Athena v. Mayo: Whither Diagnostic Method Patents

by Dennis Crouch

OK, here is an important case: Athena Diagnostics, Inc. v. Mayo Collaborative Services, LLC, Docket No. 19-430 (Supreme Court 2019).  In its new petition, Athena asks — did the Supreme Court really intend to bar patenting new diagnostic methods absent creation of new technological equipment? [Petition for Writ of Certiorari][Appendix].

At issue are Claims 7-9 of Athena’s U.S. Patent No. 7,267,820. The district court dismissed Athena’s infringement complaint — finding the claims ineligible.  That decision was reluctantly affirmed by the Federal Circuit. The appellate court then denied en banc review — with eight separate opinions from the 12-member court.  In its Supreme Court petition, Athena now presents the question as follows:

The question presented is: Whether a new and specific method of diagnosing a medical condition is patent-eligible subject matter, where the method detects a molecule never previously linked to the condition using novel man-made molecules and a series of specific chemical steps never previously performed.

[Petition].

The invention process in this case started with the reality that the biological cause of Myasthenia gravis (MG) could be identified for only about 80% of patients.  The inventors here discovered that a substantial portion of those “unknown cause” patients generated autoantibodies to “muscle-specific tyrosine kinase” (MuSK). MuSK was previously known as a naturally occurring human protein.  Although the autoantibodies to MuSK were not previously known, but do naturally occur in individuals with the condition.  The key discovery of the inventors is the link between the autoantibodies and the particular form of MG.  Under Mayo v. Prometheus, that link is an unpatentable law of nature.

After discovering the link, the researchers designed and then patented a method of finding those MuSK antibodies to help diagnose the particular form of MG. Since the autoantibodies were not easy to directly detect, the claims requires that a lab first tag MuSK proteins with a radio-label (such as Iodine-125) and then mix the proteins with body fluid. If the autoantibody is present in the fluid then it should bind with the tagged-MuSK.  At that point, you immunoprecipitate any antibody/MuSK complex and look for the label in the precipitate.  The patent explains that these steps are well known in the art – “Iodination and immunoprecipitation are standard techniques in the art.”  However, they had never been done with MuSK and its autoantibody. At that tight level of granularity, these steps could be called “a series of specific chemical steps never previously performed” as they were in the petition.

If you think that Myriad Genetics might provide insight to this case, it will also be important to recognize that radio-labeling MuSK actually creates a new molecules — “novel man-made molecules.”

Claims 7-9 of Athena’s U.S. Patent No. 7,267,820 are at issue. These depend from a very broadly written claim 1 that Athena did not defend on appeal. Claims: 

1. A method for diagnosing neuro … disorders related to [MuSK] comprising: … detecting in a bodily fluid … autoantibodies to … MuSK.

7. A method according to claim 1, comprising

contacting [labelled] MuSK … with said bodily fluid,

immunoprecipitating any antibody/MuSK complex … from said bodily fluid and

monitoring for said label on any of said antibody/MuSK complex …,

wherein the presence of said label is indicative [of the disorder]

8. A method according to claim 7 wherein said label is a radioactive label.

9. A method according to claim 8 wherein said label is [Iodine-125].

Patent at issue.

I’ve unfortunately been reminded of Dickens multiple times this week. The Dickens link with this brief comes in the form of melodrama. The following comes from the petition introduction:

[T]he Federal Circuit issued an unprecedented cry for help from this Court to clarify the patent eligibility of medical diagnostic tests. This Court should heed that cry and provide much-needed guidance on the proper application of the judicially-created exceptions to Section 101 of the Patent Act. . . .

[Among members of the Federal Circuit] there was broad consensus that this Court’s review is desperately needed. Numerous government officials, practitioners, and scholars have echoed and amplified the message that the law of patent-eligible subject matter is in a state of turmoil and there is no more important question facing the patent system. . . .

If these claims do not even meet the threshold requirement of being the kind of subject matter eligible for patent protection, that is the end of patent eligibility for the overwhelming majority of medical diagnostic methods—leading to profound consequences for future investment in scientific research and public health.

It actually took me quite a while to write this post — I must have fainted from simply reading the introduction.

Seriously though – this is an important issue. The Federal Circuit judges agreed that this is the type of invention that SHOULD be patent eligible, but is NOT patent eligible.  The Supreme Court should also recognize that its action (or inaction) in this case will likely be followed-up by Congressional action — as such a well reasoned opinion would go far to smoothing that process.

 

 

 

26 thoughts on “Athena v. Mayo: Whither Diagnostic Method Patents

  1. 5

    DC : The Federal Circuit judges agreed that this is the type of invention that SHOULD be patent eligible

    Exactly what is the “type of invention” they are talking about?

    Literally no oxygen-breathing judge or attorney believes (or is capable of defending the viewpoint) that “no diagnostic patents are eligible after Mayo”.

    So what exactly is the CAFC talking about? If the CAFC can’t be bothered to be clear about this stuff, then there’s little point in paying attention. They’re just whining along with the little whining attorneys who comes suited up and prance around before them, huffing and puffing and shedding croc tears about the “end of innovation” and “oh the children!” … while the PTO is granting historic numbers of patents and hundred million dollar patent deals are being made every day.

    If the CAFC can’t even be bothered to follow the logical outcome of their own decisions (hint: the outcome is never going to be “nobody will want to learn stuff anymore derp gotta have ten million Silly Con Valley Bro investor money before a finger gets lifted derp!”) or the decisions being sought from them (hint: nobody is suggesting that “a claim that describes a diagnostic method is ineligible because … diagnostic”) then what the heck is going on in those hallowed halls anyway? Last time I checked these life-appointed fossils were paid a lot of money.

    Why, it’s almost enough to make one think that the real issue is that Rich Whitey just isn’t getting rich enough quickly enough. Look at all the data that Rich Whitey had to crunch to discover that correlation! A whole bunch of data. Crunching is teh hard!

    1. 5.1

      real issue is that Rich Whitey

      If you don’t stamp out the blatant use of the R card, you can dam well expect the blatant use of the R card to proliferate.

      1. 5.1.1

        So, if I point out that Rich Whitey is in fact buying access so he can enrich himself at the expense of everybody else, you are threatening to respond with … what exactly?

        Answer the question, Bildo. You’re a very serious person and totally not a regular defender here of rich powerful white r@ c i s ts like Perznit Spraytan and his political party.

        1. 5.1.1.1

          you are threatening to respond with … what exactly?

          I am not threatening to “respond with” anything as I point out YOUR racy ism.

          Your “reply” here is a non-sequitur and mere dust-kicking to my pointing out that YOU are playing the R card.

          There is NO “defense” of anything that YOU want to reframe my post into being.

          This is yet another edition of Malcolm Being Trump (but cannot figure out why).

  2. 4

    This appears to be another case of confusion between eligibility and obviousness. Both the courts and litigators have had extreme difficulty distinguishing these two principles, particularly in cases involving biotechnology and computer software.

    In this case, the method of tagging MuSK antibodies does not occur in nature, so the method itself should not be disqualified from eligibility. However, the inventors admit that the claimed method requires steps (iodination and immunoprecipation) that are well known in the art. Consequently, this presents the question whether applying standard techniques to MuSK antibodies would have been obvious.

    Although the inventors purportedly discovered the MuSK antibodies, which enabled them to design “novel” molecules by being the first to tag them with radioisotopes, the discovery itself is not eligible since the antibodies are naturally occurring (even if they had not previously been discovered).

    But, after discovering the MuSK antibodies, would it have been obvious to use iodination and immunoprecipitation for diagnostic purposes, particularly under the “obvious to try” line of cases? In KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 421 (2007) the Supreme Court stated:

    A claimed invention would have been obvious if “a person of ordinary skill has good reason to pursue the known options within his or her technical grasp. If this leads to the anticipated success, it is likely that product was not of innovation but of ordinary skill and common sense. In that instance the fact that a combination was obvious to try might show that it was obvious under § 103.”

    Since the claimed method admittedly requires use of known steps within the technical grasp of a person of ordinary skill, the remaining questions may be whether there was good reason to use those particular steps and whether they would lead to anticipated success. Those are fact questions that should be resolved by summary judgment (if undisputed) or trial (if disputed), not by dismissal for ineligibility.

    1. 4.1

      Some guy named Jai Rho: This appears to be another case of confusion between eligibility and obviousness. Both the courts and litigators have had extreme difficulty distinguishing these two principles, particularly in cases involving biotechnology and computer software

      It’s not “courts” who have extreme difficulty with the distinction. It’s blog commenters … like you.

      the method of tagging MuSK antibodies does not occur in nature, so the method itself should not be disqualified from eligibility.

      This is nothing more than your personal opinion (in which case we can and should question your motives) and does not reflect the current state of the law or the practical reality of applying the law to patent claims. Feel free to justify your opinion with facts and logic but don’t assume that your opinion is correct just because it sounds good to you. That, in fact, is a mistake that is often made by “courts and litigators” and usually leads to the wrong result.

      The mere fact that a claim describes something that “does not occur in nature” does not and should not be the test for eligibility. The reason why is that it is not only possible, but easy to write claims that satisfy this “test” but which impermissibly allow patentees to use the patent system to protect (i.e., to control) “things that occur in nature”. The public’s interest in preventing that unlawful protection from occurring is –as you surely know — paramount.

      Let’s provide a simple example. Let’s say I discover a naturally occurring molecule that has previously not been described (let’s call it “Molecule X”). I am not allowed to claim that molecule because it’s a naturally occurring molecule. But wait! According to you I can broadly claim “A method comprising the step of studying Molecule X” and “A method comprising the step of isolating Molecule X” and/or “A method of detecting Molecule X using any antibody that works” or “A method of tagging Molecule X using any prior art tagging method” because … none of those things are found in nature. As any thoughtful person can see, what you suggest is simply using words to scriven the prohibition against claiming naturally occurring things into a toothless rule. In fact, 101 is the proper tool for the job here.

      Your suggestion that 103 works “better” is only true if you believe that you should be able to scriven around 101 (“because … reasons”) or if you believe that there should be special exceptions to 101 when the otherwise ineligible subject matter is “really cool” or “will make someone filthy rich which is derp the only way to derp promote progress derp”.

      In essence, what you want to do is create a new legal doctrine under 103 that treats previously undescribed but naturally occurring subject matter as prior art and then asks whether the modification is an obvious one. So here’s the problem with that: in 99.9% of these problematic claims, the method applied to the naturally occurring subject matter is going to be in the prior art. Why is that the case? Because most intelligent attorneys working with their clients would recognize that if the methodology itself is new and patentable on its own terms it would be silly to limit claims reciting that new methodology to the “newly discovered” phenomenon (e.g., Molecule X) that is being detected. In other words, it’s always prima facie obvious to use a prior art detection method to detect some “new” species falling within the genus of things that the method was designed to detect. Given this practical reality, the new 103 doctrine you are proposing to enact boils down essentially to this: otherwise ineligible subject matter can be protected by a patent if … it’s commercially valuable or some other (judge created) “secondary factor” can be ginned up to overcome the prima facie case. So now you’ve created a loophole in 101 that you can drive a truck through because you’ve created an easy way for every otherwise highly problematic eligibility claim to sail past summary judgment, where so many of these claims otherwise would properly expire.

      Let me know if you have any questions about any of the above. You’ll note that I’m making very. very few assumptions and I would suggest that all of you do the same. Also do not fall into the trap of pretending that “all diagnostic patents are ineligible” because that is absolutely not true. The best and most important “diagnostic patents” are just as eligible as they always were because they recite non-obvious objective physical structure or non-obvious physical transformations of matter.

      1. 4.1.1

        What you view as “paramount” is nothing more than your cognitive dissonance on display.

      2. 4.1.2

        “there should be special exceptions to 101 when the otherwise ineligible subject matter is “really cool” or “will make someone filthy rich which is derp the only way to derp promote progress derp”.

        Isn’t this kind of the point of the patent system? Fuel, fire, genius, and the like.

        1. 4.1.2.1

          rp,

          Malcolm does not KNOW what the real purpose of the patent system is.

          The plain fact that a Quid Pro Quo is involved — and that people GET “property” from which they may (gasp) want to make money with simply goes against his Liberal Left “sensibilities.”

          But you may ask, “Isn’t Malcolm a professed patent attorney whose job it is IS to obtain innovation protection in the form of property, from which people MAY WELL — and in most all likelihood WILL — want to make money with?”

          The clear answer is: Of course.

          Which is exactly what causes the rants and angst that you see so very often from Malcolm. Having it BE his job to create something that he despises IS the cause of his cognitive dissonance, and the level of that cognitive dissonance evidences itself IN his voluminous rants on this blog.

  3. 3

    ” The Federal Circuit judges agreed that this is the type of invention that SHOULD be patent eligible, but is NOT patent eligible”

    Well, if they say so. I guess the country should be ruled by judges eh?

    1. 3.1

      meh, who needs One Document above All Three Branches (and the likes of checks and balances), eh 6?

  4. 2

    Does the fact that even the patent owner’s attorneys will not defend their claim 1, plus the D.F. paragraph 1 comment suggestion here, suggest that better claim drafting could overcome rejections of some of these diagnostic patents?
    Is the usual resistance to admitting the need to file reissues* part of the problem?
    *loss of prior date infringement recovery for reissue amended claims is a lot better than losing the entire life of the patent.

    1. 2.1

      I am not sure that I will agree that better claim drafting could solve the problem (the claims here should be fine under §101 in a sane world), but I will certainly concede that different claim forms would do the trick. That was Judge Lourie’s point in his Athena concurrence from the denial of en banc review—you can still claim these sorts of inventions as methods of treatment under Vanda, even if you are not permitted to claim the diagnostic method simpliciter. This is a nonsensical exaltation of form over substance, but I suppose that it at least means that the industry can cobble together a work-around to keep R&D going.

      The better way, however, would just be to admit that Mayo is unworkable nonsense. Just as the SCotUS had to use Diehr to undo its Flook mistake (even while superficially maintaining that Flook was still good law), the Court would do well to use this case to undo its Mayo mistake (even if it needs—for purposes of saving face—to pretend that Mayo was all just hunky dory).

      1. 2.1.1

        This is a nonsensical exaltation of form over substance,

        How long would that last with a Supreme Court that actively denigrates “scriveners” that write claims geared to the actual words of Congress?

    2. 2.2

      The patent in question (US7,267,820) dates back to a British priority application from June 2000 and is nearing the end of its life. Perhaps claim 1 might have been defendable back then, but not now. Overreaching in patent claiming is not a good idea, but without a crystal ball as to future developments in law is sometimes unavoidable.

      In any case, as for claims 7-9, in principle at least, the form shouldn’t matter, as: “Each claim of a patent (whether in independent, dependent, or multiple dependent form) shall be presumed valid independently of the validity of other claims; dependent or multiple dependent claims shall be presumed valid even though dependent upon an invalid claim.” (cf. 35 U.S.C. 282(a))

  5. 1

    Several thoughts:

    1. If the patentee had claimed a new molecular complex per se – viz., the antibody/labeled MuSK complex – and a method of making that complex, I think they’d have an easier time of it than with this “mix/detect/if A detected then X” type of claim.

    2. Sadly, the fact that the labeled protein doesn’t exist in nature doesn’t necessarily mean anything to SCOTUS. In Mayo, the robed English majors said that isolated DNA is the same as naturally occurring DNA (notwithstanding the fact that the isolated DNA has hydrogens where the naturally occurring DNA has more DNA attached) because “the information it contains is the same” – as if DNA, RNA and ribosomes care about the human construct we call “information”. A sympathetic (or merely sane) judge would agree that the labeled protein doesn’t occur naturally, and pass the claim through 101 on that basis. An unsympathetic (or merely ignorant) judge could say, “For your purposes the labeled protein reacts with the antibody exactly the same way the unlabel protein reacts, so you’re claiming a law of nature.” It’s still the same crapshoot it’s been for the past seven years.

    3. This case is alot like Sequenom. In that case, the CAFC also said “this invention is novel and totally non-obvious but under SCOTUS’s precedent we have to rule it’s not eligible under 101 – our hands are tied”, and an 8-member SCOTUS refused cert. The principal difference here is the make-up of SCOTUS: J Scalia’s vacant seat has been filled by J Gorsuch, and J Kavanaugh has replaced J Kennedy. Will that make a difference?

    1. 1.1

      To your point three, does not the fact that a question of statutory law is coming down to the makeup of the Bench not tell you that Legislating from the Bench is occurring?

      The score board is broken – and the emphasis on that fact must be elevated.

      We STILL have present each of the two shears of the Kavanaugh Scissors.

      We should ALL be helping the Court see that it has the tools to cut through the Gordian Knot of its own creation.

    2. 1.2

      To your point 1, the fact that we are musing about “easier” as if we somehow should give up on the law that is proper and settle for “easier” SHOULD highlight that mischief is afoot.

      This is nothing more than pretending that the Act of 1952 did not happen.

      But it DID happen, and the statutory category of “Process” simply is NOT a handmaiden of the hard goods categories, and ANY “easier” approach that settles for the pre-1952 level is clearly not a proper legal approach.

      The Court does not get to pretend that the Act of 1952 did not happen.

      We — as attorneys — have an ethical responsibility to NOT let the Court pretend that the Act of 1952 did not happen.

    3. 1.3

      I agree 100% on all 3 points, Dan. The patentee could have drafted other claims covering the same invention that would likely have survived §101 challenge, but honestly there is no reason why these claims should fail §101.

      I predict no cert. I suppose that it is just possible that the justices will have enough humility to read the en banc opinions and realize that they made a big mistake in Mayo/Myriad/Alice. More likely, however, seven of the same nine who handed down unanimous opinions in Mayo/Myriad/Alice will look at this petition and say to themselves “we just settled this question in 2014, why revisit it in 2019?”.

      If they were not willing to take cert. in Sequenom (with an even more compelling set of facts), I am hard pressed to see why they will be moved for Athena. For better or worse, Congress is our best hope to fix this mess.

      1. 1.3.1

        I agree with the “not Sequenom, so certainly not here view based solely on the fact that the Supreme Court appears to lack the humility of recognizing its own mistakes.

        So even though there is a ready tool (hint: Kavanaugh Scissors) for the Court to extract itself from its own made mess of a Gordian Knot, the addiction of fingers in the nose of wax is just too much, and Congress should not wait for the Court to Act.

      2. 1.3.2

        Given that the Court asked for views of the Solicitor General in both Hikma Pharmaceuticals USA Inc., et al. v. Vanda Pharmaceuticals Inc., No. 18-817 and HP Inc., fka Hewlett-Packard Company v. Berkheimer, No. 18-415, I would not be surprised if the Court does the same in this case. Incidentally, the Solicitor’s brief on at least Berkheimer should come back soon.

        I don’t claim to have any special insight, but I feel like the Court has to recognize the need for clarity given that uncertainty, and disagreement between various judicial actors, seems to be increasing, rather than decreasing. See, e.g., Judge Moore’s dissent issued today in American Axle & Manufacturing, Inc. v. Neapco Holdings LLC, no. 18-1763 (Fed. Cir. Oct. 3, 2019), where she suggested that “The majority opinion parrots the Alice/Mayo two-part test, but reduces it to a single inquiry: If the claims are directed to a law of nature (even if the court cannot articulate the precise law of nature) then the claims are ineligible and all evidence of non-conventionality will be disregarded or just plain ignored.” American Axle, dissent slip op. at 1 (Moore, J., dissenting).

        1. 1.3.2.1

          but I feel like the Court has to recognize the need for clarity given that uncertainty, and disagreement between various judicial actors, seems to be increasing, rather than decreasing.

          Sorry J, but you are trying to use “logic” as to what the Court has to recognize.

          The Court has to do NOTHING that the Court deigns that it so chooses (wants) to do.

          What the Court should do is an altogether different matter.

          The Court is to blame for the current Gordian Knot, and as noted in the Congressional Hearings of Senator Tillis, the Court has shown NO proclivity for fixing the mess they created.

    4. 1.4

      Dan Feigelson you are exactly right that this case is a lot like Sequenom.

      Greg we are getting down the path on the Garmin thread, maybe move the discussion here if you have a response to my last.

      Of course this case easily fits my information doctrine:

      Is it a method? Yes

      Does the method result only in an item of information? Yes

      Does the utility of the information depend on meaning consumed by persons? Yes

      Ineligible.

      If the precipitated antibody/MuSK complex could gain eligibility as a new composition, that would provide patent protection to the invention. But if like Sequenom, the true novelty is merely “There is gold in them thar hills”, that is a valuable discovery, but not a patent eligible invention.

      We can make a policy decision about discoveries that are useful for medical diagnoses- we already have, as noted in this thread, with method-of-treatment claims.

      Nonetheless, the fractured opinions of the CAFC and Supreme Court, going back years, show that there is no consensus on how to handle information content in inventions. There should be.

      1. 1.4.1

        [I]f two people honestly find that some item of information has totally different meaning- because meaning is the only way information conveys utility- it absolutely cannot be litigated or even regulated in a free society. We cannot say that the information is either useful or an improvement to any particular person.

        Why does this matter? The degree of utility is never a matter in dispute. Nor does it ever matter that invention [X] is useful to (e.g.) oil drillers, but not to cotton millers. I just do not see why it is supposed to matter that a given invention’s utility is useful only to a narrow set of the public. That might well affect the commercial value of the invention, but what does it have to do with the patent’s validity?

        1. 1.4.1.1

          Sorry, I evidently closed my italics too soon. The entire first paragraph of 1.4.1 is Martin’s quoted argument.

        2. 1.4.1.2

          Greg, its not a ‘utility’ issue. It’s an invention issue.

          Heres a hypo that should make it easy for you: I (a 45 year old man) live in a dorm room with 5 roommates. People have traditionally put a sock on the doorknob to let other roommates know they are engaged in relations inside, and so not to enter. I dont engage in relations, but I do put a sock on the doorknob to let other roommates know that I am watching My Little Pony (a popular kids TV show), and not to enter because I get really angry when I am interrupted

          I claim: “A method comprising: putting a sock on a doorknob, wherein presence of the sock on the doorknob indicates that a 45 year old man inside is watching my little pony.”

          Do you think I invented something patentable? It is certainly useful (at least to me, and probably to my roommates), novel, non-obvious, and easily enabled.

          The issue is the novelty in the hypo claim is “wherein [information X] indicates that [Y]” (just like the patent at issue in this thread). I didnt invent the sock on the doorknob, I just changed what it means to have a sock on the doorknob. That is what we mean that we are essentially trying to patent the meaning (or the utility) of information to an external observer. If you think my hypo claim should be patentable, and you think it through, you should certainly see how it would lead to unsustainable issues.

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