Just a little while ago, the Supreme Court issued a unanimous decision (rare these days) in the Myriad Genetics (NASDAQ:MYGN) case. I summarized the state of play up until the most recent arguments here, and if you're just getting up to speed on this issue, I'd read that post first. There are a lot of things this case is not about, and there are a lot of headlines that are going to mess things up. I would not be surprised to see "Myriad Wins" and "Myriad Loses" coming up at the same time in a news search.
Here's the actual decision (PDF), and here's the key statement:
A naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but cDNA is patent eligible because it is not naturally occurring.
The earlier appeals court decision was broader, and found that isolated stretches of otherwise natural DNA were, in fact, patent-eligible, because they are not found as such (unwound, de-histoned, cleaved at both ends) in nature. But this ruling dials that back a bit. A cDNA, stripped of introns, etc., is indeed a work of human ingenuity, and is patent-eligible (as indeed, it had been considered to be before this decision). Here's more:
It is important to note what is not implicated by this decision. First, there are no method claims before this Court. Had Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method pat- ent. But the processes used by Myriad to isolate DNA were well understood by geneticists at the time of Myriad’s patents “were well understood, widely used, and fairly uniform insofar as any scientist engaged in the search for a gene would likely have utilized a similar approach,” 702 F. Supp. 2d, at 202–203, and are not at issue in this case.
Similarly, this case does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, “[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its unchallenged claims are limited to such applications.” 689 F. 3d, at 1349. Nor do we consider the patentability of DNA in which the order of the naturally occurring nucleotides has been altered. Scientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of §101 to such endeavors. We merely hold that genes and the information they encode are not patent eligible under §101 simply because they have been isolated from the surrounding genetic material.
Unfortunately, many of the news blurbs on this issue are smudging these questions around. I don't actually expect this ruling to have much effect, to be honest, except as a way to help resolve the question of whether stretches of raw DNA are patentable. The glory days of trying to patent such things are long gone, in any case. And since there are many more useful forms which are patentable, any headlines about "No patents for DNA!" are misleading.