Analysis

The Supreme Court finished an hour of oral argument on Wednesday on a highly complex patent case, seemingly as deep in confusion at the end as at the beginning, and the problem came from a single source: try as they might, neither Justices nor lawyers could imagine a hypothetical that would actually make the complexity go away.   Over and over, the Court puzzled over how one could start with a law of nature, which is not eligible for a patent, and then find a way to expand on it that is creative enough to earn a patent.  It is an inquiry, one of the Justices said early on, that might lend itself to the conjuring of “millions of hypotheticals.”  But the hypotheticals that were forthcoming were not very helpful.

The Court is what Justice Stephen G. Breyer once called “this generalist Court,” so it does not imagine itself to be as astute in judging, say, patent law as it might be in making a constitutional judgment.   And it has well learned that, when a case before it presents genuine legal complexity, it can help to think about it differently, through perhaps familiar examples drawn from everyday life.

Indeed, Justice Breyer is sometimes very adept at doing just that, although he also occasionally runs the hypothetical too far out, and it becomes as complex as the underlying legal concept he is trying to make intelligible.   Early in Wednesday’s argument on Mayo Collaborative Services v. Prometheus Laboratories (docket 10-1150), a case about patenting a process of judging when a patient is getting too much or too little of a given drug, Breyer tried what he obviously thought was a simple hypothetical.

A patient, he posited, has a headache, and takes aspirin for it.  An “amazing thing” happens: by looking at the patient’s little finger, one notices that it is changing color.  If it is one color, a doctor concludes, the patient took too little aspirin, but if it is a different color, the conclusion is that the patient got too much.  “Now,” suggested Breyer, “I’ve discovered a law of nature and I may have spent millions on that.  And I can’t patent that law of nature.”  But, interrupting himself, Breyer said that is not what the doctor did.  The doctor applied the law by looking at the little finger.

Breyer then asked Mayo’s lawyer, Stephen M. Shapiro of Chicago, “is that a good patent or isn’t it?”   Shapiro said it was not.  Keeping it simple, the lawyer said that “you’ve added to a law of nature just a simple observation of the man’s little finger.”   Breyer commented: “Ah.  Now, we’re into the problem.  And that is the problem of how much you have to add.”

So far, so good.  But then the exchange over the aspirin-taking shifted, with Breyer asking Shapiro to put the matter into legal phraseology, and the clarity that had seemed to be about to emerge slipped away.   Shapiro started talking about “adding a law of nature to prior art, and prior art plus prior art equals nothing that is patentable.”   Justice Antonin Scalia jumped in: “Does that render it unpatentable because it’s not novel?”   Novelty, of course, is something an invention must be to get a patent, but it is a separate question from whether an invention is eligible in the first place even to be considered for a patent — the key point in this case.   Even at this early stage, differing patent concepts were getting inter-mixed, adding a new layer of complexity.

It did not help matters that Shapiro and the Justices insisted, much of the time, in trying to parse out the legal implications of whether a test of a patient’s reaction to a given dosage of a drug measured on a scale to 400, measured less than that, or measured more than that — perhaps even out to infinity.   The numbers supposedly were meaningful, but neither Justices nor lawyers were probing just why that had a bearing on the issue of patentability.

It also was a bit curious that Shapiro very likely could ultimately win the case for his Mayo group clients if he were to press an argument that the Justice Department had introduced into the case, but he insisted on pressing for a ruling on the issue of the patent eligibility of the patent held by Prometheus that Mayo supposedly had infringed.  The medical community, the lawyer said, wants a “robust standard” on what is basically eligible to be patented, in order to make sure that claims of new discoveries of laws of nature in medicine do not get turned into someone’s monopoly exploitation right.   He thus seemed entirely uninterested in promoting the Justice Department notion that the Prometheus patent should never have been issued in the first place, because it was not really new.

When Shapiro was able to move back to his core argument, that too wide an opening for medical patents threatens to put the vast storehouse of medical science out of reach to anyone who doesn’t have a patent on it, he was more persuasive, especially when he ticked off a long list of diseases that he said could not be diagnosed by doctors in their normal practice without risking infringing on the Prometheus patent monopoly.    But the Justices’ uncertainty about patent law concepts kept getting in the way of clarity.

And when Shapiro alluded to a dissenting opinion Justice Breyer had written five years ago, an opinion that seemed to bolster Shapiro’s argument significantly, Breyer all but disowned the basic point of that dissent: he said the opinion in 2006 was not at all helpful in spelling out what one had to add to the use of a law of nature in order to make the addition patentable.   If one looks to the dissent “to find an answer to that question, you are better than I, because I couldn’t find it,” Breyer confessed.

When Solicitor General Donald B. Verrrilli, Jr., took the stand to make an argument straddled between the positions of Mayo and Prometheus, he promptly encountered a hypothetical from Chief Justice John G. Roberts, Jr., seeking to test what kind of new idea would be patent eligible.

“I have a great idea,” the Chief Justice began.  “You take wood, you put it on a grate, you light it, and you get heat.”   Because it achieves a result, Roberts wondered, could he get a patent on it?   No, Verrilli said, because it was “not novel, and it’s obvious.”   But that was not Roberts’ point: he was trying to flesh out what the government thought was patent eligible in the way of a “great idea,” not whether another part of patent law not dealing with basic eligibility would rule out a patent as lacking novelty.

Pressed by Breyer to get back to the patent-eligibility issue, the Solicitor General laid out the example of a cardiac stress test, producing an image of a heart that doctors can then examine and then improve the patient’s treatment.   Describing how it works, Verrilli said that no one “would suggest that that’s not a patentable process.”  But, he quickly added, the way Mayo would define patentable process, the stress test would not qualify.   As he examined that claim, he remarked in passing about “all the trouble we are having in this case figuring out what the standard is.” He also expressed concern, along the way, about using a standard of patentability that would “call into question lots and lots, thousands in fact, of medical use patents.”

Prometheus Laboratories’ lawyer, Washington attorney Richard P. Bress, was often allowed to continue to make his points without a great deal of interruption by the Justices.   In doing so, he was defending his client’s patent in strictly legal terms, without trying to bring the argument down to a simpler level.   After he did allow himself to digress, in an exchange with Justice Samuel A. Alito, Jr., to discuss a hypothetical about patenting a process for cross-breeding plants, Justice Breyer sought to try out other hypotheticals.

Suppose, Breyer said, that someone has discovered that using a little fertilizer makes plants grow but using too much burns up the plant.  He suggested one could get a patent on a measurement of fertilizer to determine the right amount.  Then, without pausing, Breyer went into a second hypothetical: Einstein had never lived, but someone invented his formula for measuring energy — E equals mc-squared.   If Prometheus’s patent for measuring how a patient reacts to different doses of a particular drug was a valid patent, Breyer wondered, why wouldn’t the two examples he gave be, too?   But Bress, in answering, went into the issue of novelty or obviousness, not basic patent eligibility.

Breyer protested: “No, no.  My question is, what has to be added to a law of nature to make it a patentable process.”  That, of course, was the foundation issue that the entire argument had supposedly meant to answer.   Bress’s answer was largely indirect, going into other examples drawn from the Court’s prior patent precedents.  He then continued for a time, again without interruption, telling the Court along the way that drawing the lines of patent-eligibility or not was “somewhat arbitrary…you’ve got to look to…what you’ve done before.”   Of course, what the Court had done before had not clarified the issue sufficiently to make it unnecessary to take a new case like Mayo’s.

In the comparatively few times he was interrupted by a question, Bress was usually asked to try to deal with a new hypothetical.  At one point, Justice Breyer tried one about a patent on a way to find out how much chicken food chickens could eat.    Ultimately, Prometheus’s lawyer opted to return to discussing the range of numbers that figure into the calculation of patient reaction that the Prometheus patent helps a doctor make.

In a closing rebuttal, Mayo’s attorney Shapiro again made a broad plea for the Court not to open “the storehouse of information for medical researchers” to the prospect of monopoly patents.  But his most useful final thrust was a hypothetical of his own.  He reiterated his basic point that what Prometheus has locked up in a patent is a way to analyze “a natural process.”  The Prometheus method, he said, tests metabolites.   Then he added: “It’s just like cholesterol.  If I eat in a French restaurant, there’s some human intervention there that gives me high cholesterol.   And if I eat wild strawberries, there’s no human intervention.  But either way, the doctors get to look at my cholesterol and hypothesize ranges that they think are essential.  It’s the very same phenomenon.  It’s entirely natural.”

It was arguably a good point.  But perhaps it was a little late in coming.

 

 

Posted in Mayo v. Prometheus Laboratories, Analysis, Featured, Merits Cases

Recommended Citation: Lyle Denniston, Argument recap: For want of a good hypothetical, SCOTUSblog (Dec. 7, 2011, 4:43 PM), http://www.scotusblog.com/2011/12/argument-recap-for-want-of-a-good-hypothetical/