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Chakrabarty Controls on Isolated DNA Sequences, not Mayo*


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: April 3, 2012 @ 10:05 pm
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Ananda Chakrabarty

Not too surprisingly, the Supreme Court granted certiorari in AMP v. USPTO, vacated the Federal Circuit’s panel decision, and remanded for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc.  On remand, the Federal Circuit is unlikely to “resurrect” the claims to the methods of “comparing” or “analyzing” DNA sequences that were deemed unanimously by the Federal Circuit panel to be invalid as being patent-ineligible under 35 U.S.C. § 101, and nothing in Mayo Collaborative Services changes that result, but simply reaffirms it.  But the story should also be no different for the claim directed to the method of screening potential cancer therapeutics that was unanimously upheld by this same panel as being patent-eligible under 35 U.S.C. § 101 because the Supreme Court’s reasoning in Mayo Collaborative Services is distinguishable for reasons given in the original AMP decision, as well as for reasons given in Judge Newman’s opinion in the remand of Classen Immunotherapies, Inc. v. Biogen IDEC.  See The Way Forward from Mayo Collaborative Services is through the Classen Immunotherapies Remand*.

Unfortunately this unspecific remand by the Supreme Court in AMP vacates as well the two-to-one ruling by this same Federal Circuit panel (Judges Lourie and Moore in the majority, Judge Bryson in dissent) that the claimed isolated DNA sequences were also patent-eligible under 35 U.S.C. § 101.  What, pray tell, does Mayo Collaborative Services change with regard to that ruling in the original AMP decision?  For those, like the plaintiffs in AMP (including the ACLU), who would like to upset this “applecart,” they’re likely to be very disappointed.  I can describe what should be the impact of the ruling (and reasoning) in Mayo Collaborative Services on the claimed isolated DNA sequences in three short monosyllabic words:  NONE AT ALL.  And the Federal Circuit can (and should) say likewise, perhaps in far more words.

First, the relevant claimed subject matter in each of these two cases is entirely different.  In fact, the relevant claimed subject matter in these two cases falls into two entirely different statutory classes described in 35 U.S.C. § 101.  The claimed subject matter of Mayo Collaborative Services is a method.  By contrast, the claimed isolated DNA sequences in AMP are compositions (i.e., chemical molecules), no matter how much the plaintiffs (and others) disingenuously focus attention on the so-called “informational content” of these isolated DNA sequences.  That means the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) is far more analogous in terms of the claimed subject matter, and thus controls, not Mayo Collaborative Services.

Second, and certainly unlike the characterization of the methods in Mayo Collaborative Services, these isolated DNA sequences are definitely not “laws of nature,” or merely “laws of nature.”  Instead, like the organisms in Chakrabarty, the claimed isolated DNA sequences are man-made, don’t exist in nature, must, at the very least, be extracted and isolated from native DNA by using man-made techniques (and potentially by man-originated synthetic techniques), and are “structurally distinct from native DNA, and have different properties and utilities.”  In other words, and unlike what some have disingenuously said, we’re not simply “plucking a leaf” in making the claimed isolated DNA sequences, and far from it.  Mother Nature does not, (and more significantly cannot) “isolate” the claimed DNA sequences.  Once again, the controlling ruling in Chakrabarty says that which is “man-made” is patent-eligible under 35 U.S.C. § 101, and the claimed isolated DNA sequences are most definitely “man-made.”

Third, I do hope we hear no more reference to the “product of nature” line of cases that was proffered by the plaintiffs and unfortunately relied upon by the district court in ruling that these claimed isolated DNA sequences were patent-ineligible under 35 U.S.C. § 101.  See Foaming at the Mouth: The Inane Ruling in the Gene Patents Case.  The applicability of the “product of nature” doctrine was not accepted by a majority of the Federal Circuit in the original AMP decision, and it should definitely not be accepted now.  Again, we’re not talking about purified natural elements such as vanadium, uranium, or even tungsten.  The claimed isolated gene sequence are not merely “products of nature,” or any such thing, but are, again, man-made, chemical molecules that “nature” cannot make.

The plaintiffs in AMP may be dreaming that the remand by the Supreme Court for reconsideration in view Mayo Collaborative Services will change the result by the Federal Circuit on the patent-eligibility of the claimed isolated DNA sequences.  In my opinion, that is no more than very wishful thinking for at least the reasons I’ve stated.  But it wouldn’t hurt for the Federal Circuit to explicitly tell SCOTUS “loud and clear” that Chakrabarty, not Mayo Collaborative Services, controls the patent-eligibility of the claimed isolated “man-made” DNA sequences in AMP.

*© 2012 Eric W. Guttag.  Posted April 3, 2012 on IPWatchdog.com.


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14 comments
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  1. Ever one to instigate, I have a question on this one. Is the DNA sequence that was isolated from the body any different in terms of base pairs from the one present as part of a chromosome in the human body? Because if it is just a DNA sequence that has been ‘sliced’ out of a full chromosome, you are going to have a hard time convincing me that it isn’t a product of nature.

    After all, none of the elements, such as uranium or tungsten as you mention, are present in nature in their pure state. Indeed, most elements found in nature are present in the form of compounds with other elements; uranium is present as yellowcake (uranium oxides). Under a theory that I could just snip DNA out of a chromosome and patent the isolated DNA, I could also separate uranium from oxygen and patent the isolated uranium.

  2. “Is the DNA sequence that was isolated from the body any different in terms of base pairs from the one present as part of a chromosome in the human body?”

    Fair question, Sean. As as I can tell, the claimed isolated DNA sequence has the same base pairs. But even so, it’s not simply a “product of nature” in the patent law sense. The key is the quote above from my article: these isolated DNA sequences are “structurally distinct from native DNA, and have different properties and utilities.” In other words, these isolated DNA sequences don’t act like native DNA, and can only be obtained by man-made techniques. Please also consider that Louis Pasteur got at least one patent in the 19th century involving the use of a purified culture of microogranisms.

    Having studied the “product of nature” doctrine and even published a law review article back in 1979 that discusses this doctrine, you’ve also got to be very carefully in labeling something a “product of nature.” Everything on this earth is ultimately a “product of nature.” What you can’t claim is the native DNA; that’s a mere “product of nature.” But what can claim is those molecules purified, isolated, etc., by man; that’s what these claimed isolated DNA sequences are.

    As far as your uranium oxide “yellowcake” example, you obviously cannot claim the ore or the uranium oxide as it exists in “nature”; that’s what the “product of nature” line of cases is really all about. But a purified composition comprising the isolated uranium having a certain degree of purity and especially having properties distinct from the native ore might be patent-eligible, but of course, would have to run the gamit of other patent validity sections, including section 103 (“obviousness”). Again, if you extend the “product of nature” concept too far, even various metallurgical compositions comprising a plurality of different metals derived from “nature” would have a hard time passing such a standard.

  3. Sean, in cases of human, the sequences are different. Introns and exons typically form part of the gene as it exists in eukaryotic (mammalian) organisms. Wikipedia has a nice overview of the process if you search “gene” including a graphic depicting the process of gene transcription, splicing, and translation (protein synthesis). I can only assume that Wiki is working on the providing appropriate links to Gene Quinn upon searching the term “gene.”

    I’d guess the chances of the CAFC overturning the prior ruling is about a coin-flip. Assuming the panel is the same, hopefully Judge Lourie and Judge Moore remain on the same page. Perhaps Judge Bryson can oversleep that day…

  4. These cases seem very different in my opinion. It seems to be that it would be tough to make claims on either side of the argument. DNA comes from man, however we do not control our DNA, so in a sense it would come from nature. It’s tough to pick a side in this in my opinion, but I am not an expert on the subject.

  5. @Sean: The isolated sequence differs because it is a molecule having a lesser molecular weight than the native DNA from which it was severed. Its end groups are chemically different because they are isolated and no longer linked to other groups in a chain. It is what chemists call a new chemical entity. Compared to the original DNA, the middle may be the same, but the ends are different. If you put it on an electrophoresis gel, it moves differently from the native DNA. It is not a product of nature because no molecule of that molecular weight exists as a chemical entity in nature. If you read the CAFC decision this is all very clearly spelled out, as indeed it is in Eric’s posting. It is astonishing that such a straightforward issue of chemical fact needs to go all the way to the Supreme Court.

  6. Paul, I agree with you that it is astonishing that this has reached the Supreme Court. However, over the last few years I’ve come to appreciate that my own astonishment amounts to less than a hill of beans in the eyes of others, and particularly courts. From what I recall of the original Federal Circuit opinion in Myriad, Judge Moore characterized the patent eligibility of the isolated DNA of Myriad’s claims at issue to be “a closer call” [than cDNAs]. I don’t think that’s a great place to start, particularly in view of Prometheus.

    Where’s my bottle of headache medicine…

  7. One point to note here from the article is the line “But it wouldn’t hurt for the Federal Circuit to explicitly tell SCOTUS “loud and clear” that Chakrabarty, not Mayo Collaborative Services, controls the patent-eligibility of the claimed isolated “man-made” DNA sequences in AMP.”

    I think you mean they should “suggest”. After all, SCOTUS tells the Federal Circuit what controls what, and not vice-versa. The SCOTUS can bind the Circuit, but is itself always free to overrule even its own earlier decisions (in principle, though Stare Decisis makes those occasions very rare indeed).

  8. Maz-

    Come on man! Do you “really” think it is SCOTUS that dictates to the Federal Circuit? The Federal Circuit will put a box around Mayo v. Prometheus so tight that it won’t have any applicability to anything other than those claims unless and until the Supreme Court takes another case, which will get the Federal Circuit to do that same thing all over again.

    SCOTUS doesn’t bind the Federal Circuit, particularly not when they get cases wrong. Just look at the history. Software is patentable despite SCOTUS saying otherwise, and secondary considerations of obviousness are mandated in all obviousness inquiries, despite SCOTUS saying otherwise. That is the reality of the situation. The Federal Circuit will deal with hundreds or thousands of these cases. Plenty of opportunity to nuance Mayo v. Prometheus out of existence like they do so ofter with incorrect SCOTUS decisions.

    -Gene

  9. Gene,

    The real problem is that there easily are dozens, if not hundreds or thousands of judges sitting on Federal benches with no well founded education in what “science” is, let alone with grounding in the sub-specialties of science such as chemistry, physics, thermodynamics, information sciences, etc.

    These people can just as comfortably talk about the four cornerstones of alchemy, namely, fire, ice, earth and sky as they can about what an “isolated” DNA molecule is or what a “law of nature” is.

    (No wonder Prometheus lost. They were guilty in the first place of having misappropriated the trade secret of ‘fire’ and disseminating the same to man. Why everyone with half a brain knows that “fire” is one of the corner stone ‘laws of nature’ –and dare we say, of the gods. How can the Prometheus people have the gall –or what’s left of it– to claim property rights in such “fundamental tools” of the alchemists? No legal craftsman’s guile can save them now. Bwahaha.)

    It’s all just noise bites to these judges; things to be manipulated with the tools of the English language so as to make the judges seem all wise and knowledgeable merely because they can pontificate on what makes an “application” of the laws of alchemy “genuinely significant” or not.

    Real scientists must be sitting around in their white lab coats, looking at these clowns in the opposingly-colored black robes, scratching their heads and wondering, “What hath God wrought now? Oh the humanity. Oh the humanity.”

  10. Maz,

    Telling SCOTUS “loud and clear” that Chakrabarty controls on the isolated DNA sequeneces is vital. First, Chakrabarty is SCOTUS’s own precedent and most directly on point. Second, when it comes to applying even their own precedent, SCOTUS is tone deaf at best and disingenuous at worst. Witness what happened in Mayo Collaborative Services where Breyer’s analysis of Prometheus’ claimed method is in direct contravention of a key paragraph in Diamond v. Diehr, and where Breyer’s opinion disingenuously says “controlling precedents reinforces our conclusion,” one of those “controlling precedents” being Diehr. Mayo Collaborative Services reasoning is so mucked up, and Breyer’s misuse and mischaracterization of basic patent claim terminology so bad that it’s no wonder patent practitioners (including me) are up in arms. You don’t gain respect from a knowlegeable legal bar by writing opinions based on such nonsenscial reasoning, and fundamental flaws in characterizing important facts (i.e., patent claim terminology).

  11. […] IP Watchdog: Chakrabarty Controls on Isolated DNA Sequences, not Mayo* – This post, written by guest author Eric W. Guttag, shares a perspective on the Supreme […]

  12. […] ShareTweetThe supplemental briefs for the parties and amicus are now finally in for the remand of the AMP v. USPTO case to the Federal Circuit.  As I’ve previously stated, the Supreme Court’s reasoning in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which caused this remand should not change the fact that Myriad’s isolated DNA sequence claims are patent-eligible under 35 U.S.C. § 101.  That’s based on the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) being the controlling precedent, not Mayo Collaborative Services.  See Chakrabarty Controls on Isolated DNA Sequences, not Mayo* […]

  13. @Gene, Comment 8
    Gene, you gave me real food for thought. As I say in my book, there are thousands of potential AMP-like plaintiffs out there who could flood the USDCs with Myriad-like law suits. If Myriad is decided similarly to Prometheus the FC would have to place a new box around each such suit, If, on the other hand Myriad is decided contrary to Prometheus, would not the AMP-like plaintiffs feel justified in suing anyway, forcing the FC to extend the umbrella of Prometheus? Either way, Congress will be motivated to act, and all stakeholders will get an opportunity to express their viewpoints in the legislation. I am hopeful that this will result in, at least and IRB codified in the patent law.

  14. […] noted before, these isolated DNA sequences are definitely not “products of nature.”  See What the CAFC Should Tell SCOTUS in the AMP Remand:  Chakrabarty Controls on Isolated DNA Sequences….  Instead, the claimed isolated DNA sequences are man-made, don’t exist in “nature,” are […]