Saturday, June 15, 2013

Two days ago the Supreme Court decided, in Association for Molecular Pathology v. Myriad Genetics, Inc. (No. 12-398, decided June 13, 2013), that human genes can’t be patented. I’m glad the Court reached this decision, mainly for the nonlegal reason that it seems wrong, and creepy, for anybody to be able to own part of the human genome.

I’m also inclined to think that what people apparently can own is enough to encourage the genetic research we hope will bring us many benefits, without the symbolic or moral problems of making our own genes patentable. The Court decides that something called “complementary DNA” (cDNA), which essentially is DNA minus those components (“nucleotides”) that don’t contribute to the production of proteins in the body, is patentable because it’s a new thing rather than the original human gene. The Court also suggests that valid “method claims” could be made for ways to solve the scientific involved in finding particular human genes (we have about 22,000 in all, according to the Court’s opinion), as well as valid “application” claims for the use of knowledge about these genes, and – the Court explicitly doesn’t rule on this one – that perhaps it would be permissible to patent genes that scientists have altered.  It’s worth adding, though, that if all of this can be owned, the symbolic force of the statement that the human genome can’t be patented is somewhat diminished.

But what strikes me most about this decision is that although it purports to be an interpretation of the patent statute, the methods of interpretation applied to the statute are quite odd. The Patent Act’s Section 101, 35 U.S.C. § 101, as quoted by Justice Thomas in his opinion for the Court, says that:

Whoever invents or discovers any new and useful … composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.

What Myriad Genetics did was to locate two genes – the BRCA1 and BRCA2 genes, which when they mutate can drastically increase women’s vulnerability to breast and ovarian cancer. There was an argument that Myriad had created a new chemical molecule consisting of just the elements of these genes, but the Court firmly rejects this argument, saying that it’s clear that what Myriad is trying to patent is not a new molecule but the identity of these genes.

Is a newly identified gene a "new and useful ... composition of matter, or any new and useful improvement thereof," as the statute requires? Arguably, yes. If matter is transformed from incomprehensible to comprehensible, one might say that it has been improved - from the point of view of us comprehenders. So, too, if a radio signal distorted by static is separated into meaningful and meaningless components, it has been "improved" - somewhat as the immense body of DNA molecular information has been broken apart so as to tease out these grimly meaningful genes. The statutory language doesn't easily fit this reading, I’d say, but it doesn't preclude it either.

But what drives the opinion isn’t, as least as the Court presents its reasoning, that kind of syntactic analysis. Rather, the Court follows its quotation from the Patent Act immediately with the observation that “we have ‘long held that this provision contains an important implicit exception[:] Laws of nature, natural phenomena, and abstract ideas are not patentable” (slip opinion at 11; emphasis added; bracketed colon in the original). I added the italics precisely to emphasize the point that this exception is not in the text.

The court then observes that this limit is itself limited, "for 'all inventions at some level embody, use, reflect, rest upon, or apply laws of nature, natural phenomena, or abstract ideas.'" So the Court sees its task as applying a "well-established standard" - the delicate balance between encouraging innovation and stifling the flow of knowledge - to determine whether Myriad has or has not created a "new and useful ... composition of matter." All this seems quite reasonable, but none of these propositions is explicitly stated in the statute.

But here's the last oddity. Having declared that the ultimate, not textually declared, issue is the proper balance between incentives to invent and freedom of information, the Court doesn't seem to undertake that weighing directly. Instead, it focuses on arguing that Myriad's discovery, which everyone agrees revealed information about the body rather than creating new physical processes or things, simply isn't a "new ... composition of matter." In contrast, cDNA, which is made based on DNA and so arguably "dictated by nature," is not the same as nature. "[I]t is distinct from the DNA from which it was derived," and therefore patentable.

I find myself rather sympathetic to Justice Scalia, who filed a very brief concurrence in the result but not the reasoning of the case. He doesn't complain about the court's seeming assertion of and then disregard for broad atextual principles. He does say, however, that the Court has waded too far into biology as a basis for decision, and that for him the case turns simply on whether what Myriad wants to patent is or is not "identical ... To the natural state." That standard one can get, pretty straightforwardly, from the text's requirement that whatever is patented be "new."

So what’s startling about this case is that it asserts that the interpretive task is defined in terms that the statute by no means spells out – a somewhat unorthodox interpretive stance in many other fields of today’s legal world, and certainly unorthodox for Justice Thomas – but then it seems to go back to the text to do the work of decision. Apparently the language the court uses to describe its role is conventional in the field of patent law (a field on which I’m no expert!). Still, it’s often observed that judges cloak their innovations in the language of orthodoxy. This case almost seems to cloak orthodoxy in the language of innovation.

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