The U.S. Government’s Position in ACLU v. Myriad Genetics: Observations on a ‘Waste of Time and Space’
|Written by: Hans Sauer, Ph.D., J.D.
Deputy General Counsel for Intellectual Property
Biotechnology Industry Organization
Posted: July 23, 2012 @ 10:33 am
On Friday, July 20, the Federal Circuit heard oral arguments in the remand of the AMP et al. v. USPTO et al. appeal – the case better known as the Myriad Genetics “gene patent” case. The supplemental briefing in this case, and the oral argument itself, continue to reveal how those with diverse perspectives on DNA patents misunderstand each other. Scientists are making dubious assumptions about the operation of patent law. Patent lawyers are making inaccurate assumptions about how the science works. And those who are neither patent lawyers nor scientists just go by what they’ve been told. The Department of Justice’s (DOJ) supplemental amicus brief and oral argument in this case are a good example of the widening disconnect.
“Kitschy, Not Catchy”
Readers will recall that this is not the first time DOJ appears in this case. Two years ago when the Myriad case first reached the Federal Circuit, DOJ filed an unsolicited brief, replete with hypothetical examples of elemental lithium, cotton, coal, isolated electrons, and other things having nothing to do with molecular biology, siding in part with the American Civil Liberties Union (ACLU), and arguing that Myriad’s claims to BRCA-encoding DNA molecules are patent-ineligible under Section 101.
Effectively, DOJ was urging reversal of longstanding policy under which the U.S. government for decades has been granting (and seeking) patents on preparations of human, animal, plant, and microbial genetic materials. DOJ’s 2010 brief did not explain any reason for such a reversal, especially in the face of interagency dissent – no intervening change in the law, no change in economic reality, not even an overt change in official government policy. And to highlight its interest, in a first for the Federal Circuit, DOJ dispatched none other than the acting Solicitor General of the United States, to deliver an oral argument about cotton, magic microscopes, and, yes, more lithium. “Kitschy, not catchy.” If comments from the bench and the ensuing decision are any indication, at least a majority of the Federal Circuit panel was decidedly unimpressed.
All Tied Up
No wonder then that DOJ would scour the Supreme Court’s Mayo opinion for something – anything – that would vindicate its prior position. Mayo didn’t say anything about a magic microscope, not even implicitly. Accordingly, this sophisticated legal tool (“… if you could see it in nature, then it’s a product of nature …”) was downgraded to the status of “helpful metaphor” during re-argument on July 20.
Clearly, a different concept was needed to help DOJ protect the public from those who would seek patents on lithium, coal, pine needles and DNA molecules. In DOJ’s supplemental brief, we accordingly read that higher authority at the Supreme Court has indeed, albeit in the form of indirect guidance, given us the principle that will allow us to decide the Myriad case: “tying up.”
DOJ is serious about “tying up.” Its brief repeats the phrase at least six times over two paragraphs, for emphasis. The plain logic goes like this: If a claim to an isolated natural substance ties up too many activities that would need to be undertaken to study or use the natural product itself, then the claim is unpatentable under Section 101:
“Mayo suggests that a court should ask whether a patent on the claimed composition has the practical effect of preempting the public’s ability to use the product of nature itself. Issuance of a patent should leave others free to study and exploit the natural substance and to devise other alterations to it. If it does not, that is a strong indication that the differences between the claimed composition and the product of nature are insufficient to render the composition patent-eligible.”
DOJ goes on to announce the applicable rule:
“[P]atents on isolated but otherwise unmodified DNA would significantly impair the public’s ability to study and make use of genomic DNA. … [A]s is true in many fields, removing the product of nature from its natural surroundings is a prerequisite to any serious study or commercial exploitation of native DNA. If the process of removing the product from its natural environment necessarily results in creation of the patented composition (and thus in infringement of the patent) – as is the case here – the patent on the composition is in practical effect a patent on the product of nature itself.”
In other words, DOJ proposes a theory of patent-eligibility that focuses not on the objective differences between the claimed composition and the natural thing, but that instead turns on the activities that would infringe the composition-of-matter claim. If the study or exploitation of the natural substance would necessarily infringe the claim, then that claim is unpatentable under Section 101.
At its heart, the DOJ patent-eligibility test is thus like an infringement analysis – only worse, because there is no actual, accused infringing conduct on which the claim could be read. Instead, the test relies on vague activities that might be undertaken by would-be infringers, for various hypothetical purposes (“serious study”) diverse modes of “commercial exploitation”), using existing or future techniques. If the Supreme Court could be faulted in Mayo for conflating patent-eligibility under section 101 with novelty and nonobviousness under sections 102 and 103, then DOJ can be faulted for further conflating validity with infringement.
On a more practical level, DOJ’s proposed test is really impossible to apply absent a firm grasp of the kinds of activities that would supposedly infringe such a claim, as well as a proper claim construction. In this way, the government’s brief forces us to make explicit our assumptions about the underlying technology, and about what we believe to be actually covered by these claims.
Let’s take two of the claims in this case as an example:
1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.
5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.
Under DOJ’s proposed test, claim 1 to a functional, full-length BRCA1-encoding isolated DNA would be patent-ineligible. DOJ’s brief tells us that the claim just ties up too much – that it would necessarily be practiced by someone engaging in “serious study” or “commercial exploitation” of the natural gene.
Says who? As I understand it, that’s very much an open question – do scientists wanting to study or commercially exploit the natural BRCA gene necessarily have to make or use such an isolated molecule? What if I told you that it is possible – even routine – to study any given gene by replicating and sequencing only the gene’s constituent pieces and “assembling” the claimed full-length gene only in a computer? If the court were to find that it is readily possible to study a natural gene without having to make or use an isolated full-length DNA copy of it, then such a claim should be patent-eligible. But if not, then not. Either way, under DOJ’s proposed test, fact-checking really matters. In order to apply DOJ’s test the court would have to find a number of case-dispositive facts, but how is the court supposed to do so, without a developed record on the matter? Can such facts even be found in a necessarily hypothetical world of “serious studies” or “commercial exploitation” that someone might want to undertake today or in the future, using present or future techniques?
Now let’s take claim 5, “an isolated DNA having at least 15 nucleotides of the DNA of claim 1.” Let’s assume, for the sake of argument, that it would be much harder to avoid infringement of that “gene fragment” claim if someone wanted to undertake “serious study” of the BRCA1 gene. The court could apply DOJ’s test, determine that scientists don’t have to work with full-length isolated copies of the gene, but that they have to work at least with gene fragments, and find that claim 5, but not claim 1, would necessarily be infringed by serious study of the natural BRCA1 gene. That result is entirely possible under DOJ’s test. The absurd outcome would be that claim 5 claims an unpatentable product of nature, but that claim 1 doesn’t. Yet how can an isolated gene fragment be an unpatentable ‘product of nature’ when an isolated full-length gene is not?
Lost in the Time Warp
The Supreme Court in Mayo has planted, at least in my mind, the psychedelic thought that a process can be patent-eligible at some point in time, and become patent-ineligible later because claim steps eventually become “routine,” “conventional,” and “well-understood,” such that the process could no longer be said to embody an “inventive concept.” That would be a strange inquiry, but at least it can be conducted at a fixed point in time, presumably at the time of the invention.
Not so for DOJ’s tying up test. Because of the test’s close relatedness to an infringement analysis, it would presumably be conducted in the present. After all, DOJ is concerned about uses that are supposedly tied up today and in the future – not about uses that were tied up at the time of the invention but no longer are today. For example, under DOJ’s theory, a claim to an isolated substance could be invalid under section 101 in one year because existing technology does not then permit any study or exploitation of the naturally-occurring substance without infringing the claim. If science the next year develops new analytical techniques that enable the study or exploitation of the natural substance without tediously having to isolate it, well, then, that claim would become patent-eligible again. I find it downright trippy, to think of issued claims phasing in and out of patent-eligibility that way. Maybe I need some lithium.
To its credit, DOJ doesn’t rely entirely on reading chicken entrails in the Supreme Court’s Mayo opinion. There is good authority there as well, such as Diamond v. Chakrabarty. We are told that Chakrabarty is consistent with DOJ’s tying-up test because the claim to Chakrabarty’s oil-eating bacterium left the public free to study the underlying natural bacteria, or the natural plasmid DNA that was used in that invention. Accordingly, the Supreme Court held the claim patent-eligible under section 101. So far so good.
But let’s take a look at another favorite, the 1948 Supreme Court decision of Funk Bros. v. Kalo, often discussed in the context of the Myriad case. In that decision, the Supreme Court struck down a claim to an agricultural inoculant comprising multiple selected Rhizobium bacteria, for use in cultivating leguminous plants. Before Funk’s invention, farm supply stores had to stock separate inoculants for clover, beans, sweet peas, alfalfa, soybeans etc, because each crop required a different beneficial root nodule bacterium for nitrogen fixation. And these different bacteria were believed to be incompatible with each other, so that they could not be mixed in one convenient package. The inventor found that carefully selected strains could indeed be combined into one handy inoculate that would work on most legumes.
In the Supreme Court, the claim to an “inoculant” containing an aggregation of different naturally-occurring bacteria was struck down for lack of “invention or discovery” under the pre-1952 Act (it was later, in Chakrabarty, recast in terms of Section 101). But if the claim was patent-ineligible, it could not have been because it “tied up” too much. In fact, Funk’s claim tied up very little, because farmers were free to continue spraying the exact same bacteria separately, like they’d always done. Justice Douglas even tells us that farmers could have bought six different inoculants for six different crops instead of one convenient package of the Funk inoculant. So if “tying up” were the Supreme Court test for patent-eligibility, the Funk Bros. claim should have passed muster – it was no more or less preemptive than Chakrabarty’s claim.
“A Waste Of Time And Space”
I have often wondered why the DOJ showed up out of nowhere two years ago, and started pressing legal theories that are contrary to decades of U.S. government policy and established patent law, and that would potentially invalidate thousands of patents to DNA molecules, enzymes, flavorants, pigments, dyes, fermentation products, fragrances, fungal antibiotics, and other naturally-sourced substances. To me, the low point during oral argument on July 20th was when Melissa Patterson from DOJ’s civil appellate division stated, on behalf of the U.S. government, that settled, investment-backed expectations just don’t carry any weight in a case like this. That it is “the principle” that governs.
It is impossible to predict what the Federal Circuit will do with the proposed “preemption” test for section 101 patent-eligibility. During oral argument, none of the three judges on the panel displayed much interest in the concept. When Chris Hansen for ACLU began to talk about the preemptive scope of Myriad’s DNA molecule claims, he was told – figuratively speaking – that he could use his argument time more productively (comment from the bench: preemption is “a waste of time and space”). Melissa Patterson for DOJ was likewise redirected from a discussion of “preemption” into other questions involving interagency dissent, the applicability of Mayo, and the utilities and qualities of the claimed DNA molecules.
So maybe the Federal Circuit won’t find “preemption” to be useful in deciding this appeal; we’ll know soon enough. I, for one, can’t make sense of the DOJ’s fixation on “tying up.” In Flook, the Supreme Court made clear that a claim’s patent-eligibility does not turn on the range of uses that are preempted versus those that remain in the public domain. Even in Mayo, the Supreme Court discussed preemption explicitly only as an underlying policy concern, as a justification for an outcome that, to the Court, seemed right and just – not as a test that distinguishes a “law of nature” from a man-made process. By elevating “tying up” to the status of an actual analytical tool, DOJ proposes an unworkable test that fails to distinguish “products of nature” from man-made inventions and leads to absurd outcomes. It asks the Federal Circuit to rely on asserted facts and unstated claim constructions. It requires strained interpretations of leading precedent. It is evasive and avoids the hard work of construing the claims and applying them to the activities believed to be “tied up” – lawyer work that, if undertaken, may or may not show that the preemptive scope of these claims isn’t all it’s trumped up to be.
PLEASE NOTE: The views expressed in this article are solely those of the author and should not be attributed to BIO or any of its members.
About the Author
Hans Sauer, Ph.D., J.D., is Deputy General Counsel for Intellectual Property for the Biotechnology Industry Organization (BIO), a major trade association representing over 1,100 biotechnology companies from the medical, agricultural, environmental, and industrial sectors in the United States and internationally. At BIO, Mr. Sauer advises the organization's board of directors and various staff committees on patent and other intellectual property-related matters. Prior to his current position, he served as Chief Patent Counsel for MGI Pharma, Inc., in Bloomington, Minnesota, and Senior Patent Counsel for Guilford Pharmaceuticals Inc. in Baltimore, Maryland. Mr. Sauer has more than 15 years of professional in-house experience in the biotechnology industry, where he worked on several research and drug development programs, being responsible for patent prosecution and portfolio oversight, clinical trial health information privacy, and sales and marketing legal compliance. He has an M.S. degree in Biology from the University of Ulm in his native Germany, a Ph.D. in Neuroscience from the University of Lund, Sweden, and a J.D. from Georgetown University Law Center in Washington, D.C., where he serves as adjunct professor.