemical comparisons. Rather than chemical bonds being broken in order to isolate the BRCA genes from their natural location, Justices Sotomayor, Breyer, and Roberts spoke of “snipping” genes out of the human body. Here's an example:
From here, the Justices began to equate the isolation of human genes with the removal of more discrete and tangible body parts: chromosomes and organs. Where Judge Lourie was willing to agree that human genes were chemically distinct when removed from the body, many of the Supreme Court Justices were hesitant to accept that genes, when analogized to other parts of the human anatomy, were in fact substantially different entities outside of the body.
We often speak of human genes and the human genome as discrete entities. Indeed, as Aryn Martin has suggested in her work on genetic chimeras, courts often think in terms of one-to-one correlations between individuals and their unique genetic ‘fingerprint’. Such analogies, it seems to me, make the genome seem more like a discrete part of the human anatomy – like a liver – than a widely dispersed chemical – such as a hormone. And, while almost no one would accept that the liver could be patented just because someone “snipped” it out of the human body, the purification of a hormone is more of a borderline case, having previously received patent protection.
Now, to step back for a minute, it seems to me that many people oppose gene patenting on the grounds that allowing monopolies over DNA sequences, as they exist in nature, disrupts research. I find it interesting that the US Circuit Court and Supreme Court have largely set aside this informational analogy, of DNA as biological code, in their deliberations about the BRCA gene case. Instead, they seem to be more interested in analogies that help them to probe what sort of material isolated DNA truly is: chemical, anatomical, or somewhere in between?
As genetic and biotech research progresses, the legalities are likely to get even stickier for lawmakers to interpret. But I feel it is essential to allow research that will help people over the long term.
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