Exhale: Supreme Court Dismisses Metabolite Controversy

Patent holders are breathing a sigh of relief with today's dismissal of LabCorp v. Metabolite -- a case pending before the Supreme Court.  That case had the potential of dramatically altering the landscape of patentable subject matter -- especially relating to method patents.  The case was dismissed as improvidently granted (DIG). In the IPO Amicus brief, we made this argument (as well as others) [IPO Brief]

Dissent: Three justices, led by Justice Breyer would have heard the case and would have found the patent invalid:

There can be little doubt that the correlation between homocysteine and vitamin deficiency set forth in claim 13 is a "natural phenomenon." . . . [The claimed] process instructs the user to (1)obtain test results and (2) think about them. . . . At most, respondents have simply described the natural law at issue in the abstract patent language of a "process." But they cannot avoid the fact that the process is no more than an instruction to read some numbers in light of medical knowledge.

The dissent also took shots at the State Street decision that started the business method craze.

Neither does the Federal Circuit’s decision in State Street Bank help respondents. That case does say that a process is patentable if it produces a "useful, concrete, and tangible result." But this Court has never made such a statement and, if taken literally, thestatement would cover instances where this Court has held the contrary. The Court, for example, has invalidated a claim to the use of electromagnetic current for transmitting messages over long distances even though it producesa result that seems "useful, concrete, and tangible." Morse. Similarly the Court has invalidated apatent setting forth a system for triggering alarm limits inconnection with catalytic conversion despite a similarutility, concreteness, and tangibility. Flook. And the Court has invalidated a patent setting forth a process that transforms, for computer-programming purposes,decimal figures into binary figures—even though theresult would seem useful, concrete, and at least arguably (within the computer’s wiring system) tangible. Gottschalk.

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32 thoughts on “Exhale: Supreme Court Dismisses Metabolite Controversy

  1. Jogging with the Davids

    Today I headed out for a quick lunchtime jog listening to a recent podcast of David Levine’s radio show, Hearsay Culture. I listened to the podcast from June 28 where he interviewes CIS fellow David Olson about the patent system….

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  2. Malcom, I submitted a post some time ago, but it didn’t seem to make it through. In response to your question: “Now ask yourself this: why not patent a a method of THINKING about administering your compound to the animal. Is there a problem with that claim, in your view?”

    I can think of several problems with the claim that is purely thinking. The most obvious is that it is not a “useful” process as that term is used in patent law. Also, it runs afoul of the general requirement of transformation of matter.

    Now, my question for you. You said: “Now ask yourself this: why not patent a a Because — according to your hypothetical –the physical act of administering the compound to the animal was not observed before in nature. It’s a big difference.”

    If claim 13 had included a final step of administering folic acid and B12 to those identified as deficient in those vitamins, would that make the claim statutory in your view?

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  3. Andrew

    Malcom, claim 13 as construed requires a physical assaying step, so no one infringes the patent by mere thought process.

    For the hundredth time: the assay was old in the art. The only “new” thing about the method was “thinking” about the results of this old assay.

    As for the purification of naturally occurring substances, I fail to see how purifying changes anything with respect to statutory subject matter.

    Tell the Supreme Court. This is ancient long-settled patent law.

    Now, this inventor didn’t invent the compound, nor did he modify it in any way. All he did was observe the natural effect it has on an animal. If that’s not invalid for patenting a “natural phenomenon”, why not?

    Because — according to your hypothetical –the physical act of administering the compound to the animal was not observed before in nature. It’s a big difference. Now ask yourself this: why not patent a a method of THINKING about administering your compound to the animal. Is there a problem with that claim, in your view?

    Denis writes

    I think that it is useful to remember that Section 100 of the Patent Act indicates that patents are available for both inventions and discoveries

    The Supreme’s have dealt with this before. The “correlation” that was discovered by the “inventor” of claim 13 was not MADE BY MAN. The inventors of claim 13 also did not discover the art of “thinking about scientific facts.”

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  4. Vaya con Dios, LabCorp v. Metabolite

    After being bombarded with 20 amicus briefs, the U.S. Supreme Court has opted out of ruling on the LabCorp v. Metabolite Laboratories case (U.S., No. 04-607) saying that it had “improvidently” agreed to hear the case in the first place…

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  5. Vaya con Dios, LabCorp v. Metabolite

    After being bombarded with 20 amicus briefs, the U.S. Supreme Court has opted out of ruling on the LabCorp v. Metabolite Laboratories case (U.S., No. 04-607) saying that it had “improvidently” agreed to hear the case in the first place…

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  6. I think that it is useful to remember that Section 100 of the Patent Act indicates that patents are available for both inventions and discoveries.

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  7. Malcom, claim 13 as construed requires a physical assaying step, so no one infringes the patent by mere thought process.

    As for the purification of naturally occurring substances, I fail to see how purifying changes anything with respect to statutory subject matter.

    Regardless, you did not address drug use patents where there is a novel, non-obvious use for an known compound. Let’s say that the inventor doesn’t “purify” the old compound, nor does he die it his favorite color — it’s just the old compound used in a novel, medicinal way.

    Now, this inventor didn’t invent the compound, nor did he modify it in any way. All he did was observe the natural effect it has on an animal. If that’s not invalid for patenting a “natural phenomenon”, why not?

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  8. Andrew wrote “Does anyone invent anything when they observe the medicinal effect a known or naturally occurring compound has on an animal?”

    It is the claimed PURIFIED compound (not found in nature) that is considered the invention. This is long established patent law and not particularly relevant to the freedom of thought issues raised by awful claims such as claim 13.

    Andrew also wrote

    “Claim 13 here relies no more on a natural phenomenon than do any of the drug use patents where the compound is not novel.”

    Yes it surely does because the drug use patents aren’t infringed merely by THINKING about the results of an unpatentable assay. This was the patentee’s own construction of the term “correlate” in claim 13. The patentee got greedy and then they got lucky when their opponents hired clueless lawyers.

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  9. Did Alexander Fleming invent Penicillin? Does anyone invent anything when they observe the medicinal effect a known or naturally occurring compound has on an animal?

    One thing the dissent got right was that “the category of non-patentable ‘phenomena of nature,’ like the categories of ‘mental processes,’ and ‘abstract intellectual concepts,’ is not easy to define.”

    The whole court-created “natural phenomena” exception to statutory subject matters is intellectually dubious. Claim 13 here relies no more on a natural phenomenon than do any of the drug use patents where the compound is not novel.

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  10. SF wrote

    I believe this case presented the following troubling issues: May a patent prevent persons from thinking about a naturally occuring phenomenon? If so, under what circumstances?

    This is the troubling issue and the answer must be: never.

    The solution to the dilemna is to require that a tangible step of RECORDING the correlation be put in the claim OR the assay itself must be NOVEL and NON-OBVIOUS (and not old in the art, as was the case with the assay in claim 13).

    There are, of course, evidentiary issues as well. How does one prove in a clear and convincing way what an alleged infringer is thinking? With a lie detector? Spare me.

    By the way, here is another example of a Metabolite type claim:

    1. A method for detection of at least one allele of a genetic locus comprising amplifying genomic DNA with an intron-spanning primer pair that defines a DNA sequence, said DNA sequence being in genetic linkage with said genetic locus and containing a sufficient number of intron sequence nucleotides to produce an amplified DNA sequence characteristic of said allele.

    This claim and the patent (5,192,659) is discussed in more detail here:

    link to bios.net

    The owners of the patent apparently have a licensing scheme worked out where they approach folks who sequence non-coding regions of DNA and argue that the non-coding DNA regions that are sequenced are linked to coding region DNA sequences. In other words, if you sequence non-coding DNA regions you inherently are obtaining information which could be used to determine coding region sequences. The alleged “discovery” of this correlation was, in fact, the basis for granting this absurdly broad claim!

    I’m not sure what percentage of biotech patents fall into this category of “patented discovery” claims but I’d wager at least 20%. And they are all pure crap.

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  11. Lemley’s objection above misses the dissent’s point.

    Remember: the assay in question was OLD in the art. The only “new” contribution of the “inventors” (mere scientists, really) was to discover a natural fact, i.e., that results of the assay may be correlated with a disease state.

    But remember: the assay in question was OLD in the art.

    One cannot discover a scientific fact and secure a monopoly on the recognition of that fact by the human brain. But that’s what claim 13 did.

    Perhaps it would help to understand the ridiculousness of claim 13 if we imagine a different correlation was at issue. Let’s say that I identify for the first time the “surprising” correlation between Asian ancestry and Bavadre’s disease. And I write a claim: A method of determining whether a patient has increased likelihood of displaying symptoms of Bavadre’s disease, comprising (1) determining whether the patient is of Asian ancestry and (2) correlating said determination with an increased likelihood of Bavadre’s disease.

    Let’s say that my claim issues (after all, the discovery of the correlation was oh-so-surprising!). Now I go around sueing doctors who LOOK at Asian patients and THINK that they are more likely to get Bavadre’s disease. And why stop at doctors? Heck, I’ll just sue the guy on the street who’s looking at some Asian person standing next to him. He’ll say, “I have no idea what you’re talking about.” Then I’ll hand him my patent which teaches the “suprising” discovery. BOOYAH! Instant infringer. In fact, anyone who is literate and/or not blind is a likely infringer, depending on how well I get the facts disseminated.

    By the way, there are lots of Metabolite-type claims out there in the biotech arena. It’s a real problem.

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  12. Tim wrote: “Bwashburn wrote ‘suppose compound A…’”

    Tim, responding to your comment, please note the following: The dissent’s view is multi-faceted and it assumes several arguendo positions. In my comment, I was referring to Justice Breyer arguendo position, in which he notes: “Even were I to assume (purely for argument’s sake) that claim 13 meets certain general definitions of process patentability….One might, of course, reduce the “process” to a series of steps, e.g., Step 1: gather data; Step 2: read a number; Step 3: compare the number with the norm; Step 4: act accordingly. But one can reduce any process to a series of steps. The question is what those steps embody…”

    My point was, that if dissent position is that irrespective of the number of steps of a process claim, the ultimate inquiry is whether it “embodies” natural phenomena, then perhaps every “new method of use claim” is unpatentable because it embodies natural phenomena.

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  13. It seems to me that there is a larger issue here beyond the specifics of this case, and that is the public perception of patents. In high profile cases, inventors need to pay as much attention to their public relations campaigns as they do to their legal campaigns. They need to sell the public as a whole on the virtues of their inventions and their own virtues as inventors. Otherwise, policitical forces will continue to turn against patents.

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  14. Tim wrote:

    “Wouldn’t doctors be exempt from infringement under 35 USC 287(c)? Metabolite sued LabCorp for inducing doctors to infringe. They didn’t sue the doctors directly. Thus, Justice Breyer’s concerns appear to be misplaced.”

    Good question. I don’t think the 287(c) protects the doctors in this case, given the filing date of the patent. “This subsection shall not apply to any patent issued based on an application the earliest effective filing date of which is prior to September 30, 1996.” 35 U.S.C. 287(c)(4)

    Would the doctors be exempt from suit on a patent filed after 9/30/96? The statute says “medical activity” means the performance of a medical or surgical procedure on a body. If “medical activity” includes “assaying a bodily fluid for an elevated level of homosysteine,” and I assume it does, the doctors would be exempt from a suit on a later-filed patent.

    But the Canadian Practioner wrote:

    The doctors “COULD be sued” because, the “the practice of a patented use of a composition of matter in violation of such patent” is not an exempt medical activity. I’m not sure I agree, although, I’m not sure what the quoted section of the statute means. If a “medical practitioner” uses a composition of matter to perform a “medical procedure,” how can one ever obtain a patent on such use that is valid with respect to a medical practitioner?

    If I’m correct that the doctors would be exempt from suit, then it seems to me that a LabCorp-type defendant would also be exempt from inducing infringement had the suit been brought on a later filed patent, and there is no need to worry that a case like this could successfully be brought again.

    Maybe someone familiar with the definition of “medical activity” in 287(c) can enlighten me as to how this “patented use” provision works.

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  15. Characterizing Claim 13 as an attempt to patent a “phenomenon of nature” is not accurate. In this case, the naturally occuring phenomenon is the following: high levels of homocysteine in a person’s blood may occur when the person has a particular vitamin deficiency. Claim 13 does not cover this naturally occuring phenomenon. Consequently, everyone is free to have high levels of homocysteine in their blood, to have the particular vitamin deficiency, or both at the same time. (I’m not sure how or why anyone would want to “use” a vitamin deficiency, but they’re free to do so.)

    Rather than patenting this naturally occurring phenomenon, Claim 13 restricts a person’s ability to think about this naturally occurring phenomenon.

    I believe this case presented the following troubling issues: May a patent prevent persons from thinking about a naturally occuring phenomenon? If so, under what circumstances?

    For now, the patentee is apparently entitled to prevent persons from thinking about the relationship between high levels of homocysteine and a particular vitamin deficiency under certain circumstances.

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  16. Tim: “The testing step cannot be done mentally so Mark Lemley is correct.”

    DDC: An assay is simply a test, and this particular claim provides no limit on what the assay could be. I have not read the specification enough to know whether the definition of that term should have only a limited meaning. However, assuming that it has a broad meaning (which the patentee argued before the lower court), performing an assay could be a pathologist looking at a slide and thinking that he saw evidence of homocysteine. (Is this mental?). Furthermore, because the assay step has no link to any form of technology, there could be later invented assay methods that are purely mental.

    All this said — my view is that an invention does not become unpatentable simply because it employs a human brain in the same way that an invention should not be unpatentable simply because it uses a microcomputer.

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  17. Tim, Section 35 U.S.C. 287 (c)(2)(A) excludes “(i) the use of a patented machine, manufacture, or composition of matter in violation of such patent, (ii) the practice of a patented use of a composition of matter in violation of such patent, or (iii) the practice of a process in violation of a biotechnology patent”. So it seems theoretically the doctors COULD be sued since the assay is a patented use.

    Dennis, the claim doesn’t require drawing blood, but it requires “assaying a body fluid for an elevated level of total homocysteine”. That means the fluid such as blood must be tested to see if the level of total HC is elevated. The testing step cannot be done mentally so Mark Lemley is correct.

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  18. Mark, I agree that the dissent’s description of the claim in question was not correct. But, yours might not be correct either. The claim requires “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.” I don’t see any blood draw requirements.

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  19. David French writes:

    The dissent in the US Supreme Court decision, LabCorp vs Metabolite labs gives courage to those that feel there should be limits on the rights granted under patents. From the viewpoint of the patent profession, this decision may be a disaster.

    No longer will it be sufficient to simply establish that the subject matter of a patent claim provides a “useful, concrete and tangible result”. The door is now open for claims to be held unpatentable even if they meet this test. Qualifying within this phrase does not necessarily guarantee entitlement to a patent monopoly, according to the dissenting judges in this ruling.

    The dissenting judges further observed that their ruling would contribute to the important ongoing debate as to whether the present patent system reflects the “careful balance” that such a federal law should establish. This is a clear warning that at least some judges of the Supreme Court of the United States are of the view that there should be limits on the scope of what should be patentable.

    I think that these comments should be viewed as a hurricane warning for those in the patent profession who wish to maximize the coverage that can be obtained under US patents.

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  20. Prof. Lemley: I admit I do not have much knowledge of patent know, but I do have a question. If a doctor took the first step and obtained the total homocysteine test result for some reason unrelated to vitamin deficiency (possibly related to brain cell deficiency), under nobody’s inducement whatsoever, then late on took the second mental step when a vitamin deficiency symptom did arose (same doctor, same patient, same *already available* test result), did the doctor infringe?

    Does patent law have a mens rea element built-in? Or does the law have a statute of limitations on infringement?

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  21. Christopher Miller wrote, “They mentoned in the Times article as well that doctors may be held to infringe these correlation claims by merely thinking about them.”

    Mark A. Lemley wrote, “The idea that the patent could be infringed merely by ‘thinking about’ a correlation is a misunderstanding caused by lack of knowledge of patent law. The claimed process had two steps (1) drawing blood and assaying it for total homocysteine, and (2) correlating an elevated level of total homocysteine with a vitamin deficiency. Step 2 could be performed mentally, but that doesn’t mean that patent could be infringed just by thinking.”

    Mark is correct. A doctor cannot mentally draw blood.

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  22. Don’t believe everything you read in dissents. I represented the patent owner in this case. The idea that the patent could be infringed merely by “thinking about” a correlation is a misunderstanding caused by lack of knowledge of patent law. The claimed process had two steps (1) drawing blood and assaying it for total homocysteine, and (2) correlating an elevated level of total homocysteine with a vitamin deficiency. Step 2 could be performed mentally, but that doesn’t mean that patent could be infringed just by thinking.

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  23. LabCorp v. Metabolite dismissed

    The Supreme Court issued a decision this morning dismissing the writ of certiorari in Laboratory Corporation of America Holdings v. Metabolite Laboratories, Inc. as improvidently granted. Justice Breyer, joined by Justices Stevens and Souter, dis…

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  24. Yeah. They mentoned in the Times article as well that doctors may be held to infringe these correlation claims by merely thinking about them. But, as long as they aren’t using a patented drug or test in their treatment, I believe they are exempt from infringement. That point shouldn’t be lost on Justice Breyer, considering that the doctors weren’t the ones sued.

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  25. Based what I read in Breyer’s decision the underlying decision was insane.

    Metabolite has a patent on a diagnostic method of using elevated homocysteine to diagnose vitamin deficiency. They also have a patent on a specific test for homocysteine levels. It is later discovered that elevated homocysteine levels is a risk factor for heart disease and the use of homocysteine tests goes up and a new test comes on the market.

    There is no breach of the patent on the lab test for homocysteine levels. The jury finds LabCorp liable for inducing doctors to breach the diagnostic method patent even though the increased usage of testing was related to heart disease risks not vitamin deficiency.

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  26. BWashburn wrote, “Suppose compound A was known in the art, and researchers subsequently discover that compound A is a cure for disease X. Isn’t the actual curing by compound A of disease X natural phenomena? So why would a claim embodying such natural phenomena be patentable?”

    Under the Metabolite dissent’s view, I believe the following claim would *not* recite patentable subject matter: performing a test to detect disease X; and thinking about the fact that compound A could be used to cure disease X.

    In constrast, actually using compound A to cure disease X would be patentable subject matter.

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  27. Justice Breyer seems to base much of his concern on perceived public policy issues, i.e. that “[t]hese restrictions may inhibit doctors from using their best judgment; they may force doctors to spend unnecessary time and effort entering into license agreements.” However, wouldn’t doctors be exempt from infringement under 35 USC 287(c)? Metabolite sued LabCorp for inducing doctors to infringe. They didn’t sue the doctors directly. Thus, Justice Breyer’s concerns appear to be misplaced.

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  28. Justice Breyer’s dissent takes issue, that in every process claim, the inquiry as to whether the claim meets the natural phenomena requirement, starts by determining what the steps of the claim embody (“The question is what those steps embody. And here, aside from the unpatented test, they embody only the correlation between homocysteine and vitamin deficiency…”, p. 14). In other words, the claim in Lab Corp., according to Justice Breyer, is unpatentable, because the crux of the invention is not the actual “test”; rather, the crux of the invention is the “natural correlation”.

    Such views by the dissenting Justices are very concerning. If I understand their logic correctly, they would essentially be invalidating all new method of use claims. For example: Suppose compound A was known in the art, and researchers subsequently discover that compound A is a cure for disease X. Isn’t the actual curing by compound A of disease X natural phenomena? So why would a claim embodying such natural phenomena be patentable?

    Adhering to the dissent’s logic, I can see no difference between a “test” process that embodies “natural phenomena” and a “cure” process that embodies natural phenomena.

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  29. Is it possible that Scalia cast his vote to dismiss cert to avoid a 4-4 split? After all, he seemed to have hinted in oral argument that he would have held the claim invalid:

    “this is my biggest problem with the case … what you’ve said is simply a statement of the natural phenomenon …”

    He also said:

    “what [claim] 13 involves is simply discovery of the natural principle that … when there is the presence of one substance in a human being, there is a deficiency of two other ones. That’s just a natural principle. What’s made by man about that?”

    Of course, he likely did not support Breyer in overturning State Street, and found it easier to dismiss on procedural grounds:

    “Why shouldn’t we do what the Solicitor General proposed … why shouldn’t I tell the Federal Circuit, you know, your definition … raises this issue and you should resolve whether …there is … no substantial usefulness?”

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  30. Now we know how at least 3 justices feel about BM patents. I think i can hear the BM death knell ringing faintly in the distance. I predict it will ring much louder in the near future. Once the right case makes it up the line, the scotus will take a sharp detour from that overtraveled state street.

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  31. Now we know how at least 3 justices feel about business method patents. I think I can hear the business method death knell ringing faintly in the distance. I predict a much louder ringing in the near future. Once the right case makes it up the line, the scotus will take a sharp detour from state street….and this is probably a good thing.

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  32. Arrgh!

    The Supreme Court today dismissed the writ of certiorari in Metabolite as improvidently granted. Details on Patently-O, which says: Patent holders are breathing a sigh of relief with today’s dismissal of LabCorp v. Metabolite — a case pending before t…

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