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 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.
Source: http://upload.wikimedia.org/wikipedia/commons/e/e1/Protein_BRCA1_PDB_1jm7.png |
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:
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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