My Mayer Brown LLP colleagues and I just filed a certiorari petition in this patent case, and I thought some of our readers would find the issue very interesting (I know I did). As we argue in the petition,
Prometheus’s claims … attempt to exclude the public from using the results of basic human metabolic testing in the research, diagnosis, and treatment of disease. They do so by claiming protection for the process of recognizing a correlation between the level of certain chemicals in the patient’s blood and the patient’s health…. [T]he claims are silent as to what should be done with such correlations and as a result purport to cover and thus preempt all possible uses of the biological correlations….Prometheus’s broad patent claims attempt to turn a physician’s thought processes into infringement…. Importantly, Prometheus’s claims do not recite what is to be done once the physician recognizes the correlation [based on blood test results]. As a result, the claims cover and preempt all such uses. They begin and end with observation of the test results. What the physician might do with that observation is irrelevant because simply thinking about the subject suffices to infringe the patent. As Prometheus’s expert testified, if the physician reads an email with the test results, it would not matter if she “crumples it up, throws it away, reads it, acts on it, doesn’t act on it, any assumptions you want to come up with.” The physician infringes the moment she recognizes the correlation.
Plus this is the issue that the Court agreed to hear in Laboratory Corp. of Am. Holdings v. Metabolite Labs., Inc., 548 U.S. 124 (2006). The Court didn’t decide the question in Labcorp because the question hadn’t been properly preserved below — but in our case it has been preserved, so it seems pretty likely that the Justices will be interested in our case just as they were interested in that one. (Knock wood.)
UPDATE: PatentlyO blogs about the case as well, as does Patent Baristas. The due date for amicus briefs, by the way, is November 25.
Soronel Haetir says:
I would hope only the test itself, if it qualifies for protection, could be patented. I also wouldn’t be surprised if this simply gets held until one of the business model cases gets a ruling and then sent back for a second look.
October 28, 2009, 10:22 amkrs says:
Same thought as S.H.–the result might be a GVR in light of Bilski, which may well be what the petitioners want.
October 28, 2009, 10:25 amyankee says:
How can “recognizing a correlation” possibly meet the nonobviousness standard?
October 28, 2009, 10:41 amAnon says:
Yankee,
It can’t. But what’s the point of your question? The claimed method is not “A method comprising recognizing a correlation.”
Besides, the question is 101, not 103.
October 28, 2009, 10:55 amCleanville Tziabatz says:
Step 1: Let’s check the statute:
“Whoever invents or discovers any new and useful process . . . or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.”
Step 2: Is Prometheus claiming a “process”? Answer: yes. some steps in the process involve ratiocination, but mental processes are processes too (hence the name).
Step 3: Legal result: the claim is statutory subject matter.
Step 4: What about legal cases that suggest a different result? Answer: Doesn’t matter.
Step 5: Why doesn’t it matter? Answer: Because the plain meaning of statutes trumps precedent. Every time.
Step 6: Appeal dismissed. Costs to Prometheus.
October 28, 2009, 11:12 amegd says:
Actually, a substantial number of patent practitioners (at least judging from a recent CLE) are arguing that a lot of the claims being addressed under 101 are also invalid under 102 and/or 103. These cases should then be dealt with substantively under these sections, rather than procedurally under 101.
I submit that this is a bit of an exaggeration. Thinking about the correlation doesn’t infringe the patent, because in order to infringe you must also meet steps 1 & 2 – administering the drug and determining the presence and amount of byproduct.
I think, based on the CAFC’s decision, that the CAFC is giving little to no patentable weight to the “wherein” clauses of Claim 1. If the claims are unpatentable without these clauses, then the claims should be unpatentable, under 102 or 103, with these clauses.
No need to drag 101 into the case.
October 28, 2009, 11:23 amCleanville Tziabatz says:
Further thought: our instinct against letting patents cover mental processes is better addressed as a limitation on infringement. The valid concern is that patentees will go after people based on their mental states, and mental states can be hard to prove, and it can be invasive to probe into someone’s mental state. We know this because many areas of the law, like mens rea law and negligence law do attempt to probe into people’s mental states. HOWEVER, if infringement law is made to require direct and tangible evidence of any mental state claim element in order for infringement to be deemed to exist, then this concern is addressed in a targetted manner. This mental states problem in patent-eligible subject matter law should not be treated as some sort of ontological issue, as many courts seem to do, but rather as an evidentiary issue. Sure, we should not be allowed to presume patent infringement as easily as we presume mens rea of a state-represented defendant, but, if the evidence of the mental process is direct and tangible, then it means that we are dealing with a mental process that is memorialized and can be controlled and optimized and improved in the way that any other “useful art” is improved. On the other hand, if the mental process is ad hoc, and not reduced to a tangible form, we probably want to keep the patent courts out of it.
Not only would my proposal increase, using patents, the incentive to make improvements to mental processes that are reduced to a tangible form, but it would also incentivize commercial actors to start memorializing mental processes that would otherwise be unspoken and ad hoc. This is an improvement on the way things are improved — what might be termed a meta-improvement.
October 28, 2009, 11:29 amAnonymous Coward says:
Could you claim prior art, in recognizing correlations? I mean that process is extremely common.
October 28, 2009, 11:31 amAnon says:
edg:
The whole point is to drag in 101. Remember Comiskey? 103 rejections appealed to the BPAI, then appealed to the Fed. Cir.
The Fed. Cir. raised the 101 rejection sua sponte…and never addressed the 103 issue that was appealed.
(aside: I’m glad Comiskey is not my client. Imagine having to explain that you’ve now amended the claims to get past the 101 rejection only to fight the 103 rejection, again, all the way up through the BPAI and Fed Cir. Another, what, 8 years?).
October 28, 2009, 11:37 amCleanville Tziabatz says:
Don’t you get that time on appeal back? Time shifting his patent term could be the best thing that ever happened to him. Last legit submarine tactic.
October 28, 2009, 11:40 amBlargh says:
How is this different from what any doctor does with any drug? Not familiar with patent law, but isn’t there a nonobvious requirement?
October 28, 2009, 11:49 amCleanville Tziabatz says:
Maybe it was not obvious to look at 6-thioguanine, as opposed to 4-thioguanine or 6-thioguanane or some other thing.
Maybe it is not easy to look at 6-thioguanine and thought not to be worth it because it would yield only marginally valuable information that was expensive to obtain.
Maybe it was not obvious to check the level of 6-thioguanine on a per red blood cell basis, as opposed to a per millilitre basis or a per gram basis.
Maybe it was obvious after all.
I doubt anybody on this thread is really quilified to judge that.
October 28, 2009, 12:01 pmegd says:
Sorry for not being clearer. Satisfying 101 should be a very minimal standard. As long as you’ve got something “made by man,” you should have patentable subject matter.
October 28, 2009, 12:30 pmbreyer says:
how can you post on your petition and not mention that the SCt is hearing argument on the 101 issue in Bilski in a month or so????!!!
October 28, 2009, 12:33 pmCato The Elder says:
A bit off-topic, I suppose, but you should know that the site has been refusing to load and throwing off “database errors” for the past week or so. It’s become more than an inconvenience.
October 28, 2009, 4:53 pmmikeyes says:
If I can get past all the inside baseball lawyer stuff, basically Prometheus has just patented the method that a lot of doctors used to develop the correct dosage of medication for a patient. Is this possible since drug levels and metabolite levels have been measured for decades (along with research on which levels are theraputic) and physicians have used these levels to titrate medications?
Am I still able to get on this bandwagon or is Prometheus completely in control of the process? (I could “improve” the process by adding a google search in between reading the blood levels and making a theraputic decision , I suppose.)
October 28, 2009, 5:32 pmCleanville Tziabatz says:
Physicists have been writing equations to equate physical quantities for many centuries now. Ergo, e equals emsee squared was obvious when Einstein came up with it.
Doctors have long seeking out new compounds for patients to ingest and thereby reduce or eliminate their maladies. Therefore, [insert new wonder drug here] was obvious.
Authors have written novels where characters describe their fictional thoughts, feelings and actions for many centuries. Ulysses by James Joyce? Obvious again!
Hey, this is a fun game. It makes me feel less unimportant than I otherwise would!
October 28, 2009, 6:01 pmArkady says:
Uh, is this question hopelessly naive: Is this at all similar to the attempt to patent hyperlinks?
October 28, 2009, 6:43 pmDavid Schwartz says:
The claim is not over recognizing a correlation, but over creating a circumstance in which such a correlation *can* be recognized and then recognizing it. You could equally well argue that a completely new medical imaging system shouldn’t be protectable because the patent would at some point say that you look at its output and infer things about the patient’s condition.
The obviousness of the invention hinges on whether doctors have or have not set up this particular set of circumstances and observed this particular correlation. If they have, the invention is obvious (or pre-existing) and they should not be entitled to the patent. If they have not, then this is a legitimately new invention, they are entitled to patent protection, and there is no harm to doctors who continue not doing this one thing they have never done before anyway.
I don’t see how the fact that this includes a correlation at one point in the process changes anything. (In fact, pretty much all medical diagnostic techniques from X-rays to blood tests involve observing a correlation at some point. The novelty is in how you set up the circumstances such that you *can* observe that correlation.)
October 28, 2009, 7:47 pmEMB says:
I’m feeling very confused by both the original post and the comments, so let me restate things in simpler terms (or try to at any rate):
0. It was previously common knowledge that it was desirable to keep the level of chemical A close to a particular number for treating a particular disease.
1. Prometheus discovered that levels of chemical A are strongly correlated with levels of chemical B.
2. Prometheus proposed the following method for keeping the level of chemical A close to the desired number:
– Test for levels of chemical B
– If they’re well above the level of B corresponding to the desired level for A, decrease the dose of A
– If they’re well below the level of B corresponding to the desired level for A, increase the does of A.
(Where I think A=thiopurine, B=6-thioguanine, whatever those are.)
I think what Mayo claiming is that:
#1 isn’t patentable because while it’s a nice discovery that took significant research effort on the part of Prometheus, it’s just a natural law of how the human body works, not a treatment or test or process.
#2 isn’t patentable because while it is a new and useful process, it’s a completely obvious thing to do given #0 and #1. Any doctor who knew about #0 and #1 would have no trouble coming up with the method described in #2 (though they might pick different levels than 230 and 400 as their cutoffs).
Does this seem like a fair summary of the facts and argument? (I have no idea what current patent law is likely to say about the matter.)
October 28, 2009, 7:59 pmTGGP says:
I’m surprised Stephan Kinsella hadn’t already jumped on this.
October 28, 2009, 10:31 pmjhubme_24 says:
Perhaps it’s too late now, but why does the petition use 6-TD as an abbreviation of 6-thioguanine (pg. 4)? It is elsewhere (including in a quotation in the petition itself) abbreviated 6-TG (pg. 11). I suggest sticking to the common shorthand, rather than inventing a new one. /nit-picking
Also, the Dr. el-Azhary situation brings up interesting questions. Could Prometheus have patented the same process without determining the exact correlation (or even without coming close)? I suppose then the patent might not be useful (and so might not be granted), but I don’t know much about patent law. If Prometheus could have done so, then wouldn’t anyone seeking to patent the true correlation be preempted, despite the false or inexact correlation given in the first patent? Or do I have no idea what I’m talking about?
October 28, 2009, 10:31 pmll says:
http://patft.uspto.gov/netacgi/nph-Parser?Sect2=PTO1&Sect2=HITOFF&p=1&u=%2Fnetahtml%2FPTO%2Fsearch-bool.html&r=1&f=G&l=50&d=PALL&RefSrch=yes&Query=PN%2F6355623 US Patent 6,355,623
“As disclosed herein, the level of 6-TG in an IBD patient treated with a 6-MP drug was found to correlate with therapeutic efficacy (see Examples I and II). In particular, a median level of 230 pmol 6-TG/8.times.10.sup.8 RBC or more was found in IBD patients who responded to 6-MP drug therapy. Thus, as disclosed herein, a level of at least about 230 pmol 6-TG per 8.times.10.sup.8 RBC can be a minimal therapeutic level of 6-TG for efficaciously treating a patient. Accordingly, a level of 6-TG below about 230 pmol/8.times.10.sup.8 RBC indicates a need to increase the amount of a 6-MP drug administered to the patient. A minimal therapeutic level of 6-TG for efficaciously treating a patient also can be, for example, at least about 240 pmol per 8.times.10.sup.8 RBC; at least about 250 pmol per 8.times.10.sup.8 RBC; at least about 260 pmol per 8.times.10.sup.8 RBC; at least about 280 mol per 8.times.10.sup.8 RBC or at least about 300 pmol per 8.times.10.sup.8 RBC. It is understood that the minimal therapeutic levels of 6-TG disclosed herein are useful for treating immune-mediated gastrointestinal disorders, including IBD, as well as non-IBD autoimmune diseases.
The methods of the invention directed to determining whether a patient has a minimal therapeutic level of a 6-MP metabolite are useful for indicating to the clinician a need to monitor a patient for therapeutic efficacy and to adjust the 6-MP drug dose, as desired. For example, in a patient having less than a minimal therapeutic level of a 6-MP metabolite such as 6-TG and who also presents as unresponsive to 6-MP drug therapy or having poor responsiveness to 6-MP drug therapy as measured by minimal or no effect on a sign or symptom of the disease being treated, one skilled in the art can determine that the dosage of a 6-MP drug should be increased. However, if it is determined that a patient has less than a predetermined minimal therapeutic level of a 6-MP metabolite but is responsive to 6-MP therapy, the current dose of 6-MP drug can be maintained. Based on measuring 6-MP metabolite levels and assessing the responsiveness of the patient to 6-MP therapy, one skilled in the art can determine whether a 6-MP drug dose should be maintained, increased, or decreased.”
The “discovery” was, I hesitate to say correlation because the result determined seems to be purely a function of the human being being administered the drug – hence no drug dosage in the claims, the relationship between the human body output and human body toxicity. That is, if there is too much metabolite there will be toxicity and if there is not enough there will not be therapeutic efficacy.
The “invention” is the relationship between metabolite and toxicity/efficacy. That is, without the “wherein” clause, there is no invention to be patented.
Administer drug, test metabolites, adjust dosage is a process, but it is so old.
I don’t understand what the CAFC was trying to get at. If what it meant was that “administer drug, test metabolites, adjust dosage is a process, and processes are patentable subject matter” then it didn’t really need to go through all that transformative stuff. If the actual process is, and it is, “administer drup to human, have human body process drug, measure metabolites produced by human body, adjust dosage” then, it seems to me they do have to go through a whole lot of smoke blowing, which is what they did, as the transformative processes are human bodily processes. Which would mean a person to whom the drug is administered and has the metabolites processed is, if not an actual infringer, a contributory infringer. That is because their personal body performs the transformative steps that make the claim 101 subject matter.
Excuse me for saying so, but that’s just stupid.
Prometheus would have been served better if it claimed a method for adjusting drug dosages, and solely in inflammatory bowel disease. Something like:
1. A method of optimizing therapeutic efficacy for treatment of an immune-mediated gastrointestinal disorder by administering drugs providing 6-thioguanine to a subject having an immune-mediated gastrointestinal disorder, comprising:
(a) determining the level of 6-thioguanine in said subject, and
(b) increasing said drug if the 6-thioguanine is less than about 230 pmol per 8.times.10.sup.8 red blood cells or decreasing said drug if the level of 6-thioguanine is greater than about 400 pmol per 8.times.10.sup.8.
If that isn’t patentable subject matter, then they should be SOL, because that is the “invention.”
They do not appear to have any new drug, new prodrug, new method of analyzing for anything.
October 29, 2009, 12:40 amCleanville Tziabatz says:
That would probably best be regarded as an enablement issue, and, yes, it could mean that the patent is invalid.
October 29, 2009, 5:34 amCleanville Tziabatz says:
Saying that there is no statutory subject matter under section 101 because there is nothing new about the patent claim would be akin to a court saying: “we do not have jurisdiction over this negligence claim sounding in tort because the defendant clearly exercised due care.” A court does not get to look at due care until its jurisdiction is established. Looking at the level of care as a factor in deciding on jurisdictional issues would be wrong. So it is with looking at obviousness issues when deciding whether there is patent-eligible subject matter.
October 29, 2009, 6:00 amDavid Schwartz says:
If there’s nothing new in the patent, then the patent is harmless. The patent will only prevent somebody from doing something that is new. If there was something you were doing before the patent was issued, you can keep doing it without infringing.
October 29, 2009, 7:54 pmCapt. Peter Wrongway Peachfuzz says:
Let me sum it up for all you patent novices out there:
The act of administering the drug was old (at least to treat immune-mediated GI disorders).
The act of determining the metabolite levels of the drug was old.
The only part of the claim that was “new” is what could be inferred from the metabolite levels (I use the word “new” extremely loosely because there is no such thing as a “new” scientific fact — such facts are either discovered or undiscovered).
The claim doesn’t require any additional action to be taken once the inference is made (e.g., communicating the inference to the patient, adjusting the dosage of the drug up or down, etc.).
Sure the patent could be killed on prior art grounds, but it shouldn’t have to get that far. The “inventors” (again, I use the term loosely) have discovered a fact of nature (correlation between metabolite levels of a drug and the efficacy of the drug) and have attempted to prevent all others from thinking about this fact. As Breyer said in the dissent of the decision to dismiss LabCorp v. Metabolite (on the ground that the specific argument of patent eligibility under 35 U.S.C. Section 101 had not been previously raised), claims like these are not even “at the boundary” of patent eligibility.
October 29, 2009, 10:33 pmReform Rodeo : HEALTH REFORM WATCH says:
[...] Wild Card: Eugene Volokh highlights on a case involving one company’s desire to patent a physician’s thought [...]
November 1, 2009, 11:21 am