All right, there's been another ruling in the Myriad gene patent case, involving genetic testing for the BRCA mutations in breast cancer. There's been a lot of coverage of this, but not all of it gets the details right. And there are a lot of details, so here goes. First off, here is the latest court opinion (PDF), courtesy of the ACLU, which was a party in this case. (That alone should tell you how involved this has become over the years). Allow me to summarize:
Myriad, and others, began offering genetic testing for these mutations in the mid-1990s. The company obtained several patents directed to the gene sequences and methods of assaying them, and informed other players in this field that they were in violation of Myriad intellectual property, specifically the University of Pennsylvania's Genetic Diagnostic Laboratory. Their cease-and-desist letters did not apply to research uses, only to commercial testing for which money was charged. By 1999, the GDL had stopped testing, and Myriad was now the only company in the US carrying out this diagnostic assay.
The plaintiffs in this case are a wide range of people, ranging from the Penn lab and others who wanted to offer BRCA testing, through people who claimed that they had been denied the opportunity to have such a test done through Myriad's exercise of its patents. The lawsuit went through a challenge in district court about whether the plaintiffs had standing to bring suit in the first place, which is an issue that came up again in this appeal, but I'm going to skip over that. It's certainly of potential interest to attorneys in the field, but doesn't get at the scientific and technical end of the case.
To that, then. the district court decision went against Myriad:
The district court held for Plaintiffs, concluding that the fifteen challenged claims were drawn to non-patentable subject matter and thus invalid under § 101. SJ Op., 702 F. Supp. 2d at 220-37. Regarding the composition claims, the court held that isolated DNA molecules fall within the judicially created “products of nature” exception to § 101 because such isolated DNAs are not “markedly different” from native DNAs. Id. at 222, 232 (quoting Diamond v. Chakrabarty, 447 U.S. 303 (1980)). The court relied on the fact that, unlike other biological molecules, DNAs are the “physical embodiment of information,” and that this information is not only preserved in the claimed isolated DNA molecules, but also essential to their utility as molecular tools.
Turning to the method claims, the court held them patent ineligible under this court’s then-definitive machine-or-transformation test. . .The court held that the claims covered “analyzing” or “comparing” DNA sequences by any method, and thus covered mental processes independent of any physical transformations. Id. at 233-35. In so holding, the court distinguished Myriad’s claims from those at issue in Mayo based on the “determining” step in the latter being construed to include the extraction and measurement of metabolite levels from a patient sample. SJ Op., 702 F. Supp. 2d at 234-35 (citing Prometheus Labs., Inc. v. Mayo Collaborative Servs., 628 F.3d 1347, 1350 (Fed. Cir. 2010), rev’d, 132 S. Ct. 1289 (2012)). Alternatively, the court continued, even if the claims could be read to include the transformations associated with isolating and sequencing human DNA, these transformations would constitute no more than preparatory data-gathering steps. Id. at 236 (citing In re Grams, 888 F.2d 835, 840 (Fed. Cir. 1989)). Finally, the court held that the one method claim to “comparing” the growth rate of cells claimed a basic scientific principle and that the transformative steps amounted to only preparatory data gathering.
I didn't even bother going into detail on this decision at the time, because I expected it to be appealed immediately, and so it was. As you'll see from the comments to that post, though, opinions varied widely about the chances for a reversal, but my informal reading was that the more someone knew about patent law, the more they expected the appeals court to reverse.
And that's just what has happened. The problem is, this isn't as wide-ranging a decision as some people (and some headlines) seem to think it is. I'll quote from the latest opinion again:
. . .it is important to state what this appeal is not about. It is not about whether individuals suspected of having an in- creased risk of developing breast cancer are entitled to a second opinion. Nor is it about whether the University of Utah, the owner of the instant patents, or Myriad, the exclusive licensee, has acted improperly in its licensing or enforcement policies with respect to the patents. The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people’s lives, or for other companies to be excluded from the market encompassed by such a patent—that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter. It is also not whether the claims at issue are novel or nonobvious or too broad. Those questions are not before us. It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, particularly including Mayo. The issue is patent eligibility, not patentability.
In other words, this decision is not designed to address the big issues that so many people think that it has. The court goes on to say, as courts at this level often do, that if someone wants to do something about all these things, then the procedure for remedy is clear:
We would further note, in the context of discussing what this case is not about, that patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be subject to the incentives of exclusive rights. But disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress, and other general questions relating to patentability and use of patents are issues not before us. . .
Still, even if we're talking about patent eligibility and not patentability per se, we still have a tough question here. Myriad says that the isolated DNA molecules that their patent is directed towards are not found in nature as such, that they have to be manipulated and isolated through human ingenuity, and that they (as opposed to native DNA) can be used in their diagnostic applications. They claim that the district court erred in focusing on the informational content of the molecules, and not the actual composition of matter itself. The plaintiffs argue that the isolated DNA molecules have to have a "distinctive name, character, and use", as the law reads, and that they are not "markedly different" enough from the natural substance, especially since (as they hold) the entire point of them is the informational sequence they represent.
The appeals court comes down in favor of Myriad here. A key part of their argument rests on the decision in the Chakrabarty case involving the patenting of genetically engineered bacteria, so if you didn't like that one, you're not going to like this. The court finds that isolated DNA molecules - unwound from their histones, cleaved at both ends, truncated - are "marked different" enough to be eligible for patents:
. . .Accordingly, BRCA1 and BRCA2 in their isolated states are different molecules from DNA that exists in the body; isolated DNA results from human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA.
As the above description indicates, isolated DNA is not just purified DNA. Purification makes pure what was the same material, but was combined, or contaminated, with other materials. Although isolated DNA is removed from its native cellular and chromosomal environment, it has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body. . .
They go on to say that "an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity that is obtained by human intervention". As you might imagine, cDNAs are found under this reasoning to be especially far from nature, and these are already held to be patentable. As to the "informational content" argument that carried the day in the lower court, the appeals court has this to say:
. . .We disagree, as it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit. Uses of chemical substances may be relevant to the nonobviousness of these substances or to method claims embodying those uses, but the patent eligibility of an isolated DNA is not negated because it has similar informational properties to a different, more complex natural material. The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. We recognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than by their functions. . .
In other words, this ruling affirms that molecular biology is, in fact, chemistry, if you want to look at it that way. The court goes on to say that if we as a society want to put DNA in a separate category for terms of patent law (because of its unique informational content, etc.), then Congress should get to work on revising the US Code. It's not a matter for the courts to write that in by themselves. The opinion also rejects arguments (made in the dissenting opinion) that make analogies to snipped a leaf off a tree or removing an organ from a human body. These, they say, are not specific, defined substances, but an isolated DNA molecule most certainly is.
There, that's the first part of the opinion. There's another section as to the methods of use, but I think this is enough legal matter for one day around here. And there's plenty of arguing room staked out already!