18 responses to “Myriad Genetics Files Infringement Suit Against Gene by Gene for Genetic Diagnostic Testing of BRCA Genes”

1. 

   EG

   July 11, 2013

   Kevin,
   Well, so much for the ACLU, PubPat, and “media frenzy” about the Supreme Court’s decision in Myriad opening the gates for others to do BRCA gene testing. Isn’t also ironic that, with all the hype about Myriad’s patents potentially impeding BRCA gene research, a university and a university affiliated research foundation are one of the suing parties.

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2. 

   Friend of the Court

   July 11, 2013

   “Claim 6: A method for detecting a germline alteration in a BRCA1 gene…comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample”
   Kevin, can you or any other of the legal experts at PatentDocs explain to an experienced patent lawyer and Ph.D. like me how this “determine and infer” claim can possibly be eligible in view of Prometheus?
   Frankly, at least with respect to this claim, Myriad seems to be filing a frivolous (and sanctionable) complaint.
   I look forward to your answer.

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3. 

   Kevin E. Noonan

   July 11, 2013

   Dear FOTC:
   Assuming you mean claim 6 from the ‘999 patent:
   Claim 6: A method for detecting a germline alteration in a BRCA1 gene, said alteration selected from the group consisting of the alterations set forth in Tables 12A, 14, 18 or 19 in a human which comprises analyzing a sequence of a BRCA1 gene or BRCA1 RNA from a human sample or analyzing a sequence of BRCA1 cDNA made from mRNA from said human sample with the proviso that said germline alteration is not a deletion of 4 nucleotides corresponding to base numbers 4184-4187 of SEQ ID NO:1, wherein a germline alteration is detected by amplifying all or part of a BRCA1 gene in said sample using a set of primers specific for a wild-type BRCA1 gene to produce amplified BRCA1 nucleic acids and sequencing the amplified BRCA1 nucleic acids.
   What you have left out of the claim may answer your question. Remember, the claims invalidated in the AMP v. Myriad case read:
   A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene or the sequence of its mRNA in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene or the sequence of its mRNA, wherein an alteration in the germline sequence of the BRCA2 gene or the sequence of its mRNA of the subject indicates a predisposition to said cancer.
   At oral argument, Myriad’s counsel tried to render this claim statutory by reminding the court that the patient’s BRCA gene sequence needed to be determined and so those aspects should be considered part of the claim as understood by one of ordinary skill. The court rejected this approach, because that would involve reading limitations from the specification into the claims.
   In claim 6 of the ‘999 patent these limitations are expressly recited, and so Myriad has a basis for asserting the claim as being distinguished from the claim(s) that were invalidated.
   At the end of the day, ALL diagnostic method claims related to BRCA gene testing will involve steps of identifying mutant from normal alleles. This claim also recites a more limited universe of mutations, and so “preempts” less of the BRCA mutation method space than the invalidated claims.
   A court may disagree, but these are not trivial issues and Myriad has the right to sort them out.
   Thanks for the comment.

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4. 

   Friend of the Court

   July 11, 2013

   “In claim 6 of the ‘999 patent these limitations are expressly recited”
   Kevin, the follow-up I submitted to my earlier which addressed those “limitations”. In a nutshell, the additional step is nothing more than a generic recitation of an old conventional data gathering step of the sort that was deemed insufficient to render Prometheus’ claim eligible.
   “At the end of the day, ALL diagnostic method claims related to BRCA gene testing will involve steps of identifying mutant from normal alleles.”
   Right. Some of those diagnostic methods might actually be worthy of patents because they aren’t merely generic recitations of old conventional methods of determining a polynucleotide sequence. I’m not sure that applies to any of Myriad’s claims.
   “A court may disagree, but these are not trivial issues”
   Can you make a non-trivial argument as to why Prometheus does not render these claims ineligible? Myriad wants to prevent people from obtaining unpatentable information about a DNA molecule which itself is ineligible for patenting. It proposes to do that by claiming the use of any conventional methods to determine the sequence at this patent ineligible locus. How is this any different from Prometheus trying to claim the use of conventional methods to determine whether a blood sample has a particular level of metabolites?

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5. 

   Friend of the Court

   July 11, 2013

   Claim 4 of the ‘857 patent:
   “A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene … from said subject with the germline sequence of the wild-type BRCA2 gene …, wherein an alteration in the germline sequence of the BRCA2 gene … indicates a predisposition to said cancer, wherein the detection in the alteration in the germline sequence is determined by … (j) screening for a deletion mutation in said tissue sample”
   What distinction can be drawn between this claim and Prometheus’ ineligible claim? It’s an old conventional data gathering step tied to an ineligible step of evaluating particular information obtained by that old, conventional data-gathering step. That’s exactly what Prometheus did.
   What’s the “non-trivial” legal issue that Myriad is resting its hopes on?

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6. 

   Friend of the Court

   July 11, 2013

   Kevin: “Myriad has the right to sort them out.”
   There’s no doubt about that. There’s also no question that Myriad’s rights, just like anybody’s rights, are limited by the laws regarding the filing of frivolous complaints.
   We’re just discussing the law, its application, and the policy ramifications.
   Myriad seems intent on pushing, possibly for existential reasons, the proposition that you and I and our wives and our children can not legally use conventional methods to study certain portions of our genomes because Myriad, allegedly, was the first to “discover” the sequences of those regions.
   As you have suggested, Myriad’s first rounds of losses only addressed their wildest attempts to broadly obtain that protection. At best, the claims Myriad is presently asserting are only marginally different in their scope and achieve the same result. Did they neglect to account for certain later-developed sequencing methods? Maybe. That wasn’t by design, however. That was a combination of mere chance and, perhaps, a lack of clever thinking on their part.
   The policy issue of promoting new diagnostic methods, on one hand, versus preventing people from using old, conventional methods to learn facts relevant to their health remains. To a considerabl extent, that policy issue was already considered by the Supreme Court — twice now. We saw two 9-0 decisions in the defendant’s favor. What about these new claims suggests that the balance should (or will be) shifted differently this time?

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7. 

   Kevin E. Noonan

   July 11, 2013

   Dear FOTC:
   The distinction with Mayo is that administering 6-TG to Crohn’s disease patients and monitoring their blood levels was in the prior art, and the “determining” step encompassed any way of making the determination (including any way also in the prior art).
   If I were Myriad, I would argue that there was nothing routine, conventional or well understood about BRCA gene testing. The fact that amplifying and sequencing were conventional isn’t enough, because in Mayo everything was in the prior art except the natural law and here the BCRA genes were not known prior to Myriad’s discovery.
   Had the Court followed the advice of amici and pretended that the gene was known in the prior art as a basis for declaring composition claims patent-ineligible you might have a point. But being able to “apply” the knowledge of the BRCA genes in diagnostic methods seems to fall within the scope of Section III of the opinion (where the Court also says that they are expressly not deciding anything about method claims because they were not before the Court in this case).
   Thanks for the comments.

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8. 

   Skeptical

   July 11, 2013

   Dr. Noonan,
   I see you making two mistakes in your post at 3:57.
   First, you state “because in Mayo everything was in the prior art except the natural law and here the BCRA genes were not known prior to Myriad’s discovery.”
   You state this as IF it were enough that a mere discovery somehow eliminates the 101 judicial exception of products of nature not being eligible.
   It does not.
   You then compound this mistake (of time dependency) by stating “Had the Court followed the advice of amici and pretended that the gene was known in the prior art as a basis for declaring composition claims patent-ineligible you might have a point.”
   You yourself quite miss the point. ‘Pretending known in the prior art’ is a 102/103 argument. Clearly, from Prometheus, such conflation was not going to be followed. Also, 101 is simply a different argument than 102/103.
   The policy and rational is NOT time dependent.
   It simply does NOT matter when something is discovered to be a product of nature. If an item is a product of nature, it simply is not a patent eligible item.
   Period.
   At that point, TRYING to apply the suggested Amici approach is simply wrong headed. It would be like trying to apply the very same approach to music.
   Music is not approached in this manner because quite frankly, you do not even get there. Music is simply not eligible.
   Understanding the fundamental difference between patent eligibility and patentability is what drives the difference between a 101 argument and a 102/103 argument.
   Perhaps I should change my moniker to ‘Amazed’ to reflect my feeling as to how many professionals seem unable to grasp this very basic difference in patent law.
   I think though – that there are just those who do not WANT to grasp this concept. A product of nature, no matter how much work goes into discovering it, no matter how much must be invested in merely isolating it, no matter what else, if the item is, in the end, a product of nature, you simply are not allowed to have a patent on the item.

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9. 

   Friend of the Court

   July 11, 2013

   Kevin: “The distinction with Mayo is that administering 6-TG to Crohn’s disease patients and monitoring their blood levels was in the prior art, and the “determining” step encompassed any way of making the determination (including any way also in the prior art).”
   This seems more like a semantic distinction, not a real one. First, it certainly would not have mattered for eligibility purposes whether Prometheus’ claim recited generically any “determining step” or a very specific but old and conventional procedure.
   Second, the patent-ineligible “knowledge of the BRCA genes” is not being applied to the old conventional methods recited in Myriad’s claims. Rather, the old conventional methods are merely being applied in their ordinary way: to acquire knowledge about a portion of the human genome.
   This is where the policy question is indistinguishable from the question already considered by the Supreme Court: can you discover a fact (“there are important gene sequences at this point on a chromosome”) and then leverage that fact into eligible subject matter merely by reciting an old conventional step for confirming that fact?
   The hook Myriads seem to be relying on is that these human gene sequences — and therefore the probes and primers complementary to these sequences — were (allegedly) unknown to humankind prior to Myriad’s disclosure. In light of the Supreme Court’s decision in Myriad, it seems a very long reach for such a consideration to make any difference in the analysis. The generically recited nucleic acids in Myriad’s method claims are ineligible subject matter. If a patentee can prevent someone from using ineligible compositions in all old conventional method which was known to depend on the use of those compositions, then the Supreme Court’s decision in Myriad would seem to be largely pointless. That you seem to have recognized already in your previous posts on this subject.
   To put it another way, why should the law make any distinction between a method that recites (1) the use of any or all generally described old conventional methods to determine information about a specific part of a genome and (2) a method that recites simply “determining the sequence”? Isn’t the concern expressed in Proometheus and Myriad decisions about the impact on the availability of the unpatentable information identical in both instances? i.e., people who are practicing the prior art are precluded in both instances from using their skills to study certain aspects of nature.
   The “progress” that the Supreme Court seems to want to encourage is the development of more accurate and inexpensive diagnostic techniques and tools for acquiring relevant information. Using patents to tie up the use of old conventional methods for acquiring that information seems disfavored by the Court, and probably justifiably so.
   With respect to the particular claims now being asserted, even if Myriad had identified some of the best mixtures of specific primers (e.g., those which work unexpectedly well in the context of the recited methods), they might be out of the weeds. That doesn’t appear to be the case.

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10. 

    Kevin E. Noonan

    July 11, 2013

    Dear FOTC:
    I think you have made a creative synthesis of Mayo and Myriad which, while logical, is not what the Court has done. In fact, the Court has avoided making the types of broad disqualification you propose.
    The point is that these claims don’t encompass “any and all” ways of determining the BRCA sequence, unlike Myriad’s invalidated claims or the Prometheus claims. That distinction should be enough to preclude a conclusion that the claims Myriad is now asserting unduly preempt the natural law.
    I don’t think the Court is interested in encouraging anything – which is good, because that it not their role. The Court is capable of limiting Congressional power to grant patents, but whether the Court thinks the way Congress does this is good or bad policy is not relevant (see the Chief Justice’s opinion in the healthcare case).
    The point is that being able to predict a risk of hereditary breast cancer based on mutations in BRCA genes is not in the prior art, and adapting methods from the prior art to achieve this result is not patent ineligible under Mayo. The Court may ultimately agree with you but they haven’t yet.
    Thanks for the comments.

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11. 

    Friend of the Court

    July 12, 2013

    Kevin, a couple points (and I’m not trying to get in the last word, just continuing the discussion!). You wrote:
    “these claims don’t encompass “any and all” ways of determining the BRCA sequence,”
    I agree. However, I deliberately used the phrase “any OR all old convential methods”. Remember that the problem with the claims in Prometheus was not that Prometheus had pre-empted “all ways of measuring TG-levels”. It was that Prometheus’ claims took ineligible subject matter (a phenomenon of nature, specifically a correlation between a phenotype and a predicted medical outcome) out of the hands of those practicing the prior art. The recitation of a specific but nevertheless old and conventional method would not have saved Prometheus claims.
    Look again at claim 4 of the ‘857 patent. Here’s the method showing just the recited steps (omitting the non-limiting and ineligible information about the “meaning” and purpose of the method and focusing on just one of the dozen or so sub-“methods” recited in the Markush group):
    4. “A method … [which] comprises comparing the germline sequence of the BRCA2 gene … in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene ….by … (j) screening for a deletion mutation in said tissue sample”
    Now compare with the claim already found ineligible:
    “A method … which comprises comparing the germline sequence of the BRCA2 gene… in a tissue sample from said subject with the germline sequence of the wild-type BRCA2 gene.”
    How is merely adding a limitation about the type of mutation identified in the tissue sample going to make any difference for eligibility? And for that matter, how does the recitation of any old conventional method add to what we all know is ineligible subject matter? “Wherein the deletion in the BRCA2 gene is determined by Sanger sequencing”? Would such a limitation remedy the defects in Myriad’s claims? I don’t see how or why. I can use conventional methods to study any part of the human genome that I want. There are no longer any sections of the human genome that are “fenced off” by patents and there is no information in the genome that is fenced off by patents. That is free territory now, provided I am using an old conventional method. Generically claimed proprietary probes and primers that are complementary to naturally-occuring sequences? Those are all ineligible now. They are free for anyone to make and use, at least in the context of old, conventional methods. How can it be otherwise without driving a semi truck through the Supreme Court’s decisions in Myriad and Prometheus?
    It’s important to remember that Myriad’s “discovery” of some natural DNA sequences they chose to call “BRCA1” and “BRCA2” is legally irrelevant. Nobody is allowed to own those sequences or any fragment of them or any DNA probe or primer that binds to those sequences, nor any other DNA molecule with a sequence that is found anywhere nature. For the same reasons underlying the Myriad and Prometheus decisions (which are certainly policy-based, as are most Supreme Court decisions, given that they are interpreting the policies Congress intended to promote), nobody should be able to prevent another person from using old conventional methods simply to see whether those sequences exist in the human genome (or, presumably, any other animal’s genome).
    Note that this analysis does not necessarily imply that all data derived from analysis of the human body is off limits as a target of diagnostic method patents. The Supreme Court in Myriad made it clear (even if they made nothing else clear) that “naturally-occuring” DNA sequences are “special.” Analyzing mRNA by creating a “new” patent-eligible cDNA and sequencing that new molecule would remain a viable option for Myriad. They certainly hoped to cover that subject matter when they wrote their claims.
    A last point regarding this statement:
    “being able to predict a risk of hereditary breast cancer based on mutations in BRCA genes is not in the prior art”
    That’s true. That correlation, however, is just a patent-ineligible fact that Myriad long ago dedicated to the public.
    “adapting methods from the prior art to achieve this result is not patent ineligible under Mayo”
    The prior art sequencing methods are not “adapted” in any meaningful way in Myriad’s claims. Claim 4 of the ‘857 patent which I’ve highlighted above recites, at best, a mere field of use limitation relative to the method claims already held to be ineligible. Essentially Myriad is saying “okay, we can’t own these two human genes but we can still prevent you from using these old methods to look at them.” Really? I highly doubt that.

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12. 

    Bob Cook-Deegan

    July 12, 2013

    Correcting some typos (delete the previous one; too early in the morning here in London):
    This exchange is really helpful. I suspect we are seeing here some of the arguments that will come out in the Ambry and DNATraits cases.
    Another question that I have not seen addressed: How much will it matter that Myriad has also now made a pledge not to sue for academic, nonprofit research or verification testing? How much do such practical considerations play into how judges and juries view the facts in a case?
    And will it matter that these are now more classic patent cases of one competitor suing another, rather than public interest lawsuits?

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13. 

    Kevin E. Noonan

    July 12, 2013

    Dear FOTC:
    Remember, the Court’s concern was preemption in Mayo, so it is important that Myriad’s claims don’t preempt every way of detecting the mutations. (This is the Diehr analysis; the use of the Arrhenius equation was patent-eligible because it was expressly tied to the method and did not preempt the equation itself). And as you recognize in Mayo all the elements of the claim were in the prior art, not generally (methods for detecting metabolites in blood) but specifically (methods for detecting 6-TG and its metabolites in blood).
    I also don’t agree that the Court said that the gene was free to use for all purposes. The isolated gene itself maybe, but methods for detecting mutations would be applications of the unpatentable discovery that the Court indicated Myriad was in a unique position to exploit because of its discovery. That section of the opinion makes no sense if your interpretation on the scope of the preclusion is correct.
    The good thing is that our dicussion (no matter how fulfilling) will eventually be superseded by a court deciding which of these claims are not invalid and whether they are infringed.
    Thanks for the discussion.

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14. 

    Gary Johnston

    July 12, 2013

    5709999, Claim 6: invalid (see Mayo)
    5747282, Claims 6, 16, 17: invalid (see Myriad; see also 102, 103, 112)
    5753441, Claims 7, 8, 12, 23, 26: invalid (see Mayo)
    5837492, Claims 29, 30: invalid (see Myriad; see also 102, 103, 112)
    6033857, Claim 4: invalid (see Mayo)
    5654155, Claims 2-4: invalid (see Mayo)
    5750400, Claims 2-7: invalid (see Mayo)
    6951721, Claim 5: invalid (see Mayo)
    7250497, Claims 3-8, 11, 14, 17-19: invalid (see Myriad)
    Myriad may want to take a close look at Professional Real Estate Investors, Inc. v. Columbia Pictures Industries, Inc.

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15. 

    Kevin E. Noonan

    July 12, 2013

    Thanks for the scorecard/predictions, Gary. We’ll see how this turns out in court.

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16. 

    Friend of the Court

    July 12, 2013

    Kevin: “the Court’s concern was preemption in Mayo, so it is important that Myriad’s claims don’t preempt every way of detecting the mutations. ”
    Whether or not the Court in Mayo was concerned with “preemption”, it is certainly not the case that all uses of the ineligible subject matter need to be pre-empted by a claim in order for the claim to be found eligible. All that is necessary is for any otherwise non-infringing actor to be turned into an infringer merely because he or she carries out the ineligible step. That’s why Mayo went down. That’s why the “old and conventional” nature of the eligible steps recited in Mayo’s claim is such a key part of the Court’s analysis. If a new and non-obvious (and otherwise eligible) method for obtaining TG levels had been recited in Prometheus’ claim, the claim would never have gotten to the Supreme Court.
    “I also don’t agree that the Court said that the gene was free to use for all purposes. The isolated gene itself maybe”
    Ineligible compositions such as isolated “genes” (really, any isolated DNA whose sequence is found in nature) are not free to use for “all purposes.” For example, I can’t use it in the context of a patented method — a method that is patented on its own terms, without reference to the sequence — without infringing that method. But I am certainly free to use it in the context of any old, conventional method, e.g., to determine whether it binds to another inelgible sequence. How can that not be the case without creating a truck-sized loophole in the Myriad decision? “Myriad doesn’t own your isolated DNA but you can’t use that old method to isolate or study your DNA without paying Myriad.” That just makes no sense. (For the record, Kevin, I think the analysis in Myriad has serious flaws … but we’re stuck with the result for the moment).
    “methods for detecting mutations would be applications of the unpatentable discovery that the Court indicated Myriad was in a unique position to exploit because of its discovery”
    First, the Court certainly didn’t hold that an otherwise old method that differed from the prior art only in the recitation of a new, ineligible polynucleotide was an eligible claim. They simply refused to stretch their brains any farther than they already were. Second, I think you should step back and consider the incredible breadth of Myriad’s claims in view of the fact that the only bona fide limitation in those claims that distinguishes them from the prior art is the location in the genome to which the old conventional methodology is directed. If we follow the Court’s analysis in Myriad, there is no more “chemistry” in those claims than there is in Myriad’s composition claims.
    Speaking of which, what about those “pair of primer” claims? Aren’t they just claiming any and every combination of ineligible polynucleotides that the skilled artisan would seek to use to obtain the ineligible information that Myriad was told it could not own? Even without the Supreme Court’s decision in Myriad, claims of that scope tend to stretch one’s patience. If they aren’t ineligible, they seem very likely to be obvious (or anticipated) in view of previously disclosed sequences in the prior art. That analysis would not seem particularly difficult to perform.
    “The good thing is that our dicussion (no matter how fulfilling) will eventually be superseded by a court deciding which of these claims are not invalid and whether they are infringed”
    They might be superseded by a court, or some aspect of the discussion might be adopted by a court, or some aspect might be adopted by a Federal legislator who found an aspect of the discussion more “fulfilling” than the court’s decision. People do read the Internet and Myriad’s claims seem to be particularly interesting to those people.

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17. 

    Kevin E. Noonan

    July 13, 2013

    Well, FOTC, Congressman Becerra has been trying for about 6 years to get a bill passed that would “outlaw” gene patenting and that has gotten nowhere. So I can’t see Congress doing anything. After all, they could have mandated infringement-free “second opinion” genetic testing with the AIA, and all that was enacted was a “study” that the PTO still hasn’t released due to infighting between the facts and (non-PTO) policymakers’ prejudices.
    Don’t misunderstand me – I don’t think that all the claims Myriad asserts will be deemed patent eligible, but they only need one valid, infringed claim to prevail and they have more than 500 in their quiver and have asserted more than a dozen here.
    One final note on your methodology. If I have old element 1 and ineligible element 2, I take it your position is that if I have a novel, useful and non-obvious combination of the two (1 + 2 = 3) that combination is not patent eligible. If I am correct about what you are arguing, I don’t think that’s the law. It may be hard to overcome the obviousness argument in some instances so I’m not saying 3 will always be patentable, but I am saying I think you are wrong in saying it will never be patentable.
    I understand that some people read the Internet, but I’m not sure those people include Supreme Court judges.
    Thanks for the discussion.

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18. 

    Warren Woessner

    July 13, 2013

    Back to the top. Claim 6 of ‘999, while it recites analyzing,also ecites ‘amplifying’ and ‘sequencing’,at least part of the gene and recites the specified mutations that may be detected. Myriad did not “lose” ny method claims with this level of detail at the Fed Cir level. Myriad may end up arguing that these steps are non-trivial transformation steps and/or that a “low” degree of generality is present in the claim. In other words, Myriad is claiming a particular use of the human gene sequence, not the sequence itself. Still, I would think that Myriad’s “case” would be stronger if the claim recited reaching a dianostic conclusion. But the biomarkers (eg the mutations) are a novel discovery and the method claims that Myriad “lost” did not recite the specific “discovery” as part of the claims.
    They may also be willing the try claim 4 of the 857 patent, simply because it is a diagnostic claim that offers a bit more detail than claim 1 did.
    The Prometheus claims failed because the Court just saw them as an old use of and old compound – but to do so, it had to ignore the numerical limitations in the claims, so the Court could call the claim an unadorned “product of nature.”
    Do you think if the claim had been drafted as a method of medical treatment, viz. “A method of treating an immunosuppresive disorder comprising administering a 6-TP generating drug so that the level of 6-TP in the subject’s blood is adjusted to between 6-10 mcg/ml” would have ever been challenged on s. 101 grounds? It might well have been inherently anticipated by the past use of AZA, but it sure looks like a patentable process to me!
    That is why it is so difficult – as your discussion proves – to generalize from Prometheus to the “fuure” of the Myriad diagnostic claims.

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