The following contribution to our gene patenting symposium comes from Robert Merges, Wilson Sonsini Professor of Law, UC Berkeley and Visiting Professor of Law, Stanford Law School.

Introduction

And so it came to pass that the Supreme Court finally, after many years, took up the question of patents on human genes. Many of us in the patent field assumed it was too late – that the Supremes had decided implicitly at some point in the past to stay clear of any effort to unravel the legal mysteries of the double helix. Well, we were wrong. And now the task ahead of the Court is to get this complex issue right. In this brief post I offer some background on the case, a few predictions about what the Court might do, and even some thoughts on what I, immodestly to be sure, think they should do.

Background: Section 101 and the “freshman seminar” effect

Patentable subject matter doctrine is deceptively simple, at least in broad outline. The statute sets out four general categories; the case law lists three exceptions. For any given invention, the inquiry is simple: does it fit in one or more categories: process, machine, manufacture, composition of matter? If so, does it fall under one of the exceptions: law of nature; natural phenomenon; abstract idea? Yes to the first, no to the second, and you move forward. No to the first, or yes first but yes second, game over. Pretty simple.

The problem is not in the structure of the test. It’s in the content, particularly the content of the exceptions. Natural laws and phenomena, as well as abstract ideas, are very general concepts. It is very difficult to pin them down with clear verbal formulations.

Why is it so hard to formulate a workable test? I have been teaching this material for twenty-five years now, and I have a theory. It’s because the Court-created exceptions can so easily veer into debates over metaphysics. One problem is the thin line between an idea and its application. Was the process claim in Mayo a mere statement of the fact of a correlation, or was it a procedure that took advantage of the correlation? Is a claim to a computer program that uses a new sorting algorithm in effect a claim to the algorithm itself? This is a prime breeding ground for metaphysical speculation. It invites what the philosophers call “essentialism”: what is the essence of this particular patent claim – idea or application?

This leads to the “freshman seminar” effect: endless hypotheticals designed to test the viability of various metaphysical principles. This effect is even more pronounced when it comes to natural phenomena. A newly discovered flower is not patentable per se. How about leaves from the flower? How about its seeds? How about parts of flowers (the stamen, say) or the inner part of its seeds? What about a mixture of ground-up seeds and water? What about one of its leaves that has been soaked in a solution that eliminates all but the fibers of the leaves? How about a chemical compound isolated from the leaves or stem of the plant? How about a new chemical altogether, made by assembling atoms isolated from elements found in the chemical compounds in the plants?

The questions resolve to this: where does “the natural,” the purely found thing, end, and where does a human-made construct, an invention, begin? There is a wide spectrum, and many choice-points along the way. The generality of the exceptions to patentability do not provide any significant help. It all ends up looking like a freshman philosophy seminar. We have fun chasing the rabbit down the hole and back up. But we end up with very little in the way of useful answers that are solid and satisfying.

If you think this effect is limited to law school classrooms, read the oral argument transcript or even the opinions in these Section 101 cases. You will be struck by high-flown inquiries into whether the claimed invention is tantamount to snapping a leaf off of a tree, or chiseling a statue from a block of marble. Someone invariably points out that everything in our world is built from natural starting materials, including football helmets, space ships, and cell phones. As I said, the discussion just naturally veers toward metaphysics.

The “degree of human intervention” test

In general, one good way out of any metaphysical morass is to go back to the real world. It can be argued, under one way of looking at the Section 101 cases, that this is exactly what the Court has tried to do. The basic idea is that instead of getting caught up in a metaphysical categorization game, the Court at its best has been looking to the real world for guidance. Specifically, it has been looking to see how much human intervention was required to change a natural starting material into the claimed invention. If the answer is not much, then the claim is to a natural phenomenon. The early software cases, such as Gottschalk v. Benson (1972), fit this description, though many students of computer science have been baffled by Justice Douglas’s insistence that a data conversion algorithm that was manifestly written by an actual programmer somehow pre-existed its codification in a computer program. This Platonic view of computer algorithms as somehow being “out there” prior to codification meets with a good deal of resistance among practitioners of the art, even if some of them do not complain much because they hate software patents for other reasons. Anyway, my point here is that the Court itself thought there was not enough human intervention between the “pure” algorithm and the patent claim at issue in the case to find it patentable subject matter.

If the invention requires some intervention, but not a huge amount, we have a close case, the canonical instance being Funk Brothers Seed Co. v. Kalo Inoculant Co. (1948). There individual naturally occurring growths from selected plant roots were combined into a sort of root nodule “all-star team,” but that was deemed insufficient human intervention. On the other hand, where there is sufficient intervention, we get a case like Diamond v. Chakrabarty (1980), in which a scientist combined free-floating DNA rings from various bacteria into an amalgamated super-bacterium – and received a valid patent for his efforts.

I have never taught Funk Brothers and Chakrabarty without someone pointing out the striking similarity of the fact patterns. But one tried-and-true response is that selecting and combining the bacterial DNA in Chakrabarty probably took longer; was more difficult; and cost more, when compared to the root nodule invention of Funk Brothers. This is plausible but hard to verify. But that’s irrelevant. The real point is that a test along these lines gives the students something firm to grasp hold of. Something better than “the invention in Chakrabarty was not essentially natural while the one in Funk Brothers was.”

Getting a hand with the real-world inquiry

I am certainly not the first person to see that the way out of the metaphysical maze is to focus on the real world. That trail was blazed by Learned Hand in his celebrated opinion in Parke-Davis v. Mulford (C.C.S.D.N.Y.1911). The key passage for me is not the holding, wherein the purified adrenalin invented by Takamine was found patentable. It is the analysis leading up that point:

Takamine was the first to make [the claimed adrenalin] available for any use by removing it from the other gland-tissue in which it was found, and, while it is of course possible logically to call this a [mere] purification . . . , it became for every practical purpose a new thing commercially and therapeutically. That was a good ground for a patent. . . . .  Everyone, not already saturated with scholastic distinctions, would recognize that Takamine’s crystals were not merely the old dried glands in a purer state. . . . The line between different substances and degrees of the same substance is to be drawn rather from the common usages of men than from nice considerations of dialectic.

Note the primary contrast here: First, we have “logic,” “scholastic distinctions,” and “dialectic”; these are contrasted with “every practical purpose,” “commercially and therapeutically,” and “the common usages of men.” Put simply, Hand says, we can get all bollixed up arguing metaphysics. Or we can look to the real world to answer the question, “was this a new thing or a purified version of a natural thing”? Personally, I side with Hand on this one.

What about human genes?

When I look to the real world I see that isolating and purifying a human gene is a capital-intensive and knowledge-intensive procedure. I realize that sequencing genes has become much easier over time. However, that does not mean there is less human intervention. Instead, it is easier because of very expensive machinery and a high degree of skill on the part of the researchers. The human intervention, in other words, is these days embodied more in machinery and know-how than it used to be. But it’s still there. I would focus on this fact. The debate amongst the Federal Circuit judges in their second Myriad opinion captures some of this reality. But I still find Judge Lourie’s disquisition on covalent bonds to sound a bit too much in essentialism. The question is not so much whether the isolated gene is, in its essence, a new thing; it is instead whether it takes significant human intervention to go from the chromosome in its native state to a purified and isolated gene. I think it does; and that the gene as claimed ought therefore be deemed a new (patentable) thing. The fact of significant human intervention, and the importance of purified genes “commercially and therapeutically,” leads me to conclude that we should call them non-naturally occurring inventions. I fully understand that these claims are not as important as they once were. But the Court took the case, and it ought to reach the right result even if the economic impact of the wrong result is not as big as it once would have been. It is important to get the principle right.

In closing: A modest proposal

If I have convinced you that Section 101 is something of a mess conceptually, I have an idea you might like. (Actually I had the idea jointly with Dennis Crouch.) Why not save this, the hardest test of patentability, for last? If we can weed out a troublesome invention using one of the classic and well-worn tests for patentability, shouldn’t we do that? Why must we torture ourselves by traversing the trickiest and least predictable test first? True, Section 101 appears in the statute before some of the other key tests of patentability (Sections 102, 103, and 112); but that is a sophomoric reason to always apply this test first. After all the statute does not itself dictate a binding sequence. It just lists the requirements.

What this would mean in practice is not that the Section 101 analysis would get any easier. In those cases where an inventor presented a claim that was novel; useful; nonobvious; and fully enabled and described in the specification, we would have to wade into the turbulent waters of Section 101 when that was indicated. But under this approach, many of the claims in the recent Section 101 cases would have washed out before we got to Section 101 (including Bilski v. Kappos and  Mayo v. Prometheus). Not a bad result, considering the headaches that often come at the intersection of complex inventions and metaphysical challenges.

 

Posted in Association for Molecular Pathology v. Myriad Genetics, Featured, Gene Patenting Symposium

Recommended Citation: Rob Merges, Selected thoughts on a Myriad of problems, SCOTUSblog (Feb. 6, 2013, 12:35 PM), http://www.scotusblog.com/2013/02/selected-thoughts-on-a-myriad-of-problems/