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AMP v. Myriad: Getting Beyond the Hype and Hyperbole*


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: June 16, 2013 @ 9:35 am
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Justice Clarence Thomas delivered the opinion of the Court in Myriad.

As the dust begins to settle on the Supreme Court’s recently issued opinion in AMP v. Myriad, and hopefully as the misguided “gloating” by the media and the ACLU settles down to a dull “roar,” what does the Myriad decision really means?  The ruling that was handed down by the Supreme Court in Myriad was pretty much as I expected, and could have been far, far worse.  Again, let’s not get lost in the mistaken (and misrepresentative) hype and hyperbole of the media and the ACLU, i.e., the “patenting of human genes has been blocked by the Supreme Court” which the Myriad case was never about in the first place.  Frankly, the “doom and gloom” I’m seeing and hearing from the patent law world (including a depressing and mind-boggling statement I saw from the AIPLA about the potential impact of the Myriad decision on biotechnology) isn’t warranted in my opinion.  And please also note that Myriad’s stock initially shot upwards in price significantly Thursday after the Myriad decision came out (although it also fell back again Friday) which suggests investors may not be necessarily as “bearish” about the financial impact of this decision compared to the media, and at least some in the patent law world.

 

The Opinion for Court written by Justice Thomas pretty much cabined the patent-ineligible part of the holding, more so than you might think.  Also, besides saying that Myriad’s claimed cDNA was patent-eligible (versus the claimed “isolated” DNA which wasn’t), I actually take solace from the following two sentences at pages 14-15 of the slip opinion

“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA.  Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2.”

In other words, Myriad’s claimed “isolated” DNA sequences didn’t look enough like an altered chemical molecule to be divorced from the native DNA, i.e., the claimed “isolated” DNA sequences were not a “difference in kind rather than degree” which comes straight out of the “product of nature” doctrine cases.  See Guttag, “The Patentability of Microorganisms:  Statutory Subject Matter and Other Living Things,” University of Richmond Law Review, Vol. 13, page 247 (1979) which discusses the “product of nature” doctrine and how it is applied.  I realize that Thomas’ opinion may require defining that “chemical molecule” in ways that go beyond how nucleotide sequences have traditionally been claimed in the world of molecular biology and genetics, but we in the patent prosecution world can cope with that and have done so in the past.  Also, much to my delight, those two sentences are somewhat of an unintended “slap” at Breyer’s derogatory comment in Mayo Collaborative Services v. Prometheus Laboratories, Inc. about not letting patent-eligibility under 35 U.S.C. 101 depend on the “draftsman’s art,” i.e., how the claims are written does matter.

By holding that Myriad’s claimed cDNA was patent-eligible, Thomas’ opinion reaffirms the major holding in Diamond v. Chakrabarty that claimed subject matter which truly only the “hand of man” can make (not simply snipped out of “mother nature”) will make it to the patent-eligibility zone.  (Whether that same cDNA makes it to patentability zone under 35 U.S.C. § 102 and especially under 35 U.S.C. § 103 is another and far more important story.)  I would also be careful in reading too much into Thomas’ statement (which is also dicta) about “very short series of DNA which may have no intervening introns to remove in creating the cDNA” might be patent-ineligible.  By definition, cDNA (i.e., complementary DNA) is a DNA molecule which is created from mRNA (i.e., messenger RNA) and therefore lacking the introns in the DNA of the genome.  Thomas (or his clerks) may not have realized that what they were talking about isn’t what would be defined (at least by a molecular biologist) as cDNA.  So the impact of that statement should have minimal, if any impact.  (Scalia was at least forthright in his concurring opinion about not being able to affirm the “fine details of molecular biology.”)

As I know, and many others far more knowledgeable in the field of molecular biology might know, the Myriad opinion essentially addresses only that 2% of the human genome that follows the pre-ENCODE approach to genetics.  That includes Myriad’s claimed BRCA genetic material which (like the BRCA gene) is basically a linear genetic segment.  The other 98% of the human genome which doesn’t follow the pre-ENCODE linear approach and which is actually three-dimensional in structure is still in play (and in view of ENCODE would likely require splicing together at least two distinct DNA sequences to code for the polypeptide which “mother nature” doesn’t do).  That means that the Myriad opinion is really inapplicable (i.e., not on point) as to 98% of the human genome that doesn’t follow the pre-ENCODE linear approach to genetics.  So the “game” of patenting genetic material (human or otherwise) isn’t over yet by a long shot.

Another somewhat hidden “silver lining” in the Myriad decision that my patent attorney brother Mark astutely pointed out is that there should be less impetus from Congress to enact legislation like the inane bills authored by Congressman Xavier Becerra (D-California, aka “The Gene Patent Terminator”) that would truly plunge us into an “anti-gene patenting hell” with far greater potential to destroy American biotech industry than does the limited holding in the Myriad decision.  See Foaming at the Mouth II: My Alternative to the New But Inane Becerra Bill .  In other words, the patenting of genetic material (human or otherwise) will hopefully slip “under the radar” of Congress.  Meanwhile we in the patent prosecution world will have the opportunity to figure out new claim drafting techniques that will make the claimed genetic material look less like something from “mother nature” (like happened with Myriad’s claimed “isolated” linear DNA sequence) and more like something that is truly the “hand of man” (more like Chakrabarty’s genetically engineered oil-eating bacteria that that added plasmids from 4 different bacteria to a host bacterium containing none of these plasmids).

Let’s finally consider three areas Thomas’s opinion expressly said were not implicated by the Myriad decision:

  1. There were no method claims before the Supreme Court in Myriad.  That includes Myriad’s claimed method for screening potential cancer therapeutics using trans-formed eukaryotic host cell containing an altered BRCA1 gene which all three panel members (Lourie, Moore, and Bryson) affirmed in both Federal Circuit panel decisions in Myriad was patent-eligible under 35 U.S.C. § 101.  See also the statement in this portion of Thomas’ opinion that, had “Myriad created an innovative method of manipulating genes while searching for the BRCA1 and BRCA2 genes, it could possibly have sought a method patent.”
  2. No “new applications of knowledge about the BRCA1 and BRCA2 genes” were involved.  In fact, this portion of Thomas’s opinion affirmed approvingly Judge Bryson’s statement that ““[a]s the first party with knowledge of the [BRCA1 and BRCA2] sequences Myriad was in an excellent position to claim applications of that knowledge,” and that many of Myriad’s “unchallenged claims are limited to such applications.”  Such “new applications” might include, for example, the use of BRCA1 and BRCA2 gene probes, such as DNA microarrays, which “mother nature” cannot make, i.e., truly require the “hand of man.”
  3. There was no “consider[ation of] the patentability of DNA in which the order of the naturally occurring nucleotides has been altered.”  Instead, this portion of Thomas’s opinion said that “[s]cientific alteration of the genetic code presents a different inquiry, and we express no opinion about the application of [35 U.S. C. § 101] to such endeavors.”

Admittedly, many of us in the patent law world might have hoped that Myriad’s claimed “isolated” DNA sequences would have at least passed muster under 35 U.S. C. § 101.  (Whether those claimed “isolated” DNA sequences would be deemed patentable under 35 U.S.C. § 102 and especially under 35 U.S.C. § 103 is, to use Justice Thomas’ words, “a different inquiry.”)  But there is much to take comfort from in Thomas’ opinion in Myriad, as well as new opportunities and ways to seek the patenting of such genetic material, including its beneficial uses.  (We may also need to “butt heads” with the USPTO which sent, in my opinion, a poorly thought through memorandum to the patent examiners for how to apply the holding in the Myriad decision which completely misses the legal rationale for when the “product of nature” doctrine applies, i.e., the difference between the “isolated” DNA sequence or fragment and the native DNA is a matter of “degree” not “kind.”)

Unlike Bilski v. Kappos where the Supreme Court couldn’t define what a patent-eligible “abstract idea” was except “we know it when we see it,” we at least know from the Myriad decision what genetic material is in the patent-eligibility “zone,” i.e., Myriad’s claimed cDNA, so we now have some idea what the “target” is.  So don’t let those in the media, at the ACLU, and elsewhere who will “crow” about the Supreme Court “blocking the patenting of human genes” get you down.  And do remind those folks who do “crow” that at least Myriad’s claimed cDNA (which even ACLU’s attorney had to confess at oral argument before the Supreme Court was truly from the “hand of man”) made it to the patent-eligibility zone.

*© 2013 Eric W. Guttag.  Posted June 16, 2013 on IPWatchdog.com.


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11 comments
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  1. Dear EG,

    I get sick and tired of people going into denial mode and repeating to themselves, “It isn’t so bad, it could have been worse”.

    It is so bad.

    We have a unanimous array of SCOTUS justices (9 of them, count!) who, in terms of scientific literacy, are a bunch of bimbos.
    Moreover, when you look to their understanding of patent law and its purposes, they are equally deficient.

    Cross multiply the two levels of incompetence and you get true Idiocracy results like AMP v. Myriad, Prometheus, Bilski …. Benson.

    That is could have been worse is no consolation prize.

    It is so bad. It is horrific.

    It’s time to stop making excuses.
    It’s time to label our Idiocracy for what it is.

    http://patentu.blogspot.com/2013/06/one-nation-under-isolated-diety-with.html

    Don’t get me wrong.
    I’m not saying Scalia is not a smart man.
    He is even honest enough to admit that at his age he cannot “study” the situation well enough to understand what is going on, but for the sake of getting along and moving along he is going to abide with the herd mentality. That is a “cop out” (as we used to say in my generation’s time). If you don’t understand what is going on, be man enough (or woman enough) to admit it instead of insisting that you are an intellectual demi-god in all matter of knowledge be it scientific or just simply cooking the corporate accounting books.

  2. Hey SB,

    I hear you but I’m not in denial mode. And its only that bad if we in the patent world let be that way. In other words, don’t “wave white flag” at those who promote the “idocracy” as you call it.

    As Gene knows and it’s not his fault, after I gave him my article for publication on IPWatcdog, I had a few additional thoughts which I wish I had gotten in. The most important would have been at the beginning of the last paragraph: Unlike Bilski v. Kappos where the Supreme Court couldn’t define what a patent-eligible “abstract idea” was except “we know it when we see it,” we at least know from the Myriad decision what genetic material is in the patent-eligibility “zone,” i.e., Myriad’s claimed cDNA, so we now have some idea what the “target” is. In other words, we now at least know how claim genetic material to get it to the patent-eligibility “zone.” That’s more than we got from SCOTUS in Bilski.

    Also, don’t underestimate those areas which Thomas’ opinion said weren’t implicated by Myriad. A key one is the second area, where the new applications can include the use of BRCA1 and BRCA2 gene probes, such as DNA microarrays, which “mother nature” cannot make, i.e., truly require the “hand of man.”

    My final thought relates to the comment after the quote from pages 14-15 of the slip opinion where reconcile this quote with the “product of nature” doctrine. Instead of saying “Thomas’ opinion requires terms for defining that “chemical molecule” which may be odds with the molecular biology world,” I should have said: “Thomas’ opinion may require defining that “chemical molecule” in ways that go beyond how nucleotide sequences have traditionally been claimed in the world of molecular biology and genetics.” In other words, you have to define in the claim how the isolated genetic material is chemically different, and especially functionally different. Myriad’s “isolated” DNA sequence, as claimed, simply wasn’t different “functionally” from how that segment functioned in it’s native environment. Most of us in the patent world may have felt differently, but that’s not the end of the world by a long shot.

    And keep your chin up, SB.

  3. “I realize that Thomas’ opinion requires terms for defining that “chemical molecule” which may be odds with the molecular biology world”

    Can you give an example of the “terms” you have in mind that would allow one to claim a specific isolated polynucleotide which happens to have a sequence that is identical to a sequence found in a longer “natural molecule”? The only terms I can think of are the terms that molecular biologists typically use: A, T, G, C etc (well-known abbreviations for nucleic acid bases that are typically defined as such in a well-drafted patent application).

  4. Gene Jockey

    That’s laughibly easy:

    “wherein said isolated DNA fragment has oppose first and second ends that are not chemically bonded to a remainder that is a naturally occurring molecule”

    DISCLAIMER: This is not legal advice to any person or for any purpose whatsoever.

  5. GJ,

    See my response to SB above. In particular, substitute the following sentence for the one you quoted: ” I realize that Thomas’ opinion may require defining that “chemical molecule” in ways that go beyond how nucleotide sequences have traditionally been claimed in the world of molecular biology and genetics.” What you’ve got to do is define that isolated segment as being chemically/functionally different (as the opinion says, what are the “chemical changes”?) in terms of its properties. In other words, the isolated genetic sequence has to do more than simply code for the polypeptide as it would do in its native environment.

    Also, if that isolated genetic segment is used as a gene probe, e.g., as part of a gene chip/microarray, that’s going to make it at least to the patent-eligibility zone under 35 USC 101 (where it’s patentable under 35 USC 102/103 is a completely different story. Further, if you splice that isolated gene segment in to the genetic material of a bacterium, virus, etc. (as I believe is done with, for example, producing human insulin), that’s essentially the same as the genetically altered bacterium in Chakrabarty. Again, how you write the claim covering that isolated genetic material that shows it’s got different functionality or is chemically different (including what else it’s attached to) relative to what that isolated genetic material looks like/does in its native environment is going to be very important after the Myriad decision.

  6. GJ,

    See also my comment in response to Ryan Chiromas’ post on IPWatchdog:

    I agree with the others that simply changing the description of Myriad’s isolated DNA sequence to the claim structure you proposed doesn’t grapple adequately with the key point n Thomas’ opinion addressing that issue. It’s more than simply claiming the isolated DNA sequence as a chemical molecule. As page 14 of the slip opinion says, Myriad’s claims do not “rely in any way on the chemical changes that result from the isolation of a particular section of DNA.” In other words, how Myriad’s “isolated” DNA sequence was different in terms of utility, chemical properties, etc., from simply the snipped segment from the native DNA nowhere appears in that claim. In particular, the “functionality” of that isolated DNA sequence was no different from that isolated sequence being part of the native DNA. We may not like that thinking or result, but we in the patent world can live with and deal with it.

  7. “And please also note that Myriad’s stock initially shot upwards in price significantly Thursday after the Myriad decision came out (although it also fell back again Friday) which suggests investors are not necessarily as “bearish” about the financial impact of this decision compared to the media, and at least some in the patent law world.”
    See the chart since then – now below 200d MA.

  8. EG,

    Have considered how your interpretation will be applied to claim 16 of the ’282 patent? The claim is this:
    16. A pair of single-stranded DNA primers for determination of a nucleotide sequence of a BRCA1 gene by a polymerase chain reaction, the sequence of said primers being derived from human chromosome 17q, wherein the use of said primers in a polymerase chain reaction results in the synthesis of DNA having all or part of the sequence of the BRCA1 gene.
    So functionally, we’re not just talking about isolated DNA because it functions as a primer, but structurally that’s exactly what it is. There’s no requirement for using it as a primer, just that it is useful that way.

  9. I do not think that “what it can be used for” saves anything from the 101 exception.

  10. MP,

    I agree with Anon that simply the statement of the “intended use” won’t help you under 35 USC 101. The big question is whether those “pair of single-stranded DNA primers ” are not only chemical different from the “sequence of said primers [] derived from human chromosome 17q,” but also “functions” differently from how that “sequence” operates in native environment. If I understand these primers correctly, and unlike the isolated DNA sequence which would/should have the helical structure of the native DNA, these primers wouldn’t (or might not) have that helical structure. Also, whereas DNA helix partially unwinds in preparing the mRNA, these DNA primer pairs are completely separate, single stranded halves of the DNA segment which is nothing like what “mother nature” does. Also, these primer can only replicate the DNA sequence when used in PCR process which is completely the “hand of man.” So it’s possible that the primer pairs of Claim 16 should make it to the patent-eligibility zone (i.e. are more like cDNA, not isolated DNA sequences) in view of Myriad.

  11. Hey EG,

    I’m starting to collect at my blog post, articles by artisans who are willing to irreverently call out the SCOTUS justices for having gotten the science wrong. See (1)-(5) just above the “Read More” divider at:

    http://patentu.blogspot.com/2013/06/one-nation-under-isolated-diety-with.html

    It’s not just that SCOTUS repeatedly gets the science wrong. They also repeatedly get the gist of patent law wrong (that of “securing” for inventors the exclusive rights to their “discoveries” –see Art. 1 Section 8, clause 8 of the SCOTUS revered document, a.k.a. US Constitution). Instead they are de-securing those rights.

    So what we have here is a cross multiplication of two incompetencies; one in science and the other in patent policy.

    If the promises that Congress makes to inventors is no longer to be of any value, namely:

    35 U.S.C. § 101 35 U.S.C. 101 Inventions patentable.

    Whoever [except for biotech folk] invents or discovers ANY
    new and useful
    process,
    machine,
    manufacture, or
    composition of matter,
    or any new and useful improvement thereof,
    may obtain a patent therefor …

    then just say so.

    (Or better yet, say it ain’t so.)