This is the sixth post in our Law and the Multiverse Retcons series, in which we discuss changes in the law (or corrections to our analysis) that affect older posts.
Today I have a quick post about a recent Supreme Court case that was under consideration when I wrote this post about the graphic novel Genetiks. As mentioned in the post, the Supreme Court had recently heard the case of Association for Molecular Pathology v. Myriad Genetics, Inc., which was intended to answer the question “are human genes patentable?” Since then the Court has handed down its decision, which many news outlets summarized as “no.” The truth is a little more nuanced than that*, but in any event the Court’s decision doesn’t change the ultimate conclusion in my original post, which was that what the company in Genetiks was portrayed as doing would not be possible under US law. If anything the Myriad decision has only cemented that.
Relatedly, I’ve gotten some questions from readers about the series Orphan Black, which apparently deals with some similar issues as Genetiks. I’ve heard good things about the series and intend to review it at some point in the future.
* Tempted as I am to delve into the minutiae of patent law, since that’s my area of interest, I will limit myself to a brief(-ish) summary.
Essentially, the Court held that DNA molecules cannot be patented if they are the same as a DNA molecule (or part of one) that occurs naturally in the human body, even if the patent claims only isolated, purified DNA molecules, which do not occur naturally. The Court based its decision on the fact that isolation and purification do not change the information content of the genetic sequence, which was the actual invention as far as it was concerned rather than the DNA molecule in a chemical sense.
However, the Court also held that cDNA molecules can be patented, even if the cDNA molecule is nothing more than an unpatentable DNA molecule run through a standard biotech process. According to the Court, that process takes an unpatentable product of nature and makes it into a patentable manufacture or composition of matter in a way that isolation and purification do not. This is evidently true even though the information content of the DNA molecule and its corresponding cDNA molecule are the same. It is difficult to reconcile these results on their face.
It is worth noting that the Patent Act itself says nothing about products of nature. The list of “inventions patentable” contains no exceptions at all, only an affirmative list. The Court arrived at its conclusion by reading in / creating an exception that is not at all present in the statute but is instead derived only from prior Supreme Court cases.
The practical upshot of all this is that Myriad will lose its right to exclude others from performing clinical testing for the BRCA1 and BRCA2 mutations. More broadly, single-gene testing is now anybody’s game. But Myriad and other biotech companies will retain other, less-valuable patent rights associated with human genes.
That’s about all I can say without getting too soapboxy. For more on this kind of thing, see my forthcoming paper, James E. Daily & F. Scott Kieff, Anything Under The Sun Made By Humans: Patent Law Doctrines As Endogenous Institutions For Commercializing Innovation, 62 Emory L.J. (forthcoming July 3, 2013).
Pingback: Genetiks and Human Gene Patents | Law and the Multiverse