Prometheus v. Mayo: Patenting Medical Methods

Prometheus Labs. v. Mayo Collaborative Services (Mayo Clinic) (Fed. Cir. 2010)

This case is one of several pending Federal Circuit appeals that are questioning whether medical diagnostic and treatment methods are the proper subject of patent protection.

The claims asserted by Prometheus are directed toward a method of “optimizing therapeutic efficacy” by first administering an active drug (6-thioguanine) to a subject and then using the subject’s metabolite blood-level to adjust future doses of the drug.  (U.S. Patents 6,355,623 and 6,680,302). Thus, most of the claims are centered around three ordered-steps of:

  1. administering the drug to the subject;
  2. determining the amount of drug in the subject’s blood; and
  3. re-calibrating the drug dosage based on step-2.

A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

The district court found the claims invalid as lacking patentable subject matter under 35 U.S.C. 101.  On appeal, the Federal Circuit reversed — holding that the steps of “administering a drug” and “determining the level of 6-thioguanine” were both sufficiently transformative of “a particular article into a different state or thing.”  That Federal Circut decision was based on the court’s machine-or-transformation test that was subsequently discredited by the Supreme Court in Bilski v. Kappos (2010).  In the wake of its Bilski decision, the Supreme Court vacated the Federal Circuit’s Prometheus decision and remanded for a new opinion.  Seeing this as a potential watershed case, Mayo immediately requested that the Federal Circuit hear the case en banc.

Briefing by October 1: The Federal Circuit has apparently denied the en banc request and has moved-forward with a rapid briefing schedule: By October 1, 2010, both parties are scheduled to submit 20–page briefs “addressing the effect of the Supreme Court’s Bilski decision on the disposition of this case. No additional briefing or oral argument is contemplated at this time.”  The scheduling order was signed by the court clerk Jan Horbaly.

Judges in Charge: The scheduling order suggests that the remand will be taken as a supplement to the original decision. A quirk of that original decision is that the three-member panel included two judges who are not on the Federal Circuit (Chief Judge Paul Michel (Ret.) and E.D. Texas District Court Judge Ron Clark). The third member of the panel is Judge Lourie.  Federal Circuit rules indicate that Judge Clark can retain on the panel on remand, but would not be part of any en banc hearing.

Related cases include Classen Immunotherapies Inc. v. Biogen Idec (method of determining an immunization schedule) and Association for Molecular Pathology v. Myriad Genetics (gene patents). 

45 thoughts on “Prometheus v. Mayo: Patenting Medical Methods

  1. 45

    Beat Force,food somewhat impossible primary officer cut prime show application protection administration requirement check prove module unable early block objective simple card dinner point work sheet cos who pass but nurse fly example division expenditure consideration admit cabinet boy escape laugh send there or table speech health we side bottle apparently data ought fair breath species read early fix black only present book radio state action bloody visitor new inside thought elderly target consideration household in decade act regional detailed manage industry laugh finally

  2. 44

    Paul,

    Lots of that Correct-but-wrong-reason stuff out there.

    To me this comes from the courts being all namby-pamby about simply admitting when they have blown a decision. Anyone looking at the history of the Supremes can plainly see no shortage of backtracking and reversed stands gilded in a cheap veneer of “refinement“, when the Justices would be much better off if they simply came out and said – “We was wrong”.

    They seem fearful that by doing so people will hold them in less esteem.

  3. 43

    TOBIAS: Many thanks for your link and for encouraging me to re-read the Chakrabarty case which is helpful, although it supports the second and narrower interpretation.

    It is interesting that Chakrabarty quotes with approval the Flook case, which in my submission was a correct decision reached for the wrong reasons. This is almost a textbook instance of the baleful effects of such opinions – the incorrect reasoning is quoted and re-quoted in decision after decision until it becomes unthinkingly accepted as good law whereas in reality it is utterly false. In Flook the six strains of bacteria had never been brought together before and had the surprising benefit that they did not inactivate one another, so that the farmer could carry out a single treatment rather than six individual treatments. The composition was new, inventive and surely patentable. The weakness was that the individual strains had not been identified or deposited in any public depository and although the patent made it known that the result could be obtained the public wishing to obtain the result after the patent had expired was in little better position than before.

  4. 42

    Mr. cole,

    Diamond v Chakrabarty,

    link to caselaw.lp.findlaw.com

    contains some discussion of the concept of “discoveries”, and refers to new minerals “discovered” in the earth, “discoveries” being free manifestations of nature, “discovering” the existence in nature of certain bacteria, the use of that “discovery” to produce a mixed culture, and the “discovery” being not nature’s handiwork, but instead that of the patentee.

    There are of course other sources, but that is as good a starting point as any.

  5. 41

    I’m not sure that I would say the SCOTUS “discredited” the MORT exactly. That said, however, I wouldn’t be terribly surprised if the CAFC determined this go-round that the Bilski patent litigation pretty much served to invalidate patents like the one at issue in Prometheus.

  6. 39

    Mr. Cole,

    It occurs to me that there is jurisprudence on the “discoveries” issue. Why don’t you read it?

    Also, the Venetians did not “invent” the US patent system.

    But I agree with you and others that the scope of 101 should be broadened greatly and that the real battle should be fought on the 103/112 battleground.

  7. 38

    I think Cy Nical has the point. If “discoveries” = disclosures (description + drawings) then the grant of power to Congress is not limited. If discoveries = something discovered in the more modern sense then there is such a limitation.

    The word, when considered in context, is truly ambiguous. On the whole I favour the first meaning because it puts no limit on the power of Congress. However, S. 2 of the 1793 Act points to the second meaning:

    Provided always, and be it further enacted, That any person, who shall have discovered an improvement in the principle of any machine, or in the process of any composition of matter, which shall have been patented, and shall have obtained a patent for such improvement, he shall not be at liberty to make, use or vend the original discovery, nor shall the first
    inventor be at liberty to use the improvement: And it is hereby enacted and declared, that simply changing the form or the proportions of any machine, or composition of matter, in any degree, shall not be deemed a discovery.

    If I was acting for a defendant, I would certainly be arguing for the second and more restrictive meaning, and endeavour to put the patentee to the proof that he has indeed made a discovery (in the modern sense) underlying the claimed subject matter.

    The second meaning is consistent with the views of the Venetians when they invented the patent system, and also with EPO practice.

  8. 37

    It bothers me that there is a word in the US constitution governing the granting of patent and no-one either knows what it means or cares much about it.

    It doesn’t come up as often as you’d think. Inventors get patents for inventions, and nobody has any interest in rocking that boat. Non-inventions tend to get blocked by one or other of the provisions already in the statute, sometimes without even much in the way of explanation (see Bilski).

    I kind of care what the words mean on an academic level, but if it doesn’t come up in a real case or controversy I’d rather people focus their limited attention on something more pragmatic.

  9. 36

    If I were writing an obviousness brief for the Supremes I would definitely go into the meaning of the patent clause because that is the foundation and origin of US law.

    The origin, yes. But it makes for a pretty measly foundation. I think no one seems to care simply because it’s not incredibly important, given the current patent regime. The Patent Clause is permissive, so even if it permits patents for “things you found lying on the ground,” it doesn’t require them. (With all due apologies to any unintended violence against Ned’s (N)atural (I)nvention (R)ights theory.) I expect that we would be more interested in the meaning of “Discoveries” if it appeared to meaningfully limit the grant of power to Congress.

  10. 35

    It bothers me that there is a word in the US constitution governing the granting of patent and no-one either knows what it means or cares much about it. If I were writing an obviousness brief for the Supremes I would definitely go into the meaning of the patent clause because that is the foundation and origin of US law.

    However, Ianae, you are in good company because no one else seems to care either.

  11. 34

    Paul Cole: Or perhaps the constitution means both?

    Perhaps. It’s probably not worth the trouble to get bogged down in what the term originally meant in the Constitution, except to trace its origins in the statute. The Constitution should be interpreted in a dynamic way, so that today it still provides meaningful rights and powers. A broadest reasonable interpretation, if you will.

    In terms of the constitutional power, it only makes sense to me if “discoveries” is understood to mean what “inventors” do that makes them inventors. Otherwise, either non-inventors wouldn’t get protection for their discoveries, or inventors wouldn’t get protection for non-discovery inventions.

    As far as the statute is concerned, I think it may have been drafted either during a period of semantic transition when both words were used to mean “inventions”, or else the word “discovers” was added to be explicitly consistent with the constitutional power. Just to be sure every inventive activity was covered and the statute was intra vires.

    However, I believe the term “invents” in 101 to be coextensive with the constitutional grant of power to Congress, as well as consistent with the remainder of the statute that only deals with “invention”, and I don’t think the word “discovers” adds anything but confusion and a dollop of history. That’s why I consider it “boilerplate”. It’s a word we only keep using because someone used it in an old document and we keep copying it in every revision.

  12. 32

    IANAE: You have raised a really interesting point. What does “discoveries” mean in the US constitution.

    I used to think it meant a new finding, such as the discovery of the chemical element gallium.

    But the older meaning is simply to disclose. Discovery of a plot meant simply disclosure of a plot. That is the way Shakespeare used the word. It is now used that way by lawyers only, not the genreal population.

    So if writers get exclusivity for their writings and inventors get exclusivity for their disclosures (written description + drawings), then the US constitution has a certain symmetry.

    Or perhaps the constitution means both?

  13. 31

    administering the drug to the subject;
    determining the amount of drug in the subject’s blood; and
    re-calibrating the drug dosage based on step-2.

    A broader claim (claim 46 of the ‘632 patent) eliminates the administering step of claim 1 above.

    And what’s missing from the claims as written is the final step of administrating an increased dose. Note that administering increased or decreased doses after an initial dose is old in the art. What is allegedly inventive here is the thought process used to justify the changed dose. That thought process consists solely of making a reasonable decision based on information that is publicly known and can not be owned by anyone. The claim preempts all substantial applications of a particular piece of information, and is therefore abstract.

    The claim is also abstract and unpatentable under Bilski because (1) the transformation recited in the claim is entirely ancillary to the only admittedly new intellectual contribution of the “inventors”, which is the discovery and publication of a pre-existing correlation; and (2) the claim AS WRITTEN does not result in any transformation except to transform the mind of the person practicing the old method. Thus, the claim is abstract.

    Mix and massage, but that’s the argument. And ultimately it’s going to win, even if needs to go back up to the Supremes.

  14. 30

    What’s a “tenet of the Constitution”?

    Read the Constitution. It’s pretty clear that “discoveries” as they used the word means “inventions”. It doesn’t mean stuff you see lying on the ground. It’s what inventors do.

  15. 28

    Close, but I think s.102 still fails. S.102(b) fails because if the law or phenomenon of nature was unknown, arguing that it was still used unwittingly gets into a sticky metaphysical trap.

    What if it was inherent? Inherent features don’t have to be known, they just have to exist.

    As to s.102(f), that’s trickier but I think it still fails to exclude newly discovered natural laws or phenomena.

    Well yes, but 101 excludes those.

    Now back to s.102(f). “Invent” is not defined in the Patent Act (a fun omission in itself). More importantly, s.101 extends patent eligibility to anyone who “invents or discovers.”

    That is indeed a troubling omission. But what to make of discovery being 101 eligible but 102(f) ineligible on the basis that 101 implies discovery is something other than invention? I don’t think we can give the word “discovers” in 101 quite that much credit. To me it sounds like the same archaic usage of “discover” that we find in the Constitution (which itself curiously makes no mention of invention but implies that inventors are people who make discoveries). It’s essentially statutory boilerplate at this point.

    But surely inventorship means something. We might not know what it is, but we debate from time to time whether a particular person is the correct inventor of a particular patent claim. Now, if you find an object on the ground and attempt to patent it, are you any more of an inventor if that object was naturally occurring than you would be if that object was built by another person?

  16. 27

    @ IANAE: “102(f) would work for that, wouldn’t it? Or maybe 102(b) public use?”

    Close, but I think s.102 still fails. S.102(b) fails because if the law or phenomenon of nature was unknown, arguing that it was still used unwittingly gets into a sticky metaphysical trap.

    As to s.102(f), that’s trickier but I think it still fails to exclude newly discovered natural laws or phenomena. As a quick aside to clarify something, laws of nature are one thing and, by definition, will not be compositions (how could a law be a tangible thing?). But the “phenomena of nature” exception has been argued to exclude compositions and other tangible things.

    Now back to s.102(f). “Invent” is not defined in the Patent Act (a fun omission in itself). More importantly, s.101 extends patent eligibility to anyone who “invents or discovers.” Hence the fact someone didn’t create what they attempt to patent appears irrelevant. S.102(f) is really there to prevent theft.

    This point of “invents or discovers” really shines light on the fatally flawed statutory analysis in Funk Bros. and it’s “funky” spawn. Funk Bros. says that just because you discovered something doesn’t mean you get a patent. Has anyone ever noticed that this is clearly at odds with the plain language of the statute? Given, s.101 didn’t exist when Funk Bros. was written, but how come no one revisited this post-1952? Why does everyone still cite Funk Bros. like it’s good law?

  17. 26

    “A rock you find on the ground is not a law of nature. It is plainly a composition of matter. Its most unpatentable feature is that you didn’t actually invent it, and you can even get around that by being the first person to find a credible utility for it.”

    I pretty clearly remember a judicial example of a law of nature being excluded being a newly discovered mineral.

  18. 25

    @ Inviting Body Punches:

    You make a very good point. Rader did take Frankfurter’s complaint an important (and admittedly controversial) step further. He appeared to include himself in the category of those making it up in the realm of s.101, though.

    I guess his statements are best viewed as a lament for the impartiality of ANY judge hamstrung by binding precedent into making a “gut” decision under s.101.

  19. 24

    “Every invention embodies one or more laws of nature.”

    Not really, but if you successfully made this argument then all claims are invalidated. Too bad you never will :(

  20. 23

    Locke: Of course, this points out why rocks, the sun, etc., are NOT statutory if one claims them exactly as they are found in nature. They are excluded under s.101 because, if they have just been discovered, s.102 is not equipped to exclude them.

    102(f) would work for that, wouldn’t it? Or maybe 102(b) public use?

    101 doesn’t exclude things found in nature, it excludes laws of nature. A rock you find on the ground is not a law of nature. It is plainly a composition of matter. Its most unpatentable feature is that you didn’t actually invent it, and you can even get around that by being the first person to find a credible utility for it.

  21. 22

    Wow. Everyone hates Rader so much that they immediately jump to his defense when he criticizes other judges for acting like Rader.

  22. 21

    @ IANAE: “You’re thinking of novelty.”

    Actually, if it’s a newly discovered law of nature or natural phenomenon, it’s not anticipated because it was not known, used or described. “Novelty” is not strictly the same thing as “new.” If something has been sitting there for millenia but no one knew it, upon being discovered it is novel under s.102 despite not being new.

    Of course, this points out why rocks, the sun, etc., are NOT statutory if one claims them exactly as they are found in nature. They are excluded under s.101 because, if they have just been discovered, s.102 is not equipped to exclude them. In other words, I guess there is a place for the judicially created, three-headed s. 101 monster. However, it must be, as Judge Rich passionately argued in Bergy, a very loose barrier to patenting.

    S.101 is simply the first door and it should only be used to shut out claims to pure laws of nature (not an application thereof) and natural phenomena as they exist in nature.

  23. 20

    IANAE–

    By moral “authority”, I assume you meant moral “duty”.

    Whether or not there was/is any such duty is determined by each judge individually in each different case.

    It is not manifest in all cases, and CAFC justices are not, and will not be, influenced by what you “would say”.

    I would turn this around on its head and advocate for LESS reasons and reasoning being articulated. Where has it gotten us? Into a jurisprudential morass.

    It makes legal research take longer, however, and makes legal “scholarship” more enjoyable and amusing, while at the same time making legal counselling sometimes less appealing, less efficient, and less effective.

  24. 19

    IBP: In case you haven’t noticed, reaching conclusions is what judges do.
    There is no duty on the CAFC justices to explain their reasoning.

    I would say that judges at every level have at least a moral authority (unenforceable though it would inevitably be) to give reasons for their decisions, if only to maintain confidence in the system.

    And of course Rader is entitled to have his opinion on whatever topic he likes. But so am I, and my opinion is that Rader is complaining about the mere speculative possibility that other judges may do precisely what he did in precisely the same situation. Which, if it bothers him so much, he should not have done in the first place, what with his role in the system being precedential and all.

  25. 18

    Locke–

    While I agree that the recusal motion is without merit, I don’t entirely agree with your characterization that Frankfurter’s actions were analogous to Rader’s.

    Frankfurter said that “101” law-of-nature arguments were unhelpful in that case, so he declined to discuss “101” and voted to invalidate based upon “112” written description grounds.

    Rader said that 101 had no helpful legal standard, and therefore that 101 decisions would be made based upon a political standard.

    The difference is that the necessary implication of Rader’s comment is that every articulated 101 determination that has been made, has been made according to a political standard rather than a legal standard.

    Frankfurter’s statement contained no such necessary implication.

    Splitting hairs, I know, but Rader went above and beyond. Sure, when non-judges allege judicial decisions to have been made on political grounds, that is one thing; but when a judge does it, what is he saying? That all of his previous 101 rulings were based upon a political standard?

    Why not just refuse to decide on 101 grounds, or articulate an entirely new 101 formulation?

  26. 17

    Locke: As long as what you’ve claimed is not found in nature exactly as you’ve claimed it, it’s patent-eligible.

    You’re thinking of novelty.

    If what you’re claiming is found in nature exactly as you’ve claimed it, it might well be perfectly statutory. A rock is statutory. Water is statutory. The sun is statutory. The problem with claiming those things is anticipation.

    101 is only a bar to claims that cover the law of nature itself, either devoid of practical application or for all practical applications.

  27. 16

    IANAE–

    In case you haven’t noticed, reaching conclusions is what judges do.

    There is no duty on the CAFC justices to explain their reasoning.

    It would have been a single conclusory sentence, but instead of being glib, it would have been eloquent.

  28. 15

    Paul Cole: Judge Rader is not always right, but on Bilski he clearly was.

    Well, yes. I wasn’t commenting on whether Rader was right in Bilski. I was commenting on Rader’s moral authority for complaining that the Bilski test is too malleable and that it invites result-oriented manipulation. Because it’s his test, and he didn’t even show his work.

  29. 14

    @ IANAE:

    “The ‘everything obeys laws of nature’ argument is exactly as specious as AI’s ‘every patent is a business method’ argument.”

    Precisely my point. The utterly unhelpful case law on s.101 merely encourages this type of logical manipulation. Because the courts have refused to draw a line (or better yet, get rid of the three-headed 101 exception monster entirely), parties and judges get to run wild and draw the line in whatever way fits their (or their client’s) world-view.

    The take home is this: Every invention embodies one or more laws of nature. The Prometheus invention is no different. Instead of embodying laws governing electromagnetic radiation the way a laser might, the Prometheus invention embodies laws governing the chemical interactions of molecules in an organism. I have yet to see ANY articulation of a meaningful difference.

    As long as what you’ve claimed is not found in nature exactly as you’ve claimed it, it’s patent-eligible.

  30. 13

    Inane: Judge Rader is not always right, but on Bilski he clearly was. That invention deserved dismissal in a single sentence, and he did it. There is much more that was said, but very little more that needed to be said.

  31. 12

    Since everything operates according to the laws of nature, opponents apparently want to only award patents for miracles (which of course would lack a credible utility under 101).

    The “everything obeys laws of nature” argument is exactly as specious as AI’s “every patent is a business method” argument.

    Also, miracles most definitely have credible utility. What they lack is enablement.

    Just like Judge Rader said, the 101 exceptions are so vague and malleable as to be ripe for manipulation by a judge so as to make any decision he wants (rather than what the law requires).

    It’s funny, because the entire Supreme Court bench agreed with Rader’s reasons why he would uphold the rejection of the Bilski claims. And Rader himself would have disposed of the case in a single glib, conclusory sentence.

  32. 10

    And don’t get me started on “laws of nature” or “natural phenomena.” The only things that don’t fall into this category are the supernatural or paranormal. Since everything operates according to the laws of nature, opponents apparently want to only award patents for miracles (which of course would lack a credible utility under 101).

    I realize this is taking the law of nature exception a little far, but this is precisely what opponents of any class of patent can do. Just like Judge Rader said, the 101 exceptions are so vague and malleable as to be ripe for manipulation by a judge so as to make any decision he wants (rather than what the law requires). By the way, Rader got a recusal motion for essentially reiterating what Justice Frankfurter said over half a century ago (see Frankfurter’s dissent in Funk Bros). Tell me that’s not funny.

  33. 9

    @ EG:

    Great comment. Let’s cut through the smoke and mirrors and mental gymnastics and get to 102/103.

    That said, on what planet would the Prometheus claim be abstract? It has a clear practical application. Use Judge Hand’s levels of abstraction analysis. A claim to the principle that dosage should be adjusted based on plasma levels is clearly at one end of the spectrum. The Prometheus claim is clearly at or near the other end since it specifies the disease, the drug, and most importantly the threshold levels for adjustment. How on earth could that be considered abstract?

  34. 8

    I just went back to review the original Federal Circuit decision in the Prometheus case, and it again points out the absurdity of judging subject matter such as this solely under the “M or T.” That the Federal Circuit ruled there was a “transformation” because the drug was converted into metabolites were analyzed to determine if there was too little/too much of the drug adminisitered is simply unnecessary “hoop jumping,” not rational reasoning. Medical diagnostic methods, calibrative dosage methods (as in the Prometheus case), and the like are “processes” under 35 USC 101, no matter what test you apply.

    Instead, as Paul Cole and others suggest, let’s judge the Prometheus method for whether it passes muster under 35 USC 102/103. We’ve had enough judicial “ink” wasted on evaluating methods such as those in Prometheus (as well as Classen Immunotherapeutics) for whether they can jump through some nebulous or illogical “hoop” test under 35 USC 101.

  35. 7

    Bob — You asked about the obviousness of the claim.

    In my summary, I left out some critical threshold information. It appears that the biggest advance here was in understanding what information from the blood sample was important in recalibrating the 6-thioguanine dose.

  36. 6

    Could somebody please explain why those three steps aren’t obvious? The procedure of measuring a level and adjusting a dose is certainly well known in medicine.

  37. 4

    I agree Dennis — Judge Clark can remain on the panel if he wishes. A Federal Circuit judge will be selected to replace CJ Michel on the panel.

  38. 2

    And Malcolm wants to lecture on method claiming – NIMBY

    Not sure what you’re driving at. Care to spit it out?

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