Patenting Information

By Kevin E. Noonan --

Diagnostic method claims, especially medical diagnostic method claims, have come under increased scrutiny ever since Justice Breyer (joined by since-retired Justices Souter and Stevens) dissented from dismissal of certiorari as improvidently granted in the Laboratory Corp. v. Metabolite Labs., Inc. ("LabCorp") case.  While these considerations have largely been relegated to the background in view of the Federal Circuit's (and Supreme Court's) focus on the Bilski case, the issues raised by the Metabolite claims, and the impending reconsideration of Prometheus Laboratories, Inc. v. Mayo Collaborative Services and Classen Immunotherapies, Inc. v. Biogen Idec cases by the Federal Circuit on remand from the Supreme Court in view of its Bilski v. Kappos decision, serve as a reminder that the issues raised by the Metabolite dissent have neither gone away nor been adequately resolved.

Diagnostic method claims are different from other statutory subject matter because they relate to an intangible product -- information.  The other statutory subject matter classes -- machines, manufactures, and compositions of matter -- are all tangible entities, capable of isolation, manipulation, and transformation.  Methods of making and methods of using these other statutory categories also result in tangible embodiments.  Diagnostic method claims, on the other hand, are directed to producing information, an intangible product, and it is (in part) this intangibility that provokes the philosophical and analytical difficulties that have arisen with regard to patenting this type of claim.

As Professor Kevin Collins (at left; now at the Washington University School of Law) has noted, diagnostic method claims have a general structure as comprising one or more "determining" steps and an "inferring" step, which can be considered as a "mental" step but is perhaps more profitably regarded as a step using the information obtained from the determining step(s) to arrive at a conclusion.  These claims are also typically characterized by a preamble that sets forth the activity (predicting, diagnosing, etc.) performed based on the inference.

Importantly, information is not, per se, patentable subject matter, at least because it is not recited as one of the statutory categories under 35 U.S.C. § 101.  Indeed, in the software field methods for manipulating information have had a variable reception as patent-eligible subject mater (Benson v. Gottschalk, Parker v. Flook, Diamond v. Diehr, Bilski v. Kappos), with the Supreme Court predominantly limiting patent-eligibility to instances where information was used to produce a real-world effect (and not to pre-empt all uses of the information.  In the biotechnology field, the only case partially on point is Bayer AG v. Housey Pharm Inc., where the Federal Circuit held that information produced by the practice of the claimed method was not a product that was imported (and thus infringing) under 35 U.S.C. § 271(g); the claim at issue recited the following method:

A method of determining whether a substance is an inhibitor or activator of a protein whose production by a cell evokes a responsive change in a phenotypic characteristic other than the level of said protein in said cell per se, which comprises:
    (a)  providing a first cell line which produces said protein and exhibits said phenotypic response to the protein;
    (b)  providing a second cell line which produces the protein at a lower level than the first cell line, or does not produce the protein at all, and which exhibits said phenotypic response to the protein to a lesser degree or not at all;
    (c)  incubating the substance with the first and second cell lines; and
    (d)  comparing the phenotypic response of the first cell line to the substance with the phenotypic response of the second cell line to the substance.

The questions naturally arise, why (and whether) medical diagnostic claims are different from other types of diagnostic claims.  Consider the following hypothetical claims:

• Hypothetical claim 1

A method for predicting a nuclear power plant reactor failure, comprising the steps of assaying pressure in a reactor coolant tank and correlating pressure fluctuations with the likelihood of failure, wherein a pressure fluctuation of +/- 7% indicates a greater than 90% likelihood that the reactor will fail.

• Hypothetical claim 2

A method for predicting escalation of a hurricane to Category 5 status, comprising the steps of assaying ocean temperature along a predicted storm track, wherein the hurricane is predicted to achieve Category 5 status if the ocean temperature changes by more than 5 degrees Celsius over less than 100 miles of the storm track.

In comparison with medical diagnostic method claims:

A method for detecting a deficiency of cobalamin or folate in warm-blooded animals comprising the steps of:
    assaying a body fluid for an elevated level of total homocysteine; and
    correlating an elevated level of total homocysteine in said body fluid with a deficiency of cobalamin or folate.

Laboratory Corp. v. Metabolite Labs., Inc.:

A method of determining whether an immunization schedule affects the incidence or severity of a chronic immune-mediated disorder in a treatment group of mammals, relative to a control group of mammals, which comprises immunizing mammals in the treatment group of mammals with one or more doses of one or more immunogens, according to said immunization schedule, and comparing the incidence, prevalence, frequency or severity of said chronic immune-mediated disorder or the level of a marker of such a disorder, in the treatment group, with that in the control group.

Classen Immunotherapeutics, Inc. v. Biogen Idec:

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 X 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 X 10⁸ red blood cells indicates a need to decrease the amount of said drug subsequently administered to said subject.

Prometheus Labs., Inc. v. Mayo Collaborative Services:

A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.

Claim 2 of U.S. Patent No. 6,033,857, invalidated in AMP v. USPTO ("Myriad").

Comparing these claims, the question naturally arises whether there are differences in structure (using Professor Collins metric, there are not) or differences in application.  One difference between the claims in the Classen, Prometheus, and Myriad cases and the other claims is that these "real" claims are all medical diagnostic claims directed to obtaining medical information about a patient.  This implicates the doctor-patient relationship, an implication certainly relevant to Justice Breyer in his dissent in Metabolite:

As construed by the Federal Circuit, claim 13 provides those researchers with control over doctors' efforts to use that correlation to diagnose vitamin deficiencies in a patient.

There is precedent for making this distinction, specifically 35 U.S.C. § 287(c), which exempted medical doctors from patent infringement liability for practicing patented surgical methods.  There are other considerations for patenting medical diagnostic claims that need to be part of this debate.  The first is the potential for a "patent thicket," as genetic information relevant to diagnoses is elucidated.  The existence of multiple rights-holders to method claims relating to correlations between genotype and disease state or propensity raises the possibility (but not the certainty) that this multiplicity could inhibit advances in personalized medicine and other applications of this genetic information.  On the other hand, precluding patenting raises the possibility that other means of protecting intellectual property -- such as trade secret protection -- will be more attractive, particularly to larger companies who would benefit from being able to avoid disclosing proprietary relationships between genetic polymorphism and disease (or the likelihood of developing a disease).  However, changing the incentives in this way would also destroy the incentives for relations between academic scientists (who need to publish their results) and industry (who would be forced to conceal such diagnostic correlations), to the detriment of the rest of us who have benefitted from the academic-industry collaboration in biotechnology for the past 30 years.

For now, the path forward depends in large part on how the Federal Circuit decides the Classen, Prometheus, and Myriad cases.  The present situation is ironic, at least because Congress intended to reduce uncertainty in U.S. patent law by creating the Federal Circuit almost 30 years ago.  In some ways, the law is even more uncertain today that it was then, under the sporadic and indifferent tutelage of the Supreme Court and its recent forays into the unfamiliar waters of patent law.

Adapted from a presentation given at the 12th Annual Biotech Patent Forum, American Conference Institute, Boston, MA, November 30, 2010.

Comments

[Geoff Karny]

Excellent article. I like your comment about “the sporadic and indifferent tutelage of the Supreme Court and its recent forays into the unfamiliar waters of patent law.” However, I have one criticism. The concern about the doctor-patient relationship is a red herring. I recognize that it is an issue that the Supreme Court and others have focused on. However, it overlooks the real world fact that companies like Labcorp actually perform the tests and report the results to the doctor. If Labcorp wants to use a new diagnostic test created by someone else, it is only fair that they pay for it in the form of a royalty. In addition, many commentators on this issue have treated in the uninformed comments of the three Supreme Court justices in the Metabolite case almost as if it were precedential opinion. I recognize their significance, but it should be pointed out (always) that they have no legal significance and, more importantly, that they were uninformed because the issue was not briefed.

[Sean Brennan]

One difference (that might make a difference to patent eligibility) is that certain claims recite criteria for arriving at the conclusion (the two hypothetical claims and the Prometheus claim); while the LabCorp and Classen claims simply recite a comparison or a correlation without reciting how to make an inference or draw a conclusion based on the comparison or correlation. The Myriad claim lies somewhere in between - will any change from the germline sequence really result in a predisposition to cancer? What about a silent nucleotide change that doesn't result in a change in amino acid sequence?
I suggest that a path to patent eligibility might be to recite criteria for taking some action (i.e., practicing a method) based on the comparison, then reciting that action (pull out a fuel rod, board up your windows, introducing cobalamin or folate into the subject) in the claim.

[Kevin E. Noonan]

Dear Sean:

The problem with your suggestion (although I think it to be a good one) is that you need to avoid the Muni Auction problem of no one tortfeasor practicing all the steps of the method. If you can make the argument that the clinical lab is acting under the direction and control of the doctor, then you have a chance that such a claim will work. As always, it will come down to claim language.

Thanks for the comment.

[Kevin E. Noonan]

Dear Geoff:

I think Justice Breyer's dissent gets such traction because it reflects how the Court tends to think about these matters. You are correct, however, that the Court also sometimes looks at the "big picture" without realizing that the important aspects are in the details that don't show up at a 30,000 foot overview. Fortunately, Justices Stevens and Souter have left the court, but we don't know the views of the new Justices (or Chief Justice Roberts, who did not participate in Labcorp). How the Court decides is likely to depend on how the issue is framed, and that becomes anyone's guess.

Thanks for the comment.

[6]

The question, first and foremost, needs to be whether or not these "diagnostics" are within the scope of the Useful Arts.

Second, one must also consider that they do indeed appear (usually at least) to preempt abstract ideas.

Until both of those issues are resolved I see no reason to believe them to be patentable.

[Kevin E. Noonan]

6:

Well, they are certainly useful, after all - ask the women who found out they had a 95% risk for cancer.

As for pre-emption, the term is "wholly pre-empt," since by definition patent rights pre-empt what is claimed for the (limited) term, pursuant to the Constitution.

Let me know what you think about the non-medical method claims - assume you can apply each to other situations.

Thanks for the comment.

[Gary Johnston]

Kevin:

As always, your prose is second to none.

Regarding your comment that Stevens and Souter have "fortunately" left the court, I think you need to stop sugar-coating things and let us know how you really feel. Oh, and you always leave out Scalia when talking about LabCorp. He voted to dismiss (nonsensically, but whatever), but if you read the transcript of the oral argument, he was more openly hostile than anyone to the key claim in the patent. This is Scalia we're talking about, not Ginsburg.

With respect to 287(c), we both know that this does not indicate congressional validation of these determine and infer patents.

As for the power plant hypo, if the method for assaying the pressure in the coolant tank is old, then no patent. Same thing for the hurricane hypo. You need more stuff in the claim.

Finally, let me ask you a question which I have posed before to colleagues: if you were on a ship at sea, and you knew the ship was sinking, would that knowledge ALONE help you avoid your demise?

[Kevin E. Noonan]

Dear Gary:

Well, knowledge is supposed to be power, but I get your point - the problem is that having treatment or other steps in the claim may make it impossible to enforce (although I am still thinking about that).

With regard to the two hypos, is it enough that someone in the past measured ocean temperatures or coolant tank pressures, but had not applied either in the nuclear reactor or hurricane context?

I wouldn't put too much stock into how hostile Justice Scalia is - he may have been having a bad day, or was irked by something else, or simply wanted to push back on the idea that the claim was patentable, even if he thought it was. All we know is what Justices Breyer, Souter and Stevens thought, in the context of those parties, briefs and arguments regarding that claim. These days, after Classen, Prometheus, Bilski and Myriad, the calculus may have changed with regard to claim language.

But I ask you - if the Labcorp claim included a novel way of detecting homocysteine, would you say it was patentable?

Thanks as always for the comment.

[6]

"Well, they are certainly useful, after all - ask the women who found out they had a 95% risk for cancer.

As for pre-emption, the term is "wholly pre-empt," since by definition patent rights pre-empt what is claimed for the (limited) term, pursuant to the Constitution.

Let me know what you think about the non-medical method claims - assume you can apply each to other situations."

Good job avoiding discussing whether or not they belong to the Useful Arts (as opposed to simply being "useful") and whether or not they preempt an abstract idea.

When you're ready to discuss those two matters let me know.

What I think about non-medical claims is that, just as you have shown, there are plenty of ways to draft non-statutory claims in other fields as well.

For instance:

"A method for predicting escalation of a hurricane to Category 5 status, comprising the steps of assaying ocean temperature along a predicted storm track, wherein the hurricane is predicted to achieve Category 5 status if the ocean temperature changes by more than 5 degrees Celsius over less than 100 miles of the storm track."

That appears to wholly preempt all uses of the abstract idea that it can be predicted that it is likely that a category 5 hurricane will develop if the ocean temperature changed by more than 5 degrees Celsius over less than 100 miles of the storm's track.

What else are you going to do with that abstract idea? Other than take relevant measurements and do a prediction as claimed?

I have a case right now (that probably shouldn't be my case btw but I'm doing anyway) that is definitely connected to a machine environment but I'm likely going to have to 101 because they are trying to get the entire abstract idea behind the invention itself (which is actually much more nuanced than the claim at issue and includes plenty of claimable, patent eligible, subject matter).

[6]

"Same thing for the hurricane hypo. You need more stuff in the claim."

Oldness has no place in the 101 analysis. Have you suddenly brought 102-103 into play?

"With regard to the two hypos, is it enough that someone in the past measured ocean temperatures or coolant tank pressures, but had not applied either in the nuclear reactor or hurricane context?"

Doesn't matter with respect to 101.

[Gary Johnston]

Kevin:

Yes, adding steps (e.g., communicating diagnosis/prognosis) would render the patent useless, but that's somebody else's problem.:)

Not completely following your question about past measurements of the ocean temperature or coolant tank pressure. But it sort of reminds me of something else I have brought to your attention in the past. There is a patent owned by Duke and licensed to Athena claiming the ApoE4/late-onset Alzheimer's association. There's at least one other issued patent out there claiming an association between ApoE4 and some other disorder/condition. Do you run afoul of the Duke/Athena patent if you genotype for ApoE4, not for the purpose of predicting late-onset Alzheimer's, but for the purpose of predicting/diagnosing the other disorder/condition? You have in the past said that the answer is not necessarily. But why? Patent infringement is a strict liability tort, right?

Yes, maybe Scalia was just cranky that day, and maybe it indicates nothing. I guess my point is that everybody seems to harp on Breyer as if he was completely rogue. I don't think so.

If the LabCorp. claim had included a novel way of detecting homocysteine, I absolutely would say it was patentable. Of course, if the mode of detection was novel, then the claim would look totally different.

[Kevin E. Noonan]

Now, 6, you know I never avoid addressing your issues.

In the 18th century, the "useful arts" was the term used to denote technology, and "science" was how knowledge was described. Thus, if you read the Constitutional clause there is a parallelism between science and authors (the copyright clause) and useful arts and inventors (the patent clause). So insofar as the hypos and the actual claims involve technology (and insofar as there are measurements, they do), these methods would fall within the category of the useful arts.

As for the pre-emption, I did address that - can't help it if you don't like the answer.

As for the hurricane hypo, there may be many other phenomena that can be predicted by a 5 degree rise in ocean water temperature - fish die-off, useful oceanic shipping routes, etc. The correlation between ocean temperature and hurricane strength is only relevant during that limited period when there are hurricanes in the first place - 5 degree differences in ocean temperature over a 100 mile stretch can occur the other 9 months of the year, so all you have pre-empted is what you have invented.

My question to you is, are you going to put in your action your opinion about what is and is not patent-eligible in the claims you are examining, or are you going to play hide the ball, twenty questions with the applicants?

Thanks for the comment.

[Kevin E. Noonan]

Dear Gary:

I guess I can ask your question in reverse - elevated homocysteine levels are also correlated with risk of heart disease. So if you practice the Labcorp method and diagnose heart disease, do you infringe their claim? Same thing with the ApoE4 claim - what you use it for (which is an affirmatively-recited limitation in the claim) determines whether you infringe.

Now, this points out one of the differences between "traditional" method claims and diagnostic method claims (of all types) - when you make and use something tangible, it is easier to see if you infringe the claim. In the absence of a claim to whatever the tangible thing itself is, the scope of methods of using claims are limited to the disclosed use - a claim having the structure "A use of the compound of claim x for anything under the sun" isn't patentable.

The novelty aspect of the Labcorp claim isn't/can't be what is determinative, unless we categorically state that diagnostic method claims are not patent-eligible unless they recite a novel method step. That could be done, but it limits precisely what most of us want - a patent system that encourages disclosure. Especially for diagnostic method claims, preventing disclosure will give rise to a new magic, practiced by people who know what data reliably predicts an outcome. Not a good idea.

Thanks for the comment.

[6]

"and "science" was how knowledge was described."

Notably, "medicine" or "medicinal arts" was what was under discussion in this thread.

"So insofar as the hypos and the actual claims involve technology (and insofar as there are measurements, they do), these methods would fall within the category of the useful arts."

Lulz, it takes more than a measurement to make a Useful Art.

People made measurements in trade, politics etc. etc. etc. (notably medicine lol) and none of those were the Useful Arts.

You of course know all this, but decline to care because you have $$$ in your eyes. I'm going to stop reminding you of it because this is getting old.

"As for the hurricane hypo, there may be many other phenomena that can be predicted by a 5 degree rise in ocean water temperature "

So? That wasn't the abstract idea at hand. Re-read the passage.

"The correlation between ocean temperature and hurricane strength is only relevant during that limited period when there are hurricanes in the first place"

Again, so? Again, re-read the abstract idea at hand.

"so all you have pre-empted is what you have invented."

All you "invented" still wholly preempts an abstract idea. That's a problem Kev. I handily wrote the abstract idea down for you if you'd bother to read it instead of making up other abstract ideas which are not wholly preempt by which to judge the claim. One must consider all abstract ideas in the analysis, not just the ones that you don't preempt Kev.

And just btw, if it is your assertion that what they "invented" IS the abstract idea which I wrote down for you (as opposed to what they claimed), then that's fine with me. All the easier to invalidate the claim.

"My question to you is, are you going to put in your action your opinion about what is and is not patent-eligible in the claims you are examining, or are you going to play hide the ball, twenty questions with the applicants?"

Only for computer-medium nonsense. For the rest of the people I'll show them the ball.

Seem fair?

I mean, they want to play hide the ball, twenty questions with me (that is, they don't want to tell me what the structure is), I'll take my turn at their game.

I have one coming up this week that it seems that I am unfortunately bound by law to reject under 101 even though there are those that counsel against it. Unfortunately for applicant those people are blatantly ignoring the law and blatantly admitting to applying their own test in lieu of applying the law. Their test just so happens to be a loose variation of the MOT wholly ignoring the abstract idea analysis which is plainly articulated in BFD&B.

[Skeptical]

"One must consider all abstract ideas in the analysis, not just the ones that you don't preempt Kev."

Seriously?

I thought this blog had better spam filters.

[Kevin E. Noonan]

Ah, 6, I see the problem. You think an "abstract idea" is the correlation between ocean temperature and hurricane force. I think the abstract idea is that the ocean can have temperature gradients and they can be used for many things. One of which, in my hypo, turns out to be predicting hurricane strength.

So I think I am claiming a specific idea, and you think it is abstract. Therein lies our disagreement, one that I fear logic cannot solve.

Also, while it isn't in the category of calling folks retards as is permitted on other blogs, the $$$ argument is as old as it is unoriginal and incorrect. I thought you were in law school - haven't they taught you the second rule of lawyering: make it as complicated and unpredictable as possible, so people need lawyers to help them figure it out? (The first rule, of course, is never sue anyone who doesn't have any money.) The more patent law devolves into arguing the angels of abstract ideas on the pinhead of pre-emption, my retirement is secure.

And, try to be nicer to your customers. I had a very pleasant talk to one of your colleagues earlier today (in a different art unit, of course), which gave me hope for the PTO's future.

[patent litigation]

Indeed, patent law hasn't been spared the confusion that often results from our move to living in an information-based economy and culture. This tangle will need to be sorted out over time. Nevertheless, Bilski did establish a (rather vague) standard, excluding mere ideas from the patent law scheme -- a standard that makes it somewhat difficult to justify offering patent protection for intangible concepts. We will have to wait and see what rulings result from Prometheus, Classen, et al., but ultimately we may find that it's better for medical diagnostic and certain other business methods to obtain protection from a scheme other than patent law.
http://smallbusiness.aol.com/2010/05/10/how-to-file-a-patent/

[James Demers]

"what you use it for ... determines whether you infringe."

Kevin, I think you've found the fatal flaw in claims of this sort (measuring A and, if a certain value is found, concluding X.) What these inventions have in common is that they take a measurement or observation that's in the public domain, add a mental step, and claim patent rights to the combination.

Strippped of its technical trappings, the Metabolite claim is no different from a claim to "A method of diagnosing disease X, comprising examining the patient, and if observation A is made, diagnosing condition X."

If I observe/measure A for the purpose of inferring something about Y, can the patentee really have an economic claim against my thinking about X as well? Am I supposed to refrain from having the "patented" thought? Little wonder the Supreme Court justices are skeptical!

Here's a less-tortured mechanical analogy: Imagine you're the first person to observe a correlation between atmospheric pressure and the weather. You can of course seek your fortune in a patented device that displays storm warnings when the pressure drops. But are you entitled to a patent on "a method of predicting storms" which consists of drawing a conclusion from a glance at a barometer?

Among those who would say "yes", there seems to be an unspoken assumption that if it's new, novel, not obvious, and profitable, it ought to be patentable. Understandably, this notion is appealing to entrepreneurs -- but it's not the law. (That said, consistency on the topic is hard to come by: see US Patent 3611365)

[Kevin E. Noonan]

Dear James:

I would add one other characteristic to your litany - "difficult to reverse-engineer." Because ultimately, the "promote" part of the "promote the progress" clause is to encourage disclosure. If something can be kept undisclosed and still be profitably used, then there needs to be an incentive to disclose = patenting. Rather than think about it as a "patent on thinking," I think about it as a patent to prevent only certain companies or individuals who have the "trick" = invention that permits them to discern these types of diagnostic correlations.

And in view of at least 40 years of inconsistency by the Supreme Court, who is to say what the law is?

Thanks for the comment.