Athena Tells SCOTUS That Mayo’s Key Argument “Collapses” Under Federal Circuit Split

By Eileen McDermott
December 9, 2019

“The court did not split based on disagreement about what the law should be—in fact, the Federal Circuit broadly agreed that Athena’s claims should be patent-eligible. Rather, the court split based on genuine disputes about how to apply the framework this Court established.” – Athena reply brief

Athena Diagnostics today filed its reply brief to Mayo Collaborative Services at the Supreme Court in the closely-watched petition asking the High Court to clarify U.S. patent eligibility law. The reply reiterates the points made in Athena’s petition for certiorari and dismisses Mayo’s argument in November that “any further action regarding the patentability of medical diagnostic claims such as Athena’s that employ conventional, known techniques should and does rest with Congress.”

The reply also comes three days after the United States Solicitor General recommended that SCOTUS grant cert in Athena or “another such case” rather than in Hikma Pharmaceuticals v. Vanda Pharmaceuticals.

Athena filed its petition for certiorari to the U.S. Supreme Court in October, asking it to fix the United States’ patent eligibility law problem. 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.

In its brief in opposition filed November 22, Mayo claimed that the Supreme Court’s precedent in the 2012 case of Mayo v. Prometheus “disposes of this case, as the district court, appellate panel, and en banc Federal Circuit each concluded.” Essentially, Mayo told the Court that there was nothing more for it to do and that Congress should address any confusion or harm that exists.

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Athena’s reply says that Mayo’s argument:

  • “collapses under the weight of the Federal Circuit’s 7-5 split;”
  • “tees up multiple points of doctrinal uncertainty identified by the Federal Circuit, amici, and government” including “the role of novel man-made molecules in method claims, the level of abstraction at which to view claims, the Federal Circuit’s one-sided approach to preemption, and what it means to view the claims as a whole;”
  • “loses sight of the procedural posture” since Mayo’s request to “dismiss under Rule 12(b)(6) on the theory that, without any factual development, the asserted claims were categorically ineligible for patent protection as a matter of law” underscores that the case “presents a pure question of law, with no factual disputes to resolve because the record must be viewed in the light most favorable to Athena. In short, it provides a perfect vehicle to clarify the law;” and
  • “gets things backwards” in arguing that Congress should take the reins. The reply brief says: “The Federal Circuit did not interpret the statutory text; it misapplied this Court’s decisions creating exceptions to that text. If Mayo wants those exceptions expanded, it is the one that should take its policy arguments to Congress. The Court has a special responsibility to ensure that the lower courts do not unduly expand judge-made law by misinterpreting the framework it created.”

The brief also emphasizes the government’s position in Vanda, which supports granting certiorari in Athena or a case like it rather than in Vanda, which the Solicitor General does not consider “an optimal vehicle for bringing greater clarity” on Section 101.

Athena chiefly points to the Federal Circuit’s 7-5 split in its decision to deny rehearing en banc as evidence that Mayo’s claim that “the Federal Circuit has had no problem applying Mayo [v. Prometheus] consistently” is disingenuous. Athena explained:

The court did not split based on disagreement about what the law should be—in fact, the Federal Circuit broadly agreed that Athena’s claims should be patent-eligible. Rather, the court split based on genuine disputes about how to apply the framework this Court established in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. 66 (2012).

Second, Athena points to Mayo’s focus on the facts of this particular case as actually highlighting the broader legal questions the CAFC has struggled to apply:

First, as recognized by Judge Dyk, there is tension between the decision below and this Court’s holding in Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S. 576, 594-595 (2013), that a “molecule that is not naturally occurring” is “not a ‘product of nature’ and is patent eligible under § 101.” Pet. 17, 29-31; App. 69a-71a. Mayo offers no good response. It implicitly concedes (at 25), as it must, that the prior Mayo case involved a drug routinely used before, not a novel manmade molecule as here.

Of Mayo’s contention that Congress must step in to make any necessary changes to Section 101, Athena warns that help from Congress is far off at best, and that Mayo should take its policy arguments to Congress itself if it wants to expand exceptions to Section 101:

The Court should not ignore the lower courts’ confusion in the hope that Congress might intervene. Despite congressional hearings highlighting that confusion and the unsustainable state of the law, Pet. 22-24, there is no legislative solution in sight, Nayak, IP Groups Developing Fresh Patent Eligibility Bill Proposal, Bloomberg Law (Oct. 17, 2019), https://bit.ly/2ONFG4t (“lawmakers have not introduced a bill” in light of “disagreement among stakeholders”). In any event, this Court has a special responsibility to clarify patent-eligibility law and rein in the Federal Circuit’s improper expansion of the exceptions to patent eligibility.

The case will go to Supreme Court conference on January 10.

The Author

Eileen McDermott

Eileen McDermott is the Editor-in-Chief of IPWatchdog.com. Eileen is a veteran IP and legal journalist, and no stranger to the intellectual property world, having held editorial and managerial positions at several publications and industry organizations. She has acted as editorial consultant for the International Trademark Association (INTA), chiefly overseeing the editorial process for the Association’s twice-monthly newsletter, the INTA Bulletin. Eileen has also served as a freelance editor for the World Intellectual Property Organization (WIPO); as senior consulting editor for the Intellectual Property Owners Association (IPO) from 2015 to 2017; as Managing Editor and Editor-in-Chief at INTA from 2013 to 2016; and was Americas Editor for Managing Intellectual Property magazine from 2007 to 2013.

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com. Read more.

Discuss this

There are currently 13 Comments comments.

  1. Bemused December 9, 2019 6:16 pm

    Good strategy by Athena: Inviting SCOTUS to again spank their favorite whipping boy, the CAFC. That strategy also allows SCOTUS to save face by taking the position that they got it right in Mayo; and that it was actually the CAFC that screwed things up royally but misapplying their reasoned guidance (tried REALLY hard not to roll my eyes when I wrote the words “reasoned guidance”).

  2. Concerned December 10, 2019 7:38 am

    “In any event, this Court has a special responsibility to clarify patent-eligibility law and rein in the Federal Circuit’s improper expansion of the exceptions to patent eligibility.”

    Humorous. Rein in the lower court’s expansion by the originators of such expansion.

    At least the district court has not required that patentable medical processes shall improve the test tube yet, like they did with processes in the computer sciences that must improve the hardware. How could the district court miss such a golden opportunity?

  3. Anon December 10, 2019 10:12 am

    There is ploy here (and a shallow one at that) to pretend that the originator of the mess of the Gordian Knot is not the Supreme Court itself.

    I despise this type of NOT being forthright with the underlying problems in the state of patent eligibility jurisprudence.

  4. TFCFM December 10, 2019 10:20 am

    Athena’s Reply: “The Federal Circuit did not interpret the statutory text; it misapplied this Court’s decisions creating exceptions to that text. If Mayo wants those exceptions expanded, it is the one that should take its policy arguments to Congress. The Court has a special responsibility to ensure that the lower courts do not unduly expand judge-made law by misinterpreting the framework it created.

    One wonders about the focus of the folks representing Athena. This argument is an utter non-sequitur.

    Athena has appealed the CAFC’s decision, applying the Supreme Court’s interpretation of section 101, as written by Congress. Mayo is not seeking to change the Supreme Court’s interpretation (at which the CAFC expressed dismay for being bound). Instead, Athena seeks to convince the Supreme Court to change its existing interpretation.

    Athena (and like-minded parties) might be able to convince the Supremes to change their minds (but don’t count on it, IMO), or they might be able to motivate Congress to enact a statute that more clearly parses what is, and is not, eligible for patenting in a way that Athena likes. However, arguing that the respondent (Mayo) is “trying to change the law” is simply disingenuous and — I would worry if I were representing Athena — risks compromising the appellant’s credibility.

  5. Anon December 10, 2019 2:24 pm

    TFCFM,

    I think that you are in error about how the law is changing.

    The Supreme Court has basically provided an open-ended re-write of the actual words of Congress with a Common Law law writing mechanism that is atextual – and thus unconstrained to the actual statutory text.

    They then invited the lower courts to “fill in the blanks.”

    ALL of this is very much the fault of the Supreme Court and a direct result of Their scrivining.

    Every single branch of the government has correctly traced the current problems with eligibility jurisprudence to the Supreme Court.

    We must get to the point of having the Emperor admit that he is wearing no clothes.

  6. angry dude December 11, 2019 3:33 am

    @Anon

    “There is ploy here (and a shallow one at that) to pretend that the originator of the mess of the Gordian Knot is not the Supreme Court itself.”

    The originator of the rip-off (aka “mess”) is located on the West Coast and everyone (except maybe you) knows it

    It’s called FAANG

    Dude, can you just stfu ?

    You are really annoying with your bs

    Instead of focusing on real causes of the “mess” (money being made by the largest corporate efficient patent infringers via ripping off small entities) you are trying to divert reader’s attention to some bs legal mumbo jumbo

    Your legal mumbo jumbo is dime a dozen and changes every day

    There is NO Patent Law in the United Stated at present and everybody knows it

  7. Anon December 11, 2019 6:36 am

    angry,

    Still having a total lack of control of your emotions, I see.

    Come back when you can grasp reason in some small fashion.

  8. TFCFM December 11, 2019 10:08 am

    Anon: “I think that you are in error about how the law is changing.
    The Supreme Court has basically provided an open-ended re-write…

    You miss the point of my comment. I’m not commenting (favorably or un-) about the Supreme Court’s interpretation of section 101. Instead, I am commenting solely about Athena’s reply.

    Athena accuses respondent Mayo of trying to change the law. That is simply nonsense, given the facts here: The CAFC said (crudely simplifying), that they didn’t much like the Supreme Court’s interpretation, but that they were bound by it, and so applied it. Athena — not Mayo — is seeking to change that interpretation. Mayo is not trying to “change” anything regarding this issue (Mayo is presumably satisfied with the current outcome).

    For Athena to argue in its reply that “Mayo is trying to change the law” strikes me as potentially-credibility-sapping nonsense. I would not have included that argument — especially given that Athena has an at-least-colorable alternative argument: that the Supreme Court’s interpretation is ‘wrong’ and/or unworkable and ought to be changed.)

    Separately, regarding what you opined (an issue not raised in my original comment):
    Anon: “The Supreme Court has basically provided an open-ended re-write of the actual words of Congress with a Common Law law writing mechanism that is atextual – and thus unconstrained to the actual statutory text.

    Judicial interpretation of enacted laws is nothing new. Indeed, interpretation of THIS PARTICULAR part of patent law is nothing new. At least as early as the 1850s (O’Reilly v Morse), the Supreme Court interpreted the patent statutes to exclude eligibility for abstract subject matter (even though the patent statute did not expressly say so).

  9. Anon December 11, 2019 3:50 pm

    TFCFM,

    The point of your comment must be taken in the context of the larger stage of what the Supreme Court has done.

    You may want to constrain your point solely to what Athena has to say in it s reply, but THAT must be taken in the larger context, and cannot be taken in a vacuum.

    Bottom line is when it comes to actual changes in the statutory law, the Supreme Court acting ultra vires (with its own Common Law law writing) is simply an error that subsumes ALL other errors.

    The “credibility-sapping nonsense” is in pretending that the larger issues are not existent, or have no effect on the law of eligibility — as written by Congress.

    As to “Judicial interpretation of enacted laws is nothing new” – there is a CLEAR difference between proper Common Law application to “fill in the gaps — where such gaps are clearly evident — or to provide interpretation when the words of Congress are unclear. NONE of that is present in 35 USC 101 (and in fact, the Act of 1952 was pretty damm explicit about resetting the MESS created by a Supreme Court that had self-christened itself with the moniker “the only valid patent is one that has not yet appeared before us.”). Your attempt then to invoke PRE-1952 reach is still-born and is NOT in accord with the actual words of Congress.

    Your sense of history – as is your knowledge of patent law, as well as when Common Law interpretation of Statutory law is proper – all remain off.

  10. TFCFM December 13, 2019 10:05 am

    Anon: “You may want to constrain your point solely to what Athena has to say in it s reply, but THAT must be taken in the larger context, and cannot be taken in a vacuum.

    You’re free to talk about whatever you like. I merely point out that you’re talking about a different issue (something like what you wish the substantive law were, or what you would like it to be) than the issue discussed in my comment (i.e., what Athena said in their reply and how it may affect their credibility.)

  11. Anon December 13, 2019 11:18 am

    I merely point out that you’re talking about a different issue

    Actually, no – my talking about an issue subsumes your point (YOU may feel like talking about something “in a vacuum,” but such is simply not reality).

    Pretending to be in a vacuum affects YOUR credibility — something already barely there.

  12. TFCFM December 16, 2019 10:12 am

    Whatever. Consider me “subsumed” if that floats your boat. You’re still talking about a different issue (what you think the law ‘ought’ to be) than the issue I discussed (a fault with Athena’s Reply).

  13. Anon December 16, 2019 5:55 pm

    When one says “whatever,” and then continues errantly, then the person saying “whatever” is the f001.

    Don’t be silly and pretend that “subsume” is somehow “too big” or difficult of a word for you to grasp. Again, pretending to be in a vacuum affects YOUR credibility – and doubling down (as you do here), only makes it vanish ever the more quickly.