Pending Supreme Court Eligibility Cases: Patenting Genetic Discovery

by Dennis Crouch

Three eligibility cases are pending before the Supreme Court.  Of these, the most interesting is likely Genetic Tech v. Merial.  [GeneticTechPetition]

The 1989 priority date of Genetic Tech’s patent reaches back to the heyday of gene discovery and the claims are directed to a technique of detecting gene alleles.  U.S. Patent No. 5,612,179. The claimed method is based upon the insight that genes are typically associated non-coding regions of DNA — i.e., based upon a the phenomenon known as “linkage disequilibrirum”, someone who inherits a particular gene from a parent is also likely to inherit the nearby non-coding DNA regions from the same parent.  Using that insight, the method amplifies DNA segments containing non-coding region associated with the gene and then checks the sequence of the associated coding section (the gene) that is incidentally amplified – looking for alleles of a known gene.

Genetic Tech explains this process in its petition:

Dr. Malcolm Simons discovered that, in the DNA of unrelated individuals, a polymorphism in a non-coding DNA region and a coding region allele could be inherited together. This natural phenomenon is known as “linkage disequilibrium.” The discovery prompted Dr. Simons to invent a new and useful process for detecting a coding region allele of a multi-allelic genetic locus by interrogating a non-coding DNA sequence that is in linkage disequilibrium with that multi-allelic genetic locus. Dr. Simons’ invention, as reflected in claim 1 of the ‘179 patent, was advantageous for a number of reasons, including that it was more reliable and quicker than prior art identification processes that used direct identification of allelic variants.

A number of companies have licensed the patent, but Merial and Bristol-Myers refused.  In the resulting litigation, the district court dismissed the case on the pleadings — finding that the claimed invention lacks eligibility as an unpatentable law of nature under Mayo Collaborative Servs. v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012).  On appeal, the Federal Circuit affirmed — holding that the relationship between coding and non-coding sequences was a naturally occurring phenomenon and that the additionally claimed laboratory techniques were used in a routine and conventional manner known at the time.  Petitioner argues that patentability can be established by the fact that no one was “using the non-coding sequence as a surrogate marker for the coding region allele …” This novel feature survived both the original examination as well as reexamination.

Questions Presented:

  1. Whether the Federal Circuit properly concluded – in conflict with other decisions of the Federal Circuit and this Court – that the definition of a patent-ineligible concept under the Mayo/Alice framework may include both a natural phenomenon and an inventor’s ingenuity in applying that natural phenomenon to a new and useful purpose?
  2. Whether a Rule 12(b)(6) motion may be properly granted based on patent-ineligibility – as the Federal Circuit determined below in conflict with other Federal Circuit decisions – when the record plausibly demonstrates that the claimed process inventively applies a natural phenomenon for a new and useful purpose, the claimed process does not improperly preempt the natural phenomenon, and the claimed process is not routine and conventional?

The defendants in this case (Merial and Bristol-Myers) waived their right to respond to the petition.  That non-response has accelerated the case with a conference set for September 26.  If the case is to move forward, we could expect the court to call for a response (CFR).

I’ll pause here to write a moment about the call-for-response system.  The respondent to a Supreme Court petition for certiorari is not required to file a response but can instead waive her right to respond.  At that point, the Supreme Court may request that a response be filed.  Although the CFR comes from the Court, it is generally known that a single Justice can request the CFR – and that request is often triggered by questions raised by a single clerk.  CFRs almost always issue prior to the conference.  Bringing this back to the eligibility issue: We perhaps didn’t get the message from the Mayo/Alice Opinions and the Sequenom Denial. If it turns out that not even a single Justice (or Clerk) seeks a response in this case, we should understand that the Supreme Court believes it has sufficiently spoken on the issue of eligibility.

= = = =

The two additional eligibility cases pending are Jericho Systems Corporation v. Axiomatics, Inc., et al., No. 15-1502 (Eligibility of Patent No. 8,560,836 under Section 101) and Essociate, Inc. v., LLC, et al., No. 16-195 (please clarify the meaning of ‘abstract idea’ and ‘inventive process’).


41 thoughts on “Pending Supreme Court Eligibility Cases: Patenting Genetic Discovery

  1. 7

    My understanding of Supreme Court procedure is that, yes, a single justice prompted by a single clerk may call for a response. But all the justices except Justice Alito use the cert pool, where a single clerk prepares the first memo reviewing the petition, and my understanding is that if that clerk recommends denial then 99% of the time the petition dies there and then. So a denial may signal less about the justices’ lack of interest than the lack of interest from a single clerk on a particular day.

  2. 5

    The patent-in-suit defines “linkage disequilibrium” as follows:

    The term “linkage disequilibrium”, as used herein, refers to the co-occurrence of two alleles at linked loci such that the frequency of the co-occurrence of the alleles is greater than would be expected from the separate frequencies of occurrence of each allele. Alleles that co-occur with frequencies expected from their separate frequencies are said to be in “linkage equilibrium”.

    Not sure to reconcile the quoted passage of the Petition for Certiorari above with that definition, and I’ve studied genetics. So what chance does the SCOTUS (or, more accurately, their clerks) have at doing so?

  3. 4

    From the brief: Dr. Malcolm Simons discovered that, in the DNA of unrelated individuals, a polymorphism in a non-coding DNA region and a coding region allele could be inherited together. This natural phenomenon is known as “linkage disequilibrium.”

    Intentionally misleading courts — especially the Supreme Court — is a really bad idea but these guys have been skimming the bottom for so long now they can’t tell the difference anymore.

    Simons did not discover “linkage disequilibrium.” He also wasn’t the first to “discover” that “non-coding” DNA sequences could be in linkage disequilibrium with coding alleles. Malarial research had uncovered that “phenomenon.” But he was certainly the first to rush to the patent office (“I’m using PCR! Look at me!”), and the Australian company that ended up owning the patents — GTG Technologies — tr0lled the junk patents like there was no tomorrow. Well, tomorrow finally came. Good riddance.

    Let’s look at the claim (as a reminder, these junky claims and the glaring eligibility problem were discussed previously here: link to

    A method for detection of at least one coding region allele of a multi-allelic genetic locus comprising:

    a) amplifying genomic DNA with a primer pair that spans a non-coding region sequence, said primer pair defining a DNA sequence which is in genetic linkage with said genetic locus and contains a sufficient number of non-coding region sequence nucleotides to produce an amplified DNA sequence characteristic of said allele; and

    b) analyzing the amplified DNA sequence to detect the allele.

    So here’s the key facts:

    There is nothing novel or non-obvious about a PCR primer pair that primes the amplification of “non-coding DNA”. That was in the prior art. Likewise, the synthetic methods used to transform individual nucleic acids into primer pairs are also old. What the patentee here is trying to do is claim ownership of the technique when it is applied to an incredibly broad class of DNA sequences, i.e., so-called “non-coding” DNA sequences that can be used to “indirectly” infer the presence of sequences elsewhere in the genome. This last bit is indistinguishable from obtaining information using old technology and “making a new correlation.” That’s why Prometheus v. Mayo controls, it’s why these claims fail miserably, and it’s why the Supreme Court is very unlikely to grant cert.

    Here’s one way to understand the huge problems presented by these kinds of junk claims. Let’s say I want to study variations in non-coding sequences in a particular region of a chromosome in a very, very interesting and potentially important segment of the human chromosome. Given those facts, can I use PCR to study those sequences without liability? Of course I can! Nobody owns the human chromosome. Now let’s say that five years later I read a paper (freshly published) that teaches that some sequence variations in those non-coding regions are “linked” to mutations in an important gene (an “allele”) elsewhere on the chromosome. All of a sudden, when I sequence my non-coding region, I’m “detecting” (indirectly) that “coding allele” when I sequence my non-coding region. All of a sudden I’m infringing this patent … and I haven’t done anything differently! Nobody has! It’s a bit of a problem, to put it mildly. And, no, it doesn’t get better for me (or 99.999% of researchers out there) if the PTO “divides” the giant piece of pie protected by GTG’s claim into a zillion smaller pieces reciting, e.g., specific alleles that can be detected by this approach (or any other old DNA sequencing technology).

    There are groups within the biotech industry that are absolutely obsessed with using patents to control who gets to use information about “correlations.” These are some of the greediest people on earth. They also tend to be ign0rant and dishonest and we saw that plainly in the run-up and response to Prometheus v. Mayo. If cert is granted in this case (unlikely) we’ll surely see all the usual players sticking their heads in the sand and telling us that children will die without these junk patents. It’s shameful.

    1. 4.1

      Let me fix that:

      “There are groups that are absolutely obsessed with using patents to control who gets to use information”

      Yup, that’s better.

  4. 3

    anon, if invention is discovery, then making a pie is the same as finding a pie. From now on, we can say reliably, can we not, that the Columbus invented the New World.

    1. 3.1

      And while we are at anon, no matter how much detail, no matter how specific, a business method remains abstract – at least according to the Supreme Court, who apparently are not using the word abstract in the same way as everybody else is using the word abstract. Thus the Supreme Court is engaging in the kind of nonsense that Congress used when it declared that discovery and invention mean the same thing.

      1. 3.1.1

        Tell me again Ned, which (singular) branch of the government was allocated the authority to write the statutory law that is patent law?


          “The Congress shall have the power … To promote the Progress of Science and useful Arts, by securing for limited Times to Authors and Inventors the exclusive Right to their respective Writings and Discoveries”

          From this it looks like ‘Discoveries’ must be patentable. On the other hand there is no mention on ‘Inventions’.

          Going just by these words the SCOTUS should only grant patents to ‘Discoveries’ and throw out all patents on ‘Inventions’ since they clearly exceed Congressional authority.

          Free Silver!


            Slashdot, as explained by the Supreme Court a number of times, an inventor may discover something, a principal or whatever, but he becomes an inventor when he creates something new using the discovered principle. It is highly consistent with the fact that the founders were not writing on the blank slate but were intending to implement in United States the patent laws of England, which protected inventions in new manufacturers.


              So while Congress enables the clause with legislation, the scotus must decide if the legislation is correct. For example Congress may allow a patent on a discovery of a fact of nature. The scotus in turn can rule that the discovery of a fact of nature is not witin the scope of the constitutional clause and reject the patent. See Mayo.


                Close – the Court can determine if the law written by Congress is within the scope of the Constitutional clause, or if the patent was duly granted under the law as written by Congress, but each of these is different than what you are saying (individual patents are not geared to the Constitutional clause – remember, the clause is a delegation of authority and is NOT the substantive law itself – that is a nuanced, but critical understanding to have).


                Slash, right.

                Here, the patent claims finding A from detecting B, where linkage between A and B is a fact of nature, and where the means and methods for detecting B are commonplace.

                Now, what did the inventor invent? Nothing. He discovered something, the linkage between A and B.

                Now, there seem to be good arguments that patenting new discoveries in this area would promote an effort to find new correlations. But clearly, the discovers are not creating anything.

                What I would like is for Congress to actually pass a statute protecting these kinds of discoveries so that the constitutional question can be addressed head on.

                1. Is it possible to Discover anything other than a composition of matter?

                  One is unlikely to Discover a machine or Discover a process or Discover a manufacture.

                  You could invent a process. But to ‘Discover a process’ would it not have to exist already and be observed by the Discoverer?

                  In this case the inventor Discovered a correlation which would not seem to be one of the 101 categories.

                  After his Discovery he Invented a process which used the discovered correlation.

                2. It is possible to discover anything that is discoverable (yes, I realize that sounds like a lawyer’s answer)

                3. Slash, the process he allegedly invented, though, was notoriously old, and it was not a process of using the correlation to do something useful.

                  The only novelty was the discovery.


              Except as has been pointed out to you Ned, we did NOT want an exact duplicate of the English system, and you once again chase your Windmill of trying to make the Process category only pertain to the other hard goods categories (which just makes it a sub-category).

              It simply is not a sub-category.

              See 35 USC 100(b) and any of my previous lessons for you on what Congress did in 1952.

              Time for you to be inte11ectually honest (or more typical, for you to run away).

                1. Attempt to pull from filter:

                  My preference is to follow the Constitutional mandate including separation of powers and to not allow judicial


                  to run

                2. So…

                  I have no idea why you want to think “my preference” is what you stated.

                  Do you know the difference between common law and statutory law?

                  Do you think that the Supreme Court is above the Constitution and can do no wrong?

                3. Your reply is a non-sequitur.

                  If these patents are unconstitutional, either the statute as a whole is, or it should be construed to avoid that interpretation. You must advocate one or the other.

                4. My reply only appears to be an non sequitur because of your lack of understanding.

                  A patent is not a law and a patent – in and of itself – cannot be unconstitutional.

                  A patent can be merely properly or improperly granted under the law.

                  It is the Court’s muckery that is at play when it looks at a patent and does not feel that that patent should not “be” and yet that patent has been properly granted under the law.

                  The Court’s muckery is also known (famously, and duplicitly by none other than Justice Stevens) as the mashing of the wax nose of 101.

                  Tell me please that you understand the difference between common law and statutory law.

                  I advocate for the proper treatment of statutory law – and against the muckery of the Supreme Court’s addiction to sticking its fingers into the wax nose of 101 in order for that body to hold onto a power it once had, but no longer has.


                What do you mean that we did not want an exact duplicate of the English system? Down to the nth detail? Of course not. Just the Statute of Monopolies and the case law interpreting that statute.

      2. 3.1.2

        I don’t think they declared that discovery and invention mean the same thing.

        I think they overloaded the word “invention” as used in 35 USC to mean invention or discovery to enhance readability and cut down on typing.

        Isn’t this a common practice in legal documents (e.g., herein after “the parties”)?

        Why does it have your nickers in a twist?

        Are you upset with the founding fathers as well? The Constitution says something about DISCOVERIES as well, I’m pretty sure.


          I am more than “pretty sure” that the lesson in statutory construction has been previously supplied to Ned, who is once again engaging in his internet style “shout down” by fully ig noring ANY point that is simply inconvenient to his IMHO-Ned “law” fantasies.

  5. 2

    When all else fails, read the statute:

    35 USC § 100 – Definitions
    (a) The term “invention” means invention or discovery.

    1. 1.1

      So there’s no confusion: I didn’t write the comment at 1.

      I also don’t expect cert to be granted. But that’s because the claims are ineligible junk.

      1. 1.1.1

        Your complaint at 7 seems to be that the claim was anticipated.

        Are you also asserting that even if the claim were new it would be ineligible?


          Are you also asserting that even if the claim were new it would be ineligible?

          The answer, of course, would depend on the elements in the claim that are relied on for “newness.”

          We’ve been over this before about five billion times. I don’t expect you to suddenly be able to follow the conversation now.


            rse, would depend on the elements in the claim that are relied on for “newness.”

            …because all composition claims are just “new” based on protons, neutrons, and electrons, and everyone knows those are all “new”….



              all composition claims are just “new” based on protons, neutrons, and electrons

              Remember, folks: this is the best and the brightest that the Patent Everything crowd has to offer.

              When he’s not posting drivel like the quote above, he’s high-fiving a guy who habitually compares patent reformers to murderers. But he’s a very serious person! We all have to pay attention to him.

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