By Kevin E. Noonan --
On Halloween, Myriad
Genetics filed its brief in opposition to plaintiffs' petition for certiorari in Association for Molecular Pathology
v. Myriad Genetics, Inc. (plaintiffs nominally
being the Association for Molecular Pathology et al., but actually the American Civil
Liberties Union and the Public Patent
Foundation). In doing so, Myriad no doubt understands the
position of the boy encountered by St. Augustine who was trying to empty the
ocean into a hole in the sand on the beach; in reality, Myriad faces not only
petitioners by the plethora of amici from
a variety of academics, patients, doctors, and civil liberties groups clamoring
for the Court to grant cert. (see "AMP v. Myriad Briefed and Distributed for Conference").
Petitioners presented three questions to the Court, all countered by Myriad in its respondents' brief:
1. Are human genes patentable?
2. Did the court of appeals err in upholding a method claim by Myriad that is irreconcilable with this Court's ruling in Mayo Collaborative Services v. Prometheus Labs., Inc., 132 S. Ct. 1289 (2012)?
3. Did the court of appeals err in adopting a new and inflexible rule, contrary to normal standing rules and this Court's decision in MedImmune, Inc. v. Genentech, Inc., 549 U.S. 118 (2007), that petitioners who have been indisputably deterred by Myriad's "active enforcement" of its patent rights nonetheless lack standing to challenge those patents absent evidence that they have been personally and directly threatened with an infringement action?
Myriad's brief begins by setting out the context in which this case was brought, long (~30 years) after the U.S. Patent and Trademark Office began granting patents on isolated genes. Citing the PTO's "specific expertise in issues of patent law" (and reminding the Court that it was content to rely on that expertise as recently as its decision in J.E.M. AG Supply, Inc. v. Pioneer Hi-Bred Int'l. Inc.), the brief recites not only a brief history of gene patenting but also instances where the Office established rules to ensure that such claims were properly within the scope of 35 U.S.C. §§ 101 and 112 (i.e., the 2001 Utility Guidelines). And the brief reminds the Court that the biotechnology industry has relied on the determination that genes are patent-eligible during that time, and the societal benefits that have accrued as a result. Turning specifically to Myriad, the brief recounts how it was that the company isolated the genes and then determined which mutations were relevant to a breast or ovarian cancer diagnosis, and the extent to which these accomplishments required human ingenuity, effort, and invention. The brief sets forth the accolades Myriad (rightfully) received for this achievement, and then discusses the extent to which the protection Myriad obtained from its patents was commensurate in scope with its contributions.
Importantly, the brief also rebuts some of the untruths espoused by petitioners and their amici, regarding the effects of the Myriad patents on the field and particularly the efforts of others, unimpeded by Myriad's patents, to undertake genetic experimentation including the Human Genome Project and continuing into the present day with individual genome sequencing. In so doing, the brief lays to rest another misstatement by petitioners (no doubt motivated by the effect the argument had on Judge Bryson at the Federal Circuit), that Myriad's claims would somehow interfere with such individual genomic sequencing, citing Chris Holman's 2012 law review article, "Will Gene Patents Derail the Next Generation of Genetic Technologies?: A reassessment of the Evidence Suggests Not," 80 UMCK 563, as well as noting alternative technologies by which mutations in the BRCA1 and BRCA2 genes could be detected that would not infringe Myriad's claims (without accentuating for the Court that these technologies could not be so used if Myriad had not identified the mutations in the first place).
Following this introduction, the brief sets forth the proceedings in the District Court and Federal Circuit below before returning to its argument countering petitioners and their amici. In so doing, the brief highlights for the Court the political motivations behind this case, stating that "[p]laintiffs' counsel hand-selected the challenged claims. As part of a strategy of 'pick[ing] one case' for a broad assault on all patents covering similar subject matter." Thereafter the brief provides the Court with "corrections of petitioners' misstatements," necessary not only to prevent the Court from relying on these falsehoods but for provoking in the Justices the question of why plaintiffs' petition is based on such misstatements in the first place. These include:
1. The first question presented bears no relation to the uncontroverted facts of this case. Petitioners seek to present this case as asking whether "human genes" are patent-eligible. Of course, the genetic material naturally existing in every human being is not an "invention," i.e., it is not the product of human ingenuity. But this case does not involve claims to such "native" human genes. The challenged composition claims are instead narrowly drawn to specific, defined DNA molecules, isolated by human scientists in laboratories, that do not naturally occur. As Judges Lourie and Moore explained, molecules of isolated BRCA1 and BRCA2 DNA are chemical "composition[s] of matter" that are just as deserving of patent eligibility as any other human-made molecule. Indeed, numerous pharmaceutical and biotechnical inventions are claimed as specified molecules. This perhaps explains petitioners' insistence on framing their first question as "Are human genes patentable?", instead of addressing the question actually presented to and answered by the lower courts regarding the patent-eligibility of molecules defined, cultivated, and isolated by men and women through the application of human ingenuity.
2. Petitioners also contend that "[s]tandard isolation results in random DNA fragments that are identical to those that exist naturally in the body." . . . By definition, however, an "isolated" DNA molecule has been removed from its naturally occurring environment. . . . A molecule cannot simultaneously be "removed from its naturally occurring environment" and "exist naturally in the human body" -- its naturally occurring environment. As Judge Lourie explained in his lead opinion: "It is undisputed that Myriad's claimed isolated DNAs exist in a distinctive chemical form -- as distinctive chemical molecules -- from DNAs in the human body," because of "human intervention to cleave or synthesize a discrete portion of a native chromosomal DNA, imparting on that isolated DNA a distinctive chemical identity as compared to native DNA." . . . Petitioners' belated factual claim that covalent bonds of DNA molecules may be broken in the body . . . is irrelevant. This assertion omits critical elements of the definition of "isolated" DNA. Isolated DNA is not merely DNA that has had bonds broken; the breaking of covalent bonds, while important, is but one part. Isolation further requires separation of the specific DNA of interest from the rest of the DNA in the body and even the rest of the fragmented DNA that may be present in a test tube outside the body. Even setting aside the human-engineered initial fragmentation breaking the covalent bonds, such specific, precisely defined (i.e., targeted) separation does not naturally occur in the body. Thus, it is a contradiction in terms to say that "isolated" DNA exists within the body. . . .
3. Contrary to petitioners' cursory and unsupported assertions, neither Myriad nor its patents hinder research of BRCA genes. One named plaintiff concedes that she "could sequence the BRCA1 and BRCA2 genes for purely research purposes," and has been doing so without impediment. . . . The undisputed facts further demonstrate that 18,000 researchers have conducted studies on BRCA1/2 genes, over 8,000 relevant papers have been published on BRCA1/2 genes, and over 130 clinical trials regarding BRCA1/2 genes have commenced since Myriad publicly disclosed its inventions. . . . Moreover, multiple laboratories provide "second opinions" regarding BRCA1/2 test results. In short, Myriad's patents do not hinder research. . . .
4. Petitioners allege that Myriad has "stopped other laboratories from creating and offering new and improved testing procedures" and has "the right to exclude the rest of the scientific community from examining the naturally-occurring genes of every person in the United States." . . . These statements are false. The challenged claims do not preempt, preclude, or prohibit others from creating and offering new and improved testing services. To the contrary, Myriad's composition claims are limited to the precise isolated molecules it created and that are recited in the patents. These claims do not preempt or preclude other technologies that have been developed and are currently being used to study the human genome and identify genetic mutations to assess a patient's cancer predisposition -- e.g., gene expression profiles, whole-genome sequencing, untargeted single-molecule sequencing, and protein-truncation testing. . . . These technologies "sequence" DNA without the need for "isolation."
In fact, earlier in this case (January 2010), petitioners stated: "It is only humans' inability -- currently -- to sequence DNA while it is in the body that requires scientists to isolate it." . . . This falsely suggests there are only two options: sequence in the body or sequence "isolated" DNA. While DNA still cannot be sequenced in the body, DNA extracted from the body but not "isolated" can be, and has been, sequenced. For example, random sequencing and protein-truncation testing have been used for years to identify genomic variations, including BRCA mutations. More recently, multiple companies, e.g., Oxford Nanopore and Pacific Biosciences, have developed single-molecule technologies that can perform untargeted sequencing of DNA, which may include BRCA genes, without infringing the challenged claims.
5. Petitioners contend that the challenged composition claims "define[] the gene according to how it functions in the body -- i.e., that it codes for and produces a polypeptide or protein." . . . That is untrue. Each claim is a specific, defined molecule isolated from the body; none is claimed in terms of its "function." Terms such as "encoding" or "coding for" are commonly used in DNA patent claims to recite physical structure, not function -- they are "structural terms" that define Myriad's human-made molecules. . . . Petitioners' contentions to the contrary, like their insistence upon redefining the question presented as "Are human genes patentable?", reflect a misunderstanding of basic scientific principles, well-established case law, and the nature of the composition claims at issue; at a minimum, they demonstrate that the petition is grounded on disputed antecedent facts.
(citations omitted, emphasis added).
Having dispensed with (or at a minimum bringing the Court's attention to these fanciful misstatements, the brief then sets forth Myriad's reasons the Court should deny the writ. Put simply, Myriad argues that the Federal Circuit has properly applied Supreme Court precedent in Chakrabarty, Mayo, and MedImmune in reaching its decision below and that the case is not in the proper posture for the Court to intervene. Applying each line of precedent in turn, Myriad argues that the Federal Circuit applied the Court's § 101 jurisprudence regarding the composition of matter claims to isolated genes, specifically the rubrics set forth in the seminal Chakrabarty case. Myriad argues that "faithfully applying Chakrabarty in view of Mayo," the Federal Circuit came to the correct conclusion that the isolated DNA claims recited patent-eligible subject matter. The brief characterizes the Court's J.E.M. case as being "on all fours" with this case, because there the Court decided plants were patent-eligible because § 101 should be given "broad scope and applicability" and the PTO have been granting utility patents on plants (~1800 patents) for 16 years (in contrast, the brief notes that the PTO has been granting patents on isolated DNA for 30 years and there are ~40,000 isolated DNA patents). Citing Festo Corp. v. Shoketsu Kinzoku Kogyo Kabushki Co. (applicable here through the auspices of Judge Moore's citation of the precedent in her concurring opinion below), "[t]o change so substantially the rules of the game now [] could very well subvert the various balances the PTO sought to strike when issuing the numerous patents which have not yet expired" (covering isolated DNA, an argument that will resonate only insofar as the Court believes that the PTO's decisions deserve some deference).
The brief next argues that the Federal Circuit's decision is not in conflict with any Supreme Court precedent, including Mayo, Chakrabarty, Funk Bros. Seed Co., and American Fruit Growers, Inc. In distinguishing Mayo, the brief also addresses the "preemption" argument advanced in petitioners' brief, reminding the Court that "all patent claims are preemptive." The concerns enunciated by the Court in Mayo regarding preemption are not implicated here on the facts, including that diagnosing risk for breast and ovarian cancer based on the presence of BRCA mutations can be accomplished using several alternative, non-infringing methods. The other three Court decisions are consistent with the Federal Circuit opinion below based on their facts, according to Myriad's brief, and in this regard point to another misstatement by petitioners:
In arguing that the results in Funk Brothers and American Fruit Growers should govern, petitioners mischaracterize the claims here as merely a "blueprint" for "coding for" the genetic material in the body; under this view, petitioners say, the patents claim only a natural function. . . . This is factually incorrect and mischaracterizes the claim language. The patents do not claim the compositions with reference to their functions; and the "coding for" language is a structural, not a functional, limitation in the claims. See In re Deuel, 51 F.3d at 1557-58. The composition claims are limited to claims for a specific, precisely defined composition with a specific, non-naturally occurring structure -- a particular, human-defined, isolated DNA molecule. . . . As the Federal Circuit ruled, the claims are directed to a specific and new chemical entity that does not exist in nature and that has uses unrelated to how the "code" operates in the body (unlike natural DNA "exist[ing] in the body as one of forty-six large, contiguous DNA molecules," the claims are drawn to "a free-standing portion;" . . . the claims "are truncations" that "are not naturally produced without the intervention of man").
(citations omitted).
Having rebutted petitioners' argument regarding the patent eligibility of the composition of matter claims, the brief then turns to the other two questions presented. Regarding the screening method claim (claim 20 of U.S. Patent No. 5,747,282), the brief rebuts yet another factual misstatement: that [petitioners] proclaim -- without record support -- that 'transformed cells containing altered DNA are conventional products widely available for purchase.'" Rather, the brief properly informs the Court that the cells are "a transformed eukaryotic host cell containing an altered BRCA1 gene causing cancer" which is "a new and useful product of human ingenuity," and thus can be distinguished from the Mayo claims because it recites something that is neither a product nor a law of nature and in so doing Claim 20 does "significantly more than describe a natural law." In addition, the brief corrects the petitioners "overstatement" that this claim would prevent "any researcher from engaging in this science to find a cancer treatment" by noting that the claim "is tied to specific host cells transformed with specific genes and grown in the presence or absence of a specific type of therapeutic," reducing the temperature of petitioners hyperbolic arguments to comport with reality (emphasis in original).
Finally, the brief addresses the jurisdictional issue, substantially repeating the evidence that the one plaintiff found to have standing, Dr. Harry Ostrer, may have destroyed that standing by moving from NYU (which supported his for-profit diagnostic activities) to Montefiore Hospital, which does not (or, more properly, petitioners have not presented any evidence that Montefiore would do so).
The brief ends with a section presenting six reasons why this case is not a good "vehicle" for review by the Court. In truncated versions, these are:
First, this case represents an abstract challenge to Myriad's patents. Petitioners alone selected the particular claims to challenge, leaving unchallenged several claims that they concede will continue to impede BRCA sequencing and other conduct in which they seek to engage . . . . Accordingly, there exist significant issues of redressability, yet another antecedent jurisdictional problem with the petition. See, e.g., Lujan v. Defenders of Wildlife, 504 U.S. 555, 561 (1992).
Second, Myriad was unable to assert counterclaims of infringement because no plaintiff was actually conducting any BRCA-related testing services; accordingly, this Court's review would be inhibited because the exact scope of the challenged claims has not been defined. The district court performed only limited claim construction, and without infringement assertions the courts had no reason to determine the precise scope of the claims' exclusionary rights. . . . Moreover, much of petitioners' effort to obtain this Court's review is premised on their unsubstantiated speculation that Myriad's claims will inhibit those "who want to undertake testing and research involving the patented genes in order to improve diagnosis and treatment for patients" and will "exclude the rest of the scientific community from examining the naturally-occurring genes of every person in the United States." . . . Such assertions have never been tested in any adversary proceeding. And had they been tested, they would have been exposed as false, for several non-infringing technologies for determining a patient's cancer predisposition are currently available. . . . Likewise, with no review of the form of testing petitioners might utilize, to determine whether such testing would infringe, there has been no analysis of what the claims do not cover, e.g., whole-genome sequencing.
Third, as to the patent-eligibility of the challenged composition claims, there is not a single opinion for the panel. Petitioners seek to make this a reason for review. . . . But, had there been a true need to reconcile divergent judicial viewpoints, it would have been appropriate for petitioners to first seek en banc review from that court. . . . For whatever reasons, they did not.
Fourth, the relevance of patenting isolated human DNA is ever diminishing in light of the publication of the entire human genome in 2001 (several years after the 1994 and 1995 filing dates of the patents-in-suit), thus presenting arguable bars to patentability under other provisions of the Patent Act (such as obviousness under § 103) for any claims to isolated human DNA molecules sought after that date. Further, such patents issued before the 2001 publication of the entire human genome will soon expire -- Myriad's patents-in-suit all expire by 2015. Thus, the unique facts of this case, presenting issues unlikely to recur, make it an inappropriate candidate for certiorari.
Fifth and finally, despite over 30 years of isolated DNA patents, this case is the first and still only appellate decision to address the patent-eligibility of such compositions. In nonetheless challenging these ruling, a change in the settled understanding of § 101 that allows patents on isolated genetic molecules. . . . Such efforts, particularly with the deeply settled reliance interests of the technology and investing communities at stake, should be addressed to Congress, not the courts. . . . Moreover, any consideration of the settled expectations that isolated molecules are patent-eligible should take into account the consequences of a legal rule that would apply far beyond the realm of human DNA. Many biotechnology companies' intellectual-property endeavors, and the investors on which those companies rely, depend on patents covering isolated DNA corresponding to non-human genes. . . . Altering the expectations that these useful developments will be patent-protected is the role of policymaking, not adjudication.
(citations omitted).
The best that can be said is that Myriad has countered every misstatement and done its best to inform the Court regarding the facts, the law, and the consequences of granting certiorari here. It remains to be seen whether the Court will be able to resist the siren song of this politically charged question, or will dive headfirst into another foray of trying to be the final arbiter of the scope and direction of American innovation.
We'll know as early as later today if SCOTUS will grant cert.
I'll comment on only one aspect of your analysis--the assertion that PacBio or Oxford nanopore sequencing would not infringe. I don't understand the logic of that assertion. There is nothing in the COM claims that calls for amplification, separation, purification, targeted excision or any other step. The claims are on "isolated" molecules of the specified sequences. In a PacBio machine or Oxford Nanopore USB device, the molecules are just as "isolated" as they are in other methods. I realize there is disagreement and many in patent law think there is a settled understanding of what "isolated" means, that the target sequences are enriched or separated from other DNA, but that is reading into the claims and probably wrong. The molecule being read out by a PacBio or Oxford Nanopore instrument is a particular "isolated" DNA by definition. If it weren't the instrument could not produce the sequence data. By my reading of the claims--which is equally open to challenge, I freely concede--most of the 8,000 articles by those 18,000 authors, only 2.5% of which had any direct relation to Myriad, involved work that infringed.
Posted by: Bob Cook-Deegan | November 30, 2012 at 11:19 AM
Dear Bob:
Unless I am mistaken, these devices never produce a full-length molecule in an isolated state, i.e. at the end of the process there isn't a tube containing a DNA molecule encoding the entire BRCA gene. If you have a basis for your understanding that differs from mine (as set forth here as a definition) then let me know.
As for the publications, isn't the point you make the point - 18,000 researchers performed work resulting in 8,000 publications (and an untold amount of work that was not published, plus all the grant proposals funded and unfunded that were submitted on this work) and the overwhelming majority don't infringe. How then does Myriad's patents inhibit research?
Thanks for the comment.
Posted by: Kevin E. Noonan | November 30, 2012 at 12:24 PM
Kevin "mutations in the BRCA1 and BRCA2 genes could be detected that would not infringe Myriad's claims (without accentuating for the Court that these technologies could not be so used if Myriad had not identified the mutations in the first place)."
Not sure what you're driving at with respect to the parenthetical, Kevin. Are you suggesting that this fact should have been accentuated, or complimenting Myriad on understating that fact?
Posted by: Keep It Real | November 30, 2012 at 12:52 PM
"It remains to be seen whether the Court will be able to resist the siren song of this politically charged question, or will dive headfirst into another foray of trying to be the final arbiter of the scope and direction of American innovation."
LOL. Maybe we should let each citizen vote on whether another person should be allowed to control which of their nucleic acids they are "permitted" to "isolate".
You really should consider toning it down, Kevin. The loss of the right to patent "isolated" DNA is not that big of deal. A much bigger problem is the development of some over-arching, ill-considered "theory" that attempts to explain when any composition of matter is an ineligible "product of nature."
Posted by: Keep It Real | November 30, 2012 at 12:57 PM
You know what I find funny? That the PTO had to establish rules that genes were claimed within 101 and 112. As a general rule the courts should take note that this occurred, and infer that it is just patent protectionism by the office, and strike the whole lot of whatever is covered by those "guidelines" down.
Posted by: 6 | November 30, 2012 at 01:44 PM
Dear Keep:
"Tone it down?" What's the fun in that?
I totally agree with you that the risk here is an broad "product of nature" ban. I think it unwise for the Court to venture into these waters (as it did today) but we can develop strategies to try to limit the scope of the scope of the damage they do.
Thanks for the comment.
Posted by: Kevin E. Noonan | November 30, 2012 at 03:18 PM
6:
You misunderstand. The utility and written description guidelines did not establish than genes are patent-eligible. They established what the Office required in the specification to support the claims. This addressed two issues: how to incorporate the Federal Circuit's Regents of the University of California v. Eli Lilly case into the Office's examination practices, and to ensure that the flood of Human Genome Project sequences were not patented in the absence of any evidence of the utility of the encoded proteins.
But now that the Supreme Court has granted cert we can see what they decide.
Posted by: Kevin E. Noonan | November 30, 2012 at 03:36 PM
Kevin,
I'm not sure why you reject my claim that we could distinguish products of nature and those of man by looking at whether the claimed invention is the result of both man's intention and design? This would fix the embarrassment of the O2-as-patentable corner you have boxed yourself into (by way of the overbroad 'isolation' line of reasoning dating back to Parke-Davis) and it makes logical and practical sense. I'd love for you to explain why you think otherwise. Show me a good counterexample, for instance.
best,
David
Posted by: David Koepsell | December 01, 2012 at 11:09 AM
David: "we could distinguish products of nature and those of man by looking at whether the claimed invention is the result of both man's intention and design"
Sure, we could do that. Then you would undoubtedly agree that Myriad's claimed compositions are not "products of nature." The claimed compositions did not exist prior to Myriad's discovery and they can't be created without man's "intention and design."
Or is there something else you want to add to your test?
Also, if I allow an organism to be exposed to mutagens for the purpose of generating a variety of sequence mutations in its massive chromosome, have I "designed" all the resulting sub-sequences (i.e., the ten base stretches of the chromosome with new mutations in it)? Or did "nature" do that?
What if I engineer an organism so that it its DNA-damage repair functions are impaired, which causes it to mutate its chromosome in certain stretches with great rapidity? Did I "design" every sequence that ever will be created in this organism? Or is "nature" doing that?
What if I simply discover an organism that naturally has a high mutation rate? Did I "design" every sequence that ever will be created in this organism? Or is "nature" doing that?
I know these are obvious questions and I'm certain you have the answer ready in hand, David. I just had to ask, though.
Posted by: Keep It Real | December 03, 2012 at 04:11 PM
MM states "The claimed compositions did not exist prior to Myriad's discovery and they can't be created without man's 'intention and design.' " and misses out on the lesson from Prometheus. My paraphrase from the sister thread fits here:
But to transform an unpatentable product of nature into a patent eligible application of such a product, a patent must do more than simply state the product of nature while adding the words “isolate[d].” It must limit its reach to a particular, inventive application of the product, one different in kind from what is available to all from Nature’s warehouse.
Posted by: Skeptical | December 04, 2012 at 06:54 AM
Actually, KIR (or MM) the claimed sequences did exist before man discovered them, their use is in finding their occurrence naturally in humans. Their prior existence is precisely what makes them diagnostically useful. There has been no alteration and thus no design by man. The finding of endpoints for genes is aided by nature's own delineation of genes via stop and promotor codons. Again, no design by man. I think design mus be more than urging mutation, to answer that question, and in Chakrabarthy it was a form of directed evolution, which might well suffice. In the case of Myriad, the researchers identified a naturally-occurring sequence, and included that sequence in their claims. No part of that sequences was designed by man, but rather is a mutation found regularly in nature associated with a higher incidence of cancers. Regarding the discussion of utility in the other thread, I find it highly amusing to claim that the use of a naturally-occurring product is in identifying the presence of that same product. Does no one else see the humor of that?
Posted by: David Koepsell | December 04, 2012 at 09:53 AM
the claimed sequences did exist before man discovered them
This is a lie. There is no "claimed sequence." There is a claimed composition of matter that is defined, in part, by a sequence of nucleotides and, in part, by its purity relative to other compositions. The claimed composition did not exist "before man discovered it."
"KIR (or MM)"
Last time I checked it's KIR. If you want me to make some other name to call you, I'm happy to do that. Just let me know, David.
I will be stunned if the Supreme Court is going to approve of this lie. I expect the Supreme Court to refute the lie in very clear terms.
Is there a reason that you won't answer the questions I aaked you, David? Are you going to play the same game that Skeptical does and pretend that simply repeating gibberish over and over makes your position more persuasive?
Posted by: Keep It Real | December 04, 2012 at 03:50 PM
David: "Regarding the discussion of utility in the other thread, I find it highly amusing to claim that the use of a naturally-occurring product is in identifying the presence of that same product"
It's actually a serious point and it'd be nice if you treated it that way. For starters, the claimed composition is not a "naturally occurring product" in any meaningful sense of the term "naturally occurring product." I can go on from there but why waste time if you're just going to babble on and on?
Let's try another hypothetical, David. Say that I synthesize a novel, non-obvious chemical and demonstrate that the chemical successfully reverses Alzheimers in 100% of patients. I claim a 95% pure composition consisting of the chemical and some stabilizers (typical composition claim). Five years after my patent is granted, Professor Skip Tickle is researching mating swarm behavior of African desert bullfrogs. During the course of performing mass spectroscopy on the sticky mixture of frog semen and clay, he discovers that for every 100 gallons of frog semen and clay created during the mating swarm, one molecule of a very similar chemical is created (it's a dimer, instead of a monomer).
Please apply your "theory" of subject matter eligibility to this situation. If you need any other facts, just say so. Please let me know first, however: is it your opinion that my claimed composition is "naturally occuring"? If not, please explain why not. Thanks.
Posted by: Keep It Real | December 04, 2012 at 04:09 PM
DK "The finding of endpoints for genes is aided by nature's own delineation of genes via stop and promotor codons"
Right. And in every case that "delineation" is so crystal clear it's no different than driving down an empty street and seeing the traffic lights. Remind me again, David: where did you get your Ph.D. in molecular biology?
Also, so I'm perfectly clear on where you're coming from, your position is that polynucleic acid composition claims are eligible as long as they don't include start and stop codons? I mean, why else would you bringing that up?
"design mus be more than urging mutation"
Just answer the questions that I actually asked David. Yes or no. It's that easy. Are you afraid of doing so for some reason? It seems that you like spouting things like "design must be more than urging mutation" than you do actually considering the implications of what you are saying.
Are you sure that your position isn't simply that all polynucleic acid compositions should be ineligible for patenting? It really seems that way. Same with Skeptical. It seems that way because every time I ask you to extend your position into logical and inevitable situatoins both of you start (1) answering questions that I didn't ask and (2) repeating the same garbage.
What's going on, David?
Posted by: Keep It Real | December 04, 2012 at 04:23 PM
Wow MM, that is some rant.
Are you even capable of a civil discourse?
I am...
Posted by: Skeptical | December 04, 2012 at 06:18 PM
KIR: try to follow... the sequences are not the result of human design. We could choose any even arbitrary beginning and end point and in no case will the sequence of nucleotides have become the result of man's design. Unlike chipping away stone to create a statue, copying a string of nucleotides (like copying a string of text) is not per se inventive, it doesn't create a product not already found in nature. In none of your examples have you pointed to a case of designing a product. Directed evolution might arguably be different, because you are purposely pushing the evolution of an organism to tolerate some environment, but your example seem to be of random mutation, which is not purposive and thus not designed. Try, for instance, selecting a random bit of my text here, copy it, paste it elsewhere, and then ask yourself: have I "created" something new in the process? What is it's use? I contend the only use and one analagous to the uses claimed in these diagnostic patents is in identifying that same string.
In my book and elsewhere I have maintained consistently that genetically engineered organisms are patent-eligible under sec 101 because they are products of man's design. I actually did answer your questions above, just not the way you wanted me to. For that, I can offer no sincere apology.
Posted by: David Koepsell | December 04, 2012 at 06:30 PM
David: "I actually did answer your questions above, just not the way you wanted me to."
LOLOLOLOLOLOLOLOLOL!!!!
You should run for Congress, David. Thankfully I've interacted with enough online "philosophers" already so I know to expect very little from them.
Anyway, the questions and your non-answers are up thread, preserved for all to see. We can return to them later when the case is decided (I know that I will!). I'm pretty sure when the Supreme Court justices will be expecting better answers than the ones you (didn't give). You never even tried to address the 4:09 hypo or answer the question I posed there, as far as I can see.
"I contend the only use and one analagous to the uses claimed in these diagnostic patents is in identifying that same string. "
First, David, claims at issue here don't recite any "uses". They claim compositions of matter. So now in addition to not answering questions, you are just flubbing the basics. In addition, the point you appear to be clumsily trying to make is a very old one and widely recognized by everyone in the field (including myself, the courts, and the USPTO) in the situation where (as in your "analogy") (1) the structure of the target *to be detected* is public knowledge and (2) the *claimed composition* is an obvious choice for detecting that structure. Nucleic acid composition claims are routinely rejected under 35 USC 103 when the above facts apply. Nobody blinks, nobody ever has.
Those aren't the facts of the Myriad case, however, as you certainly know. So your analogy isn't very well-considered. This is why I ask you again: is your position simply that nucleic acid compositions should remain ineligible ... just because? Can you answer at least that question "yes" or "no"? Right now it seems your position is that a composition that is "designed" is eligible ... except when it's shown later that "nature" might have made it before (even when there is no evidence that nature did make it before).
"In my book"
You wrote a book? LOL. I'm going to do you one better, David: you're IN my book. Along with a few other characters who insist on wading into the deep end of the pool without their flotation devices.
Posted by: Keep It Real | December 05, 2012 at 04:40 PM
I won't dignify your incivility with any more attempts at responses. As you should know, sequence claims must have clearly expressed uses under guidelines from the USPTO to prevent willynilly sequence claims. None of your examples presented any purposive mutation, and thus no design, which is what I claim ought to be the distinguishing feature setting apart natural products from artifacts. My position is clear, on record, logical, and soundly based on principles enunciated by the Supreme Court. I wish you well, and hope you are a better person in real life than you appear online.
Best,
David
Posted by: David Koepsell | December 05, 2012 at 10:27 PM
KIR, just so the record is spotless on my responses... Regarding your 4:09 hypo, the chemical you created was the result of design and intention, and the patent would be justified, you didn't discover it, you invented it, even though we might later find a natural equivalent. Regarding the "composition of matter" vs. sequences issue, the claims recite compositions of matter defined by specific sequences, which sequences were discovered, not designed. I think the distinction between design and discovery is pretty rudimentary, and none of your counterexamples seem problematic in that regard. Some more examples: I toss a bunch of gears and such in the air and they fall to earth in the form of some useful machine, just by happenstance. I did not design that, it was chance. I cut and paste random sequences of letters and end up with a pleasant poem somehow, I didn't design that and cannot claim to have created it nor should I be granted some monopoly rights over it. I identify some mineral in the ground and find that it works nicely to write on slate, I didn't design the mineral and ought not to get some monopoly over the mineral which is a product of nature. I think in each case where there is a clear difference between products of nature and those of man, there must be some mixing of intention with deliberate design to result in a new product for there to be a product of man. Some other examples that I believe help bolster this point: we create all sorts of accidents all the time that end up being products of man but not inventive. Excretions (use your imagination), footprints from our walking, garbage piles, etc., none of which is the product of design though they may in some cases be the product of intentional action. Those accidents are not products of nature, nor are they "inventive" warranting some monopoly protection, they are accidental products of man. This is why I think design is critical to cross the threshold of patent-eligibility. I doubt any rational person supports granting monopolies over even useful excretions, etc., even though they are sometime the intentional products of man. I am doing my best to bring some order to this problem, consistent with principles embraced by the courts, and I happen to think in the case of diagnostic gene patents, because the claimed compositions of matter are sequences of nucleotides that are not the result of both man's intention and design, they ought not the be patented. As I said before, consistently and repeatedly, genetically engineered organisms are typically the products of both intention and design and thus meet the threshold, are not products of nature, and should be patentable.
Anyway, that should sum it all up and I think close any loose ends in the thread.
all my best,
David
Posted by: David Koepsell | December 06, 2012 at 10:45 AM
David:
"the chemical you created was the result of design and intention, and the patent would be justified, you didn't discover it, you invented it, even though we might later find a natural equivalent."
Okay, that's an extremely important point that you should make a greater effort to make.
So really your position is not that novel nucleic acid compositions shold be ineligible in every case where the composition consists of a sequence of nucleotides that appears in a "natural" organism's un-engineered genome. Rather, your position is that the eligiblity of novel nucleic acid compositions should be determined according to the manner in which those novel nucleic acid compositions were conceived and reduced to practice.
Thus, if I use my genius and certain design principles to create a novel non-obvious isolated nucleic acid composition encoding a novel protein that catalyzes the conversion of X->Y, my composition remains eligible even when it is discovered 5 years after my patent grant that an identical gene exists in a thermophylic archaebacteria. Do I have that right, David? I assume the answer doesn't change if the gene is found in a human but let me know if I'm mistaken.
"I identify some mineral in the ground and find that it works nicely to write on slate, I didn't design the mineral and ought not to get some monopoly over the mineral which is a product of nature. "
What about if the mineral is really rare and only works nicely to write on slate if it is purified in large quantities, which requires extensive and novel man-made processes, and you claim the mineral composition so that it encompasses the purified mineral in chunks of a certain size that do not exist in nature? Is that composition claim ineligible? Can you explain the policy behind your rule, and how that policy jives with your answer to my 4:09 question?
"As I said before, consistently and repeatedly, genetically engineered organisms are typically the products of both intention and design and thus meet the threshold, are not products of nature, and should be patentable."
I hope you're being to understand, David, that repeating these vague statements achieves very little when you are talking to someone who has years of experience in the area you are seeking to "achieve order."
Posted by: Keeping it Real | December 06, 2012 at 12:43 PM
The substrate for the natural product doesn't matter at all, as I've said, the issue isn't about "human" genes but products of nature. That is where the supreme court draws the line.
I'd say patent the processes for purification but purifying something nature designed doesn't suddenly make it man made, see, e.g my arguments about O2. The policy behind the rule is to reward invention and not mere discovery of natural laws, products, or abstract ideas. I didn't make that policy, the supreme Court did. I think it's sensible.
Posted by: David Koepsell | December 06, 2012 at 04:34 PM
Actually David, the Supreme Court didn't make the policy either (at leas they don't own up to it, at least not fully).
They claim the authority for the policy comes from the implicit words of Congress (the branch of government constitutionally sanctioned to come up with patent law).
As I mentioned to EG though, whether the Supreme Court could really keep their fingers out of the pie, well, I'm...
Posted by: Skeptical | December 06, 2012 at 05:37 PM
David: "The substrate for the natural product doesn't matter at all"
I do recall using the term "substrate" and I do not want to guess that the term means to you or why you are making this statement. Are you addressing something that I wrote? If so, please reproduce the statement you are responding to so we are not talking past each other. I suspect it is likely that you are misreading something I wrote so I would advise not jumping to conclusions before making strange statements about "substrates."
Better still, why not simply respond directly to the straightforward questions I asked you in my 12:43 pm comment? Again, it's a bit mystifying trying to understand your position, the basis for that position, and its logical ramifications if you refuse to answer questions about it.
"the issue isn't about "human" genes but products of nature."
Well, the question certified is most definitely about "human genes", but let's not quibble about that.
I'm still mystified as to why you seem so intent on avoiding directly answering questions. It appears that the quoted statement of yours is an attempt to resspond to one aspect of the first hypothetical in my 12:43 comment. But you ignored the more important and interesting question which was an attempt to clarify your earlier-stated position about "design" versus "discovery" and see how you would apply it to the eligibility of nucleic acid composition claims. My 12:43 comment is very clear so I will let you re-read it and hope to see you address the questions I asked and confirm that I understand your position on these straightforward, practical scenarios. As you know, I've been prosecuting in this field and thinking about these issues for many, many years. I, too, would like "order" to be brought to the area. That is why I believe it worthwhile to think these issues through carefully and understand precisely how subject matter eligibility is determined and, equally importantly, why.
I look forward to your thoughtful answers to the questions and requests for clarification in my 12:43 comment.
Posted by: Keep It Real | December 06, 2012 at 06:00 PM
At the beginning of my previous comment, I wrote: "I do recall ..."
I should have written: "I do NOT recall..."
I apologize for the confusion.
Posted by: Keep It Real | December 06, 2012 at 06:02 PM
I answered 12:43 completely at 4:34. To clarify my use of the term "substrate" I meant it colloquially to refer to the underlying conditions in which something lies. The air is one substrate in which O2 molecules are found, so is a tank of O2. In each case, the O2 molecules are not the result of man's design. Thus "purified" O2 or a purified mineral remains undesigned even while processes developed to make each more useful might be designed. Similarly, "isolating" some naturally occurring nucleotide sequence from its substrate (the rest of the genome) does nothing to change the fact that the sequence has evolved and not been designed.
Posted by: David Koepsell | December 07, 2012 at 08:22 AM
And actually, KIR, or MM, I know nothing about you. Who are you? Besides, the appeal to authority is a fallacy. Only arguments and reason matter to me.
Looking forward to seeing how it plays out in SCOTUS, where it matters.
Posted by: David Koepsell | December 07, 2012 at 10:39 AM