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The Depressing Mayo v. Prometheus Oral Argument at the US Supreme Court ~pj
Sunday, December 11 2011 @ 12:43 AM EST

Groklaw had two eyewitness reporters, RFD and Webster, at the oral argument of Mayo Collaborative Services v. Prometheus Laboratories Inc. on Thursday at the US Supreme Court, and each provides impressions of the experience. I'll show you in a minute. All the filings are at that link. The transcript is now available too, as is the audio recording, so you can follow along with as much detail as you'd like.

I confess that reading the transcript made me feel profoundly depressed, in that I can't believe they are even arguing over this patent, or that it even issued in the first place. At what point can you patent the application of a law of nature? That was the question, with a side order of should patents issue if the applicant spent a lot of money on research? You think I exaggerate. The ABA Journal puts it like this:

The question presented is:

Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry.

So you see, I am not kidding. The parties have spent millions to argue about this in courtroom after courtroom all the way to the Supreme Court. I believe the Mayo Clinic has better uses for its money, but it had to spend it to try to protect freedom for doctors to do their own blood tests and prescribe dosages of the type of medicine at issue for patients with certain autoimmune diseases who need it, but now can't do so without infringing on Prometheus' patent.

Patenting the practice of medicine.

Jump To Comments

I do wish everyone would quit interpreting patent law to make it as broad as possible and look at the issue not just from the standpoint of the drug companies who want patents but the public which is affected by them. Then again, had I lived in the Middle Ages, I likely would have rolled my eyes at arguments about how many angels could fit on the head of a pin. It's hard, and depressing, to listen to such arguments, if you are, like me, a logical person, because your brain keeps coming back to the reality that such questions can only be discussed if you go below the surface of the argument and admit the whole topic is ridiculous and shouldn't even be happening.

Trust me. Doctors will continue to try to find good protocols. Drug companies... well, if they had as much compassion as rats do, they'd make it easier for the Mayo Clinic to treat their patients and come up with competing protocols, because that's what is good medicine. Does anyone really believe that a system that requires you to research patents before you can figure out how much of a drug to use or how much to give, and then have to pay off someone who figured out one answer, when you have a different idea, and then patent your own answer -- and if we do this for each drug and each protocol, will this lead to *more* innovation?

Mayo says that Prometheus's patent is based on medically unsound numbers, by the way, and with this patent in place, they are not allowed to try anything else without violating the patent. Talk about getting back to fundamentals.

If the court doesn't understand this, how will they ever get their heads around the damage that software patents are doing? All Microsoft has to say is that they spent a lot on research. Bam. Pick up your patent. And yet look at the utterly avoidable damage to customers in the mobile phone space alone because of patents, and ask yourself, isn't there a better way than this?

Cory Doctorow apparently felt the same way:

If the Supremes rule in favor of the patentability of adjusting drug doses and other common medical procedures, it will make doctors liable as patent infringers merely for practicing medicine. What's worse, judging from the hearings, the justices are ready and willing to make this loony idea into the new standard for patentability.
Jonas Anderson, Assistant Professor at American University Washington College of Law, provides a summary of the arguments on Patently O. He attended as well, and in one sentence, here's what he says the issue was: "The case raises the question of whether a patent claim that covers correlations between blood tests and patient health is 'patentable' under 35 U.S.C. § 101."

Patently O's Dennis Crouch noticed a question from one of the Justices, Justice Breyer, and he wonders how patent lawyers would respond:

JUSTICE BREYER: Suppose I discover that if … someone takes aspirin … for a headache and, you know, I see an amazing thing: if you look at a person's little finger, and you notice the color [indicates that] you need a little more, unless it's a different color, you need a little less. Now, 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 I say: I didn't; I said apply it. I said: Look at his little finger.


JUSTICE BREYER: Okay? Is that a good patent or isn't it?

MR. SHAPIRO: No … Well, because you -- you've added to a law of nature [to] just a simple observation of the man's little finger.

You have to have Javascript on, to read the comments. The very first one answers in part, believe it or not:
I say it's patentable. You aren't patenting the change in the finger - that's a law of nature. And there's no law of nature that says you treat with aspirin. If it costs millions to discover because it wasn't obvious but is extremely valuable, then it's the exact type of research and discovery we should encouraging.
I couldn't make that up, but sadly, some of the Justices seemed to think like that too. The argument "but it cost a lot of money to figure this out" seems to matter to them.

Anderson explains it like this:

A healthy amount of discussion centered around the impact on innovation that a decision in this case will have. Justice Breyer, who had been extremely skeptical of diagnostic method patents in his dissent in LabCorp, noted that discovering laws of nature can be an incredibly expensive process. His search for a line between phenomenon and application seemed to center around balancing the incentive to discover new laws of nature with a desire to allow access to those laws to follow-on innovators.
There is, of course, an obvious response. Patents on laws of nature or discoveries of some new aspect of laws of nature don't encourage innovation. They block it, as Mayo's counsel kept trying to point out, arguing that Prometheus's patent blocks an entire field, with serious consequences to patients, since the Mayo Clinic believes that Prometheus's numbers are wrong.

Justice Scalia's questions at one point gave me chills. Mayo's lawyer is answering another question when Scalia jumps in with some of his own:

MR. SHAPIRO: -- the specificity. If it leaves room for others to have their own tests with different numbers and different procedures so that it isn't just one test for the whole country, then yes, if it's specific enough. The specificity is the key.

What -- what the Court said in Bilski, of course, is that you can't preempt a whole field, a broad field with -- with your -- your patent, which this one does. And if you look at the diseases that are covered -

JUSTICE SCALIA: I'm -- I'm not comfortable with that. I mean, it depends on how -- how broad it is?

MR. SHAPIRO: Yes. If -- if you -- if you preempt all the numbers up to infinity and all autoimmune diseases, that's a vast field. It's much bigger than -- than the field -

JUSTICE SCALIA: What about up to 700? Is that okay?

MR. SHAPIRO: Well, no. I -- I think -


MR. SHAPIRO: No. I -- I think -



JUSTICE SCALIA: How are we supposed to apply that kind of a rule?

MR. SHAPIRO: I think doctors have to have make their own judgments about these natural phenomea.

JUSTICE SCALIA: Above 830 or below 830? Which?

MR. SHAPIRO: Well, I -- no. I think -

JUSTICE SCALIA: It just seems to me not a -- not a patent rule that we could possibly apply.

MR. SHAPIRO: Well, it's the rule I believe adopted in Bilski and in Flook, that you can't wipe out a whole field so no one else can have a competing test. The result for the public is that these numbers would be frozen for 20 years and a very serious person couldn't get a second opinion from Mayo Clinic, which uses different numbers. That's why we think -

JUSTICE SCALIA: But doesn't -- doesn't any -- any medical patent rely on natural processes? I mean, even if you invent a new drug, what that new drug does is -- is natural. It affects the -- the human physiognomy in a certain natural way.

MR. SHAPIRO: Oh, yes.

JUSTICE SCALIA: Is it -- is it therefore precluded from patentability?

MR. SHAPIRO: No, it's not. And in fact, this drug was patented.

JUSTICE SCALIA: What is different here?

MR. SHAPIRO: The difference is the specificity. If you invent a drug which has a particular chemical formula, others can invent other drugs. There's room for competing drugs in the medical world. And you'll -- many, many patented drugs -

JUSTICE KENNEDY: I thought your answer to Justice Scalia would be -- and please correct me -- the difference is, is that what the Respondent is claiming is a -- a patent on the measurement of the result.

MR. SHAPIRO: Yes, it -- it is a patent -

JUSTICE KENNEDY: But a measurement in a different answer. I mean, that's how I would have answered the question. But -- but that's obviously not the right way to do it.

MR. SHAPIRO: I think that's -- that's one -- one part of it.

JUSTICE SCALIA: Well, that's another one of your arguments, but one of your arguments says you can't patent nature.

MR. SHAPIRO: You can't patent nature, that's correct.

JUSTICE SCALIA: Right, and that relates to the question that I asked.


JUSTICE SCALIA: Now, tell me why you can't patent nature, then?

MR. SHAPIRO: Because -- because of the law of nature doctrine that has existed for 150 years in this Court. Congress has never disagreed with that. Pieces of nature can't be monopolized. Neither can formulas.


JUSTICE KENNEDY: But nature always has a reaction to the drug.

MR. SHAPIRO: Pardon me?

JUSTICE KENNEDY: Nature always has a reaction to the drug.

MR. SHAPIRO: Yes. So all doctors -- that's part of the storehouse of information. All doctors can look at that reaction. They can calibrate it the way they see fit. They have different opinions. And it's important for all of us that they have those different opinions. We found that the numbers that they were using were way off for skin disorders, dangerously high. 400 is the wrong number. The correct number is 150 to 300.

Now, it's very important for patients to be -- with life-threatening conditions, to be able to get that information.

JUSTICE BREYER: All right. So how do you -- that's -- I see that. I will spare you the reasons why I think the law of nature doctrine exists, because they are not relevant to my question.

My question is, I think it's hornbook law that the law of nature cannot be patented.


JUSTICE BREYER: It is also hornbook law that the application of a law of nature can be patented.


JUSTICE BREYER: All right. So in this case, what I think the claim is is that we are applying a law of nature. Now, we read the words of applying it: Administer a drug, determine the level. And then it uses the word "wherein," which I will ask them what that means. But -- but -- so they say those two words, administer the drug, determine the level, are the application of the law of nature that they found.

Now, there's something odd about that in your view -


JUSTICE BREYER: -- at least. And I want to know what.

MR. SHAPIRO: For us, the real oddity is that this numerical calibration that they've given extends up to infinity, and it precludes every other blood test.

JUSTICE BREYER: All right. Suppose it didn't. Suppose I discover that if I take aspirin, someone takes aspirin, I discover they have to take aspirin for a headache and, you know, I see an amazing thing: if you look at a person's little finger, and you notice the color of -- it shows the aspirin, you need a little more, unless it's a different color, you need a little less. Now, 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 I say: I didn't; I said apply it. I said: Look at his little finger.


JUSTICE BREYER: Okay? Is that a good patent or isn't it?

MR. SHAPIRO: No, it's not.


MR. SHAPIRO: It's not a good patent.

JUSTICE BREYER: If you can tell me why not, I'll have an understanding of where you are coming from.

MR. SHAPIRO: Well, because added to a law of nature just -- just a observation of the man's little finger.

JUSTICE BREYER: Ah. Now, we're into the problem. And that is the problem of how much you have to add.

See what I mean? Why isn't there a lawyer anywhere who will stand before the court and when asked such questions answer: None of this should be patented, because the patents hurt people. It's so dangerous, we need to build a high fence around this area, and not let those patent lawyers or their money-struck clients anywhere near it.

Justice Breyer goes on to say that case law seems contradictory on this point, with Flook saying one thing and Diehr another. And what else would you expect, if instead of drawing a clear line, you keep trying to fudge it so that you can't patent laws of nature, except when you sort of can?

Justice Kagan asked the lawyer for Prometheus a pertinent question that showed she has a clue:

JUSTICE KAGAN: But, Mr. Bress, here's what you have not done. What you haven't done is say at a certain number you should use a certain treatment, at another number you should use another treatment. I guess the first question is why didn't you file a patent like that? Because that clearly would have been patentable. Everybody agrees with that.
Speak for yourself, but it's true that everyone there agreed, even Mayo's lawyer. She continued:
And I think that the difference that people are noting or some people are noting is that this is not a treatment protocol, it's not a treatment regimen, all you have done is pointed out a set of facts that exist in the world, that exist in the world, and are claiming protection for something that anybody can try to make use of in any way and you are saying you have to pay us.
Sigh. If there is one thing that Linux, FOSS, and Android have demonstrated, not to mention the traditional practice of medicine, it's that open sharing of how you do things leads to innovation and more rapid development and advancements in knowledge.

But now let's see now how the oral argument struck a normal person, as opposed to patent lawyers or law professors. Here's RFD's account:

On Decemper 7, I went to the Supreme Court attend the hearing on MAYO COLLABORATIVE SERVICES V. PROMETHEUS LABORATORIES, INC. The question Mayo presented was:
Whether 35 U.S.C. § 101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve "transformations" of body chemistry.
Section 101 covers what subject matter is, or is not, patentable. A very loose reading of this section has led to patents being granted for business methods, software, and mental processes. I will not attempt to cover the details of the case--that has been done elsewhere-- and the transcript is now available. For those of you who have not attended a Supreme Court hearing, I will try to give you a feel for what it is like.

The Supreme Court building is in downtown Washington DC on Capital Hill, across the street from the U.S. Capital. Parking is very restricted in the area, and the easiest way for most people to get there is by Metrorail or taxi.

Seating in the courtroom is limited, so you need to get there early. I rode the Metrorail to the Capital South Station and walked a few blocks to the Supreme Court building. I got there about 7:00 am (the hearing was at 10:00) and several people were already waiting in line in the rain. Court security personnel soon arrived and handed out numbered cards which reserved your place in line but did not guarantee you a seat. My number was 37, which was fortunate, because about 8:00 am, those of us with numbers 1-50 were escorted into the building. The rest had to wait outside in the rain.

We passed through the first security checkpoint and I was then able to wait in the cafeteria.

In the cafeteria I sat near several recent law school graduates who worked for EPA. They were there for the second hearing which dealt who owned certain segments of the Missouri River bed in Montana (those segments Lewis and Clark had to portage around). They had a card game going and we also discussed both cases.

A little before 9:00 am we lined up by number in the corridor outside the cafeteria and at 9:00 am we were led up the stairs to where there were coin-operated lockers and a coatroom. After stowing everything not permitted in the courtroom, we went through the second security checkpoint and were then escorted in small groups into the courtroom.

The courtroom has a very high ceiling and is rather ornate. In the front is a raised platform where the justices sit. There are the usual bench seats, both in front of and behind a bar that divides the room. In addition, there are individual chairs tucked in to every nook and cranny--this where I was seated. The view from many of these seats is blocked by columns, but I was able to see all the justices, although I had to lean forward to see Justice Sotomayor.

There did not seem to me to be any typical visitor. There were lawyers, law students, tourists, school children and many, many I would not try to categorize. I would guess that there were 300-400 people in the courtroom, but I may be way off.

At 10:00 am everyone rose, and the justices entered. The first order of business was the admission of several lawyers to the Supreme Court Bar. This took about 10 minutes.

Immediately after that, the attorney for Mayo stepped up to the podium and started with the usual "Mr. Chief Justice and may it please the court."

There was a total of one hour for argument with Mayo going first, U.S. Solicitor General second, Prometheus third and with Mayo then closing.

Questions from the Justices began almost immediately. Many of the questions dealt with the issue: Should the court decide this case under § 101 (eligible subject matter) or under § 102 or § 103 (novelty, obviousness, etc.) as the Solicitor General has advocated.

I was rather surprised by questions from Justice Sotomayor--it did not seem she understood much about this case.

The Solicitor General was asked why the court should not take up the § 101 issue, and I thought he had a rather weak response--looking at § 101 requirements first would not make it any easier for the patent examiners. One of the justices remarked that it might make it easier for practitioners.

I will not attempt to predict how the court will decide this matter, but I remain hopeful that the court will start to clean up the mess the Federal Circuit has created.

That's the impression of a normal person. Us normal people end up at the Mayo Clinic or at our local hospital, where the impact of the decision the court reaches will affect us all, for good or for ill. Here's what Justice Sotomayor asked, and recall that her ex-husband is a patent lawyer, so lack of comprehension isn't likely the issue, jumping in with hostile questions almost as soon as the lawyer for Mayo, Stephen Shapiro, opens his mouth:
MR. SHAPIRO: Thank you, Mr. Chief Justice, and may it please the Court: We're here today to urge the Court to reinstate the district court's decision, which faithfully applied this Court's precedents under section 101 of the Patent Act. The problem with the Prometheus patent is its broad preemption of a physical phenomenon, which prevents others like Mayo Clinic from offering a better metabolite test with more accurate numbers. And this is a huge practical problem for patients.

These thiopurine drugs are strong medicine. Too much of this can be fatal; too little can leave - leave a chronic lingering disease in the patient.

JUSTICE SOTOMAYOR: I'm sorry. I didn't think that this patent covered the actual machine. Mayo is free to develop a new machine.

MR. SHAPIRO: Well, what it can't do is use any number from 400 up until infinity, and it believes that's the wrong number. And it can't have a -- a different standard for a legion of autoimmune diseases, and there are dozens and dozens of them. And that's a broad field to preempt the natural phenomenon.

JUSTICE SOTOMAYOR: It -- it actually is much narrower than that. It's within a range, two ranges actually. And so it has already changed one range, and that's not the subject of the district court's finding that the lower number it's proposing is infringing. So it's not as broad as you are stating.

MR. SHAPIRO: Well, you -- you see, Your Honor, we believe the correct number is 450 to 700. And that's necessary to cure various autoimmune diseases. And Prometheus took the position that its patent preempts everything above 400, all the way up to infinity, it said, for all autoimmune diseases, dozens and dozens of them.

JUSTICE SOTOMAYOR: Well, it took that position, but the district court narrowed it to 15 percent, to 15 -

MR. SHAPIRO: Well, you know, actually it didn't, Your Honor. You will see in that opinion, there are two rulings: one is the 15 percent ruling, which lowers the number; but it said 400 and above all the way to infinity. There's no upper limit on this.

So as a practical matter, there's no room for anybody else to offer a metabolite test. And what this means for patients is one opinion in the United States. If you have one of these life-threatening diseases -

JUSTICE SOTOMAYOR: It can offer the test.

MR. SHAPIRO: -- you get one opinion.

Pardon me?

JUSTICE SOTOMAYOR: It can offer the test. It just can't recommend the dosage to the doctor.

MR. SHAPIRO: Well, it -- it can't have a test that has a different therapeutic range, because that's a preemption. They take the position -

JUSTICE SOTOMAYOR: Tests do two things: they measure something -


JUSTICE SOTOMAYOR: And therapeutic range does something else. The tests can happen. The doctor gets a number. What the doctor does with that number is a different issue.

MR. SHAPIRO: And -- and what -- what Prometheus submitted and the court agreed is if you are notified, if you are aware of their range when you're drawing blood, that's an infringement right then and there, if -- if you're aware or warned by their number. So any doctor in the United States that draws blood and is aware of this range of theirs is preempting. And the practical result is we haven't been able to offer this competing test now for 7 years.

If you suffer from an autoimmune disease, how are you feeling right about now? Disgusted? Asking, how is this possible? Well, I am.

Now for Webster, a lawyer, although not a patent lawyer, and with Web's own patented style. Kidding, it's not patented, just inimitable, which is better than a patent:

Preamble I: Nothing about Patents

He received the email request about noon Monday. “Can you go to Prometheus v. Mayo?” Which happens to be at the Supreme Court Wednesday morning.

The first decision: whether to go. Having just ended a month-long trial, it sounded a bit heavy -- recreational patent gazing. He glanced at his calendar; he knew something was there Wednesday. Ouch! It was the case of the client who called last night to complain about her program. Some men in the program were bothering her –, and she had missed some tests, – and one or so was dirty... It was a problematic case. He would need a good “stand-in” attorney. No problem! It was a good stand-in who got her into the program in the first place, when counsel didn't even think of it. He immediately made a couple calls and got nowhere beyond voice mail. He also needed to bone up on Prometheus if he was to understand the argument.

He went online and pulled a Prometheus decision, a seating chart of the Justices, and some practical tips on getting in and attending a hearing at the Supreme Court. By late Tuesday he had read a Prometheus decision and plotted the bus and train options. He didn't have anyone to take care of his own case yet. It was just marijuana! When Dan called saying he could stand in, he knew he was on his way. The first time to the Supreme Courtroom! He had been to the building for papers once. High ceilings and marble are the rule-- even in the bathrooms.

The second decision was how to go. He feared it might be well-attended due to the concern of many about patents in this town. He had attended a Federal Circuit [Bilski] argument that was a packed house with a turn-away crowd. The practical tipsters said to get an early train, get in line, get a number, get breakfast, then get back in line. There is not much public space left when you consider the judges, the lawyers, the new admit-tee lawyers, invited guests and dedicated tourists. He much preferred the bus at rush hour since he could get a seat, see the world, and it didn't trap him in a tunnel every time someone jumped on the tracks. He wondered what a three-judge panel would decide. But time was of the essence, first-come-first-serve, so he opted for the train despite a longer walk from the station.

Though one lives in the Capitol, one goes decades without stepping onto its hallowed places. Almost all of the national history is reflected on Capitol Hill. He works blocks from the Mall but goes years without setting foot on it. The Inauguration was the last time, – the last one.

Preamble II: Something about Patents

The case was a threat to the patent establishment. No one cares about the quality of patents. It is only important that they exist so one can generate value from them. One can invent, apply, sell, license, threaten and sue over patents. Their owners and their lawyers need many, and the respect of such, since they are always expiring when business must go on.

Thiopurine drugs had been used for years to treat autoimmune disease, but they appeared to be fickle -- at times producing non-responsiveness and toxicity. Prometheus won a patent on administering this drug, measuring the metabolites, and then prescribing an adjusted dosage to avoid problems and improve the condition. This patent applies to [almost] all autoimmune disease. That is a lot, so it preempts the field for others to experiment, say the patent owners. If you give this drug, measure the blood and then prescribe accordingly, that uses the patent. The Mayo Clinic applied the drug, measured the metabolites, and used a different level to prescribe. Prometheus threatened them. They stopped but they were sued.

The District Court struck down the patent in a summary judgment, saying it was patenting a mere mental process of observing a natural phenomenon—the bloods reaction to the drug. They didn't have a patent on the drug-- just the process of reading and reacting to its effect.

Prometheus was of course upset that the Court disturbed its cash cow, but they took a lot of that cash and appealed to the Federal Circuit. There they found friendlier judges who reversed the summary judgment and reinstated the patent. The Mayo Clinic appealed to the Supreme Court. The Supreme Court was deciding Bilski, also about what is patentable subject matter. The Supreme Court sent the Mayo appeal back to the Federal Circuit to reevaluate its decision in the light of Bilski.

The Federal Circuit parsed it out again and sent the same result back to the Supreme Court. The Circuit held that the patented steps “are part of treatment regimes for various diseases using thiopurine drugs.” See Bilski, 545 F.3d at 963.” Prometheus v Mayo, 638 F.3d 1347, 1359. They point out that part of the patent might not be patent-eligible under Section 101, but it might be part of a steps in a patent that is. The astounding thing is that the drug and the blood tests are not new. Just reading the metabolites and acting on that information was patented. The Circuit finds this permissible since it specifies treating the diseases. So no one can take this knowledge and use it without paying Prometheus, not even the Mayo Clinic.

In the argument, Mayo was going first to try and reinstate their summary judgment invalidating the patent. They get 25 minutes. Then the Solicitor General for the United States was going to go for ten minutes. They had filed an amicus brief, not in support of either party, asking the court to do nothing. Then Prometheus would go, asking the Supreme Court to affirm the Federal Circuit. There were many amici. Those not in support of either party were really against any change and for Prometheus. Maintaining the Federal Circuit's pro-patent control is paramount to the process and many livelihoods. It is as if no one wants a “bright line” simple standard. Even with Bilski all methods and software patents are contestable. That's a lot of lawyer pin-dancing.

Preamble III: On Site

Pre-dawn Washington presented a warm, soft drizzle. One had to remember to use the umbrella lest he get slowly soaked. Added to the warm December air was the sight of a line in front of the Supreme Court of only a few dozen. It didn't even go around the corner. The lawyer felt relieved. He wouldn't have, if he had known how slim the margins were.

As he had asked—everyone who came up behind him asked if this was the right line. Almost everyone was new or rare to the Court. This was not a young or teenage crowd. This was a suit-and-dress crowd. Nevertheless, the males in couples did grope their partners as the lawyer killed time with a downloaded sudoku. Many discussions broke out amongst strangers, as people inquired which of the two arguments held their interest. Some didn't know, they just knew somebody involved in argument or Bar admission.

One guard made an announcement followed by another handing out numbered cards. He was handed 36. Fifty was the magic number. He could go in the Supreme Court, have breakfast, use the restroom, and wait again. The rest, maybe up to 200, would wait outside. Many -- or most -- would not get in. He went to the cafe and had breakfast, coffee and a sausage, egg and cheese. He wondered if the kitchen staff had hereditary positions. At 8:30 he got in the designated line by number. Upon this numerical re-acquaintance many conversations resumed. Promptly a tall white Capitol Hill policeman rudely shouted the crowd down, reminding that this was a “working building.” An initial informative request in the first place would have accomplished the same. It did not sound like the halls of freedom – or justice for that matter. His bellow disrupted more work than the herd.

The line moved quickly, and he was first seated in a back section with its curtains drawn back. One could see the Justices' bench and little else. The usher promised many a better seat if the reserved sections remained open at 10 AM. Fortunately, as promised, he moved forward to a back row but face-to-face with the Chief Justice. The room was dignified and old. No sleek glass or metal. There was wood and curtains and stone. It was high but not at all overbearing. Another usher directed him to move to one side so others could be put in the lousy section he had just left. He moved to the right, where there was a woman with a red dress.

She asked him what argument he was there for. He said the first patent argument. He asked her. Her husband was being admitted to the Bar of the Supreme Court as were about a dozen others. In response to a question, he explained why he was there and, more for himself, he talked about what she would hear.

Then suddenly and without much ado all were called to silence and the clerk chanted the opening announcement. Then the new Bar members were announced and sworn in with less ado and the first party was up and winging.

The Arguments: Mayo the Petitioner

Mr. Shapiro attacked the patent as a broad preemption of natural, physical processes. He was stunningly interrupted by the rookie Justice on the far left seat, Justice Sotomayor. It was stunning since she sounded so off-base. She asked about the “actual machine.” In an argument about treatment, knowledge and diagnosis, where neither the drug or the blood testing were at issue, “machine” sounded uninformed. Our reporter looked down. He was embarrassed for the Justice. [Transcript, p. 3] For her sake he hoped it was a term of art.

They then argued over the scope of the patent, Shapiro saying it was 400 to infinity, which bound all doctors to the patent and all autoimmune disease.

Justice Kennedy then intruded with a discussion on preemption and specificity, ironically using as an example a much more complex test. Shapiro warmed to this chat and flung out that Bilski held that a patent can't preempt a whole field “which this one does.” [p. 7.]

Justice Scalia joined this discussion, asking for a range that would not preempt. How do you limit patents? “It just seems to me not a -- not a patent rule that we could possibly apply.” [. 8, ll. 20-21.] Shapiro countered with his theme -- don't preempt doctors. Let them develop better test limits as the Mayo Clinic has.

Justice Kennedy popped back up and pointed out that it was a patent on a measurement of a result. [p. 10.] Justice Breyer then joined in on the topic of patenting a law of nature. He pointed out that you can't patent a law of nature but you can patent an application of the law of nature. His question becomes how much of an application. [pp. 10-14.] Shapiro adds an esoteric touch when he invokes a law of nature as “prior art.” [p. 14.]

There follows a very active discussion with Mr. Shapiro, with the Justices prodding him to answer the question on limiting applications of the laws of nature to a certain number range or certain diseases. Shapiro was all for limiting the patent and avoiding preemption and letting doctors cure people, but he couldn't give them a rule or formula though he could cite the usual suspected cases, Flook and Bilski. [p. 20.] He discusses their own past decisions with them, i. e. Breyer's. [p. 20.]

Your reporter couldn't keep up with the notes. Too many Justices were firing too fast. Shapiro had to be extremely well-prepared. The Justices treated him like their expert. They asked about patents affected by this decision. They ask him about the patent. He refers to pages of the joint appendix and lists the diseases. [p. 19.] He had to be ready for every possible question and still maintain his client's position. He had to react, not think, and rely on his immersion in the topic. This reporter had just spent a month in a trial so he appreciated immersion. He also understood partisanship. If a lawyer can't delude himself, how can he persuade a jury or the Court?

Shapiro did well with the hand he was dealt. He had some aces showing, and he huffed the health argument. He had just been invited to discuss the issue with nine very intelligent people who know each other well and do this very thing for months on end. One is personally always unnerved to be in a courtroom where he does not understand every comment and the role of every person present. Despite this supreme, exalted place, this was a working courtroom where all maneuvered toward decision in command of their respective nuances and with the tools at hand whether the topic be drug frisks or blood metabolism. The Federal Circuit declared Shapiro's a losing hand. A novel insight on nature that cures people was patent-worthy. Mayo should pay for this insight and cure people. Counsel surveyed the array. How many people did Shapiro need to persuade to reach five?

The United States: An Amicus Indeed …

Shapiro's time expired, and in seconds he was thanked by the Chief Justice and in the same breath he called “General Verrilli.” [p. 25.] The General does not want the Court to address this case. The Court is addressing it under the statute 101, whether it involves patentable material. He would much prefer if the examination for obvious and novel were confined to section 102 and 103 inquiries. He does not want to wipe out a fertile field of patentability. [p. 29.] Chief Justice Roberts was active in this discussion.

One wondered if the Chief's position revolved around how the General saw it. Left unsaid is the fear the General shares that the Court will do something simple and broad, like eliminate discovering nature from patenthood. Left even more unsaid is that they may do something that affects monopolizing parts of the planet's genomes, which is arguably part of nature. That would certainly leave billions of dollars un-concentrated and at the disposal of the masses. So counsel was rather convinced that the General who had filed an amicus brief in favor of no party was most in favor of the status quo just as the Federal Circuit had found it. This puts him in the Prometheus camp.

The General does suggest that the patent could be snagged under section 102: “But there was no new process that already exists, with a new inference drawn at the end, and that's why you can capture this under 102. ” [pp. 30-31.] He desperately wants the Court to not act under 101 and sweep a broad category of patents away. He wants to leave that in the Federal Circuit's brier patch. The Supreme Court, as this discussion shows, is looking for an answer -- how to limit such patents and impose some consistency on the Federal Circuit.

The General concludes succinctly voicing his worst fears:

And I do think if one were to say that that's an unpatentable natural phenomenon -- and this is what I mean about the destabilizing risk of thinking about this as a 101 issue rather than 102 or 103 you're going to call into question lots and lots, thousands in fact, of medical use patents where the patent is:
  • Administer a therapeutically effective dosage of this drug in order to treat this disease.
  • ...If one says that it's nonpatentable because all you are doing is patenting the application of a law of nature, you're invalidating all those process patents.
[pp. 32-33, 34.] He got that in discussing it with Justice Breyer. He had to be brief but he made his point.

Prometheus Speaks: A Word from the Front-runner

As suddenly as he arrived the General was gone, and Mr. Bress took the podium for Prometheus. One thought, what an ironic name. The mythological character ruined Zeus' monopoly on fire by giving it to mortals. Your reporter noticed that the Justices left him alone longer than any other speaker. He started off uninterrupted for almost three minutes.

During that time he explains his patent. But Justices Alito and Breyer channel the discussion into the day's topic, patenting nature, the never-resolved question. Justice Breyer offers examples of patents on the level of fertilizer and relativity. Bress handled himself well and won wider swaths of time than his predecessor. He was ready for preemption as he discussed the Morse patents:

In Morse there were two different claims that were being discussed, actually eight different claims being discussed. But one of the claims had to do with the actual invention of how you can make a telegraph work. And Morse described a working telegraph system and he got a patent for that.

And the second one that he tried to claim was the use of electricity to write at a distance. And the reason he didn't get that one is that it was expressed at such a level -- high level of abstraction, that it would preempt many, many things that he had never invented and never thought of.

[pp. 41-42.] Bress has specific inventors and inventions at the ready. He goes into the Diehr rubber patent by going back to the original Firestone rubber patent. He blithely moves on for minutes with no challengers until...
But, Mr. Bress, here's what you have not done. What you haven't done is say at a certain number you should use a certain treatment, at another number you should use another treatment. 1 guess the first question is why didn't you file a patent like that? Because that clearly would have been patentable. Everybody agrees with that. ...

And I think that the difference that people are noting or some people are noting is that this is not a treatment protocol, it's not a treatment regimen, all you have done is pointed out a set of facts that exist in the world, that exist in the world, and are claiming protection for something that anybody can try to make use of in any way and you are saying you have to pay us.

pp. 45-46. Justice Kagan lays it on the line, a jolt.

Bress recovers by diving into specifics, science even, where the judges dare not challenge him. He gains a few minutes without molestation. Justice Breyer tries again to make him give an example of a patent that just reveals new information without any new process. Bress wants to answer but not help them too much. He is clearly knowledgeable enough to help them, but he doesn't want to cross his own position. Justice Breyer and he also get into the novelty problem in that Prometheus succeeded with the same methods where others failed. Bress of course assures the court that success is its own reward. The result is successful. No matter it used prior methods. *They* found the answer. [pp. 46-52.]

At the end, the Chief Justice ends with questions about 101, 102 and novelty. Bress wants nothing to do with 101. The other sections handle it more precisely, says Bress. They don't relieve and free the doctors, say the judges.

Mayo's Last Word

The Chief tells Shapiro he has four minutes of rebuttal. Shapiro pounds away on the health angle. Justice Scalia floats his opponent's argument that the patent should just be contested as not useful. Shapiro tees off:

It's important that 101 be the robust test here. This is the only provision under which this Court has issued decision after decision for 150 years protecting the public domain. ...This is very important to – to doctors around the country.
[p. 57.] He stresses that it has cost the hospital millions to defend this suit twice to the Supreme Court, and they still face treble damages and an injunction. [p. 58.] He accuses Prometheus of trying to preempt diseases that they never researched. [p. 59.] He concludes:
So we urge the Court to protect the research process here that's so fundamental to American health and to the economy and the healthcare industry.
[p. 59.] And so it was submitted with insightful questions, illustrative examples, many answers and no apparent consensus.


Abruptly it was over. Just as fast as the lawyers could grab their briefcases and leave, the next crew was in their places and being announced. Your reporter sat there to see if it was anything interesting. He had gone to all the trouble to be sure to get in, so he felt he may as well check on anything interesting or historic. The case involved the State of Montana taxing some utility companies. It involved riparian rights and frontier precedents before statehood. It would be historically fascinating, the utilities using the Feds to beat down the State government. But counsel could put no more effort into following the arguments. He got up and left. He retrieved his coat with the dead phone still in the pocket. He deliberately left by another exit, the big steps down the front. It was no longer raining, and he surveyed the East side of the historic Capitol. He headed by foot toward the local courts to check his folders and his problematic marijuana case.

He walked close to the East lawn of the Capitol. There he saw some of the cities most venerable citizens, the trees, many with memorial plaques. He read a few names. None were familiar. He hoped the garage didn't extend under the lawn. The Hill has its own police force. It is a handy entity that protects the public, the Hill from the public, and probably the congressmen from themselves. Unlike most places in town he could remember nothing but a traffic case from the area. Oh, he remembered a garage employee also sold coke somewhere up here.

As he passed to the West side he noticed police cars up Constitution Avenue and no traffic. At about first street he saw a parade turn on to Constitution a few blocks ahead. They were coming toward him a couple blocks away. Who were they? They were in red. There were about a hundred. They carried banners and chanted. He figured it was the Occupy people.

At the corner he stepped to the curb to listen and try and read some signs. For the second time that morning a rude policeman shouted at him, this time from across Constitution Avenue, “Stay right there! Don't come over!”

“What does Democracy look like?” The chant back, “Look here!” They were heading toward the seat of power, the Hill. Good luck without lobbyists or lawyers. Counsel wondered if he might become a witness to a case he might pick up if he stuck around. He went on to court to buy his stand-in lunch.

The Washington Post's Robert Barnes notes that Justice Breyer almost had to recuse himself:
Breyer was one of the most active questioners in the case but almost had to sit it out. Prometheus did not inform the court until Tuesday night that it had been purchased, after the court agreed last term to hear the case, by Nestle, a company in which Breyer’s wife, Joanna, owned stock. She sold it Wednesday morning before the arguments.
In case you were wondering what kinds of things might lead a judge to recuse himself, now you know.

Barnes also highlights, as did Webster, the one of the two questions from the Justices that didn't make my skin crawl, from Justice Kagan:

Justice Elena Kagan summed up the argument for those who wonder whether Prometheus had actually invented anything.
“This is not a treatment protocol, it’s not a treatment regimen,” Kagan said. “All you have done is pointed out a set of facts that exist in the world . . . and are claiming protection for something that anybody can try to make use of in any way, and you are saying, ‘You have to pay us.’ ”
Richard P. Bress, an attorney for Prometheus, said the company had gone to great expense to determine the proper levels and gave doctors valuable information. Before the test, he said, “doctors had no way to tailor for each individual, based on their metabolism, the right dosage of these powerful but potentially toxic drugs.”
The new proffered standard, then, seems to be, from Prometheus's standpoint, whether you spent a lot of money on research. And as Mayo pointed out, what if your numbers are wrong and patients are harmed because everyone is terrified to change them for fear of being sued?

I know. This shouldn't even be a question on the table. Sadly, it is.

The other question that made sense was from Chief Justice Roberts:

CHIEF JUSTICE ROBERTS: So I have a great idea. You take wood, you put it on a grate, you light it, and you get heat. That recites a series of acts performed in the physical world that transforms the subject of the process, the wood, to achieve a useful result, which is heat. So I can get a patent for that?
Believe it or not, the answer was no, not because it's not patentable subject matter, but because it's not novel. So cavemen entrepreneurs could have patented it?

For anyone who wants to read some commentary from the Prometheus point of view, IP Watchdog has some here and here. I'm not going to pretend, however, that it's only fair to present both sides here at length. I'm giving you the links. Here's the brief [PDF] by Prometheus, so you can bathe in their thoughts. I note that they do mention machines in the introduction.

It's like the famous signature one Groklaw member uses:

Some say the sun rises in the East. Some say it rises in the West. The truth is probably somewhere in the middle.
The simple truth is that patent law in the US has become dangerous and harmful. And profoundly depressing.

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