On December 7, 2011, the Supreme Court heard oral arguments in Mayo Collaborative Services v. Prometheus Laboratories, Inc. While the issue before the Court is patent-eligibility under 35 USC § 101, the arguments veered into the topic of patentability under 35 USC §§ 102 and 103, whether the Court intended to raise that issue or not.

The Claims At Issue

Because much of the oral arguments focused on the reach of Prometheus’s claims, it is helpful to remember the claim language at issue. The claims relate to personalized methods of optimizing the dosing of specific drugs used to treat gastrointestinal autoimmune diseases. Representative claims from the patents are set forth below.

1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) administering a drug providing 6-thioguanine to a subject having said immune-mediated gastrointestinal disorder; and
(b) determining the level of 6-thioguanine in said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the amount of said drug subsequently administered to said subject and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

46. A method of optimizing therapeutic efficacy and reducing toxicity associated with treatment of an immune-mediated gastrointestinal disorder, comprising:
(a) determining the level of 6-thioguanine or 6-methylmercaptopurine in a subject administered a drug selected from the group consisting of 6-mercaptopurine, azathiop[u]rine, 6-thioguanine, and 6-methyl-mercaptoriboside, said subject having said immune-mediated gastrointestinal disorder,
wherein the level of 6-thioguanine less than about 230 pmol per 8×108 red blood cells indicates a need to increase the[] amount of said drug subsequently administered to said subject, and
wherein the level of 6-thioguanine greater than about 400 pmol per 8×108 red blood cells or a level of 6-methylmercaptopurine greater than about 7000 pmol per 8×108 red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

For more background and analysis of this case, see my previous articles and the articles on Foley’s Personalized Medicine Bulletin blog. For a more detailed discussion of the oral arguments, see this article on Foley’s Personalized Medicine Bulletin blog.

Question Presented

As stated in Mayo’s Brief, the question before the Supreme Court 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 patent effectively preempts use of the naturally occurring correlations, simply because well-known methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

As stated in Prometheus’s Brief, the question is:

Whether the Federal Circuit correctly held that concrete methods for improving the treatment of patients suffering from autoimmune diseases by using individualized metabolite measurements to inform the calibration of the patient’s dosages of synthetic thiopurines are patentable processes under 35 U.S.C. §101.

Questions Asked

Judging from their questions, most of the Justices appear to be keenly interested in this case.

An exchange with counsel for Mayo (at pages 11-13 of the transcript) reflects the question that at least Justice Breyer was struggling with:

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. . . .

And so … how much has to be added [to a claim] to make it an application of a law of nature? And how would you put that [test] in[to] words?

He raised the same issue in an exchagne with counsel for Prometheus (at page 40 of the transcript):

JUSTICE BREYER: No, no. My question is, what has to be added to a law of nature to make it a patentable process? . . . And if you put too little in the answer to that question, I believe I can take things that like E equals mc-squared and make them patentable. And if you put too much in, you are going to wreck your own case.

MR. BRESS: Your Honor, I will try very hard not to do either.

I don’t think that either party (or the Solicitor General) offered a direct answer. Now the big question is whether the Court will provide its own answer when it decides this case!

Muddled Questions of Patent-Eligibility (101) vs. Patentability (102/103)

One of the legal questions before the Court is whether it is appropriate to “peek” into the issues of novelty and non-obviousness when making a determination under 35 USC § 101, such as by only considering whether the novel steps recite more than a natural phenomenon. Even in trying to probe this issue, it was difficult to separate the concepts.  Chief Justice Roberts seemed to have a particularly hard time getting a straight answer.

First, there was this (excerpted) exchange between Chief Justice Roberts and the Solicitor General (at pages 26-27 of the transcript):

CHIEF JUSTICE ROBERTS: I see on page 9 of your brief you say: “A classic patent-eligible process recites a series of acts performed in the physical world that transforms the subject of the process to achieve a useful result.” So I have a great idea. You take wood, you put it on a grate, you light it, and you get heat. That is -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 it’s obvious.

CHIEF JUSTICE ROBERTS: No, no, no, no.

GENERAL VERRILLI: You can’t get a patent for it. . . . [T]hat’s our point, Mr. Chief Justice, that the right way to look at this issue is under 102 and under 103.

Later, the Chief Justice made this comment to counsel for Prometheus (at page 54 of the transcript):

CHIEF JUSTICE ROBERTS: Well, it seems to me that’s your — 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 eliminate 101 and say oh, we’ll catch everything later on.

The most honest answer to that question appears to be that the jurisprudence surrounding §§ 102 and 103 is relatively well-understood, while that surrounding § 101 is a quagmire.  As counsel for Prometheus stated, “when the problem is obviousness, the right place to go are the sections that actually have very clear rules on how to apply those.”

What Is The Question?

The difficulty I have with the “preemption” analysis is that before you can ask whether a claim impermissibly preempts a natural phenomenon, you have to decide the scope of the natural phenomenon that must not be wholly preempted. Here, Mayo defines the the natural phenomenon somewhat narrowly while Prometheus defines it somewhat broadly.

The thrust of Mayo’s arguments is that the Prometheus claims do not satisfy § 101 because they wholly preempt a natural phenomenon relating to the metabolite levels of the recited drugs. As stated at page 5 of the transcript:

[A]s a practical matter, there’s no room for anybody else to offer a metabolite test.

Prometheus saw it differently, as stated at page 45 of the transcript:

Now, we are not trying to [claim] the general broad idea that you can use metabolite readings after you administer the drug to determine . . . what the best level of the next administration might be. . . .  What we are talking about here is A, a very specific class of drugs, the thiopurines used for———

Another difficulty that I have with the “preemption” test is that patents are intended to give the patent holder a right to exclude—to preempt—certain subject matter. When a patent relates to a specific diagnostic or therapeutic method, it necessarily relates to a natural phenomenon. When does such a patent improperly preempt that natural phenomenon? 

If I find that drug X cures disease Y, would a method of treatment patent impermissibly preempt the natural phenomenon that drug X cures the disease?

If I find that a large class of drugs cures a large class of diseases, would a method of treatment patent impermissibly preempt the natural phenomenon that all of those drugs cure all of those diseases?

(No question has been raised regarding the patent-eligiblity of therapeutic method claims, but Justice Scalia did ask the Solicitor General about them, and the “preemption” test could be applied in the therapuetic context.)

Didn’t the Founding Fathers decide that granting patents promotes the progress of the useful arts by securing for limited times to inventors the exclusive right to their respective discoveries? Does that mean that “preemption” for a limited time strikes an appropriate balance between the competing interests championed by the parties and amici?