Gene Patent Debate Continues: Federal Circuit Finds Isolated Human Genes Patentable

By Dennis Crouch

Association for Molecular Pathology (AMP) and ACLU v. USPTO and Myriad Genetics (Fed. Cir. 2012)

On remand from the Supreme Court (GVR), a three-member panel of the Court of Appeals for the Federal Circuit has released its highly anticipated decision in AMP v. Myriad. The key results:

  1. Affirmed: The courts properly have jurisdiction over the declaratory judgment case.
  2. Reversed: Myriad's composition claims to isolated DNAs, including cDNAs fall within the scope of Section 101 patentable subject matter.
  3. Affirmed: Myriad's method claims directed to comparing or analyzing gene sequences are not subject matter eligible.
  4. Reversed: Myriad's method claim to screening potential cancer therapeutics via in vitro changes is subject matter eligible.

This decision largely follows the decision previously released by the same panel in 2011. Each member of the court wrote separate opinions, with the opinion of the court filed by Judge Lourie, Judge Moore concurring in part and Judge Bryson dissenting in part. In dissent, Judge Bryson again employed his leaf analogy – arguing that a gene that was merely isolated from the human body cannot itself be patentable in the same way that a naturally grown leaf does not become patentable simply because it is plucked from its tree. Judge Bryson writes:

[E]xtracting a gene is akin to snapping a leaf from a tree. Like a gene, a leaf has a natural starting and stopping point. It buds during spring from the same place that it breaks off and falls during autumn. Yet prematurely plucking the leaf would not turn it into a human-made invention. That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted "markedly different characteristics" to the plucked leaf.

The majority (here judges Lourie and Moore) disputed the leaf analogy based upon the apparent technical difficulty of isolating human DNA.

It is also important to dispute the dissent's analogy to snapping a leaf from a tree. With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent, whereas isolating genes to provide useful diagnostic tools and medicines is surely what the patent laws are intended to encourage and protect. Snapping a leaf from a tree is a physical separation, easily done by anyone. Creating a new chemical entity is the work of human transformation, requiring skill, knowledge, and effort.

Although it may well be comparatively difficult to isolate DNA, at the time of the invention (and even more so today) the process of isolating human DNA was well known and (once the gene sequence was known) was not something difficult for one skilled in this art. I personally isolated selected portions of DNA (non-human) back in 1992 (before the priority date) as part of the introductory biology course that I took in college. It was easy. The majority's analysis here essentially rejects any notion that the Mayo court would find an invention consisting of a combination of old-technology + newly-discovered-product-of-nature to be subject matter ineligible.

The core of the majority argument regarding the isolated DNA claims is that the process of removing the DNA from the human body necessarily transforms those molecules into something new and different. As Locke might say, the mixture of the naturally occurring DNA with human ingenuity and labor resulted in a new arrangement of matter heretofore never seen. The Judge Lourie writes:

The isolated DNA molecules before us are not found in nature. They are obtained in the laboratory and are man-made, the product of human ingenuity. While they are prepared from products of nature, so is every other composition of matter. All new chemical or biological molecules, whether made by synthesis or decomposition, are made from natural materials. For example, virtually every medicine utilized by today's medical practitioners, and every manufactured plastic product, is either synthesized from natural materials (most often petroleum fractions) or derived from natural plant materials. But, as such, they are different from natural materials, even if they are ultimately derived from them. The same is true of isolated DNA molecules. . . .

While purified natural products thus may or may not qualify for patent under § 101, the isolated DNAs of the present patents constitute an a fortiori situation, where they are not only purified; they are different from the natural products in "name, character, and use." (quoting Chakrabarty).

To be clear, the change in the molecule that the court is discussing is that the isolated DNA molecule is cleaved from the larger chromosomal DNA molecule by enzymatically cutting it off at each end and slightly altering the terminal amino acid groups. In a concurring opinion, Judge Moore agreed that the isolated DNA is patent eligible, but rejected the notion that the chemical difference between the in situ gene (part of the chromosome) and the isolated gene is sufficient to justify the conclusion. Rather, Judge Moore identified the altered chemical along with the new and beneficial utility achieved because of the isolation as dual keys to patent eligibility. (Note – for further study – Lourie's dicta that isolation for new purpose is insufficient).

The point of this rehearing was to consider the impact of Mayo on this case. As suggested by the above paragraph, the Judge Lourie's answer here is basically that Mayo has no impact here. Of importance, the court indicated that the holding in Mayo should be limited to method claims and thus cannot be applicable to Myriad's DNA composition claims.

The principal claims of the patents before us on remand relate to isolated DNA molecules. Mayo does not control the question of patent-eligibility of such claims.

This cabining of Mayo will be the key to any petition for a writ of certiorari. To be fair, when considering the Supreme Court's analysis in Mayo v. Prometheus, the CAFC found that precedent applicable to analysis of the method claims. Of course, the CAFC had already held those method claims ineligible even before Mayo (in its prior decision). Interestingly, even though in dissent, Judge Bryson agreed that the "Supreme Court's recent decision in Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S. Ct. 1289, 1293 (2012), does not decide this case." Judge Bryson implicitly agrees that the distinction is based upon claim form – because Mayo "involved method claims." However, he did draw the same analogy that I penned immediately following the Mayo decision – that the discovery of the DNA sequence is the heart of the invention and that the rest of the claim structure is merely window dressing.

In Mayo, which involved method claims, the representative claim involved the steps of administering a drug to a subject, determining a metabolite concentration in the subject's blood, and inferring the need for a change in dosage based on that metabolite concentration. The [Supreme] Court found that the method was not directed to patent-eligible subject matter because it contributed nothing "inventive" to the law of nature that lay at the heart of the claimed invention. . . . In concluding that the claims did not add "enough" to the natural laws, the Court was particularly persuaded by the fact that "the steps of the claimed processes . . . involve well-understood, routine, conventional activity previously engaged in by researchers in the field."

Just as a patent involving a law of nature must have an "inventive concept" that does "significantly more than simply describe . . . natural relations," a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product. In cases such as this one, in which the applicant claims a composition of matter that is nearly identical to a product of nature, it is appropriate to ask whether the applicant has done "enough" to distinguish his alleged invention from the similar product of nature. Has the applicant made an "inventive" contribution to the product of nature? Does the claimed composition involve more than "well-understood, routine, conventional" elements? Here, the answer to those questions is no.

Neither isolation of the naturally occurring material nor the resulting breaking of covalent bonds makes the claimed molecules patentable. We have previously stated that "isolation of interesting compounds is a mainstay of the chemist's art," and that "[i]f it is known how to per-form such an isolation doing so 'is likely the product not of innovation but of ordinary skill and common sense.'" Aventis Pharma Deutschland GmbH v. Lupin, Ltd., 499 F.3d 1293, 1302 (Fed. Cir. 2007). Similarly, the structural changes ancillary to the isolation of the gene do not render these claims patentable. The cleaving of covalent bonds incident to isolation is itself not inventive, and the fact that the cleaved molecules have terminal groups that differ from the naturally occurring nucleotide sequences does nothing to add any inventive character to the claimed molecules. The functional portion of the composition—the nucleotide sequence—remains identical to that of the naturally occurring gene.

The majority suggests that I have "focus[ed] not on the differences between isolated and native DNAs, but on one similarity: their informational content." In light of Mayo, that approach seems appropriate. The informational content of the nucleotide sequences is the critical aspect of these molecules; the terminal groups added to the molecules when the covalent bonds are broken—to which the majority and concurring opinions attribute such significance—are not even mentioned in the claims. The nucleotide sequences of the claimed molecules are the same as the nucleotide sequences found in naturally occurring human genes. In my view, that structural similarity dwarfs the significance of the structural differences between isolated DNA and naturally occurring DNA, especially where the structural differences are merely ancillary to the breaking of covalent bonds, a process that is itself not inventive.

Regardless of your policy perspective on patent eligibility, Judge Bryson's opinion is clearly the most faithful to the Supreme Court's Mayo decision. The only problem is that Judge Bryson ignores other relevant subject matter eligibility cases such as Chakrabarty and Funk Bros. Of course, this highlights a real problem with subject matter eligibility doctrine – the cases do not fit together in any coherent fashion.

+ + + + +

An interesting aspect of Judge Lourie's opinion is his attempt to wash his hands of the public policy results of the decision:

[I]t is important to state what this appeal is not about. It is not about whether individuals suspected of having an increased risk of developing breast cancer are entitled to a second opinion. Nor is it about whether the University of Utah, the owner of the instant patents, or Myriad, the exclusive licensee, has acted improperly in its licensing or enforcement policies with respect to the patents. The question is also not whether is it desirable for one company to hold a patent or license covering a test that may save people's lives, or for other companies to be excluded from the market encompassed by such a patent—that is the basic right provided by a patent, i.e., to exclude others from practicing the patented subject matter. It is also not whether the claims at issue are novel or nonobvious or too broad. Those questions are not before us. It is solely whether the claims to isolated BRCA DNA, to methods for comparing DNA sequences, and to a process for screening potential cancer therapeutics meet the threshold test for patent-eligible subject matter under 35 U.S.C. § 101 in light of various Supreme Court holdings, particularly including Mayo.…

Congress is presumed to have been aware of the issue [of gene patents], having enacted a comprehensive patent reform act during the pendency of this case, and it is ultimately for Congress if it wishes to overturn case law and the long practice of the PTO to determine that isolated DNA must be treated differently from other compositions of matter to account for its perceived special function. We therefore reject the district court's unwarranted categorical exclusion of isolated DNA molecules.

In other words, we don't make policy, we just call balls and strikes.

Next Steps: In my estimation, this case is not over. There is a strong possibility of either an en banc rehearing by the full 12-member Federal Circuit and/or a grant of certiorari by the US Supreme Court.

More to come, but for now read the opinion here: /media/docs/2012/08/10-1406.pdf

  

About Dennis Crouch

Law Professor at the University of Missouri School of Law. Co-director of the Center for Intellectual Property and Entrepreneurship.

175 thoughts on “Gene Patent Debate Continues: Federal Circuit Finds Isolated Human Genes Patentable

  1. MM–

    It is only your ego that causes you to extend the correctness of a guess on the outcome, to the correctness of the underlying reasoning.

    As I have already shown, according to your low standards, I or anybody else can similarly claim victory.

    As the saying goes, even a broken clock is correct twice a day.

  2. What were those silly Supreme Court justices doing asking the CAFC to review the case in light of Prometheus?

    Asking the Federal Circuit to write their opinion for them. Which the Federal Circuit did.

    Now they can deny cert and enjoy more time with their families.

  3. Having read through the first 100 or so posts in this thread, I can’t help but laugh at the fumbling treatment given by MM and others to the concepts of, in particular, “preemption” and “utility”.

    That’s funny. According to you I don’t understand these concepts. And yet my understanding of these concepts allows me to accurately predict the results of many of these cases.

    There is someone “fumbling” in these threads, to be sure, but it isn’t me.

    Maybe you should move the goalpost and try kicking again, IBP.

  4. if you repeat a lie often enough

    You’ve been asked before to identify one such alleged “lie”, suckie, and you failed miserably.

    GFY

  5. I would again point out that mere repetition does not imbue something with the quality of truth, validity, accuracy, or veracity.

    They don’t care for any of that. All they care about is that if you repeat a lie often enough, some people will accept it as the truth.

    That’s why shilling will never go out of style.

  6. Having read through the first 100 or so posts in this thread, I can’t help but laugh at the fumbling treatment given by MM and others to the concepts of, in particular, “preemption” and “utility”.

    And to serve as a counterpoint to the incessant repetition by certain posters of misunderstandings they hold, I would again point out that mere repetition does not imbue something with the quality of truth, validity, accuracy, or veracity.

  7. “that initial discovery ”

    Should we incentivize that initial discovery by giving them rights to the discovery itself, or only to limited applications of the discovery itself as we do in every other art?

  8. Maybe I’ve done all my work in the stone age, but I’ve never done sequencing on a PCR product without purifying it first (leading to much more than a brief moment of isolation), and in many cases doing gel purification. Either way, the amplicon is surely “separated from other cellular components” etc.

  9. Wow, that’s some eplectic rant of rage for such a simple question.

    Speaking of simple questions, are you up to answering my questions yet, MM?

  10. I suppose that in the amplification and sequencing steps there is a VERY BRIEF moment where there will be a single-stranded DNA that comprises at least 15 consecutive nucleotides of the cDNA, but WOW, that is a SERIOUS stretch. The 15mer claims have massive prior art problems anyway, so in this case, who really cares. Myriad might think about a reexam if the specification supports longer fragments of the cDNA. But again, with respect to this particular test, calling these “isolated” is to completely turn the word on its head.

  11. I don’t understand how you are going to sequence your amplicons without isolating them as defined in the spec (example def. below from a Myriad BRCA patent).

    “Isolated” or “subitantially pure”. An “isolated” or “substantially pure” nucleic acid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins. The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.

  12. Ned,

    I am having a hard time accepting your “discovery of a problem” view. To me, it sounds too much like the discovery of the correlation that sunk Prometheus. The logic you wish to apply here is the same logic that was not accepted there. Here, the discovery of the BRCA gene, there the discovery of the optimum amount.

    I am also having some difficulty with the post-treatment and identification of “what the invention is” (not your action, but the courts’). To me, this is sounding in some type of “the gist of the invention,” or “the true spirit of the invention” and too easily leads away from accepting the more objective “invention as claimed.”

  13. Casual, yes.
     
    But, I have argued that prior to Chakrabarty, such an exception did not exist and that the different utility requirement was not required by the prior case law on the grounds that every prior case had required the difference in kind because the product of nature itself was known and therefor prior art .
     
    Others have made a persuasive case that the invention being claimed here was the discovery of BRCA gene itself.  The ease of isolation or the utility of the gene once isolated was quite beside the point, because that was not the invention.  The Supreme Court itself has made this point that sometimes invention can be in the discovery of a problem, and once problem has been identified, the solution, even though obvious, was still patentable because of the discovery.  If this is the situation here, then the requirement of a separate utility for the BRCA gene is a red herring.

  14. Yes, the amplicons wlll be longer than 15 nucleotides in length. But they are not “isolated” as that term is defined in the specification (or anywhere).

    I don’t know what “similar diagnostics claims” means. I’ve been talking about this case specifically. In the context of the way Myriad performs its test, and the way ANYONE would perform a commercial test to screen for the presence of mutations in BRCA1, a claim to a mutation screening method comprising isolating the cDNA (or a fragment thereof), sequencing the isolated cDNA (or a fragment thereof), and then comparing the sequence to wild-type, is worthless.

  15. “Anyone see a pattern…?”

    Well, there is a past pattern of the CAFC relying on it’s narrow interpretation of Diehr by using MOT as the sole test for patent eligible subject matter, and then being GVRed and/or overturned by the Supreme Court who in turn says Diehr controls.

    I think we see the beginning of that fact pattern emerging again in Prometheus, with the Court relying on Diehr’s concept and application analysis as controlling precedent, and using “integration” as the key to as the Court said: “transform the process into an inventive “application” of the formula. ( See Prometheus Cite Below ).

    However the pattern of being overruled by the Court can be broken by the CAFC by adding “Integration Analysis” to Concept and Application to either uphold the GVR cases or overturn them. That’s the opportunity that exists in Utramercial’s GVR in view of Prometheus. And while I don’t really have a dog in the Isolated Human Genes debate it does stand to reason that anything that is “isolated” is not “integrated” and would probably fail “Integration Analysis” and therefore should not be patent eligible. subject matter.

    “The Court pointed out that the basic mathematical equation, like a law of nature, was not patentable. But it found the overall process patent eligible because of the way the additional steps of the process “integrated” the equation into the process as a whole. Those steps included “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly re- calculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time.” Id., at 187. It nowhere suggested that all these steps, or at least the combination ( in of those steps, were in context obvious, al­ ready in use, or purely conventional. And so the patentees did not “seek to pre-empt the use of [the] equation,” but sought “only to foreclose from others the use of that equa­ tion in conjunction with all of the other steps in their claimed process.” Ibid. These other steps apparently added to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.”

  16. Amplify coding regions and sequence amplicona via Sanger sequencing

    The amplification of the coding regions as you suggest results in amplicons that have at least 15 nucleotides of the DNA of claim 1. Given that length is significantly more than 15 nucleotides, the likelihood of anticipation is decreased. I’m sure you can think of a way to write a claim that looks at the all such amplicons to cover the full length of the coding region.

    The reason we are talking about this is to think about whether there is a claim construction for the diagnostic method that would result in something that would have been patent eligible under 101, to inform us as we consider how to write similar diagnostic claims in the future.

  17. No, this is not what is in use today. Oh, I also have no idea what you are talking about.

    I’ve already said that if the claim comprised isolating the cDNA, and then sequencing the isolated cDNA to determine the presence of mutations, such claim would be patent-ELIGIBLE. I’ve also said that such a claim is practically worthless because of the expense and time involved. If the claim comprised isolating a DNA having at least 15 nucleotides of the cDNA, and then sequencing that isolated DNA to determine the presence of mutations, such claim would likewise be patent-ELIGIBLE. However, forgetting for a moment that the 15mer claims have major prior art problems (any given 15mer is likely to have been published prior to the date the application was filed), how would this claim be useful? The inventors disclosed the fact that mutations of the BRCA1 gene were correlated with cancer. They gave examples of specific mutations. Let’s say you isolate a 15mer (and ONLY a 15mer) and then sequence that. Suppose the sequence of the 15mer is the exact same as the wild-type. Does this convey any useful information about whether a person is at risk for cancer? You have to look at the whole gene, right?

    Why are we talking about this again?

  18. The claimed product has to have some utility that is different kind from the utility of the naturally occurring product

    Ned, I wonder if you realize that what you describe is the current Product of Nature judicial exception to patent eligibility.

  19. MM, but why?  I think Moore is right that simply relying severing covalent bonds is not sufficient or even credible final answer.  There has to be more.  The claimed product has to have some utility that is different kind from the utility of the naturally occurring product.  As I have said before, I think the proper rule is that the claimed subject matter has to be something not found in nature, i.e. extracted, isolated or purified.  And secondly that in this man-made form, that it have a substantial utility not found with the natural product.  Even under this test there is a problem with isolated DNA in that it has no utility that is different in kind from the utility of the product in its natural state.  Now if Judge Moore is incorrect about this as a matter of fact, then result may be as you say.  But we have in this case a 2 to 1 finding that isolated DNA is not markedly different in its utility from that of its naturally occurring DNA.

    I think this is why judge Lourie did not want to address the utility of the claimed composition.  He rested his case on structural differences alone.  If that is not sufficient to carry the case, then I do not share your optimism about the en banc victory of Myriad.

  20. He welcomes your table pounding.

    Lolz from the guy that pounds more (paper) tables than anyone on these threads; yet more of MM accusing others of what he is famous for.

  21. I don’t really care about whether they would do the test that way now.

    Sorry, above was really directed at Hans’s comment below re: the applicability of the claim to methods actually used.

  22. your weird-arse paranoid suspicions

    Lolz, coming from the person who thinks anyone outside of the vocal minority is a ‘suckie.”

  23. Freshly deemed eligible is “An isolated DNA having at least 15 nucleotides of the DNA of claim 1 (full length BRCA1 gene).”

    Just put that in the method we discussed above instead of cDNA and you have a diagnostic claim that at least passes 101, and is in use today.

  24. It’s sort of strange that

    What were those silly Supreme Court justices doing asking the CAFC to review the case in light of Prometheus? Couldn’t the Supreme Court tell that their decision meant nothing to the panel? When was the last time was saw that? (oh, yeah – Prometheus in view of Bilski, right?)

  25. I don’t really care about whether they would do the test that way now.

    Huh?

    Also, I see a big difference between ineligible and anticipated, since I’m thinking about future patents.

    Whatever that’s supposed to mean.

    I’d stick to asking questions. You’re better at that.

  26. Hans First, utility has to be satisfied as of filing. Was BRCA1 cDNA specifically, substantially, and credibly useful for anything at the time of filing? Further research doesn’t count.

    I agree that a generic hand-waving utility wouldn’t (and shouldn’t) count where the gene is essentially a black box without a specific connection to a disease. But that wasn’t the case here. I may be wrong about the facts but this particular nucleic acid was (and still is) a very desirable and interesting composition.

    It’s sort of strange that In re Fisher was not invoked more often by these judges. The facts there are vastly more similar to this case than the facts in Prometheus.

  27. The holding of the majority is that isolated DNA is eligible only because of Moore’s vote to support Lourie.

    If this goes en banc, it’ll be a landslide in favor of Myriad.

  28. I’d do it precisely the way Myriad does it right now, and how it has always done it. Amplify coding regions and sequence amplicona via Sanger sequencing, then compare to reference sequence, then characterize any variation.

  29. First, utility has to be satisfied as of filing. Was BRCA1 cDNA specifically, substantially, and credibly useful for anything at the time of filing? Further research doesn’t count. Yes, the specification disclosed a link between mutations of the gene and cancer, but again, I’m talking about the utility of the cDNA (or polypeptide produced by the cDNA) itself. Malcolm’s argument may be persuasive, but that’s sort of like a research use. I think it’s at least a close call.

  30. There are 67 BRCA1 plasmids on Addgene, so there must be some utility. Why don’t you ask the people that bought or deposited them what they use them for?

  31. Malcolm, Lourie is called the majority opinion, but he was just one of three.  The holding of the majority is that isolated DNA is eligible only because of Moore's vote to support Lourie.  But, she also concluded that had the law been applied to isolated DNA, it would not have been eligible.
     
    Regarding why someone would patent something virtually useless, that is a good question.  But that is not really what she "held."  It's utility was not markedly different from the utility of naturally occurring DNA.
     
    In truth, she seems to agree with the government position, but votes against the government because of the PTO decided to issue so many of these kinds of patents.  This effectively puts the power to make law in the hand of petty bureaucrats.  I think you and I share the view that Beauregard claims should not be given any credibility simply because some bureaucart decided to withdraw the case from the Federal Circuit in order to deny the courts the opportunity to determine what the law was regarding these claims.  (What a fricken arrogance that was.)
     
    If anything, Moore's point of view has to be confronted.  The PTO cannot have the power it has arrogated to itself. 

  32. MM, Thanks for the response. I don’t really care about whether they would do the test that way now. It would have been a perfectly reasonable way to do the test at the time the patent was filed and well afterward.

    Also, I see a big difference between ineligible and anticipated, since I’m thinking about future patents.

    LOL at the paranoia and argument about my silly name.

  33. what is the specific, substantial, and credible utility of an isolated DNA encoding BRCA1 (yes, I know what BRCA1 is and what it does).

    I’d say it’s useful for expressing and obtaining recombinant protein in sufficient amounts and purity that it can be studied and perhaps further engineered for therapeutic processes. I’d argue that given the proven link between mutations in the gene and cancer, the utility is specific and substantial, unlike the utility of, say, an EST or an isolated nucleic acid encoding a putative gene of unknown function.

    Persuasive?

    Regardless, Hans, it is indeed a semi-serious question and it’s a worthwhile one to contemplate. Moore has a start but given all the dust and b.s. kicked up by the ACLU, the record with respect to this issue is pretty screwed up (that wasn’t the case for In re Fisher, as I recall).

    See also my Aug 18 2:57 comment.

  34. There are at least or or two modestly interesting policy arguments that could be used to justify not patenting nucleic acid compositions encoding “naturally occuring” human genes.

    I don’t see any interesting policy arguments to justify not patenting something that is obviously different than what is in nature.

  35. For example, the full length gene is too large to be used as a probe. See J.A. 4322 (a probe is a DNA molecule usually 100-1,000 bases long). Likewise, an entire isolated gene appears unsuitable for use as a primer in genetic screening for mutations in that same gene. See J.A. 4323 (Primers “are complementary to an exact location of a much larger target DNA molecule.”). The isolated full length gene does not clearly have a new utility and appears to simply serve the same ends devised by nature, namely to act as a gene encoding a protein sequence.

    Sort of begs the question why anyone bothers to isolate genes. I mean, why not just use the gene in the chromosome for expressing the protein?

    Is Moore referring to isolated whole human genes? Is anyone getting patents to such sequences? They would all seem obvious given the publically available sequence of the human chromosome.

    What about a gene isolated from a newly discovered plant that, when expressed recombinantly in cells and implanted into a child with leukemia, cures that child? No claims allowed to the isolated gene because it “acts as a gene encoding a protein sequence”? Does the same apply to every other isolated compound found in any organism, no matter how difficult to isolate, no matter how low of a concentration in the organism, just because an argument can be made that the “utility” of the chemical in the non-human organism is the same as the “utility” of the chemical when administered to a human (e.g., it interferes with the functioning of a receptor on the surface of the cell)?

    Really? What in the heck is the policy argument supporting this legal result?

    This again is where the majority’s analysis is spot on. There are at least or or two modestly interesting policy arguments that could be used to justify not patenting nucleic acid compositions encoding “naturally occuring” human genes. But as a general rule? Really?

  36. ?? MM,

    You want to explain how your post makes any sense (even assuming your tinfoil hat “everyone is suckie” conspiracy theory?

  37. http://heinonline.org/HOL/LandingPage?collection=journals&handle=hein.journals/jpatos67&div=79&id=&page=
     
    Also,
     
    "
    The so-called experimental use defense to liability for infringement generally is recognized as originating in an opinion written by Supreme Court Justice Story while on circuit in Massachusetts. In Whittemore v. Cutter, 29 Fed.Cas. 1120, 1121, (C.C.D.Mass.1813) (No. 17,600), Justice Story sought to justify a trial judge's instruction to a jury that an infringer must have an intent to use a patented invention for profit, stating:
    [I]t could never have been the intention of the legislature to punish a man who constructed such a machine merely for philosophical experiments, or for the purpose of ascertaining the sufficiency of the machine to produce its described effects.
    Despite skepticism, see, e.g., Byam v. Bullard, 4 Fed.Cas. 934 (C.C.D.Mass.1852) (No. 2,262) (opinion by Justice Curtis), Justice Story's seminal statement evolved until, by 1861, the law was "well-settled that an experiment with a patented article for the sole purpose of gratifying a philosophical taste, or curiosity, or for mere amusement is not an infringement of the rights of the patentee." Peppenhausen v. Falke, 19 Fed.Cas. 1048, 1049 (C.C.S.D.N.Y.1861) (No. 11,279). (For a detailed history and analysis of the experimental use exception, see Bee, Experimental Use as an Act of Patent Infringement, 39 J.Pat.Off.Soc'y 357 (1957).) Professor Robinson firmly entrenched the experimental use exception into the patent law when he wrote his famous treatise, W. Robinson, The Law of Patents for Useful Inventions § 898 (1890):
    § 898. No Act an Infringement unless it Affects the Pecuniary Interests of the Owner of the Patented Invention.
    [T]he interest to be promoted by the wrongful employment of the invention must be hostile to the interest of the patentee. The interest of the patentee is represented by the emoluments which he does or might receive from the practice of the invention by himself or others. These, though not always taking the shape of money, are of a pecuniary character, and their value is capable of estimation like other property. Hence acts of infringement must attack the right of the patentee to these emoluments, and either turn them aside into other channels or prevent them from accruing in favor of any one. An unauthorized sale of the invention is always such an act. But the manufacture or the use of the invention may be intended only for other purposes, and produce no pecuniary result. Thus where it is made or used as an experiment, whether for the gratification of scientific tastes, or for curiosity, or for amusement, the interests of the patentee are not antagonized, the sole effect being of an intellectual character in the promotion of the employer's knowledge or the relaxation afforded to his mind. But if the products of the experiment are sold, or used for the convenience of the experimentor, or if the experiments are conducted with a view to the adaptation of the invention to the experimentor's business, the acts of making or of use are violations of the rights of the inventor and infringements of his patent. In reference to such employments of a patented invention the law is diligent to protect the patentee, and even experimental uses will be sometimes enjoined though no injury may have resulted admitting of positive redress. [Emphasis supplied, footnotes omitted.]
    Roche Products v. Bolar Pharmaceutical Co., 733 F. 2d 858 – Court of Appeals, Federal Circuit April 23, 1984
    http://scholar.google.com/scholar_case?case=8683875025660350460&q=story+and+the+experimental+use+exception&hl=en&as_sdt=2,5

     

  38. No, I think that acts that would otherwise infringe if done for commercial purposes if done for private do not infringe.  Story said this a long time ago.  It was accepted law until the Federal Circuit through a monkey wrench into the exception in the '90s.

  39.  MM, I this is the what will ultimately decide this case, either en banc or on petition, is Moore's opinion.  This from Moore:
     
    "All of the same structural arguments apply to any
    length of isolated DNA so, like the shorter strands, an
    isolated DNA coding for a gene does have a literal chemical
    difference from the gene as it appears on the chromosome.
    Unlike the shorter strands of isolated DNA, the
    chemical and structural differences in the isolated gene do
    not clearly lead to an “enlargement of the range of . . .
    utility” as compared to nature. Funk Bros., 333 U.S. at
    131. For example, the full length gene is too large to be
    used as a probe. See J.A. 4322 (a probe is a DNA molecule
    usually 100-1,000 bases long). Likewise, an entire isolated
    gene appears unsuitable for use as a primer in
    genetic screening for mutations in that same gene. See
    J.A. 4323 (Primers “are complementary to an exact location
    of a much larger target DNA molecule.”). The isolated
    full length gene does not clearly have a new utility
    and appears to simply serve the same ends devised by
    nature, namely to act as a gene encoding a protein sequence.
     
    If I were deciding this case on a blank canvas, I might
    conclude that an isolated DNA sequence that includes
    most or all of a gene is not patentable subject matter."
     
    I would suggest that isolated DNA, without some substantial change that does something to change its utility, is going to be held not eligible.
     
     
     

  40. Malcolm, as far as I can tell, you and I agree on just about everything as it concerns patent law, but lemme axe you this semi-serious question: what is the specific, substantial, and credible utility of an isolated DNA encoding BRCA1 (yes, I know what BRCA1 is and what it does). If I have breast cancer and I swallow a tube of BRCA1, will my cancer go away? Will it cure my headache (induced by reading the posts on this board)? Since one would never use the cDNA to screen for mutations, what’s it good for? Gene therapy? Really? Wouldn’t that have required undue experimentation back in 1994/95? If you want to attack “gene patents” I’ve always thought a good place to start would be utility.

  41. Suckie will never, ever answer that question, Ned. Suckie will only say that “Nobody knows!”

    Does this mean that are almost ready to answer my questions of you? Remember the questions you tried to make your own and ask others of?

  42. Even if you want to argue that ineligible “phenomena of nature” includes compositions of matter, Myriad’s claims to not read on any such compositions.

    Do you recognize that this was what the case was about
    (that it is not if you want to argue PoN)?

  43. AND ALL THOSE YEARS I BELIEVED THOSE LIES. Patrick Egan is like Frosting on the Cake I ate all by myself. I know I should eat more fruits and veggies, but this New Cake looks so delicious, I can’t help myself. Patrick I think you are even stupider that I was.

  44. R&D may have worked on Kent as a Design Patent.. NOT! But if you try to steal someones Patent you do it after it becomes a Patent, not while you are stealing it. Because Publishing is a RED HERRING, AYE MATI
    Also when you answer the phone… remember where you are.

  45. Ned Moore ended up saying categorically, I think, that isolated or purified compounds are eligible because of history

    I think she was quite clear about her personal reasons for concurring and the reason was not simply “because the PTO has been granting patents on isolated sequences for a long time.”

    Certainly that was a factor in her decision and maybe the deciding factor. But it’s a real distortion of her concurrence to read that as the only factor.

    Again, the method claims which she found ineligible are also claims that have been granted for years. Did you notice she didn’t seem to spend much time discussing that?

  46. using non-m0r0n pseudonyms

    with

    Marryadd (phonetically Myriad).

    W

    T

    F

    The only way you think this is not a m0r0n pseudonym is if it is you wearing a sockpuppet. Add in the “politeness” and it’s a very high probability that you are conversing with yourself.

  47. Lol. I would make that make that bet, but my lunches would becomes insufferably boring if the USSC should mess up. Tell you what, 1k vs. 3 mo of no posting? I can stand 3 mo as much as you can stand to lose a k.

  48. Marryadd does it naturally follow that the diagnostic method would have been eligible if only it had clearly claimed the step of making or sequencing the isolated cDNA (deemed eligible itself) prior to the comparison of the sequences

    A great question. The answer is likely yes but I’d go further and say that the claim would not be eligible unless it recited (1) probing the sequence with the novel nucleic acid composition or (2) identified the cDNA sequence as one comprising the mutation. In other words, a claim that covered a method of sequencing the non-mutant sequence, probing with a probe designed to detect the non-mutant sequence, and “determining” the lack of the mutation would still be ineligible OR anticipated (doesn’t really matter … identical analysis and identical result).

    It’s nice to see people actually using their heads and thinking about this stuff, though. Also unsurprising that they are using non-m0r0n pseudonyms. That helps distinguish them from our trolls.

    Let me know if you have any follow-up questions, Marryadd.

  49. SPL I am a biologist, not an attorney, and I am a bit confused about this …. wouldn’t the Supreme Court’s Prometheus ruling still invalidate the Myriad patents on the basis that the invention is just reporting a law of nature?

    Hi SPL. I’m a biochemistry Ph.D. and an attorney. It’s understandable that you are confused. There is a great deal of misinformation being put out there, mostly be people who have little understanding of the science and even less understanding of the patent law and its application to chemical compositions.

    Prometheus concerned the eligibility of process claims that recited a mental step and could be infringed merely be practicing the prior art and thinking about what to do next (one needn’t actually do anything after the thinking step to infringe the claims). Because such claims are effectively claims to the “naturally occuring correlation” itself (to the extent they prevent practitioners of the prior art from thinking about the correlation), the claims were found ineligible.

    It’s also extremely important to remember that the Court in Prometheus could have created a brand new law out of whole cloth and stated that mental steps should be ignored when claims are analyzed for novelty. That pathway would also have rendered any claims such as those at issue in Prometheus ( [oldstep]+[newthought]) invalid, as only the [oldstep] would remain. The Court was unwilling to create this new paradigm for examining patents and went instead with the perfectly reliable and reasonable 101 hammer.

    Myriad’s composition claims are a completely different animal. The composition claims to not prevent a single person on earth from thinking about the correlation between the BRCA1 mutation and cancer. None. Nada. Zilcho. And because the compositions are new and useful and concrete (structurally described), the claims do not cover any of the judicial exceptions. Even if you want to argue that ineligible “phenomena of nature” includes compositions of matter, Myriad’s claims to not read on any such compositions.

    To the extent that Myriad’s compositions make it more difficult for companies and scientists to engage in new technologies that arose after Myriad’s patents are granted, that’s neither here nor there. All patents do that. This issue was discussed and distinguished in Prometheus.

    To the extent that Myriad’s compositions read on compositions that arise during practice of prior art methods, that certainly creates problems for Myriad’s claims but unlike the claims in Prometheus, those are problems that the other patent statutes are PERFECTLY suited for addressing.

    I hope this helps. Let me know if you have further questions.

  50. crelboyne, is sequencing one’s own genome an act of infringement?

    If it is, then I have a big problem with Myriad’s patent.

    Why? Are you going to make copies of your genome and sell it for millions of dollars?

    Geebus.

    News flash Ned: if you are bummed that you can’t sequence your own genome without infringing a patent, then you might as well advocate taking down the entire patent system.

    I’m bummed that I can’t entertain my cat with a laser pointer.

  51. Also read Chris Holman’s brief. Sure, some methods of genome sequencing will be covered by the patents (anybody can design an infringing method), but will ALL of them?

    No.

    And the SECOND that Myriad sues someone for infringing because they sequenced a genome, they’ll be slapped with an inherent anticipation argument that it will cost them millions to litigate and they won’t win.

  52. I think Prometheus did suggest that had the determining step been less conventional, the claims might have been eligible. What did they mean by this?

    Suckie will never, ever answer that question, Ned. Suckie will only say that “Nobody knows!”

    Just like nobody could predict that Prometheus claims had to be ineligible or anticipated. It was wrong to even discuss the lack of novelty of the claims! That was Kevin Noonan’s position. I think he’s grown up a little since then. Just a little, though.

  53. As has been commented on many times, there is no such “timing” requirement for the 101 question.

    Yes, you’ve commented on that many times. Too bad the question has never been squarely put before the Supreme Court, suckie.

    Then again, you thought there was an absolute prohibition at looking at whether a step in a method claim was old or not when determining whether the claim was eligible under 101. Remember that, suckie?

    I do.

    9-0. You lost. And you lost because you couldn’t understand the consequences of your m0r0nic “theory” being enshrined into law as you envisioned it.

    I’ve already explained to you what happens when you fail to explain exactly what is and what isn’t a “product of nature”: giant pieces of s—t start hitting the fan. Justice Breyer is aware of this. That’s why Prometheus lost. That’s why the ACLU is going to lose on their bogus nonsensical and unworkable “products of nature” theory.

    If you’re ready to have a serious discussion about rendering claims to composition X ineligible under 101 just becuase “nature” has acted on Y and turned into X years after the filing date, let me know. If not, then please STFU and troll some other blog. Like Quinn’s blog. He welcomes your table pounding.

  54. Both Moore and Bryson seem to agree that isolated DNA does not have “markedly different characteristics” from that found in nature

    Except Moore would agree that the claimed nucleic acid molecules have great utility to human beings whereas the closest “naturally occuring” counterparts in cells (e.g., mutant chromosomes) have no practical utility.

    You really are wandering off into the weeds, Ned. Are you trying to find out where the majority hid the ACLU’s body?

    LOL.

  55. I’ll get to this, Michael.

    Before reading Watson’s shtick, I should mention that in my opinion Watson is a mediocre human being (at best) who happened to be in the right place at the right time and owes everything to Francis Crick.

    In short, I’ll ignore the fact that Watson wrote the brief. It’ll be better that way.

  56. If the Supreme Court holds that isolated, novel, non-obvious structurally described nucleic compositions with a specific, substantial use are ineligible when an identical string of nucleic acids is shown to exist in a chromosome “in nature” only after the filing date of the application, I’ll give you $1,000.

    If I’m right, you can just quit posting here as I’ll never ever let you forget what an insufferable dxpshxt you’ve been during this entire non-debate.

  57. Given the majority’s arguments for the eligibility of the drug screening method based on the man-made nature of the transfected cell line, does it naturally follow that the diagnostic method would have been eligible if only it had clearly claimed the step of making or sequencing the isolated cDNA (deemed eligible itself) prior to the comparison of the sequences? (And not also claimed BRCA DNA or BRCA RNA, which can be found in nature)

  58. Mutiny, aye captain? Make up law as we feel with no basis in the statute, eh? Hog wild disregard of the consitution which dictates who gets to decide patent law, ya scurvey brigand!

  59. In this thread IANAE, true to his tar d nature, thinks that I was talking about the discovery of the isolated gene. I was not. Which got IANAE off on a tangent, as he has been for the entire thread.

    Stop getting off on tangents because of your tar ded nature IANAE or I will have to cut you out of the discussion.

  60. “The discovered gene is a very specific molecule, and very specific molecules have always been statutory subject matter.”

    Then by all means, why do they not claim it? Oh, they’d get 101’d? Oh, really?

  61. Michael, Watson discovered the double heix.  He argues that patents should not inhibit R&D into the human genome.  I fully agree.

    The simple and elegant solution is to create an exception to infringement for pure research, or even R&D that is designed to make and use post-expiration.  The non commercial or protected nature of the activity should control.

    The problem we have is not created by the patents on DNA per se, but by the Federal Circuit that held that R&D for protected post-expiration commercial exploitation to be an infringement.  It am not sure what the law is about pure research, or making a patented product for idle curiosity, but these too should not be infringements.  It is the Federal Circuit itself that has caused the very problem that Watson says can be fixed by denying patents on isolated DNA.

    I think this issue needs to be addressed, perhaps by the en banc Federal Circuit, even if in dicta.  They should signal that pure R&D and the like as I have described it above is non infringing "fair use."

     

  62. I am a biologist, not an attorney, and I am a bit confused about this. My reading of the new opinion is that the court ruled that Myriad’s “composition of matter” claims (i.e., the isolation of the BRCA genetic material) were patent eligible, but that its “method” claims (i.e., the process of isolating the genes and looking for the mutations) were largely patent ineligible. I think they also made it clear that they were not ruling on final patentability, but only on whether the “invention” was eligible.

    Even if one accepts that the chemically modified isolated genes are not natural products and are, thus, patent eligible, isn’t the key to patentability the downstream correlation of the mutant genes with the predisposition to getting breast and/or ovarian cancer? And aren’t those correlations simply laws of nature? And wouldn’t the Supreme Court’s Prometheus ruling still invalidate the Myriad patents on the basis that the invention is just reporting a law of nature?

  63. anon, no.  I think she said clearly that in this case, had she been writing on a blank slate, she would have voted for ineligibility.  She recognizes the hand of man, but that, in her view, is not sufficient under Chakrabarty, Parke-Davis and Merck.  The isolated DNA itself must have markedly different characteristics, and it does not.

    So, anon, we have ourselves a very weird situation with a majority against eligibility if the law were applied correctly.

  64. anon, I think Prometheus did suggest that had the determining step been less conventional, the claims might have been eligible. What did they mean by this?

  65. I seem to recall that a Critique on Bryson Section II was on that thread.

    Dennis, any luck on reviving the lost comments?

  66. I don’t know if this is entirely correct.

    I do know that it is entirely correct. I will agree to no less.

  67. anon, “The entire aspect of trying to insert “known” into the 101 equation is a red herring. As has been commented on many times, there is no such “timing” requirement for the 101 question.”

    I don’t know if this is entirely correct. I think it is required to the extent one is seeking to identify the novel subject matter. But whether, after that, that subject matter is an invention is really a question of 103, not 101. Perhaps we can agree on that much.

  68. The pattern is clear, albeit the subject matter differs and reading the tea leaves of the Supreme Court is not for the feint of heart – pun intended.

  69. And if the cruel joke that is Mayo v. Prometheus is any indication, this won’t get any better at the Supreme Court.

    Can you elaborate, crelboyne?

  70. Ned,

    The entire aspect of trying to insert “known” into the 101 equation is a red herring. As has been commented on many times, there is no such “timing” requirement for the 101 question.

  71. I think Moore does not agree that isolated DNA has “markedly different characteristics” than wild DNA

    Ned, isn’t it rather the case that she thinks that you need both evidence of the hand of man and new utility; and wouldn’t that “new utility” be the evidence of “markedly different [fill in the blank]”?

    I am still contemplating Moore’s “don’t rock the boat” position, and reserve comment.

  72. Judge Bryson is a very intelligent man, but his continued hand-wringing over whole genome sequencing is simply inexplicable. Listen to the oral arguments. At the very end Myriad’s counsel says James Watson had his genome sequenced … and was found to be a BRCA carrier. Also read Chris Holman’s brief. Sure, some methods of genome sequencing will be covered by the patents (anybody can design an infringing method), but will ALL of them? Doubtful.

    Again, people who don’t understand the science or the industry are deciding the future of patents, the industry, and patients’ lives. And if the cruel joke that is Mayo v. Prometheus is any indication, this won’t get any better at the Supreme Court.

  73. Man And Nature,

    Engaging IANAE is futile, as he is only interested in word play and cannot be taken seriously. It is clear that a Product of Nature exception serves as a baseline and the court in any case reviews the facts of the case to see if the claimed invention is “enough.” Only f_ools and pedantic f_ools troll otherwise.

  74. Mr. Nature, I think Moore does not agree that isolated DNA has “markedly different characteristics” than wild DNA. She votes with Lourie only not to rock to boat.

    The majority (Moore, Bryson) does not agree, in principle, that isolated DNA is inventive over wild DNA to the extent that invention means “markedly different characteristics.”

    Then see crelboyne below for the real invention.

  75. I fully agree with this post. But there is a problem. There not one word in it that talks about “marked different characteristics.” It makes the point, simply, that extracting or isolating something from nature alone is sufficient for 101 purposes. This implies that any analysis of whether the isolated composition has “markedly different characteristics” from that found in nature is answered by the fact of isolation itself from a 101 point of view.

    This is correct, IMHO.

    Both Moore and Bryson seem to agree that isolated DNA does not have “markedly different characteristics” from that found in nature. Moore’s vote in favor eligibility therefor really does not solve the 101 issue if “markedly different characteristics” remains a sine qua non.

    I want to again emphasize my view that “markedly different characteristics” is required when one is purifying a known compound. This may be an issue particular to purification for 101 purposes, but I think the better analysis is that “markedly different characteristics” is required only to show novelty, that the purified compound is different from a known material.

    Parke-Davis can be read that way. Merck certainly can be read that way. “Markedly different characteristics” should be confined to novelty, and not to 101.

    101 should relate solely to whether the claimed compound is the product of man, albeit, from nature.

  76. In the factual context of this case, the work of isolation was enough. That is not to say that “isolation” per se is enough.

    Right, because the act of isolating one gene is completely different in character from the act of isolating another gene. Maybe you can point to the specific “factual context” of this case that you think might not apply to other gene patents.

    Explain again how this supposed “Product of Nature” exception is anything more than “you can’t patent what you didn’t invent” or “you can’t patent what was already known/obvious”.

  77. In the factual context of this case, the work of isolation was enough. That is not to say that “isolation” per se is enough.

    You are most defintiely not completely right to ‘miss the fact’ of that exception, as that exception is very much still something to be accounted for.

    Your attempt at dismissing it is ludicrous.

  78. As usual, people don’t understand the technology and opine anyway. Isolating whole cellular DNA is in fact easy. Isolating DNA corresponding to a specific gene is much more difficult. Before Myriad made its discovery, isolating DNA corresponding to the BRCA genes was IMPOSSIBLE (without the isolator discovering the gene herself).

    If it was so easy any freshman biology student could do it, why did it take decades and millions of dollars?

    Sure, many (but definitely not all) of the laboratory and computer techniques were routine, but initially isolating the genes was definitely inventive. Once you know where to look, of course isolation is easy. This is the core concept of patents and intellectual property protection: Once the cat’s out of the bag, copying is easy; thus we want to incentivize that initial discovery by giving a limited term of exclusivity.

  79. The claims to modified DNA were deemed not a Product of Nature, but changed enough by the hand of man.

    Yes, and “modified” here means “isolated”. Like any other gene that anybody with a brain would ever claim.

    If isolated genes are per se not subject to the product of nature exception, I’m completely right to “miss the fact” of that exception. But thanks for sharing.

  80. You need to read the decision again.

    The claims to modified DNA were deemed not a Product of Nature, but changed enough by the hand of man.

    Perhaps you just don’t have a clue as to what a Product of Nature is…(if so, I will not teach you, nor suffer your foolishness any more).

  81. While they may not refer to it inname, it is clearly there, and it underpins the entire distinction of man’s efforts.

    The DNA claims were upheld under 101. You need to read the decision again.

  82. You need to read the decision again. While they may not refer to it inname, it is clearly there, and it underpins the entire distinction of man’s efforts.

    I recognize that you are likely just trying to kick up dust, but will give you the benefit of the doubt.

  83. IANAE states: “The discovered gene is a very specific molecule, and very specific molecules have always been statutory subject matter.

    This is clearly incorrect and misses entirely the fact that there is a Produc of Nature Exception. The Product of Nature exception covers a very wide range of material things, from crystals to plants and most definitely covers a large number of “very specific molecules.”

  84. The discovered gene is.

    The discovered gene is a very specific molecule, and very specific molecules have always been statutory subject matter.

    The information content of the gene might well not be statutory, but then neither is any information content one might find in a lunar module.

  85. MM, OK. I will look again. 
     
    But the bottom line is that Moore ended up saying categorically, I think, that isolated or purified compounds are eligible because of history.

  86. Best post on the linked (and broken) Patently-O July 19, 2011 thread:

    Spoiler Alert: This is a long post.

    Bryson: “Yet some of Myriad’s challenged composition claims effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing.

    False.

    a claim to a composition does not limit anyone from identifying the composition (akin in this thread to merely repeating the knowledge of the composition’s structure, be it AGCGCTATCATATACG or whatever. The knowledge itself is not claimed, just as a claim to a new widget does not prevent anyone from discussing the knowledge of the new widget’s shape or inherent characteristics.

    Now, the isolation arguement, and whether isolating that particular sequence is a separate argument, a separate discussion.

    The Chakrabarty-Funk Bros. line of cases in distinguishing between naturally occurring substances and nonnaturally occurring manufactures, along the characteristic of “a product of human ingenuity ‘having a distinctive name, character [and] use’ ” is the frontier being explored.

    Bryson: The only material change made to those genes from their natural state is the change that is necessarily incidental to the extraction of the genes from the environment in which they are found in nature.”

    Bryson wishes to dismiss an act of man that is required in order to arrive at the actual claimed entity. This is hardly “incidental.” Likewise, for a composition claim, the method of arriving at the composition need not be novel itself – that line of thinking runs the risk of conflation and befuddlement.

    Bryson: “Yet there is no magic to a chemical bond that requires us to recognize a new product when a chemical bond is created or broken, but not when other atomic or molecular forces are altered” – this simply is too broad a statement to merit any agreement. Chemistry does in fact matter.

    This also implies that there is magic when other atomic or molecular forces are altered. Why make such an artificial distinction? The example introduced first in a footnote – an element such as Lithium – is a strawman, as an element is not being extracted – but a molecule. Bryson thinks the two should be characterized the same. That is just not so, and hardly “arbitrary” as Bryson would have us believe. Bryson also neglects to notice that elements have actually been patented. Whether Lithium itself should have been able to be patented, then, may be a debatable (but separate) topic – but suffices to weaken the point of his argument.

    Likewise the example of dirt and diamonds is a strawman, as the diamond does not depend on the dirt like the excised strand depends on the larger molecule for its purpose within the larger collection. The difference in the relationship of the components of a dirty diamond and a full DNA molecule make this attempted analogy downright laughable.

    The argument then proceeds on page 9 of the dissent to discussing the language of the claims “with the protein being defined by the amino acid sequence encoded by the naturally occurring BRCA1 gene. From a molecular perspective, that claim covers a truly immense range of substances. But this is not a 101 point – this is a 112 point. To mix these points is not wise.

    Bryson continues: “That would remain true if there were minor differences between the plucked leaf and the fallen autumn leaf, unless those differences imparted “markedly different characteristics” to the plucked leaf.

    This is a much stronger argument. While I am sure that – to the leaf – being plucked does in fact impart a markedly different character – for example, the ability to continue developing from a bud to an autumn beauty, a claim to something extracted from nature should do more than simply cleave at nature’s cleaving point. However, the amicus briefs dicuss this transcription process and point out that this is just not the same as the claimed product. Bryson himself admits slyly to this with his comment of “Of course, it is an oversimplification to say that something that can be characterized as “isolated” or “extracted” from its natural setting always remains a natural product and is not patentable. Bryson wishes to hide in an oversimplification, admitting the weakness of doing so and thus the frontier we must explore further here, not stopping at the broad oversimplification. We must explore further other aspects of the argument – such as “use.” Whether the use must necessarily be entirely different or not is a debate point – not a given presumption.

    Bryson: “In the case of the BRCA genes, by contrast, nature has defined the genes as independent entities by virtue of their capacity for protein synthesis and, ultimately, trait inheritance.

    But the same logical argument can be taken to the extreme with the baseball bat in so far as the characteristics of the particular wood chosen for the baseball bat lie in the wood as nature provides. Where to draw the line at the activity of man is the touchpoint. If Bryson’s position were to be adopted, patenting would be out of reach for all of man’s mere mechanical changing of the workblocks found in nature. The quote to the late Chief Judge Markey, the first Chief Judge, that “[o]nly God works from nothing” is appropriate here. Must bats be made by first completely deconstructing the input material such that that material no longer has any of the inherent characteristics actually found in nature? If that were true, than any input material that provided at least the same elements would do. Anyone familiar with baseball knows this not to be true.

    The marble example in the footnote actually leads away from Bryson’s position, as is not the IP protectable result composed exactly of the same material as the starting slab? The fact that Bryson admits to the freeing of something to a level of protection that still shares every characteristic of the startng point material weakens his earlier argument.

    Continuing in the vein (sorry for the pun), of introducing arguments that weaken his own position, Bryson continues on page 12: “On the other hand, the purified natural substance is patentable if the “purification” results in a product with such distinct characteristics that it becomes “for every practical purpose a new thing commercially and therapeutically.” Clearly, the claimed item is different commercially and therapeutically. Bryson leaves this major argument without a rebuttal, almost as if he thinks by stating the position he has adopted it to support his belief. It actually holds the opposite.

    Originally Posted Jul 30, 2011 at 10:37 AM by Critique on Bryson Section I (emphasis added)

  87. The key at the Supreme Court will be “inventive contribution.”

    That was the driver behind the 9-0 Prometheus decision.

    Recall that chain of events: District Court says “No,” CAFC reverses (argues MOT met as a result of CAFC view of SC decision on a different matter), goes to SC, is GVR’d, back to CAFC and CAFC reiterates its previous decision – unanimously – with virtually the same arguments (MOT met), back to SC and WHAM, 9-0 District Court was correct and CAFC told point blank their understanding of what the SC wanted was critically incorrect.

    Anyone see a pattern…?

  88. Herein the pith:

    Just as a patent involving a law of nature must have an “inventive concept” that does “significantly more than simply describe . . . natural relations,” a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product. In cases such as this one, in which the applicant claims a composition of matter that is nearly identical to a product of nature, it is appropriate to ask whether the applicant has done “enough” to distinguish his alleged invention from the similar product of nature. Has the applicant made an “inventive” contribution to the product of nature? Does the claimed composition involve more than “well-understood, routine, conventional” elements? Here, the answer to those questions is no.

    Only Bryson says no.
    The majority (for different reasons) say yes.

  89. This is a very basic question directed to Mr. Mooney, a question that is almost certainly naive because this is not a “technology” with which I have any meaningful familiarity.

    Mr. Mooney, as we both know I have “ragged” on you for many of your comments that I believe are inappropriate. At the same time, however, I have read many of your substantive comments, they appear to reflect your intimate familiarity with the related subject matter, and provide an insightful perspective. Hence the reason why my question is directed to you.

    I happened to read an amicus “brief” (I am being charitable because it was essentially an op-ed piece about his personal views) from James Watson that was filed with the court this past June/July. Certainly Mr. Watson is held in high regard for his work in this subject matter area.

    Besides Mr. Watson’s strong objection to patents in thie subject matter area, I am quite curious about how his views relate to existing patent law jurisprudence. I his just a personal opinion, which reesm to be the case, or is there something in his “brief” that has even a modicum of merit?

    My request is merely for my edification because I have never worked in this subject matter area. Clearly you have. Might you share some top-level thoughts? They would be appreciated.

    Regards,

    “Grandpa”

  90. “It didn’t work. And now it’s never going to work now.”

    How much you want to plunk down, and what odds will you give me?

  91. “The claim is directed to compositions of matter which are described in structural terms. The claims are not directed to “locations.””

    Benson’s method was directed to a method not “his algorithm”.

    We all know what the claim is ostensibly drawn to MM. The question, just like in every other 101 case, is what, in the end, does the claim cover? It is a question of breadth. If the breadth is pretty much the same as a claim to that discovery limited with some limitations like “except for research” and “only for commercial operations” yo sht is preemptin’ on it bro.

    You and I have already discussed it to death, we both know what the other side’s position is, all that remains is for the USSC to make clear to you guys, for the 3rd time in the last few years, what the law is. One wonders why this is necessary, but I suppose you guys have simply brain washed yourselves so well that it will take decision after decision after decision to drill it into your mind.

    I will say though, it would have been nice to see the panel actually do an analysis more than “lulz”. They should leave the lulzing to me on my lunchbreak and stick to substantive analysis.

  92. Biotech heres another field of invention that I created totally with my invention of the electron scanning microscope and my subsequent identification of the reproductive function of the celllar dna chain in my high school biology class. I should be granted a parent patent for this.

  93. Ned But then we have both Moore and Bryson saying a markedly new utility is required.

    Nothing new or troublesome here, Ned. See In re Fisher. Novel isolated nucleic acid compositions are not eligible for patenting merely based on a recitation of the generic property of recognizing complementary sequences or encoding a protein. Like all compositions, nucleic acid compositions must have a specific, credible and substantial utility to pass 101. The only difference is that the nature of the requisite utility was thoroughly debated at the Fed Cir in In re Fisher. The applicant lost that case.

    You may recall that Rader dissented from that decision, arguing that the generic inherent utility was enough.

  94. “drafting efforts designed to monopolize the correlations.”

    … drafting efforts designed to monopolize the discovered gene

    “Drafting efforts designed to monopolize the claimed lunar module.”

    Do you have an actual point to make, 6? Stop being such a poor loser.

  95. Further, she seemed to agree with Bryson that isolated DNA had no new utility.

    Geebus cripes, Ned, take a breath. As a generic matter, the statement is legally accurate. It’s the same reasoning used in In re Fisher to deny eligibility to ESTs, all of which were also novel and non-obvious nucleic acid compositions.

    Do I need to explain to you the difference in utility between the ESTs in In re Fisher and the compositions claimed by Myriad? Again?

  96. “But the discovery of the sequences is an unprotectable fact, just like Dr. King’s discovery of the chromosomal location of the BRCA1 gene.”

    There you go MM. That is one way of stating what is being preempt.

    Wrong. That is one of equating two completely different things. The statement is simply false to the extent it claims equivalence between those two things. The claim is directed to compositions of matter which are described in structural terms. The claims are not directed to “locations.” The claims are not directed to “information” about location. Thinking about the “locations” or the sequence information itself is not “pre-empted.”

    You are just kicking up dust, 6. It didn’t work. And now it’s never going to work now.

  97. MM, as promised, I took another look at Moore's opinion.  She agreed that cDNA and the short sequences were chemically different from anything found in nature.  That was sufficient.

    Not so with isolated DNA.  Further, she seemed to agree with Bryson that isolated DNA had no new utility.  She agreed only not to rock the boat, relying on history (Parke-Davis, Merck, and U.S. Patent 141,072, claiming “[y]east, free from organic germs of disease,” issued to Louis Pasteur in 1873.

    So, where does that leave us?

    Regarding isolated DNA, I still do not know what the majority actually agreed to except that isolated DNA or purified whatever are eligible without more on the simple basis that these compounds are man made and do not occur in nature.

  98. “But the discovery of the sequences is an unprotectable fact, just like Dr. King’s discovery of the chromosomal location of the BRCA1 gene.”

    There you go MM. That is one way of stating what is being preempt. I prefer, myself, a more detailed explanation, but it is how the good judge puts it and it is no more or less correct than my more specific enunciations over the last month. It is, in the judge’s words, the discovery of the sequence. In my view, this is better stated as the subject matter which is being preempt is the realization of where the structural part of the natural whole genetic sequence which is this gene begins and ends and what it encompasses. But we’re really just splitting a hair at that point. Neither of those are patent eligible, even in your view, and if either are preempt then they Myriad loses.

    I will leave it to the supremes to be the first to actually read the breif submitted to them and actually do the analysis since the panel can’t be bothered to and I have done it in the past to the best of my ability.

  99. “drafting efforts designed to monopolize the correlations.”

    … drafting efforts designed to monopolize the discovered gene.

    The drafting effort includes slapping “isolated” thereupon.

  100. Moore and Bryson both agree, it seems, that new utility is also required, and perhaps, dominates.

    As a practical matter, I don’t believe this is a shocking development nor do I understand why it is a “problem.” Do you believe patents should be granted on, e.g., novel amputated animal parts if the only utility for the parts is insubstantial(e.g., dog food)?

  101. I agree with your analysis of Prometheus. However, the problem we have with Myriad now is that a majority does not agree that structural changes are sufficient. Moore and Bryson both agree, it seems, that new utility is also required, and perhaps, dominates.

  102. More reality checking on this “most faithful to Prometheus” baloney:

    link to genomicslawreport.com

    The Prometheus decision says nothing about gene product claims, so is irrelevant to [the composition claims at issue] in Myriad.

    Indeed. And irrelevant it will remain. It was not written to be applied to properly claimed compositions. You might as well try to apply Ames v. Iowa to Myriad’s composition claims.

  103. With all due respect, Dennis, this:

    [Bryson’s] opinion is clearly the most faithful to the Supreme Court’s Mayo decision.

    is simply ridiculous. Why is his opinion “clearly the most faithful”? Because Bryson uses more of the same words?

    Bryson’s opinion is the most faithful to the Mayo decision only if one believes that the intent of the Supreme Court in Prometheus was to render every composition of matter with any similarity to a “natural composition” to be ineligible for patenting if the composition was prepared using “old conventional means”. Is that what you believe Dennis? Really??

    Let’s look at Prometheus v. Mayo again (and I’ll even use Bryson’s skewed interpretation):

    The [Supreme] Court found that the method was not directed to patent-eligible subject matter because it contributed nothing “inventive” to the law of nature that lay at the heart of the claimed invention. . . . In concluding that the claims did not add “enough” to the natural laws, the Court was particularly persuaded by the fact that “the steps of the claimed processes . . . involve well-understood, routine, conventional activity previously engaged in by researchers in the field.”

    Got that? In Prometheus, the “inventive act” was the discovery of a novel but indisputably ineligible “law of nature” (in fact, it was an abstract principle or fact or an “unpatentable natural correlation” to use of the words of the Court itself, but it doesn’t matter: it remains indisputably ineligible on its own). In Prometheus that “law of nature” took the form of an ineligible mental step of thinking about an alleged fact — this point is irrefutable and it’s absolutely key to the Supreme Court holding because, as recognized by the Prometheus court, ALL inventions implicate laws of nature and natural phenomenon.

    The failure of Prometheus’ claims arose from the (again, indisputed) fact that the only other steps recited in the PROCESS claim were “old and conventional” and practiced routinely by the “relevant” practitioners in the field. As a matter of indisputable fact, then, those practitioners become infringers merely because they are informed of the “unpatentable natural correlation” recited in the claims. That is why the claims were effectively deemed to be claims to the correlation itself.

    Here’s the concluding sentence of the case:

    “For these reasons, we conclude that the patent claims at issue here effectively claim the underlying laws of nature themselves.”

    What was the first of those reasons presented in the Opinion: “[the claims] tie up the doctor’s subsequent treatment decision whether that treatment does, or does not, change in light of the inference he has drawn using the correlations.” How is it possible for a claim to do that? Because infringement required only that the doctor think about the “unpatentable natural correlation” while looking at data obtained using prior art methods. That is what the Prometheus court meant when they discussed claims that EFFECTIVELY covered ineligible subject matter.

    I invite you, Dennis, to provide a sensible alternative explanation for the Court’s 9-0 holding in Prometheus. Good luck.

    Here’s the actual Court-characterized holding of Prometheus, by the way:

    Because the laws of nature recited by Prometheus’ patent claims … are not themselves patentable,the claimed processes are not patentable unless they have additional features that provide practical assurance that the processes are genuine applications of those laws rather than drafting efforts designed to monopolize the correlations.

    See anything about compositions there? Do you see anything about any process being rendered ineligible due to the inventor’s method of discovery of the claimed invention? Me neither. Why is Bryson’s analysis the “most faithful”?

    Let’s just jump to the chase, as the majority did here and as the Supreme Court certainly will should they actually grant cert on the ACLU’s nonsense. Here’s the question again:

    What is the judicially exempted subject matter that Myriad is seeking to “monopolize” with their claimed nucleic acid compositions, which INDISPUTABLY do NOT read on ANY judicially exempted subject matter? For the sake of argument, I’ll even grant you that “laws of nature” encompass “natural products” (however you wish to define “natural”). What is the judicially exempted subject matter and what is the theory by which Myriad’s claims have the practical effect of reading on that subject matter and removing it from the public domain?

    Where is the argument? The argument is crystal clear in Prometheus. It’s clear as mud in Bryson’s “most faithful” dissent. How do you explain that?

  104. “You seem to recall incorrectly. They applied preemption just as it has been applied since Benson, and indeed, Morse. And they will apply it again. Mark my words.”

    6, you and MM are both wrong. There is a fundamental difference between the way Prometheus used Pre-emtpion and the way you would abuse it. The Prometheus case turned on “Integration Analysis”. But unlike you and MM, I can actually cite the law to prove exactly what I claim.

    What’s important to remember is that it’s Diehr’s concept and application analysis that is controlling precedent, with Prometheus’s “integration” as the key to as the Court said: :transform the process into an inventive “application” of the formula. ( See Prometheus )

    “The Court pointed out that the basic mathematical equation, like a law of nature, was not patentable. But it found the overall process patent eligible because of the way the additional steps of the process “integrated” the equation into the process as a whole. Those steps included “installing rubber in a press, closing the mold, constantly determining the temperature of the mold, constantly re- calculating the appropriate cure time through the use of the formula and a digital computer, and automatically opening the press at the proper time.” Id., at 187. It nowhere suggested that all these steps, or at least the combination ( in of those steps, were in context obvious, al­ ready in use, or purely conventional. And so the patentees did not “seek to pre-empt the use of [the] equation,” but sought “only to foreclose from others the use of that equa­ tion in conjunction with all of the other steps in their claimed process.” Ibid. These other steps apparently added to the formula something that in terms of patent law’s objectives had significance—they transformed the process into an inventive application of the formula.”

  105. Malcolm, Lourie’s opinion largely adopted my own analysis of the cases, including that of Wood-Paper and Cochrane v. Baldische, that largely debunked the PoN exception. He ended up concluding that man made compositions are eligible even if they are from nature. A requirement for some new utility was obviated:

      While purified natural products thus may or may not qualify for patent under § 101, the isolated DNAs of the present patents constitute an a fortiori situation, where they are not only purified; they are different from the natural products in “name, character, and use.”It seems we have either a new structure (that is useful) or a new utiltiy that is not found in the natural product.

    But then we have both Moore and Bryson saying a markedly new utility is required. They simply dispute whether isolated DNA had such a new utility.

    It appears then, that a majority do not agree with Lourie’s analysis that a change in chemical structure is sufficient.

    So, where does that leave the law? We seem to have a majority that a new utility is required.

    I don’t know if this analysis is right, but I will re-read Moore’s opinion. What are your views on this issue?

  106. “Judge Breyer’s opinion is clearly the most faithful to the Supreme Court’s Mayo decision”

    I should say so!

    (I think you mean “Bryson” instead of “Breyer” in a couple places DC)

  107. You can also cite the Supreme Court of Unite States holding :

    ““ Diehr and Flook, the cases most directly on point, both ad- dressed processes using mathematical formulas that, like laws of na- ture, are not themselves patentable. In Diehr, the overall process was patent eligible because of the way the additional steps of the pro- cess integrated the equation into the process as a whole. 187. These additional steps transformed the process into an inventive application of the formula.” (Syllabus Prometheus V Mayo 566 U. S. ____ (2012) )

    MM, you know you can’t deal with the “Claims as a Whole” ruling or “Integration Analysis, so you can run away and hide like the juvenile cowardly troll you are.

  108. No, but you can cite The Supreme Court of the United States holding:

    “In determining the eligibility of respondents’ claimed process for patent protection under § 101, their claims must be considered as a whole. It is inappropriate to dissect the claims into old and new elements and then to ignore the presence of the old elements in the analysis. This is particularly true in a process claim, because a new combination of steps in a process may be patentable even though all the constituents of the combination were well known and in common use before the combination was made. The “novelty” of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.”

    Deal with it!

  109. Nope. Just like software is an abstract idea, this is naturally occuring. It doesn’t matter how much work it took, it’s still unpatentable subject matter per your own rationale.

  110. 101! 101! unpatentable subject matter!!! natural phenomena!

    Isolated genes are patentable subject matter just like software.

  111. “Firstly, because a structural claim to the DNA doesn’t actually preempt the “information content” of the DNA”

    Does the dissent say that it does? Did I say that it does? Oh, neither of us did? Why bring up yet another canard?

    Look listen, it may well preempt on such information content or it may well not. I have not spoken to that issue in some year’s time or more and Kev has assured me that the information has many substantial uses outside of research and the such so I will take him at his word on that and not press it.

    “And secondly, because you’ve said several times that you’d be fine with a Beauregard claim expressed in terms of structure, which is much more preemptive of the information content at issue.”

    Remember, I’m only ok with that because if you get them to that point then their battle is lost and they don’t have any econimically valuable B claims to get because 112 and 102/103 will take you the rest of the way in invalidating them. But if you’re concerned about it, then I say more power to you, go get em tiger! They may well preempt on the information content and that may well be unacceptable. I simply provide them succour on the issue because I’m leading them to the gallows either way.

  112. preempting methods for whole-genome sequencing

    I guess the majority forgot about that part of section 101 which says that claims which potentially make it more difficult to perform certain whole-genome sequencing methods because of de minimus infringement of a composition claim are ineligible subject matter.

  113. J. Bryson – I respectfully dissent from the court’s holding that Myr-iad’s BRCA gene claims and its claims to gene fragments are patent-eligible. In my view, those claims are not directed to patentable subject matter, and the court’s decision, if sustained, will likely have broad consequences, such as preempting methods for whole-genome sequencing, even though Myriad’s contribution to the field is not remotely consonant with such effects.

    Huh?

  114. Did I read that right?

    Lourie threw Parke-Davis and Merck under the bus. Purified compositions unchanged in chemical structures are not eligible?

    Moore (strongly) disagreed with Lourie. Her views validate Parke-Davis and Merck. The new utility provided by the isolated, purified or extracted compound to her is critical to eligibility.

    Then we have Bryson that seems to endorse the marked new utility approach of Parke-Davis and of Merck.

    What do we have? Lourie seems to be in the minority, not the majority. The case split on the debate between Moore and Bryson on whether the isolated DNA had a markedly new utility.

    Did I miss something here?

  115. the dissent points out for you succinctly what it is which is preempt.

    I haven’t read it. Didn’t want to lose my lunch.

    Perhaps you can re-post the relevant “succinct” section here for all of us to see and examine?

    I assume in his analysis Bryson discusses in detail the existence of non-nucleic acid compositions for determining the presence and absence of mutant sequences, and the usefulness of patents on compositions such as Myriad’s for promoting the development of alternative probes. I wonder what other facts Bryson discusses. I probably will never have read a discussion which beams with the blinding candor of Bryson’s brilliant dissent, and may never read such again.

  116. They applied preemption just as it has been applied since Benson, and indeed, Morse. And they will apply it again. Mark my words.

    No doubt they will apply it again. But they aren’t going to apply it to novel, non-obvious nucleic acid composition claims with a demonstrated substantial utility.

    Why would they? I mean, what would be the point of doing that and how exactly would they justify doing it only to novel, non-obvious and useful nucleic acid claims and not to other novel, non-obvious and useful chemical compositions?

  117. Why dredge up that old canard?

    Firstly, because a structural claim to the DNA doesn’t actually preempt the “information content” of the DNA. The information content is free to be used by the public in whatever way they want, as long as they don’t make use of the claimed molecule.

    And secondly, because you’ve said several times that you’d be fine with a Beauregard claim expressed in terms of structure, which is much more preemptive of the information content at issue.

  118. on preemption the gene claims will go down

    What exactly is the judicially excepted subject matter that is “pre-empted” by the isolated nucleic acid claims corresponding to the mutated gene sequences?

  119. The “Bryson leaf” must be a fig leaf, being used in its traditional artistic sense to cover those parts of a naked sculpture best not carefully publicly examined?

  120. suckie The ONLY words that matter are the words that comprise the exact passage and holding of the court.

    “Your honor, as taught by the legendary legal expert Suckie Sucktical, if you can’t cite a statute or case law that expressly forbids putting someone in a barrel filled with broken glass and rolling them down a steep hillside into the ocean, using those exact words, then my client MUST GO FREE!!!!”

    LOL.

    MTBHTDT

  121. “None of the pre-emption advocates were ever able to explain what judicial exception was pre-empted.””

    It’s in the dissent opinion and I’ve set it forth any number of times both on this board and patent docs. Why dredge up that old canard?

  122. “They addressed the breadth of the claims and their relation to “nature” rather extensively, 6.”

    The only place they were to be discussing breadth was in their preemption analysis, and they declined to do so.

  123. “I seem to recall the Supreme Court carefully couching their analysis in terms of “the facts before us.” Those facts related to a method claim which recited an old conventional step and an allegedly new mental step.”

    You seem to recall incorrectly. They applied preemption just as it has been applied since Benson, and indeed, Morse. And they will apply it again. Mark my words.

  124. Soor does brosensky. But not only does 101 apply to every claim, the same judicial exceptions and preemption doctrine apply to them all as well.

    I’m sure MM and yourself are gleefully patting yourself on the back right now while not believing, but you may well mark my words, or indeed bet me large sums of $$$, that on preemption the gene claims will go down. cDNA may survive.

  125. Indeed, as MM has stated above, the majority spends one paragraph (or two?) discussing, in a 100 page opinion, the only issue in the entire case worth bringing up on remand. Preemption. And they do so without any analysis thereof. Had they have bothered with analysis then they would have reached the same conclusion as the dissent.

    And for that reason, this will be easily reversed.

    At least the dissent spent his one paragraph on preemption wisely.

    I will say that I do not believe at current time that I take issue with the cDNA claims, though there may well be an issue with them as well which I have not fully investigated.

    There’s obviously lots more to say but I have things to do beyond see a panel hold practically the same way they did before.

    Oh but btw MM, the dissent points out for you succinctly what it is which is preempt. Although I have stated it in different words previously, he is talking about the same thing. It is naught but the incompetence of lourie and moore, along with moore’s compassion, that caused this case to turn out erroneously now twice. Although, to be sure, the plaintiff jumping hither and thither with differing arguments doesn’t help things. If they would focus on the only possible thing that would invalidate the claims, preemption, and do so like a laser, perhaps the CAFC would not so gleefully decline to even meaningfully address the complaint before they are reversed.

  126. MM “In other words,…..”

    You just lost again. The ONLY words that matter are the words that comprise the exact passage and holding of the court.

    Just like in Prometheus, you can’t provide any citation for your whacky dissection theories,

  127. So plant leaves are eligible subject matter.

    To forestall any confusion, let me re-word this: plant leaves are not per se ineligible subject matter.

  128. Dennis: The majority’s analysis here essentially rejects any notion that the Mayo court would find an invention consisting of a combination of old-technology + newly-discovered-product-of-nature to be subject matter ineligible.

    Okay, that sentence just gave me a headache.

    For starters, the majority is crystal clear that the claimed compositions are not “products of nature” so the premise of your (Bryson’s?) “notion” is rejected before we even get to the substance of it.

    Second, as noted above, not even Bryson would dispute that if I cultivate a new and useful plant (using ancient techniques) I can obtain a utility patent on that plant. And I can also claim a leaf from that plant that I merely “snapped off.” So plant leaves are eligible subject matter.

    Bryson’s hypothetical, to the extent it has any relevance to 101 whatsoever, is bizarrely divorced from the facts of the case and just sends everyone down a worthless rabbit hole.

    Here’s the deal: any competent patent drafter can obtain a patent to a new non-obvious and useful (in the 101 sense) leaf tomorrow, regardless of the gobbledygook in this case regarding the eligibility of tree leaves.

  129. Except where the majority decides that Mayo somehow, while telling us all about 101, doesn’t apply to compositions.

    101 applies to every claim. So do 102 and 103, but some claims survive their application and some don’t.

    Does that seem right to you?

  130. IANAE, regarding the product of nature except, one, appears, cannot claim a product of nature.  One can claim, it is said, a product that is different in "kind" from the product of nature.  Thus, it is said, one cannot claim metallic Lithium, even if it does not exist in metallic form in nature, because Lithium is a product of nature.  Using this rationale, the product must be modified structurally in some man made manner from that which exists in nature.  That is why the Court held the claimed modified bacteria in Chakrabarty patent eligible.

    Lourie's simple response is that isolated DNA IS chemically different and is man made.  Stop there.  But, if the Lithium example is valid at all, this cannot be right.

    It is for that reason I think the whole PoN exception is bogus.  I think anytime one extracts, purifies, isolates a composition from nature into a form that is useful in that form, that is enough.  

  131. Mayo somehow, while telling us all about 101

    Hmm. “All about 101”? Really? I seem to recall the Supreme Court carefully couching their analysis in terms of “the facts before us.” Those facts related to a method claim which recited an old conventional step and an allegedly new mental step.

  132. With respect to (1), I concur with IANAE.

    With respect to (2), I believe that the Supreme Court will read the Federal Circuit’s opinion (and an en banc opinion isn’t going to change a thing) and will conclude that it’s not worth granting cert because the facts speak for themselves.

    They will wait until some later point in time when a scenario similar to the hypotheticals I’ve been proposing is before them, i.e., where a claim to a man-made composition is alleged to read literally on a composition that is alleged to have existed “naturally” before (or after) the patent was filed but was not discovered until after the filing. That’s the far more interesting legal question, in my opinion. It’s not an issue in Myriad.

    Happy to be wrong, of course. Even if the Supreme Court grants cert, the result isn’t changing.

  133. “Contrary to the conclusions of the district court and the suggestions of Plaintiffs and some amici, § 101 applies equally to all putative inven-tions,”

    Except where the majority decides that Mayo somehow, while telling us all about 101, doesn’t apply to compositions.

    /facepalm.

  134. In her concurrence, Judge Moore also fails (IMHO) to carefully distinguish the very relevant case law (e.g., Supreme Court’s In re Brenner and Fed Cir In re Fisher) on the subject of utility of nucleic acid claims.

    See her statement in Myriad:

    The ability to use a short strand of DNA as a primer or probe to determine whether a patient has a mutation is a new and important utility substantially different from the role of that DNA as it occurs in nature.

    Compare with the majority in In re Fisher (2005):

    the claimed ESTs …. can … be used to detect the presence of genetic material having the same structure as the EST itself. … [W]e conclude that Fisher’s asserted uses are insufficient to meet the standard for a “substantial” utility under § 101.

    The real distinction is that Myriad’s claimed nucleic acid compositions (which are certainly accurately characterized as “probes”) are taught in along with a SPECIFIC substantial utility for those probes beyond the “new” utility (i.e., recognizing a new sequence) disclosed by Judge Moore.

    I note that Moore’s concurrence at footnotes 5 and 6 is spot on and is entirely sufficient by itself to destroy the defendant’s arguments regarding the eligibility of Myriad’s composition claims.

    I also note that her concurrence will be extensively cited by Beauregard claim amici when those claims are up on the chopping block. Unfortunately, the policy issues of upholding the settled patent rights of life sciences patentees are quite a bit less compelling when applied to patents primarily directed at methods of exploiting information about a person for monetary gain (which is why Moore doesn’t give any lip service to the “settled expectations” of patentees who own claims to methods of thinking about the differences between two DNA sequences).

  135. 1) Is the information content of DNA the equivalent of a LoN?

    Even if it is, a patent on the isolated sequence (or even just the sequence) doesn’t preempt the information content. A sequence listing wouldn’t infringe, nor would reading the sequence listing, or thinking about the sequence listing while doing ordinary prior art research or medicine. The claim only “preempts” the molecular structure of the isolated sequence, which is what any composition claim is supposed to do.

    2) Regarding the PoN exception,

    What’s the law on that exception, again?

  136. MM, here is the case and the sole possible reason for a petition to the SC.

    1) Is the information content of DNA the equivalent of a LoN?

    2) Regarding the PoN exception, if the extraction/isolation becomes routine, does a claim to isolated DNA effectively preempt a PoN?

    While this is not over, I share your views on this matter.

  137. It should be judged under 103 and not 101 IMO

    Better yet, like every claim it should be judged under both statutes and a few others. And ultimately that’s what going to happen.

  138. I noticed in their analysis of the “sequence comparision” claims that the majority refers repeatedly to the “abstract mental steps” (as opposed to only “mental steps”) recited int the claim. Then they state:

    the Supreme Court held that the steps of administering and determining, combined with a correlative “wherein” clause, were not sufficiently transformative of what was otherwise a claim to a natural law. That holding governs Myriad’s claims to methods of “comparing” and “analyzing” DNA sequences…. Myriad’s claimed methods of comparing or analyzing nucleotide sequences are only directed to the abstract mental process of comparing two nucleotide sequences

    In other words, the Federal Circuit uses “natural laws”, “mental steps” and “abstractions” interchangeably. That is correct in this context because (as I’ve noted repeatedly) it does not matter whether a “natural law” or an “abstraction” is being pre-empted by a claim in which patentability hingest on the novelty of a mental step. The claim is ineligible regardless of the utility or nature of the subject matter being contemplated by the alleged infringer.

  139. “The inventors of the patents”

    Now inventors invent patents. /facepalm. Although, that Freudian slip that the CAFC just made there may well be true about what happened in this patent.

  140. but you missed it.

    Hmmm. They addressed the breadth of the claims and their relation to “nature” rather extensively, 6. Maybe you are reading the wrong opinion?

    By the way, did you ever figure out what judicially exempted subject matter was pre-empted by Myriad’s composition claims, 6?

    As I’ve noted before, I would not be surprised at all if the Supreme Court simply refuses cert. at this point. There’s no legal issue to resolve here except for the imaginary ones in the ACLU’s collective mind.

  141. With respect to the analysis of claim 20, the majority should have gone an extra step and discussed the impact of the utility requirement on the 101 analysis. From the decision:

    Claim 20 recites a method that comprises the steps of (1) growing host cells transformed with an altered BRCA1 gene in the presence or absence of a potential cancer therapeutic, (2) determining the growth rate of the host cells with or without the potential therapeutic, and (3) comparing the growth rate of the host cells.

    Thus, once one has determined that a claimed composition of matter is patent-eligible subject matter, applying various known types of procedures to it is not merely applying conventional steps to a law of nature. The transformed, man-made nature of the underlying subject matter in claim 20 makes the claim patent-eligible. The fact that the claim also includes the steps of determining the cells’ growth rates and comparing growth rates does not change the fact that the claim is based on a man-made, non-naturally occurring transformed cell—patent-eligible subject matter.

    Here’s the weird twist that the court should have noted, however: this analysis only applies where the nucleic acid sequence has a known utility beyond a mere tool for researching its own function. If I am the first to sequence a particular genome, I can not simply identify the expressed sequences and claim each of them because the compositions lack a substantial utility as a per se legal matter. For the same reason, I could not claim cells comprising each of the expressed sequences until I know more about the sequences. And again for the same reason, I should not be able to turn an otherwise inelgible method (comparing growth of two cells) into an eligible method using cells transformed with the patent-ineligible sequences. To be clear, this is a question of utility under 101, not subject matter eligibility. But it is an important (and obvious) exception to the Federal Circuit’s analysis here which they might have mentioned to pre-empt shenanigans down the road.

  142. “or too broad. Those questions are not before us.”

    Actually whether they are too broad was before you, but you missed it.

  143. “The point of this rehearing was to consider the impact of Mayo on this case. As suggested by the above paragraph, the court’s answer here is basically that Mayo has no impact here.”

    Good to know that the CAFC straight up still will not apply the law.

  144. Judge Bryson’s leaf analogy is untenable, because an isolated leaf (i.e., a leaf physically separated from a tree) exists in nature while an isolated DNA does not exist in nature.

  145. Mike The majority’s reasoning in the leaf analogy is pretty weak sauce. Since when is difficulty a 101 criteria?

    Short partial answer: the utility requirement as applied to nucleic acid sequences, at least, requires that inventors who wish to claim sequences show a non-substantial function for the sequence. Nobody can isolate a known nucleic acid sequence and obtain a patent on it unless they show a substantial utility for the molecule. More answer below…

    If it had been really hard to pull the leaf off it would have been patent eligible?

    Who cares? We don’t live on that planet.

    I agree with you that the majority’s response to this argument is the weakest part of the majority’s opinion regarding the composition claims (not that it matters; the other arguments are more than sufficient). The problem with Bryson’s argument is that it is so incredibly d— it is difficult to know where to begin. The fact of the matter is that if I invent a new, non-obvious and useful plant, I can get a utility patent on the new plant. And I can get a utility patent on the leaf from that plant that I “snapped off”. It’s certainly eligible subject matter. End of analysis. Bryson wouldn’t argue with that.

    So what is Bryson talking about then? It’s *Bryson’s* argument (not the majority’s argument) that new nucleic acid compositions are the equivalents of “merely” picking leaves on your neighbor’s tree. According to Bryson, every nucleic acid sequence in any animal anywhere in the world is just sitting out there waiting to be picked up and used. Well, to a certain extent that’s true but guess what? The USPTO and other patent offices are pretty effective at identifying the old and/or obvious sequences and denying patents directed to those sequences (whether Myriad’s broad claims are exceptions to this rule or not remains to be seen). Vast sums of money and time were invested in preparing a sequence listing system for patent offices around the world for this very purpose. Moreover, the law requires that claimed sequences have a substantial known utility beyond merely recognizing their complement for the purpose of further research on the sequence.

    If it were up to me, I’d say that a claim to an isolated tree leaf is eligible subject matter but unpatentable per se (as obvious) absent a showing that the tree was invented by the patentee. Done.

  146. “None of the pre-emption advocates were ever able to explain what judicial exception was pre-empted.”

    So you’re telling us you weren’t persuaded by 6’s, “You just wait” explanation?

    Lulz

  147. Mike: Neither of those thoughts, however, ought to remove a new, non-obvious use of the leaf (or gene) from patent eligibility, e.g., a diagnostic tool or what have you.

    You’re not being very clear here. I will simply point out that absolutely nothing in the majority opinion suggests that new non-obvious uses of naturally occurring products are ineligible for patenting.

  148. The majority waves “pre-emption” away like a harmless fly:

    Plaintiffs argue here that they are preempted from using the patented DNA molecules. The answer to that concern is that permitting patents on isolated genes does not preempt a law of nature. A composition of matter is not a law of nature.

    Done. There really isn’t much more to be said. None of the pre-emption advocates were ever able to explain what judicial exception was pre-empted. This is how vapid, non-arguments are properly addressed.

  149. The majority’s reasoning in the leaf analogy is pretty weak sauce. Since when is difficulty a 101 criteria? If it had been really hard to pull the leaf off it would have been patent eligible? That doesn’t seem right.

    If isolation becomes a common place task (cough), it would remove it from patent eligibility? That doesn’t seem right either.

    Neither of those thoughts, however, ought to remove a new, non-obvious use of the leaf (or gene) from patent eligibility, e.g., a diagnostic tool or what have you.

    SCOTUS should grant cert on this case and put it out of its misery.

  150. The ability to visualize a DNA molecule through a microscope, or by any other means, when it is bonded to other genetic material, is worlds apart from possessing an isolated DNA molecule that is in hand and usable. It is the difference between knowledge of nature and reducing a portion of nature to concrete form, the latter activity being what the patent laws seek to encourage and protect. The government’s microscope could focus in on a claimed portion of

      any complex molecule

    , rendering that claimed portion patent ineligible, even though that portion never exists as a separate molecule in the body or anywhere else in nature, and may have an entirely different utility. That would discourage innovation.

    Anwhere else in nature. Like in the liver of an antarctic fish.

    Any of this ring a bell, 6? It should.

  151. it is the distinctive nature of DNA molecules as isolated compositions of matter that determines their patent eligibility rather than their physiological use or benefit. Uses of chemical substances may be relevant to the nonobvious-ness of these substances or to method claims embodying those uses, but the patent eligibility of an isolated DNA is not negated because it has similar informational proper-ties to a different, more complex natural material. The claimed isolated DNA molecules are distinct from their natural existence as portions of larger entities, and their informational content is irrelevant to that fact. We rec-ognize that biologists may think of molecules in terms of their uses, but genes are in fact materials having a chemical nature and, as such, are best described in patents by their structures rather than by their functions.

    The familiar songs are always the sweetest.

  152. The majority:

    With respect, no one could contemplate that snapping a leaf from a tree would be worthy of a patent,

    With respect to Judge Bryson, the USPTO grants patents on lamer “inventions” than this on a weekly basis. The vast majority of them are related to the use of one or more computers for collecting, storing and disseminating “new” information.

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