On April 15 of 2013, the Supreme Court of the United States will hear a case challenging the practice of patenting DNA sequences, including human genes. With the forbidding title of Association for Molecular Pathology v. Myriad Genetics, this case is all but certain to have a huge impact on the history of biotechnology, the patent law, and interactions between science and capitalism more broadly.
Today, I am posting the first of a two-part piece on the case, with some thoughts on patenting living things and parts thereof.
The case currently before the US Supreme Court concerns a biotech company called Myriad Genetics. During the mid 1990s, Myriad successfully filed for a patent on two genes (BRCA1 and BRCA 2) that dramatically increase a woman’s risk of developing breast cancer. Having sequence both of these two genes, Myriad Genetics developed a diagnostic test, which it currently markets for several thousand dollars. It is worth emphasizing that Myriad’s patent covers the genes themselves, not just the diagnostic procedure. In agreeing to hear the case, the Supreme Court explicitly signaled its willingness to address the question “Are human genes patentable?”
(For more, see the Petition for a Writ of Certiorari. You can also read some commentary as well as download friend of the court briefs here.)
Rather than discuss the case in all its particulars, I’ll focus on what I take to be one of its more interesting dimensions: the extent to which challenges to what are called composition-of-matter patents can force the court to wade into the deep waters of ontological deliberation. At the risk of stating the obvious, I’ll remind everyone that ontology is a branch of metaphysics that studies the nature of being. Ontology is about what there is. In contrast, epistemology concerns how we come to know things.
According to Title 35, Paragraph 101 of the United States Patent Code, any “new and useful process, machine, manufacture, or composition of matter” may be subject to patent protection. However, there is a well-known and longstanding exception to this extremely broad formulation: the so-called product of nature doctrine. It holds that naturally occurring entities such as physical laws or minerals cannot be subject to patent protection. As such, the court has often found itself in the position of having to decide what is and is not a genuine product of nature. In so doing, it has had to specify where nature ends and culture begins.
Patent law is often seen as a kind of bargain between society and individuals. The state agrees to give a monopoly over a new and useful invention in exchange for its disclosure or publication. The granting of a monopoly over an intangible good is not to be taken lightly because it hinders other people’s access to it. But the practice is usually seen as justified by the fact that doing so not only discourages the keeping of trade secrets, it also incentivizes discovery and thus acts as a spur to technological progress.
If the patent law represents a kind of bargain or balancing act between the interests of individuals and the society, it makes sense to think carefully about where to draw the line between patentable and non-patentable subject matter. In particular, I think most people would agree that the law would no longer be fulfilling its proper function if it allowed someone to privatize whole swaths of the natural world simply by describing them and thus claiming an ownership right. It can’t be right that whoever discovers coal’s ability to release thermal energy when lit on fire therefore has a right to stop anyone else from digging up and burning hydrocarbons. (Although the latter might not be such a terrible turn of events in this day and age!)
The product of nature doctrine goes back to ex parte Latimer from 1889, in which the United States Patent Office ruled that a new fiber produced from pine needles was not patentable subject matter. Its most canonical expression, however, was articulated by William O. Douglas, Associate Justice of the United States Supreme Court. Writing the majority opinion in Funk Brothers Seed Co. v. Kalo Inoculant Co. (1948), Douglas declared that a mixture of naturally occurring bacteria was not patentable because these, “like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men. They are manifestations of laws of nature, free to all men and reserved exclusively to none.”
Justice Douglas’ opinion continues to influence legal arguments about the proper scope and interpretation of 35 USC § 101. Part of its remarkable staying power is due to the fact that Chief Justice Warren Burger relied on it extensively for his 1980 decision in the case of Diamond v. Chakrabarty. As I’m sure most of you are aware, this was the case in which the United States Supreme Court ruled that genetically modified organisms were eligible for patent protection because they are products of human ingenuity rather than nature.
Chief Justice Burger’s argument in Diamond v. Chakrabarty explicitly contrasted the latter’s invention to the one under dispute in Funk Brothers v. Kalo Inoculant. To get Burger’s reasoning straight requires a passing familiarity with the details of both cases.
The Funk Brothers case concerns a patent that had been granted on a mixture of various Rhizobia, bacteria that fix nitrogens after becoming established in the root system of plants. Farmers had long known that inoculating their plants with bacteria helped them to grow, but each plant required its own, specific strain. The patent under dispute in Funk Brothers was for a *mixture* of many bacteria that could successfully inoculate a whole range of plants, which made the mixture more widely applicable and thus economical than what was currently available on the market.
Justice Douglas struck down the patent under dispute in Funk Brothers because making a mixture of exiting bacteria, he reasoned, did not qualify as a genuine invention. Rather, it represented “no more than the discovery of some of the handiwork of nature.” “No species acquires a different use,” he went on to argue. “The combination of species produces no new bacteria, no change in the six species of bacteria, and no enlargement of the range of their utility. Each species has the same effect it aways had.”
Chakrabarty’s patent claim was in many respects similar, but in others quite different from that under dispute in Funk Brothers. Whereas the latter concerned a mixture of pre-existing bacteria, Chakrabarty claimed to have engineered a whole new organism. He did so by introducing several small pieces of naturally occurring circular DNA molecules--called plasmid--into a species of pseudomonas bacteria. It is worth emphasizing that Chakrabarty did not claim to have manufactured any new pieces of DNA. All that he did was to introduce existing DNA molecules into a new organism. In the “Summary of the Invention” section of his original patent application, Chakrabarty wrote, “Having established the existence of (and transmissibility of) plasmid-borne capabilities for [breaking down petroleum molecules into more simple chemical compounds], unique single-cell microbes have been developed containing various stable combinations of [those plasmids].”
Despite their many similarities, Chief Justice Burger went out of his way to draw a stark contrast between Chakrabarty’s patent and the one under dispute in the Funk Brothers case. In Chakrabarty’s case, he wrote, “the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility.” Because the “discovery is not nature's handiwork, but his own,” Burger concluded, “it is patentable subject matter.”
What I find so remarkable about this case is that in trying to decide whether a genetically engineered organism is patentable subject matter, the United States Supreme Court was not just compelled to decide what is and is not a product of nature. Rather, by way of trying to answer that question, it had to address an antecedent question about the level of biological organization at which nature produces its handiwork. That is to say: different strains of bacteria remain a product of nature even when they are brought into a new mixture with one another (and thereby acquire a new efficacy), whereas a new mixture of circular DNA molecules is a product of human ingenuity.
As an exercise, you can re-read Justice Douglas’ decision above and replace each instance of the word “species” and “bacteria” with the word “plasmid.” I admit the phrasing sounds awkward, but the effect is pretty compelling nonetheless.
What is going on here? The answer, of course, is quite a lot. But let me just close with one thought and then take the issue up again in my next post, where I will examine the legal reasoning in the Myriad Genetics case itself.
The patent law is designed to encourage innovation and it does so by rewarding technological breakthroughs. I suspect that one reason we balk at the idea of patenting products of nature is that we don’t want to reward the mere act of describing something that was previously created via some other means, whether it is evolution or God or what have you. Reading Douglas’ decision, one gets the sense that he took *moral* offense at the notion that someone could receive financial rewards for doing no more than harnessing “nature’s handiwork.”
Of course, nobody thinks that discovery is an easy or straightforward process. But patent law does assume that it is fundamentally different from the act of invention. One way in which the two are kept separate is that both are governed by different reward systems. Whereas a new discovery brings with it an accrual of credit, inventions bestow a more material kind of reward.
My aim here is not to *endorse* a clear-cut distinction between invention and discovery. I am well aware that discoveries often come with financial and other kinds of material rewards. Similarly, it need hardly be pointed out that inventors are routinely given significant credit by the scientific community for the work they have done.
What I would like to suggest, however, is that one reason we are so invested in making a distinction between invention and discovery, products of nature and human ingenuity, is that doing so helps us keep alive an even more fundamental distinction, namely the one with which I began. That is the distinction between ontology and epistemology, between the nature of things in themselves and how we experience, know, or represent them. Seen in this light, it is no surprise that questions about patenting things like live organisms and human genes should elicit such strong emotional and moral reactions. After all, to give up the dream of drawing a hard line between acts of description and intervention would force us to revise a great deal more than just Title 35, Paragraph 101 of the United States Patent Code.
In the next post, I will link these issues up with more fine-grained concerns about giving ontological primacy to certain levels of biological organization and characterizing genes as informational objects.
Great post, Lukas. I just recently had a conversation with a lawyer from the German Farmers Association, where we talked a lot about biopatents and the position of the Association. I was particularly struck by the ways in which biological knowledge/facts were translated into the legal realm and that in the end, courts and judges decide about, as you emphasized, ontological questions. While I really like how you link the dichotomy invention/discovery to epistemology/ontology and point to implications and consequences, I am also interested in another aspect of all this. Talking to that lawyer, I tried to figure out, how she, who has no background in the life sciences or even biopatents, approaches this highly technical topic. Or more general, how judges etc. do that. What is their epistemology? The epistemology with which they "wade into the deep waters of ontological deliberation", as you put it. The epistemology which is the basis for their ontological decisions, which in turn, as I would suggest, feed back into the life sciences, altering their ontologies as well.
Good to hear from you Christian. It's been too long! (Will you be at ISH in Montpellier this summer?)
You are exactly right that patent law forces lawyers and judges to make decisions of BOTH and ontological AND epistemological nature. For example, the myriad genetics case that is currently before the Supreme Court hinges, in part, on the notion that isolated sequences of genomic DNA (e.g. BRCA 1/2 genes cut out from the rest of the genome) are not a product of nature. But as Eric Lander (head of the Broad Institute at Harvard & MIT) points out in a friend of the court brief, most biologists agree that this is factually inaccurate. DNA molecules are broken up all the time. For example, the enzyme DNase cleaves DNA molecules at non-specific sites (i.e. at random intervals), cutting it up into smaller pieces after a cell dies. The laws of probability being what they are, it is all but certain that the specific regions of DNA protected by the BRCA 1/2 patent routinely occur in an isolated state in the human body.
I'll have more to say about this in my next post, but for now, let me just say this: the main argument I am trying to make is that questions about whether something is or is not a product of nature often and interestingly end up turning on what you take that thing to be. If we take it for granted that nature works at the level of individual organisms and species of organisms (i.e. that individuals and species are the units of evolution) then the argument that Chakrabarty's patent is for and invention whereas the patent under dispute in Funk Brothers is a discovery makes intuitive sense. But if we engage in an epistemic shift and say that evolution works at the level of DNA molecules too then the two start to look a lot more similar.
I'd be curious to hear more about how you see the ontology of the patent law feeding back into both the ontology & epistemology of the life sciences. Could you be roped into writing guest post?
Too long, indeed. Unfortunately, I will not be in Montpellier. At least I didn't submit anything.
Thanks for the offer, but I don't think that I am able to write a whole post on it, as it's only a vague deduction. But given that applicability has always been an integral part of the history of the molecular life sciences with an ever closer association between academic and commercial research, I would just expect, that the ways in which the products of research are judged in the legal realm feed back into how researchers think about their objects. Susan Wright has argued in a similar way, showing the transformation of norms and practices in the context of commerical application of molecular biology in her 1986 paper "Recombinant DNA Technology and its Social Transformation, 1972-1982" (there is surely more recent stuff). If you then consider Rheinberger's argument that especially in molecular biology it is not possible to separate practices, theoretical knowledge and objects/things, this must then also affect the scientists' ontology (besides the question, whether it is at all possible to separate epistemology and ontology in Rheinberger's approach). With ontology, I refer to Ursula Klein's and Wolfgang Lefèvre's concept of 'historical ontology' in "Materials in Eighteenth-Century Science. A Historical Ontology". Legal decisions must have far-reaching consequences in terms of funding. Patentable and thus artifical objects/methods will be favored over natural ones. At the same time, researchers themselves will look for what can be shown to be artifical and thus patentable.
But as I said, this is neither based on empirical material nor am I able to provide examples from biopatenting. I am still lingering around in 19th century zoology.
Great post - having read a number articles that stubbornly stuck to the legal minutia of this case, I'm really glad to see someone do something more broad and interesting with it.
I'll hold most of my thoughts for Part II, but briefly:
First, Diamond v. Chakrabarty seems to me to have done a lot to generate the sharp historical line that's come to separate "biotechnology" from "other stuff" (cultivation of microorgamisms for brewing, Loeb-style tropisms, breeding, other agricultural technologies like that of the Funk Brothers). Usually, as you note, that line is construed in terms of ontological order: agriculture, say, involves shuffling around nature's units, while biotechnology involves manipulations inside those units.
Now, historians (Robert Bud comes to mind) have written the latter back into the story of the former. However, the science-venture capital nexus that characterizes biotechnology is of a different order, institutionally and economically if not (necessarily) intellectually and technologically. And patents have been the glue in that science-VC bond. So it seems like there's a really fascinating entanglement here of financial and institutional ontology, on the one hand, and biological ontology, on the other.
Second, it seems to me that even more than the discovery/invention binary, patent law relies on and instantiates a distinction between principle and application (going back to the demonstration requirement of early modern privileges, as Biagioli has pointed out). I'd be curious to hear your take on how these two heuristics used to demarcate science and engineering/technology relate to each other.
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