Category Archives: Gene Patenting

Myriad Genetics Patent Struck Down!

As I’m sure most of you have heard, the US Supreme Court issued its ruling on the Myriad Genetics case today. There were no real surprises to speak of in the decision, as the court ruled exactly along the lines the executive branch asked it to. In an amicus curiae brief, lawyers for the US Department of Justice argued that whereas DNA sequences ought to not be eligible for patent protection, modified or so-called “complimentary” DNA does not qualify as a product of nature and is therefore patentable. The Supreme Court’s ruling, authored by Justice Thomas, towed exactly this line.

We’ve covered this case previously on this blog (here, here and here) so I won’t go into all of the details now.  But there are a couple of things worth pointing out.

Myriad’s argument that gene sequences are patent eligible because the act of isolating DNA turns a product of nature into an invention is a stretch, to say the least. Still, there was widespread concern that invalidating Myriad’s patents would strike a serious blow to the biotechnology industry, with major repercussions for America’s post-industrial economy. This helps to explain why the court went out of its way to emphasize the distinction between gDNA and cDNA (the latter is basically regular DNA with all the introns cut out).  As Eric Lander, the head of MIT and Harvard’s Broad Institute argued in his own friend of the court brief, the decision to uphold patents on cDNA helps to ensure the future profitability of biotech.

Second, my earlier prediction–the court’s ruling would hinge on the ontological question of whether genes are physical objects or informational entities–turned out to be right. Writing for the court, Clarence Thomas insists that Myriad’s patent claims “focus on the genetic information encoded in the BRCA1 and BRCA2 genes,” not their “chemical composition.” Hence, the fact that isolating these genes for sequencing required breaking covalent bonds in the DNA molecule is of no legal significance.

In the end, though, there were no real surprises in the court’s legal reasoning. Still, there was at least one major surprise (to me anyway).  It was the fact that the court issued a unanimous ruling today! I had predicted the court would strike down the patentability of gDNA but uphold the patentability of cDNA, but I had no idea which judges would vote which way. And I never would have guessed they would all agree on this issue. (Especially given the many differences of opinion on the circuit and appeals courts.)

Finally, and somewhat ironically, perhaps the most interesting part of the court’s decision turned out to be Justice Scalia’s concurring opinion, which I’ll reproduce here in full.

Is Scalia just being his usual snarky self, insisting that he have the last word? Or is he making a much more substantive argument about how Supreme Court justices ought to approach legal questions whose resolution requires taking a stand on technical issues that hinge on extra-legal expertise? Or, is Scalia actually saying that he’s unwilling to legislate ontology from the bench?

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.