The Ontology of the Patent Law, Part II

Illustration of "native" DNA in the human cell, from the majority opinion in Ass. for Mol. Path. v. Myriad Genetics, United States Court of Appeals for the Federal Circuit

A few weeks ago, I wrote a post about a case the US Supreme Court will hear on April 15th concerning whether genes can be patented. As we get closer to that date, I want to pick up the thread where it was left off.


As a quick reminder, the case before the court now concerns the validity of a patent that was granted to Myriad Genetics on a pair of genes (BRCA 1/2) whose presence has been shown to confer an increased risk of developing breast cancer. Here, I want to examine how this case turns on a difficult ontological question, namely: what kind of things are genes?

A number of people who support Myriad’s patent argue that human genes ought to be understood as a molecule like any other. They are a material object, nothing more and nothing less.

Others, including the co-discoverer of DNA’s molecular structure, Jim Watson, have urged the court to endorse a divergent vision. In a friend of the court brief, Watson argues that although genes are indeed a chemical molecule, they are also something more.

According to Watson, a gene is primarily an informational object. “It is a chemical entity,” he writes, “but DNA’s importance flows from its ability to encode and transmit the instructions for creating humans.” Watson goes on to cite some of the terminology commonly used in molecular biology, such as “transcription” and “translation” as evidence for this claim. He then makes the following, totally fascinating, statement:

“The myopic viewpoint thinks of a human gene as merely another chemical compound, composed of various bases and sugars. But history and science teach us otherwise. … The human genome’s ability to be our instruction book on life distinguishes it from other chemicals covered by the patent laws. No other molecule carries the information to instruct a human zygote to become a boy or a girl, a blonde or brunette, an Asian, African, or Caucasian.”

The reason this distinction between genes-as-molecules versus genes-as-information matters so much is that it speaks directly to the question of whether genes are patentable. According to the United States patent law, any “new and useful machine, manufacture, or composition of matter” can be patented. That language is extremely broad, and it is designed to encourage innovation. But there is also an important exception, which states that a product of nature is not patentable. So the Myriad Genetics case crucially turns on whether the BRCA 1/2 genes are a product of nature.

In an earlier decision in favor of Myriad Genetics, the US Federal Circuit Court of Appeals argued that isolated genes do not occur in nature. As the majority opinion pointed out, “DNA in the cell … is packaged into twenty three-pairs of chromosomes.” (See the figure above.) That is, the genes on which Myriad Genetics holds a patent are always part of a larger assemblage. But Myriad Genetics did not seek patent protection over whole chromosomes. They only applied for a patent on a section of DNA that had been isolated and purified. As the court’s ruling noted, Myriad “cleaved” the BRCA 1/2 genes “from their native chemical combination with other genetic materials.” This rendered them a human invention, for “an isolated DNA molecule is not a purified form of a natural material, but a distinct chemical entity that is obtained by human intervention.”

(It is worth pointing out that in another friend of the court brief, Eric Lander argues that the Appeals Court’s decision rested on a factually inaccurate assumption. In fact, DNA in the human body is constantly broken and repaired. So much so that it is statistically certain that isolated versions of both the BRCA 1 and 2 genes have appeared in nature.)

Watson’s claim that genes are primarily informational objects throws a wrench in the Appeals Court’s reasoning. It also echoes the argument made by Judge Robert Sweet of the United States District Court of New York in the first hearing of this case. In his ruling to strike down Myriad’s patent, Sweet wrote that although certain chemical differences may distinguish DNA in the human body from DNA that has been isolated and purified in the lab, those differences are irrelevant to the case at hand. That’s because chemical differences alone are not enough: isolated DNA would have to be “markedly different” from the DNA sequences routinely found in nature to qualify as a genuine invention.

But what constitutes a marked difference? Answering this question is tricky and, according to Judge Sweet, requires taking the nature of the object in question into account. In fact, although Judge Sweet did not use the word himself, we might say that it requires taking the essence of the object into account. The question before the court, then, is whether purifying a stretch of DNA by isolating it from the rest of the genome changes its essential nature somehow.

Why would this be?

To see why this is the case, Federal Circuit Court of Appeals Judge Bryson asks us to imagine a baseball bat that has been fashioned out of an Ash tree. There is a real sense in which the bat is just a “purification” of the tree because you can fashion a bat simply by taking away the wood around it. The bat has been “extracted” from the Ash tree much like the BRCA 1/2 genes have been extracted from the genome. But in fashioning a tree into a bat we have changed its function and thus completely changed its nature. “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.” The same is not true for the BRCA 1/2 genes.

In fact, exactly the opposite is true! The reason that Myriad patented the BRCA 1/2 genes is that they serve as a diagnostic tool. But for them to succeed on this score, it is crucial for the isolated sequences retain their homology to those regions of the genome that confer an increased risk of developing breast cancer. To quote from Bryson dissenting opinion again: “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.” For this reason, the process “does not result in the creation of a human invention.”

Let me just close with a couple quick observations. First, much like the case of Diamond v. Chakrabarty that I discussed in my previous post, this case again forces the court to wade into the deep waters of ontological deliberation. As you’ll recall, the Diamond v. Chakrabarty decision saw the court privilege one level of biological organization (whole organisms) over another (circular pieces of DNA) in deciding whether or not something is an invention or “nature’s handiwork.” This is surprising, and it links up with a controversy within biology about the levels at which evolution operates (usually referred to as the units of selection debate).

Now the court is again being asked to make an ontological decision. But this time, it’s not about whether we should privilege one level of biological organization. Rather, it’s about whether genes are just a chemical molecule or if they are something more; namely, an informational entity.

Of course, historians of science have been thinking about this question for some time. For example, Lily Kay’s book Who Wrote the Book of Life argues that molecular biologists during the 1950s and 60s adopted the DNA-as-code metaphor because many of them had a background in physics and mathematics and because research on computers and information-processing was taking off at the time. Philosophers of biology, too, have debated the utility of thinking about genes in this way. (Here is an excellent review by Peter Godfrey-Smith.)

Despite all the debates, almost every historian and philosopher agrees that when biologists like Watson talk about genes as informational objects they are speaking metaphorically. DNA is not really a set of instructions or a codebook, but it might be heuristically useful to think of it in that way.

The question for most historians and philosophers of science, then, is not whether genes are informational entities, but whether the metaphor has been a useful and productive one. There is a deep irony in the fact that we are about to see the United States Supreme Court grapple with exactly this question, but that it will be doing so in a very literal way.

"Slow Science" and the Sequester

We asked Robin Wolfe Scheffler, who studies the history of biomedicine, cancer virology and scientific infrastructure, what thoughts about contemporary science his work has given him. He sent us the following guest post; you can find out more about Robin's work here.

Last week, Nature and Science had two very different takes on the same problem.

In Science, the editor warns that the current behavior of the United States Congress, particularly the budget sequester, “might justifiably be considered deranged when [it] fail[s] to take actions that will generate tremendous future benefits.” Meanwhile, Nature features an essay profiling five examples of “slow-science”—projects which have been running for decades, even centuries.

While Science warns of the hazards of failing to anticipate major problems in the future, such as the rising rate of Alzheimer’s, the projects in Nature range from profound (the Belgian Solar Influence Data Analysis Center ) to “ignoble” (the pitch drop experiment, depicted below).

Waiting for Science to Happen: The Pitch Drop Experiment
(http://i.dailymail.co.uk/i/pix/2012/05/11/article-2142928-130980EE000005DC-647_638x863.jpg)

I’m sure that readers of this blog could name other candidates for “slow science.” As a historian of the experimental life sciences sciences, I found this emphasis to be salutary. Below, I offer some thoughts on what "slow science" means in the context of the sequester.

In 2010, a group of scientists in Berlin issued the “slow science” manifesto. An offshoot of the better-known slow food movement, they held in part that: “Science needs time to think. Science needs time to read, and time to fail. Science does not always know what it might be at right now. Science develops unsteadi­ly, with jerky moves and un­predict­able leaps forward…Society should give scientists the time they need, but more importantly, scientists must take their time.”¹

However, most of the historiography of the recent sciences focuses on firsts and “breakthroughs.” Where time figures in these narratives, they have often focused on the means by which the tempo of scientific activity has been sped up in, e.g. in computing, in scientific publishing, or in the interaction of venture capital with molecular biology. Indeed, the quest for compressing time might be a candidate for one of the signature ‘ways of knowing’ in the laboratory life sciences.

Of course, we historians will generally be sympathetic to the idea that scientific activity should be regarded as a contingent or unpredictable process rooted in a longue durée timespan.

Historians of more recent science have started to rediscover the longer temporal scale of scientific practice, including AmericanScience's own Joanna Radin’s work on freezers and suspension, Hans-Jörg Reinberger’s idea of science as a process, or Paul Edwards’ recent book on climate science and research infrastructure. As a matter of fact, my colleagues studying the history of astronomy or natural history may argue that this is less a rediscovery than a removal of selective amnesia!

These developments, I think, open up space for a new analysis of temporality, as a feature of scientific work which communities of scientists are capable of both compressing and dilating. My discussion so far has omitted the most looming temporal structure for most contemporary practicing scientists—that of grant applications and laboratory budgets. Scientists have lamented the difficulty of obtaining long-term support for years. 

Today, the situation is much more fraught. The natural sciences are not yet in the position of political science, which just saw its National Science Foundation funding cut for all but those projects which were involved in “directly promoting national security or the economic interests of the United States.” However, astronomers, particle physicists, and ecologists cannot but be reminded of how the current sequester, and attendant cuts has renewed awkward questions concerning the “payoff” or utility of public support for basic scientific research.

As numerous historians of science have noted, such as those in last September’s Isis Focus Section, the difference between basic versus applied science has routinely been invoked by segments of the scientific community in moments of crisis as ideological categories to defend their budgets and secure their autonomy. It may be the case, if it gains further traction, that the promotion of an ethic of “slow science” represents the most recent variant on a set of claims about the nature of science advanced by scientists to preserve the autonomy of the scientific community. 

Grand claims as to what science is, however, only go so far. We might instead try to answer a set of more immediate, overtly political questions: who would pay for all this slow science, for example, and on what grounds? 

The Super Conducting Super Collider: A casualty of the history of science?
(http://assets.nybooks.com/media/photo/2012/04/17/weinberg_1-051012_jpg_470x633_q85.jpg)

More proximately (for this blog), what role will historians of science fit within this new discussion?

The relationships between historians of science and scientists in financial crisis have not been smooth in the past. Indeed, during the heated “Science Wars” of the 1990s some historians of science even found themselves accused of causing the demise the multibillion dollar Superconducting Super Collider. As EO Wilson declared at the 1994 History of Science Society meeting, “multiculturalism equals relativism equals no supercollider equals communism.”²

However, the discussion surrounding sequestration appears to be of a different kind than other Federal budget crises faced by the sciences since the Second World War. Like other current debates over health care, financial regulation, or civil rights, our current political environment has placed a set of previously settled questions up for grabs. 

This is, of course, profoundly unsettling for scientists, but it may also open up the discussion over how public support for science should be structured in a manner that we haven’t seen in decades. Is slow science synonymous with big science? How could support for long-term projects be established, both financially and politically?

If this is the case, our ability as historians to talk about the rhythms, infrastructures, or scales of scientific work may allow the history of science to play a major role in adjusting the frame of science policy. 

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[1] This group is not particularly well known, a fact illuminated by their manifesto's opening line: “We are scientists. We don’t blog. We don’t twitter.”

[2] I suspect satire is at work here, but in either serious or satirical forms his comment captures the political charge that histories of science could take on. If anyone reading this saw Wilson’s address, I’d love to know what the temperature of the room was!

-Ome Sweet -Ome

We asked Evan Hepler-Smith, a historian of science whose work focuses on how chemists have used language, data, and method over the last hundred years, what the sort of questions he asks might reveal about contemporary science. He sent us the following guest post; you can find out more about his work here.

Recently, a small group of scientists has begun been laying the foundation of a new interdisciplinary field. Their ambitions include applying biological mechanisms to the synthesis of new drug candidates, integrating huge collections of biological and chemical data, and linking western pharmaceutical science with the study of traditional Chinese medicine at the molecular level. They call their new field “chemomics.”

So far, chemomics isn’t much more than a twinkle in the eye of a few pharmaceutical chemists, but it already has a catchy name, which makes one reflect on how, as Patrick McCray recently remarked, nearly everything seems to have an “-omics” these days.

In the life sciences, there’s the proteome, the microbiome, the interactome, and dozens more (not to mention the genome – more on this ur-ome in a minute). -Omes have colonized neuroscience (the connectome) and cultural studies (the culturome). Like other trends in scientific terminology and method – the “molecular” sciences, “computational” fields, neuro-everything, and the many faces of translational medicine – -omes can be easy to scoff at. But they’ve attained impressive cultural, institutional, and intellectual stature, and that makes the suffix¹ worthy of historians’ attention.

The connectome: where “neuro-” meets “-omics.”(Source: http://www.nature.com/polopoly_fs/7.3435.1332258664!/image/brain.jpg_gen/derivatives/landscape_630/brain.jpg)

The scientists have certainly been paying attention. 

There are Wikipedia articles, a blog, and at least two journals dedicated to “-omics.” -Omes engage some of the most prominent themes in recent science, from Big Ideas to Big Data. In the inaugural issue of OMICS in 2002, the editor-in-chief explained that the mission of the journal was to “facilitate a forum for new voices, provide tools for networking researchers from diverse fields and industries, and act as a catalyst for innovative, perhaps even controversial positions.”² The homepage of Nature’s now-defunct -Omics Gateway explains, with British candor, “Many of the emerging fields of large-scale data-rich biology are designated by adding the suffix ‘-omics’ onto previously used terms.”

Source: http://online.liebertpub.com/action/showCoverImage?journalCode=OMI&

The best-known -ome is the genome, and it seems safe to trace the explosion of -omes, beginning in the mid-90s, to the Human Genome Project. (For example, OMICS began its life as Genome Science and Technology, edited by Craig Venter.) Most of the younger -omes are the fruit of both the HGP’s successes (its totalizing vision and enthusiasm for public-private collaboration) and failures (the considerable gap between knowledge of the genome and knowledge of the organism).

-Omes also seem to share certain structural features. Let’s return to chemomics.

Chemomics, write its proponents, is the study of molecular subunits with a specific biological function. Each such subunit is a “chemoyl”; the set of all chemoyls is the “chemome.” Chemomics studies³ the chemome “using approaches from chemoinformatics, bioinformatics, synthetic chemistry, and other related disciplines.”⁴

On this basis, we might sketch a tentative picture of what’s in an -ome. First, the -omemaker carves up some portion of the world into a set of atom-like units (chemoyls, the “molecular interactions” that make of the interactome, the n-grams of culturomics). These units should be accessible to study using familiar methods from one or more disciplines, like chemistry and statistics. Their treatment as a significant level of organization, however, is usually something new. The -omicist reassembles these units to build up a picture of the world (proponents of the chemome hype it as a “biological periodic table”). Finally, collaborators from different disciplinary backgrounds start investigating this -omeland, usually by generating, collecting, and interpreting Big Data.

-Omes derive significant rhetorical and conceptual power from an easy slippage between the levels of the individual, the community, and the abstract ideal type. (The contributors to Keith Wailoo, Alondra Nelson, and Catherine Lee’s new volume on genetics and identity have explored some consequences of this slippage.) And they tend to make use of powerful metaphors (like the “biological periodic table”), often derived from traditional disciplines, to describe their entities and arguments.

From the genome to the microbiome, we are all -omebodies.
(Source: http://rutgerspress.rutgers.edu/Custom/ProductImageHandler.ashx?ProductID=4098&endHeight=270&endWidth=190 )

Interdisciplinarity is a challenging topic for historians of science used to arguments (and source bases) framed in disciplinary terms (though this hasn’t stopped Cyrus Mody, among others, from tackling it effectively). -Ome studies (-omework?) could be a productive route for advancing the study of interdisciplinarity, popularization, and Big Data in recent science. 

A careful look at chemomics, for example, could tell us something about the nexus of the multinational pharmaceutical industry, traditional therapeutics, state funding of science in China, the cultural authority of the life sciences, and the translation of computational methods and data between fields. The same could be said for better-known -omes, and for the other clusters of fashionable new fields mentioned above. At the very least, all those neologisms make tempting targets for some old-fashioned free-text-search culturomics.

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[1] An etymological tangent, per the OED: the Greek -oma, a generic suffix for converting verbs into neuter nouns (e.g. diploma), made its way into English mainly in the form of Greek medical terminology, particularly swellings and tumors (carcinoma, sarcoma, lymphoma). In part through the influence of French and German forms, the variant -ome began to pop up, and got attached to the names of specific structural elements of plants or animals (rhizome, chromosome). “Biome” and “genome” were coined in the early twentieth century, and in somewhat different ways, both expanded the sense of -ome from “part” to “part-that’s-also-a-whole.”

The resemblance of –ome and –omics to the -nomy and -nomics of economics is an etymological coincidence but surely didn’t hurt the popularity of either suffix.

[2] Eugene Kolker, "Editorial," OMICS A Journal of Integrative Biology, 6:1 (2002): 1.

[3] -omics literature seems to be rife with pseudo-passive constructions like this; there are “-omes” and “-omicses” but not many “-omicists." What are the stakes of choosing a name for a practice that does or doesn’t lend itself to a name for practitioners?

[4] Jun Xu et al., “Chemomics and drug innovation,” Science China Chemistry 56:1 (January 2013): 71-85.

A Short History of Neuro-Everything

Braaaaaaaaains are everywhere these days. In the wake of the big announcement about the Brain Activity Map (BAM) Project, publicity around the mind sciences has been ramping up. This week is "Brain Awareness Week," meant to raise public awareness about neuroscience. And today, Scientific American MIND announced a new homepage and blog network.

A Portrait of the Author as a Brain Scan 

All of this attention has produced some reflection. Patrick McCray has contextualized BAM in what he calls "the *-omics of everything." He and others—including Gary Marcus—have highlighted the technological and methodological challenges such dynamic mapping faces, compared to the "static" maps of the Human Genome or Human Connectome Projects.

What's interesting about all this is how ubiquitous the brain is already. As I noted recently, it's all over the academy: neuroaesthetics, neuropolitics, neuroeconomics, neurohistory—the list goes on. Pivoting away from the ubiquitous suffix ("-omics") McCray noted, I want to pay attention to this prefix. With apologies to Bill Bryson, I think we need a short history of neuro-everything.

Again, apologies to Bill Bryson!

Vaughan Bell recently argued that this "everyday brain talk" is beginning to constitute a "folk neuroscience," a set of popular misconceptions about the brain. Whereas ongoing research is revealing just how complex the brain is, "we live," he writes, "in a culture where dull biological platitudes make headlines and irritating scientific cliches win arguments." We're not far from Lehrer.

Others have noted the same problem. Roger Scruton, for example, suggests that this "neuro-envy" took hold in the wake of Patricia Churchland's Neurophilosophy (1986). Following Churchland's lead, various humanistic disciplines were rebranded as "infant sciences," complete with the "neuro-" prefix and ready to have longstanding questions answered with brain imaging technologies. 

Source: http://philosophyfaculty.ucsd.edu/faculty/pschurchland/images/neurophilosophy.jpg

Scruton calls this "Brain Drain," and there's a certain truth (and tangibility) to the title. The names he and others have heaped on the trend are telling: "neurononsense," "neurobabble," "neurobollocks," "neurocrackpottery"—like the list of "neuro-disciplines," the list goes on. The degree of derision has risen right along with with the attention and money paid to such efforts. "Brain drain" indeed.

As the Neurocritic recently asked: "What's in a name?" Well, some—including Vaughan Bell—have pegged the birth of "neuroculture" to around the same time as "neuroscience" was coined (the 1960s). While neither blogger claims to care much about the term's origins, they both see its emergence as symptomatic of a new era, in which, as Bell puts it, "everyday brain concepts have bubbled up from their scientific roots and integrated themselves into popular consciousness." 

Here's where historians of science might come in handy. For example: is "bubbling up" (from science to society) the best way to describe what's going on? That is, how do terms and concepts cut between fields and across boundaries? How and when do such efforts get described as "pseudoscience," and what do such charges have to say about the norms we attach to science and its authority?

There's a lot to unpack here, but let me just focus on two lessons or approaches that historians might take with respect to the "neuro-everything" moment.

The first has to do with this question of "bubbling up" into popular consciousness. How does "brain talk" travel? One place to look might be the law: as a New York Times piece called "The Brain on the Stand" makes clear, the field has had a big impact on everything from evidence to jury selection. Some see neuroscience's contributions as fundamentally new; others think its old concepts with new names. 

Source: http://www.lawneuro.org/images/photoNeuronsVibrant.jpg

But the courts can't be the primary site for transmission. What about marketing? Remember that controversial op-ed on how people literally love their iPhones? The science took a beating (here's a summary), but this is the sort of research marketing firms are willing to pay for (in fact, the author commissioned one such firm to do it!). 

We're still not quite there. And, while the primary locus has got to be the media outlets and bestselling authors who splash neuro-answers on covers and above the fold, that still doesn't explain why audiences (and academics!) are willing and eager to pay for those sorts of answers. Nor can it just be the growth of neuro-imaging data and technology (though that, too, plays a part). 

Bell's idea of "folk neuroscience" is too blunt—it seems to assume the sort of one-way transmission most historians and sociologists of science deny. What we need is a better account of the shifting values that attach to these questions and answers, one no doubt rooted in the stories people were already telling (or will to tell) about themselves before "fMRI" was even a twinkle in neuro-everyone's collective eye.

Part of an answer might come from the second approach historians might take, which has to do with the notion of "pseudoscience." As Michael Gordin has recently shown, the charge of "pseudoscience" tells us more about the scientists using it than about those they're using it against. Thus, we might see current fights over the "neuro-" prefix as part of an ongoing fight within the cognitive sciences about proper methods and objects of study. 

Which makes sense. But what about the humanists, who object no less strenuously?  Sure, they might see fMRI of Austen readers as (possibly) pseudoscientific—but they're actually more likely to react to its failures with respect to disciplinary norms and methods within the humanities. So-called "neuro lit crit" is perilous not because it's bad science but because it's bad humanities—"pseudohumanities," if you will. 

Source: http://graphics8.nytimes.com/images/2010/04/05/opinion/05rfd-debate/05rfd-debate-blogSpan.jpg

These neuro-fields seem like a special case of the "boundary-work" historians like Gordin—following sociologists like Thomas Gieryn—have done such a careful job unpacking. I say special because, unlike mere "pseudosciences," something like "neurohistory" brings contestation over the norms and methods of both the sciences and the humanities into the frame. What a mess!

But the payoff could be big: a short history of neuro-everything—or at least a conversation about it—might be just the sort of bridge between "the two cultures" we've been waiting for. 

The Ontology of Patent Law, Part I

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.