About two weeks ago, the Federal Circuit—one of the nation’s Courts of Appeals, and therefore the second-highest level of the federal judiciary—handed down its decision in Association for Molecular Pathology v. PTO, a case about the controversial subject of gene patenting. The court upheld the patenting of genes—though not other patents, which cover certain methods of comparing or testing genes, and this has sparked some (to my mind, correct) outrage on the part of researchers, who see gene patenting as an obstacle to research and progress in genetics.
It’s important to understand the decision on its own terms. Steven Salzberg at Genomics, Evolution, And Pseudoscience, accuses the court of “contorted reasoning” which demonstrated “scientific ignorance” and “bought” “nonsense.” Salzberg ridicules the court for focusing so much on the meaning of the word “isolated.” This is not fair to the judges, who together produced a very interesting, complicated, 105 page opinion on the intricacies of patent law. Although I agree with Salzberg that the conclusion the court reached is unfortunate and ought not to be the law, it’s important for those concerned to pay attention to what the court actually did and why, rather than to criticize them from a scientific point of view. This last is especially important, because patent law is law, not science, and the judges did not purport to do science; they purported to do law. That the law is bad on this issue is not—or at least, mostly not—their fault.
Here’s what the court actually did—and why it focused so much on the question of “isolated.” Patent law says that you can’t patent naturally occurring phenomena. I can’t patent a rock or a tree. But I can patent something I make: a hammer, for example. That appears to be a clear conceptual distinction, and in most cases it’s good enough. But the law—and, indeed, all human reasoning, including science—is based on drawing conceptual lines in a world that is not discontinuous: putting things into clear intellectual categories even though they are richly interwoven in the world of real phenomena. So a hammer, which is patentable, is really just made up of rocks and trees: it’s made of steel, which comes from iron, which comes from rocks—and the handle’s made of wood, that comes from a tree. What, then, is the patent covering? It attempts to cover that ineffable element of creative work whereby the person took the natural elements and made something that wasn’t there before: that is, the hammer-ness of a hammer that is really just composed of the same stuff that already existed before the hammer-maker came to town.
The court in this case was called upon to decide whether the genes that Myriad claimed under its patent were more like the rocks and trees—natural, unpatentable phenomena—or more like the hammer—a distinctive, man-made thing that is patentable. And the problem here is that these analogies, which are already weak enough, really break down in the face of what modern science does. We get into far more complicated—indeed, metaphysical—questions than distinguishing a hammer from a rock and a tree. Consider the steps necessary to make a hammer from a rock and a tree. Iron ore exists in a vein in natural rock. It takes human ingenuity and effort to remove the iron ore from its natural state. Is iron ore man-made? We then engage certain processes to transform it into iron. Is the iron patentable? Now we go through another process to make it into steel. Is that patentable? Now we make a hammer head out of it. Is the hammer head patentable? We cut down the tree—is the timber patentable? We go through various steps to make it into a finished, sanded, smooth, well-shaped handle. Now is it patentable? There is never a point along the process where have entered the realm of the artificial or man-made; the whole thing is a continuous process. Yet the law says that at point A it’s natural and not patentable, and at point B it is artificial and patentable. And the best term that lawyers have come up with for drawing that line is this: “the Supreme Court has drawn a line between compositions that, even if combined or altered in a manner not found in nature, have similar characteristics as in nature, and compositions that human intervention has given ‘markedly different,’ or ‘distinctive,’ characteristics.”
That’s not great, but when you try to do better, you find that a clear line is very elusive here. Thus the court has held that when something is drawn from nature and then made into something “markedly different” from something found in nature, then it is patentable, even though it is—like everything else on earth—composed of natural materials.
In a case called Diamond v. Chakrabarty, the courts held that a special kind of bacterium was a manufactured, artificial thing that is patentable, because it was “markedly different” from any kind of bacteria found in nature—that is, it was more like a hammer than like a tree and a rock. The bacteria was capable of digesting oil, so that it could help clean up oil spills. Nothing like that existed in nature. Thus it had “markedly different characteristics from any [bacterium] found in nature and one having the potential for significant utility. [This] discovery is not nature’s handiwork, but [the manufacturer’s] own; accordingly, it is patentable.” 447 U.S. 303, 310 (1980).
So what about the gene patents? Are they more like the hammer, or the patentable bacterium, or are they more like a tree and a rock and naturally occurring DNA? Well, that requires a consideration of what is actually being patented. What the court calls “isolated DNA” is not simply a natural molecule or something that’s been purified from a natural state, it “has also been manipulated chemically so as to produce a molecule that is markedly different from that which exists in the body.” Because it does not exist in nature, as a consequence of the manipulation process, the isolated DNA is a patentable new thing, like a hammer.
One criticism of this approach was advanced by the dissenting judge: it seems to be saying that snapping off a leaf from a tree makes the leaf patentable because leaves don’t exist in nature, and the manipulation of the tree has produced something “markedly different” from a tree. The court answers that objection as follows:
[Such an example does not] present the case of a claim to a composition having a distinctive chemical identity from that of the native element, molecule, or structure…. [T]he leaf the same leaf…. In contrast, a portion of a native DNA molecule—an isolated DNA—has a markedly different chemical nature from the native DNA. It is, therefore, patentable subject matter…. [N]o one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, not one creating a new chemical entity.
It’s on this point that I think the decision falls apart. It is true that isolated DNA has distinctive chemical characteristics, but “distinctive” to whom? Not to nature, but to human beings, who have choose to consider certain distinctions significant enough to describe one chemical as different from another—just as it is human beings who have decided that the distinctions between a cat and a tiger are significant enough to describe them as different species. You can’t really draw a god’s-view distinction between cats and tigers; we have chosen to regard them as distinct. So while two chemicals may be distinct from each other, the relevancy of that distinction is contextual. And any part of something will have some qualities distinct from the whole of which it is a part. A book is a book—yet the pages will burn, while the character of Captain Ahab cannot. Drawing the “markedly different” line at the level of distinctiveness appears to me to be a sort of question begging fallacy. In my view, it would make more sense to require that the chemical distinctiveness of the new thing be the result not merely of separation but of some other, further action. Not merely snapping off the leaf, but some other step of transforming the leaf, should be required before calling the leaf “distinct” in this sense.
Yet, to be fair to the majority opinion, there are problems with such a position. When I make a widget, I do so by taking natural things and transforming them from their natural state; it might not be possible to distinguish between the process of isolating something from nature and the process of making it into a patentable thing. The court sees the isolation of DNA as a something more than mere separation; rather, in its view, the process of separating makes the separated piece into something it was not before—something that is conceptually distinct, with its own distinctive characteristics and uses. It’s not merely breaking off a leaf; it’s kind of like making a leaf where there was no leaf before—or like making a hammer out of a tree and a rock.
In my opinion, however, such analogies break down in the context of genetics, and it seems that a more sensible third way is that advanced by the government, which proposed what it called the “magic microscope” test:
According to the government’s test, if an imaginary microscope could focus in on the claimed DNA molecule as it exists in the human body, the claim covers unpatentable subject matter. The government thus argues that because such a microscope could focus in on the claimed isolated BRCA1 or BRCA2 sequences as they exist in the human body, the claims covering those sequences are not patent eligible.
The court rejected this argument because
it misunderstands the difference between science and invention and fails to take into account the existence of molecules as separate chemical entities. The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect. The government’s microscope could focus in on a claimed portion of any complex molecule, rendering that claimed portion patent ineligible, even though that portion never exists as a separate molecule in the body or anywhere else in nature, and may have an entirely different utility. That would discourage innovation. One cannot visualize a portion of a complex molecule, including a DNA containing a particular gene, and will it into isolation as a unique entity. Visualization does not cleave and isolate the particular DNA; that is the act of human invention.
At bottom, therefore, the case turns on the question of whether the process of isolating the DNA is a kind of invention. The court says it is, because the processes don’t just capture a wild thing, but make it into something it previously wasn’t. That’s a reasonable view, but I think it’s wrong because every process of isolation will result in something that is characteristically distinct from what it previously was—yet that factor does not make it any less a natural thing. As Judge Byrson wrote in his dissenting opinion,
to argue that the isolated BRCA gene is patentable because in its native environment it is part of a much larger structure is no more persuasive than arguing that although an atom may not be patentable, a subatomic particle is patentable because it was previously part of a larger structure, or that while a tree is not patentable, a limb of the tree becomes a patentable invention when it is removed from the tree.
Of course, it is an oversimplification to say that something that can be characterized as “isolated” or “extracted” from its natural setting always remains a natural product and is not patentable. One could say, for example, that a baseball bat is “extracted” or “isolated” from an ash tree, but in that case the process of “extracting” the baseball bat necessarily changes the nature, form, and use of the ash tree and thus results in a manmade manufacture, not a naturally occurring product. In that set-ting, man has defined the parts that are to be retained and the parts that are to be discarded. The result of the process of selection is a product with a function that is entirely different from that of the raw material from which it was obtained. In the case of the BRCA genes, by contrast, nature has defined the genes as independent entities by virtue of their capacity for protein synthesis and, ultimately, trait inheritance. Biochemists extract the target genes along lines defined by nature so as to preserve the structure and function that the gene possessed in its natural environment. In such a case, the extraction of a product in a manner that retains the character and function of the product as found in nature does not result in the creation of a human invention.
This is a fascinating and complicated issue, and reasonable arguments can be made on both sides. I think the dissent is more sensible in this context, but it’s important that we don’t just attack the court for its alleged “scientific illiteracy.” The question here is not a scientific one—it’s a line-drawing exercise, and as with all line-drawing exercises, there are reasons for and against putting the line here versus there. And while this case certainly reveals the obsolescence of much patent thinking in today’s world, that obsolescence isn’t the judges’ fault.