Earlier today, at 10:05 am precisely, the United States Supreme Court heard oral arguments in the case styled Mayo Collaborative Services v. Prometheus Laboratories. A press release issued by the AIPLA sums the cautious optimism of many: the Supreme Court “appeared to move closer to the Federal Circuit’s understanding of patent eligible subject matter.” Of course, no one will really know for some time, and there is certainly enough reason to worry after the oral argument. Predictably Justice Breyer seems ready to rule virtually all process claims unpatentable, and surprisingly Chief Justice Roberts seemed more in agreement with Breyer than anyone else.
In all likelihood it will be at least a couple months before we know the outcome of this case, which holds in the balance the future of medical treatment claims. In fact, the average length of time for the Supreme Court to decide patent cases since Markman in 1996 is about 3 months. The most recent Supreme Court cases have lingered on average over 5 months. How the Supreme Court operates is one of the better mysteries in our form of government, and there will be absolutely no signaling of when to expect a decision. The Supreme Court will just one day announce a decision. Notwithstanding, I’m going to hazard a guess that we will have a decision between the end of March 2012 and the end of May 2012. I don’t see this as an end of the term opinion.
For additional commentary and summary of the Supreme Court’s oral argument see:
Supreme Court Tackles 101 in Mayo v. Prometheus
Having dispensed with the obligatory predictions, allow me to turn my attention to the substance of the oral arguments. Leading off today was Attorney Stephen Shapiro, who represented Mayo. He started with authority:
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.
Shortly there after a highly skeptical Justice Sotomayor intervened, repeatedly challenging Shapiro’s contention that the patent claims at issue are enormously broad. “It actually is much narrower than that,” Sotomayor said. Justice Sotomayor then continued to push, dissecting the process steps, saying “Tests do two things: they measure something and therapeutic range does something else. The test can happen. The doctor gets a number. What the doctor does with that number is a different issue.” In short, Justice Sotomayor did not seem to be buying the Mayo argument.
Justice Kennedy then chimed in, placing the Diehr hypothetical on the table, essentially asking if there is constant monitoring and an established protocol whether at some point the process may be patentable even if there is preemption. Shapiro conceded it may be patentable, but then offered his view of what the Supreme Court said in Bilski: “you can’t preempt a whole field, a broad field with — with your patent, which this one does.”
Frankly, I don’t see that in Bilski. Apparently neither does Justice Scalia, who immediately cut Shapiro off saying: “I’m not comfortable with that. I mean, it depends on how broad it is.” Scalia then jousted with Shapiro probing the limits. In an exasperated way Scalia said that Shapiro was not offering “a patent rule that we could possibly apply.”
Justices Scalia, Kennedy and Breyer then took Shapiro on a discussion of the parameters of patenting nature. Obviously, nature cannot be patented, but at its core in this and other cases is the reality that laws nature are at work in every invention. Scalia said: ” 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 natural. It affects the human physiognomy in a certain natural way.” This was echoed by Justice Kennedy.
Justice Breyer, always the professor, said: “I think it’s hornbook law that the law of nature cannot be patented. It is also hornbook law that the application of a law of nature can be patented.” He went on to point out the language of the claims that speak to application of a law of nature, such administering a drug and determining a level. “So they say those two words, administer the drug, determining the level, are the application of the law of nature that they found. Now there something odd about that in your view at least, and I want to know what.”
Given that Justice Breyer is the one who penned the dissent in the Lab Corp. case, where the Supreme Court dismissed certiorari as having been improvidently granted, if Mayo loses him they have no chance to prevail. Justice Breyer seemed to be serving up a softball question to get Shapiro to explain that what Prometheus did was simply add a trivial step to what was an underlying law of nature. Justice Scalia, however, was not buying. Here is the question and answer sequence:
MR. SHAPIRO: After Bilski, which reaffirmed what was said in Flook, a conventional step isn’t sufficient, because that’s just adding a law of nature to prior art, and prior art plus prior art equals nothing that is patentable under the Flook decision. And also, the step that you add has to narrow your preemption —
JUSTICE SCALIA: Well, excuse me. Does that render it nonpatentable because it’s not novel? Is that the reason why it renders it nonpatentable?
MR. SHAPIRO: Well —
JUSTICE SCALIA: That’s not what we’re talking about here; we are not talking about novelty, are we?
Finally, we have gotten to the nut. Regardless of whether Supreme Court precedent says otherwise, it is completely illogical to say that adding conventional steps means an invention is deficient under 101 as not being patent eligible subject matter. Justice Scalia is 100% correct. That is a novelty argument. The patentable subject matter inquiry is one that asks whether the claimed invention is patentable even if it is new and even if it is non-obvious. Shapiro, lead by Justice Breyer, make a fatal mistake of patent law. Section 101 merely ask whether there is an invention present that the law is wiling to recognize with a patent. Whether it is sufficiently novel or whether it is only comprised of conventional steps is an inquiry under 102 and 103.
Then Justice Ginsberg asked another critical question: why didn’t you raise 102 and 103? The response: The medical community needs “a robust section 101 standard because under 102 and 103 you could patent E=mc2. That’s new, its nonobvious; but you cannot patent it under 101 because it’s a law of nature.” What Shapiro conveniently left out, however, is that there is no application recited in the equation E=mc2. It is merely descriptive. Simply stated, the Prometheus claims are not naked, descriptive statements of a law nature as is the equation E=mc2. In the Prometheus claims there is at least a modicum of application interjected, as even Justice Breyer had to admit. This application should remove the inquiry from 101 and should put you into novelty (102) and nonobviousness (103).
Justices Breyer and Sotomayor took turns pushing Shapiro to given them some kind of bright line test. Time and time again Shapiro would respond that Supreme Court precedent says that patents cannot preempt a broad field. That is simply not true and is a disingenuous argument. You can, in fact, preempt a broad field if you have invented something that is broad. In this regard the Shapiro argument was like fingers on a chalk board for me, laying out the “patents are evil” argument, not wanting to acknowledge that there is nothing wrong with a broad patent if the invention is commensurate with the broad claims. In this sense Shapiro and his client Mayo seemed to assail the patent system at its core making an argument that if the invention is too broad then no patent should issue.
I guess fundamental and important inventions ought not be patentable because they cover too much space. Really? Did I miss that in the Constitution, or buried in Title 35 of the United States Code, or somewhere in Title 37 of the Code of Federal Regulations? No. There is no support for the absolute statements made about patent law by Shapiro. I just hope the Supreme Court knows enough about patent law to appreciate that, which is far from a given.
After all this dancing and jousting, Justice Kagan was heard from for the first time, asking a critical question to probe the line being drawn: “Mr. Shapiro, is there a patent that Prometheus could have written that you think would have met the 101 test?” Shapiro explained that if the claim included a treatment protocol it would have been fine in his estimation. Kagan probed further, asking why that mattered. Shapiro curiously responded: ” We shouldn’t require Americans to get one opinion from Prometheus when they want an opinion from Mayo Clinic.” Justices Kagan and Kennedy seemed perplexed by that answer, as am I. So the Mayo argument exposed seems to be that Americans want Mayo to be able to infringe without paying royalties to Prometheus. I’m not sure I have ever seen an “its OK to infringe if Americans want Mayo” defense to patent infringement codified in Title 35.
Next up was the United States Government, acting as amicus curiae, and largely supporting Prometheus. That is significant because where the United States is not a party to a litigation the Supreme Court adopts the government view in upwards of 75% of cases.
Arguing for the U.S. was Solicitor General Donald Verrilli, Jr.. Verrilli started by saying:
Each party in this case has got a valid point. Mayo is correct that you can’t get a patent by tacking a mental step onto an utterly conventional process for administering drugs and testing their effects. But that is an issue under sections 102 and 103 of the Patent Act.
And the government is right. This, however, didn’t deter Chief Justice Roberts from exposing his naivety regarding the most basic of patent law issues.
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?
GENERAL VERRILLI: No. It’s not novel, and its obvious.
CHIEF JUSTICE ROBERTS: No, no, no, no. Well, let met put it —
GENERAL BERRILLI: You can’t get a patent for it.
CHIEF JUSTICE ROBERTS: That’s patent eligible?
GENERAL VERRILLI: But that’s our — that’s our point, Mr. Chief Justice, that the right way to look at this issue is under 102 and under 103…
I guess Chief Justice Roberts wanted to pretend that a method of igniting wood to produce heat was novel and non-obvious. That type of ridiculous hypothetical would rear its head again repeatedly. Assume something that is clearly not patentable under 102 and 103 is novel and non-obvious. Should it be patented? OF COURSE! Which part of this are you not understanding? The first person to invent something is entitled to a patent, so presumably has Neandrathals had a patent system the caveman who invented a method of creating fire would have been awarded a patent. And rightfully so, after all that whole fire thing when it was first invented was fairly revolutionary, don’t you think?
The Chief Justice seemed to be exceptionally poorly prepared if you ask me. Mr. Chief Justice, just because something isn’t novel or because it is obvious has nothing to do with whether the invention is patent eligible subject matter. You make the same mistake as the anti-patent zealots who want to collapse all of the patentability requirements into 101. Just because 101 is about patent eligibility doesn’t mean a patent will issue upon satisfying that single, threshold inquiry. There are distinct considerations in three distinct sections of the statute — 101, 102 and 103.
Not to be deterred, and not yet finished demonstrating a lack of comprehension of the patent process and what it means to invent, Chief Justice Roberts actually went on to ask: “It is easier to throw something out at the threshold level, isn’t it, than to move further down the line?” OMG! Because it is easier we should just ignore the statute and collapse all the patentability requirements into a single inquiry under 101? Did he really say that? As unbelievable as it seems, yes, the Chief Justice did say exactly that, which is extreme even for the Supreme Court in a patent case.
Verrilli would go on to repeat and defend his statement that 101 is not appropriate, but that the claims at issue should be unpatentable under either 102 or 103, or presumably both. He ended his argument explaining that if 101 is used to defeat these process claims because they are merely “patenting the application of a law of nature, you’re invalidating all those process patents.” Perhaps a little over-broad, but not by as much as many will want you to believe.
Next up was Attorney Richard Bress, arguing on behalf of Prometheus. The Supreme Court seemed extremely hot in the early going, particularly with Mr. Shapiro, but Bress was given nearly two-and-one-half pages of transcript text before he received his first question. Was the Supreme Court spent after peppering Shapiro and then having more of a manageable conversation with Verrilli? Were they just buying the Prometheus argument? There was certainly a lot less nit-picking of the Prometheus argument.
Enter Justice Breyer, who asked a rather ridiculous hypothetical, probing to see whether this invention would be patentable. Breyer’s hypothetical:
Patent: A method for determining when there is too little or too much fertilizer. Put some fertilizer in a field and measure how much there is, wherein less than a quarter of an inch is too little and wherein more than half an inch is too much.
Bress said that wouldn’t be patentable because it is not novel. Breyer than says to assume it is novel. Really? Perhaps we should assume the Queen of England is a man while we are at it, but wouldn’t that make her the King? Oh, right, details getting in the way of an otherwise fine hypothetical. My bad!
Ridiculous hypotheticals from uninformed Judges do nothing to forward any relevant, intellectually honest discussion. We can assume whatever we are told to assume, but just because you call a dog’s tail a leg doesn’t mean that the dog has 5 legs. The dog still only has 4 legs regardless of what you call the tail! If there is no prior art and an inventor invents exactly why should a patent be denied? Time and time again it seemed that Justice Breyer and Chief Justice Roberts believed that very broad inventions should not be patentable under any circumstances even if they are new and non-obvious. James Madison must be rolling over in his grave, and so is Thomas Edison.
Justice Breyer was also enamoring himself with the fact that he could conceive of ways that E=mc2 could be made patentable. Breyer asked: “What has to be added to law of nature to make it a patentable process?” The very question in and of itself demonstrates an acute lack of understanding. Nothing added to a law of nature makes a patentable process. Laws of nature are simply not patentable and no word games played by Justice Breyer will change that. What is, however, patentable is a unique application of a law of nature. That very point has been confirmed and reconfirmed by the Supreme Court numerous times. So nothing added to a descriptive mathematical equation, such as E=mc2, can render a descriptive mathematical equation patentable. But if you come up with process steps that rely on that equation in a particular context then you have a patent eligible process. Exactly how and why this is difficult to comprehend is almost perplexing to me.
Bress, who was continually given long stretches of time to respond and make argument uninterrupted, turned to explaining what the Supreme Court actually ruled in Bilski. In my estimation he did an outstanding job. Bilski didn’t say you cannot have a broad patent, as Shapiro tried to argue, or that issues of novelty are to properly be considered under 101. Rather, Bilski dealt with a mental process and there was just nothing concrete and tangible about it. Yes, as the law of Bilski has developed at the Federal Circuit and at the USPTO it seems that Judge Rich was really correct with the State Street standard, but that is another issue for another day.
If you look at Bilski, a general way of — a general — the concept of hedging. Now Bilski was limited, admittedly and this Court discussed it and said, well, they tried to limit it with the conventional step of having the inputs determined by random analysis techniques. I would like to focus on that for a second, because the Court said that was not significant extra solution activity. It wasn’t enough to either render the process a physical one in the world or to narrow its scope. Well, why is that?
Because random analysis techniques are themselves just an abstract idea. So you were adding one abstract idea to another one and it’s no wonder that the Court found that it didn’t narrow it to a patentable scope.
Justice Breyer, undeterred, continue to come up with ever more bizarre hypotheticals. He at one point said he wanted to tall about whether there are patents on processes that generate useful information. A confused Bress seemed to frustrate Breyer a bit, who said:
I’m thinking a a patent to find useful information that chickens can only east so much chicken food. That nobody has ever known before, you know. Okay. Now there’s something like that. But they tell you the useful information that’s going to be found right in the patent. In other words, we have a patent to discover some useful information and here is the useful information. And now here’s — see, that’s what they’re complaint —
Justice Breyer is thinking about chickens? I’ll pause here and let you insert your own Supreme Court chicken joke…
Bress’s response: “I’m not sure that I am understanding, Your Honor…” You and me both Bress! Chicken patents and patents on fertilizer that recite a process that is clearly not novel but to which novelty is to be assumed. Yikes! Whatever opinion Breyer writes, and I sure hope it is the dissent, will be one interesting read!
Justice Scalia then asked a series of questions picking up on Justice Sotomayor’s earlier questioning about whether no other test could possibly be pursued by Mayo.
JUSTICE SCALIA: Suppose somebody thinks you’re wrong, that the numbers you’ve come up with are wrong. And they want to develop better numbers that will help the medical profession. Your patent precludes them from doing that. Am I right?
MR. BRESS: No, Your Honor.
JUSTICE SCALIA: No?
MR. BRESS: And let’s explain why not… So you’ve got Dr. el-Azhary, who believes that the right ceiling level is 300. Okay? So if she sees a patient and says, “I’m going to associate 290 with toxicity,” that won’t violate our patent in the least.
Our patent says if you associate over 400 with toxicity, that’s within our range. If she associates 290 with toxicity, no violation.
The trouble with this argument is that it isn’t exactly what Mayo argued. On rebuttal later Shapiro would explain that Mayo found that the right range was 450 to 700, which would be blocked by the patent. So, as is typically the case, you have to take both sides with a grain of salt. Shapiro repeated would say that no test could be created without violating the patent, presumably for the purpose of making the patent claims seem far broader than they are, thereby feeding his preemption argument. On the other hand, Bress answered Scalia’s question directly but probably left an impression that isn’t exactly correct. The Mayo test would fall within the claim, which is the whole point of the patent infringement lawsuit in the first place.
As it turns out, Justice Breyer was not the only one who seemed off in the distance. Once again Chief Justice Roberts came back to wanting to simply dispose of all these cases with 101. He actually said to Bress: “the problem with your whole approach is that every time you’re pressed on 101, your answer is to fall back to 102 or 103 or the utility part of 101. And I’m just wondering why it’s beneficial to essentially elimiate 101 and say oh, we’ll catch everything later on.” You have to be kidding me! This stuff isn’t that hard, is it? Shouldn’t a bunch of Ivy Leaguers be able to figure this out?
Had the Chief Justice presented that to me I would have pointed out that even assuming the approach “eliminates 101″ his approach would eliminate 102 and 103, which would nullify a greater portion of the statute, thereby making his interpretation more chaotic. But seriously, wanting to reserve patentable subject matter for 101 and refusing to collapse 102 and 103 into a completely different statutory provision is just sorta common sense and basic first year law student statutory interpretation.
Perhaps we should take the Chief Justice’s “expedient” approach to the logical extreme and really save time for the district courts. Why not dispense with the presumption of innocence because upwards of 95% of the people police arrest are guilty of something. So why not just throw them in jail rather than going through the paces required in the Constitution and a variety of statutes? I mean — why apply two, three or four statutes when you can just apply one, or even better when you can just look at someone and tell if they are guilty! Obviously nonsensical when you talk about Criminal Law and Constitutional principles, less obviously nonsensical when you talk about doing the same thing in a patent case, and therein lies the problem of the Supreme Court being involved in patent decisions.
All in all it seemed to me that the majority of the court seemed more skeptical about the Mayo position and more supportive of the Prometheus position. That being said, it is extremely troubling to contemplate the possibility that Chief Justice Roberts was more in tune with the thinking of Justice Breyer. It is also disheartening to see such a fundamental misunderstanding of patent law on the part of the Chief Justice. At the end of the day the Justices of the Supreme Court will say what the law is on this issue, but sometimes it is hard to imagine a less qualified bunch to opine on a patent issue.