April 17, 2014

avatar

On the Legal Importance of Viewing Genes as Code

The Supreme Court yesterday issued its opinion in the much–awaited Myriad case, which challenged the validity of patents on isolated human genes. The Court held that the isolated genetic sequences claimed in Myriad’s patents did not satisfy the inventive threshold for patentability, although the complementary DNA (cDNA) claimed in the patents did. One of the more interesting elements of the case for me is the extent to which the outcome turned on a single conceptual choice: When assessing patentability, should the legal analysis focus on the isolated DNA’s chemical structure or its information-coding function? The Court decided that the information-coding function was the proper focus. That choice led the justices to the inevitable conclusion that the isolated sequences were not patentable. The Court of Appeals for the Federal Circuit, by contrast, had focused on the sequences’ chemical structure and had reached the opposite conclusion.

Why did this conceptual choice turn out to be so consequential? To be patentable, an invention must be the product of human ingenuity. Products of nature and natural phenomena are excluded from the scope of patent protection. The leading case in the domain of patents on living organisms is Diamond v. Chakrabarty, in which the Court said that patent protection could extend to “anything under the sun that is made by man.” The scope is very broad (i.e., “anything under the sun), but it isn’t unlimited (i.e., it has to be “made by man”).  The question courts must ask to separate products of nature from products of human ingenuity is whether the claimed invention is “markedly different” from something that is found in nature.

To reach the conclusion that the isolated genes at issue in the case were markedly different from naturally occurring ones, Judge Lourie of the Federal Circuit, who wrote the lower court’s majority opinion, emphasized the transformation that occurred in the chemical structure of the isolated gene during the process of isolation.

Isolated DNA has been cleaved (i.e., had covalent bonds in its backbone chemically severed) or synthesized to consist of just a fraction of a naturally occurring DNA molecule…. Accordingly, BRCA1 and BRCA2 in their isolated state are not the same molecules as DNA as it exists in the body; human intervention in cleaving or synthesizing a portion of a native chromosomal DNA imparts on that isolated DNA a distinctive chemical identity from that possessed by native DNA.

For Judge Lourie, severing covalent bonds—the chemical equivalent of snipping the desired piece of DNA on either end with a scissors—was a sufficient human intervention to make the isolated sequences patentable.

Judge Bryson, who dissented in the Federal Circuit, disagreed. Judge Bryson believed that the patentability question hinged on whether the process of isolation functioned in any way to change the informational content of the genes.

The isolated BRCA genes are identical to the BRCA genes found on chromosomes 13 and 17. They have the same sequence, they code for the same proteins, and they represent the same units of heredity.…The only difference between the naturally occurring BRCA genes during transcription and the claimed isolated DNA is that the claimed genes have been isolated according to nature’s predefined boundaries, i.e., at points that preserve the ability of the gene to express the protein for which it is coded.

Viewed as coded information and not as a chemical molecule, the isolated genes are no different from their naturally occurring counterparts, which means that the element of human ingenuity required for patentability is lacking.

The Supreme Court agreed with Judge Bryson’s approach, concluding that Myriad’s patent claims were directed to the informational content of the isolated genes and not their chemical structure.

Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule. Myriad’s claims are simply not expressed in terms of chemical composition….Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes…[Myriad’s] claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.

The Court was presented in the case with two scientifically sound and plausible ways of thinking about isolated genes. From a scientific perspective, the two views are not mutually incompatible, but from a legal perspective, the chemical composition view supports the assertion of exclusive property rights and the coded information view doesn’t. In what I think is the right result, the coded information view won the day.

Comments

  1. Jonathan Epstein says:

    … and yet somehow the court ruled that the cDNA, which has the same information content as the (complementary) naturally occurring mRNA, was patentable.

    • Pseudonym says:

      Almost. They ruled that cDNA (which cannot be extracted from the cell) is a human creation, and hence potentially patentable. They did not rule out the possibility that it may be unpatentable on other grounds which were not before the court, and indeed explicitly said (see footnote 9) that it was not making a decision on that.

      The information in the cDNA in question is dictated by nature. SCOTUS decided that this is legally irrelevant to deciding whether or not it’s a human creation, because the cDNA in question cannot be extracted directly.

      You forget that there are several grounds on which something may be ineligible for patent protection. One of them is the “obviousness” test, which to this lay person would seem to me to be more relevant here. SCOTUS did not decide this question because a) it wasn’t before them, and b) it wasn’t needed to resolve the case. Only a subsequent court case will be able to sort that out.