Supreme Court Grants Cert in AMP v. Myriad

By Kevin E. Noonan --

In a decision that should surprise no one, the U.S. Supreme Court granted certiorari today in Association for Molecular Pathology v. Myriad Genetics, Inc.  The grant was limited to the first question presented, whether human genes are patent-eligible, and the Court denied certiorari on the other two questions (thus letting stand the Federal Circuit's determination that screening methods using genetically transformed cells are patent-eligible under the Court's Mayo v. Prometheus precedent, and that a declaratory judgment plaintiff must cite actual injury to have standing).

The decision is unsurprising in view of the (relative) specificity of the question presented and the overwhelmingly one-sided nature of the amicus briefing (see "AMP v. Myriad Briefed and Distributed for Conference").  Later posts will discuss potential outcomes and stratagems for ensuring that the Court is fully informed on the facts rather than the rhetoric of gene patents. But one thing is certain:  anyone with skin in this game who sits on the sidelines should be ashamed.

Comments

[EG]

Kevin,

So how should SCOTUS respond to the question posed by the ACLU/PubPat ("Are Human Genes Patentable")? Answer: as Myriad correctly says in opposition, "you're asking the wrong question." Myriad's claimed subject matter simply DOES NOT PATENT HUMAN GENES. That should be the end of story.

[6]

As EG notes, Myriad is going down hard because the question on appeal isn't even being presented in the fashion they want.

[Skeptical]

I am skeptical that Myriad is going down hard because of the question is being asked.

Why are you assuming that an answer of human genes are not patentable spells doom for Myriad? I don't think you quite read EG's post: Myriad is not claiming human genes.

[Bob Cook-Deegan]

To move a step beyond EG, my own prediction is that SCOTUS will point out that the way Myriad's claims were constructed they in effect *did* claim any human use of BRCA1/2 genes, and will draw--or decide and thus force CAFC and USPTO to draw--a line between discovery and invention. That is, they will conclude that "isolated" is not a magic word that when inserted into a sentence confers patent-eligibility. The underlying ability to patent DNA-based inventions will not be fundamentally altered, but claims will have to be crafted more narrowly to demonstrate a clear "invention" beyond "discovery." Bryson was quite clear that Myriad could have claimed any number of DNA constructs (e.g., probes, primers) that protect what they do in their labs in Salt Lake City, but the claims reached to more. By shooting for the moon and missing, Myriad did not land in the stars, but in the mud. My guess: the answer to the question will be that human genes are not patentable per se, but DNA molecules that draw on gene discovery will still be patentable--just not the molecules corresponding to the sequences as found in nature.

[David Koepsell]

The reasons the patents are valuable is because they specify claims to nucleotide sequences found in humans that are associated with a significant incidence of cancers. How are these nucleotide sequences not human genes? The "isolation" conceit is what's at stake, and as the District Court found, the lawyers' tricks involved in claiming the sequences are not otherwise naturally occurring sequences, products of nature, and not the creations of man just aren't going to carry the day with the court that decided Mayo.

[EG]

"How are these nucleotide sequences not human genes?"

David,

Like the "philosopher" you profess to be and not a molecular biologist or even a chemist as am I, you miss the point completely, as did the ACLU/PubPat. Myriad isn't patenting "human genes"; they are patenting "isolated" DNA sequences that don't include the "native" DNA. Read Myriad's patents which say as much.

Also, if you would bother to read Professor Holman's amicus brief submitted to the Federal Circuit, you would also understand why phrasing this case as "patenting human genes" is completely absurd. I know suggesting you read what Professor Holman said in his amicus brief is a "sore subject," but he is, after all, a biochemist and patent attorney which you've admitted you're not. Injecting "pseudosciene" and "philosophy" into this discussion doesn't address the real issue here.

[EG]

"my own prediction is that SCOTUS will point out that the way Myriad's claims were constructed they in effect *did* claim any human use of BRCA1/2 genes, and will draw--or decide and thus force CAFC and USPTO to draw--a line between discovery and invention."

Bob,

If SCOTUS does that, then they're reaching out for a question not asked by the ACLU/PubPat. The question posed by ACLU/PubPat is "Are Human Genes Patentable." That's the wrong question to ask, and not the issue in Myriad in any event, so the ACLU/PubPat should be "hoisted on their own petard" for asking the wrong question.

If SCOTUS does reach out the way you suggest, then SCOTUS has entered the legislative domain which is not theirs and gone far beyond their role in our constitutional framework. In terms of interpreting patent-eligibility under 35 USC 101, their role is to interpret and apply the statute involved and the question before them, nothing more. And if you sense I've got a jaded view of SCOTUS when it comes to patent law questions like this one, you would be correct (and I'm not along in that view either).

[Skeptical]

EG,

I am skeptical that your view of "SCOTUS has entered the legislative domain which is not theirs and gone far beyond their role in our constitutional framework" will stop SCOTUS from doing what they want to do.

Look at ANY 101 decision since the 1952 act and you will see that the power the Court relies on is not DIRECTLY its own, but rather ITS reading of what the Court FEELS is IMPLICITLY written by Congress.

Of course, you could blame this on Congress, as they could if they wished write the law to be less ambiguous... (of course, the jaded amongst us would say that even that would not stop an activist Court).

[Keeping it Real]

David: "How are these nucleotide sequences not human genes? The "isolation" conceit is what's at stake, and as the District Court found, the lawyers' tricks involved in claiming "

Okay, take a deep breath David. It's hardly a "conceit" or a "trick" to insert a bona fide limitation into a composition claim for the purpose of avoiding ineligible subject matter (or the prior art, for that matter). That's what the term "isolated" was and is intended to do: it prevents nucleic acid claims from reading on chromosomes in human cells (whether those cells are comprised by human beings or not). It's no more of a "trick" or a "conceit" to recite the term "isolated" in this context than it is to recite a composition comprising a previously known chemical in a particular concentration and/or state of purity than was previously obtainable (without undue experimentation).

Please correct me if I'm wrong, but even the ACLU is not asserting that people carrying a BRCA1 mutation are literally infringing Myriad's claims, or even infringing under the doctrine of equivalents.

In my opinion, there are genuine written description and/or enablement issues with the breadth of some of Myriad's composition claims that could (and should) render the claims invalid.

The lurking 101 issue with these claims that appears to be danced around most vigorously to date is, in my opinion, an issue of specific, substantial utility. It's more or less settled (although the Supreme Court never dived in with its own analysis) that the merely knowing that a novel, non-obvious polynucleic acid sequence is "important" in an organism is not enough to render that novel, non-obvious nucleic acid sequence eligible for patenting. In other words, one can not simply determine that a novel (previously unsequenced) nucleic acid has some "function" in a human and then obtain a patent-eligible claim to that nucleic acid. The reason given for this (by the CAFC, anyway) is that the use of the new sequence merel for further research into the function of that sequence is not "specific and substantial" enough to satisfy the utility prong of 101. This rule came into existence when Incyte and a few other companies began filing reams of patent applications on reams of nucleic acid sequences whose only known "utility" at the time of filing (typically) was that they were "expressed" and as a result more meritorious of further study than some random sequence.

Now some will argue that the mutant BRCA1 sequence claimed by Myriad has a substantial and specific utility because it has been correlated with breast cancer and the specific, substantial utility of the claimed nucleic acid compositions is therefore a tool for detecting breast cancer. It shold be noted at this point that the genetic susceptibility to at least some types of breast cancer was well understood long before Myriad was incorporated and the identification of the responsible sequences was guaranteed regardless of whether patents to nucleic acids were ever going to be granted or not.

And here is where the policy issues come into play: should the mere existence of a correlation between a DNA sequence and a disease suffice to render a novel nucleic acid composition comprising that sequence eligible for patenting?

It's a serious question and here's why: with the increased availability of sequence information and computing power for analyzing that information, it's going to become trivially easy to correlate sequence information with all kinds of "conditions" and "risks." But for the fact that so much sequence space is already disclosed (and therefore unpatentable), Myriad would represent the tip of a fantastically enormous IP iceberg, just as Incyte obviously did at the time their business model was (correctly and justifiably) crushed into dust.

[Keeping it Real]

David: "How are these nucleotide sequences not human genes?"

I also wish to follow up on EG's response to this question, above.

Please recognize, David, that in nearly every case there is absolutely no difference between a "human" gene sequence and a "chimp" gene sequence. And in an enormous number of cases, there is no distinction to be made between an "E. coli" gene sequence and a "human" gene sequence (ignoring the fact that humans comprise as many or more bacterial cells as they do human cells).

This is because all known organisms living on earth use the same (or very similar) chemicals for reproductive purposes (i.e., to "encode" the instructions for making copies or, more accurately, near-copies of themselves).

This is why the recitation of "human genes" is more than a bit problematic. Another problem is that while most humans are very similar to each other (male humans being much more similar to each other than they are too any female human, and vice versa) only identical twins share the "same" genomes (and I use quotes because even in that circumstance there are surely many sequence differences as a result of chromosomal damage/repair unique to each individual).

Consider: every animal on earth is continually evolving as they reproduce. Our own DNA is being damaged and repaired and evolving as a result as we sit at our desks. A nucleic acid sequence in a chromosome that never before existed in any human on earth at time X may exist in a single human being somewhere at later time Y. Would a novel, non-obvious claim to an isolated nucleic acid composition with great utility suddenly become ineligible at a later date when that single human being is identified? How can that result be reasonably justified?

Another question: what is so special about human beings? what about our pets? wouldn't the same policy concerns articulated with respect to human beings mandate removing cat and dog gene sequences from protection as well? We love our pets dearly. Why stifle research that could make their lives better by creating a giant patent thicket that prevents others from studying their genomes?

[Keeping it Real]

More food for thought (for the record, I don't have any "skin" in the nucleic acid patenting game, to borrow Kevin's phrase):

While investigating leukemia, Professor Joeblow discovers that the cells of all human children include a tiny organelle (the "Blowgornelle") which uses a completely different coding paradigm to manufacture functional chemicals. Mutations in these chemicals are responsible for 50% of childhood disease mortality. The molecules coding for these chemicals are referred to as Z-Genes.

Because the building blocks involved are fewer in number and because of inherent restrictions on the length of Z-genes, a computer can be used to describe every possible Z-gene sequence.

Scenario 1: Because he was funded by government grants and believes strongly in rewarding the public for its investment and because he knows that there are many others who were pursuing the same line of research but who weren't lucky enough to be "first" and because he knows he will be "set for life" because of tenure and the Nobel Prize etc, Professor Joeblow simply publishes his findings and dedicates to the public the know-how to make, express and detect each and every possible "normal" and "mutant" Z-gene sequence.

Scenario 2: Professor Joeblow publishes his findings about the existence of the Blowgornelle and its unique genome but not the genome sequence or any of the Z-genes. Immediately after reading about Joeblow's discovery, a single 19 year old genius in his basement realizes that each and every possible normal and "mutant" Z-gene sequence can be determined with a computer. So he writes a program and the day after Professor Joeblow's publication, the 19 year old genius files a patent application claiming each and every sequence. The patent is granted immediately.

Scenario 3: Same as scenario 2 except there are seven hundred 19 year old geniuses thinking more or less the same thing and between them they file two thousand distinct patent applications, each directed to different Z-genes but between them they cover the entire sequence space. Every patent is granted immediately.

Question: Under which scenario will progress in understanding and treating childhood diseases proceed more quickly?

[6]

"Why are you assuming that an answer of human genes are not patentable spells doom for Myriad?"

Because the court has already said that such is the question on appeal. It is yes/no and the only way it can be the question that is on appeal is for the case to turn on it. The USSC doesn't take cases to answer obscure questions that the case won't even turn on.

[David Koepsell]

Actually dear overly excitable critics I agree the issue is not whether the patents should issue for "human" genes, but whether the claims cover products of nature. I've read Holman's and others' briefs an you'll see in the brief I joined in that we view the isolation argument as pure rhetoric devoid of logic. The claimed sequences are not the intentional design of man, which I argue is what would be necessary for them not to be products of nature. So far, no one can provide a worthy counterexample, meaning you all believe it is perfectly sensible, for instance, to treat identical molecules differently depending only upon their origin. Our famous O2 example for instance. I'm quite comfortable raging that no O2 molecule ever has been other than a non patentable product of nature. You have to defend the claim that they could be, and I believe that the Supreme Court will agree that while we might be able to synthesize natural products they don't cease to e products of nature. To be a product of man, it must be designed by man rather than nature. Anyway, we shall see what logic wins the day. Best to all!

[David Koepsell]

"raging" should read "arguing" damned iOS autocorrect.

[Skeptical]

Mr. 6. I am skeptical that you understand what “question on appeal” means as to the “yes/no” nature and your continued assumptions regarding the question itself as opposed to how the claims are construed.

And as loathe as I am to align with Mr. Koepsell (I have seen his writings here and at IPWatchdog, and the pedantic nature of most conversations leaves me unimpressed), he does claim a logical vantage point by pointing out that the nature of the question revolves around the Product of Nature Exception to patent eligibility. “How” you got to something is simply of no import if that same – or effectively that same – something is already free to all from Nature’s warehouse – even if (as noted in Chakrabarty), that something has only just now been (i.e. even well after a patent has been granted) newly discovered. In other words, yes, even a discovery ten years after filing fully rightfully (logically and legally) changes the patent eligibility of an invention. I would point out to Mr. Koepsell (and agree with MM in part) that “conceit” is ill-chosen for describing “isolated.” That choice of word shows a “miss” from the proper legal concept – and one recently used by the Supreme Court in Prometheus: “enough.” Both “isolated” and “purified” are indeed legitimate terms of art in patent language, and MAY provide ENOUGH change to induce patent eligibility. But importantly, they MAY also NOT provide ENOUGH. More on this below.

I would posit that cert was accepted to at least (once again) slap at the CAFC who EFFECTIVELY ignored the Court’s Prometheus decision by returning a result post-remand virtually identical to the one pre-remand. The Court remanded for a reason, and that reason was not to hear from the lesser court “your thoughts do not apply.” I would also note, with some small irony, that the last time that happened, we had Bilski.

I find myself very skeptical with MM’s several stories. I am not even going to touch the horrific strawman Joeblow story, as there are just too many canards to wade through. The one about the argument pivoting about substantial utility at least sounds very plausible on its face – until one realizes that this has never been an issue in this case, has never been addressed by either side, and is not likely to be even mentioned by the Court. Lurking? Danced around? I fail to see any rational basis given the record for making these assertions. It is more likely that this is just a more palatable argument to MM, especially given the historical parts of the story he presents. Unfortunately for his viewpoint, this issue is NOT an issue in this case at all. Trying to substitute a different policy argument at this stage of the game just will not work.

Near as I can tell, what he is trying to substitute for with the specific, substantial utility is an issue that has been discussed in the case, one that the Supreme Court is only too willing to visit: its Judicial Exceptions (here, the Products of Nature Exception). To get beyond this exception, something more is needed. The parallel to Prometheus is self-evident. Absent from MM’s stories are any notion of the criticality ascribed to “change in kind” that is required from any “magic words” such as “isolated” or “purified.” Neither word alone has ever been sufficient to garner patentability over the precursor Product of Nature beginning material. A simple thought experiment shows why: Substance (unpurified) in nature – not patent eligible. Is purifying by 10.0% enough? By 0.1% enough? By 0.0000001% enough? The answers to these questions are provided by Learned Hand: “enough” is when a change in kind has been effected. So even if you do 'purify," the patent eligibility question has not been resolved.

Same thought experiment can be applied to “isolated.” Merely changing the end structure MAY NOT BE ENOUGH.

One has to ask the better question: Has there been a change in kind? Are Myriad’s not-questioned-changed-structure claims EFFECTIVELY changed in kind from the Product of Nature beginning material? In this it appears to many (e.g. Mr. Cook-Deegan if I may be so bold), that the answer will be “NO.” The use of either “isolated” or “purified” on their own as “magic words” fails. One must go beyond the words and evaluate the invention itself, or to paraphrase Prometheus:

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.

[Gary Johnston]

Keep says:

"And here is where the policy issues come into play: should the mere existence of a correlation between a DNA sequence and a disease suffice to render a novel nucleic acid composition comprising that sequence eligible for patenting?"

I says:

Word. This is where the attack should have always been focused in this case. There is a VERY compelling argument in this case that there was and is no specific, substantial, and credible utility for the isolated DNAs. I won't go into specifics, but I was knee-deep in the Incyte/Millenium/HGS craziness of the late 90's/early 00's, and I have always been rather skeptical that a correlation between sequence variants and susceptibility to disease is enough to render the composition claims useful. Seems to me that you need something more. But as I've said here before, Myriad's test doesn't use any of the claimed compositions, so no biggie.

[RubberTipPencil]

Obviously, the Jim Watson amicus brief will be the key brief, if he files one at the Supreme Court. But I suppose the clerks can just read a copy of it on this blog if they want to.

[Hibob]

While another analogy might not be particularly welcome ... let's substitute logs, as in log cabins, instead of Judge Bryson's leaves. Specifically logs that have been "isolated" from trees by cutting to size and notching the ends; the Lincoln-logs are useful for building cabins.

Trees are products of nature. Notched logs, building cabins, etc are all well established in prior art. It's well known that different types of wood can be used for theirdifferent properties. Could someone, having noticed that Cedar trees are rot resistant, patent a cedar notched log for being rot resistant? Does the answer change if the cedar notched log is made from wood that was synthesized industrially (PCR amplicon) but is still absolutely identical to wood cut from a tree in every way?

As far as diagnostics go the question is moot, or at least will be within a decade. Why pay anyone ~$3k for a single diagnostic when instead for the same money you could have your genome sequenced thus bypassing ALL of the genetic diagnostic patents (and fees) at once, forever?

[Keeping it Real]

Hibob: "As far as diagnostics go the question is moot, or at least will be within a decade. Why pay anyone ~$3k for a single diagnostic when instead for the same money you could have your genome sequenced thus bypassing ALL of the genetic diagnostic patents (and fees) at once, forever?"

Indeed. And now you understand why certain parties are so very very aggressively pushing courts (and the public) to accept the eligibility of methods of looking at your sequence information and providing a diagnosis, whether that diagnosis requires a "very special" algorithm or simply a glance at a region of your genome known to be of particular importance. That's where the $$$$ stands to be made ... by an extremely small and already quite wealthy segment of our society. If the insurance companies get their way, the rest of the public will end up paying for all this "processed information", one way or the other.

[Keeping it Real]

Skeptical: "Absent from MM’s stories are any notion of the criticality ascribed to “change in kind” that is required from any “magic words” such as “isolated” or “purified.”

Please tell me exactly how we know when a claimed composition that is indisputably novel is sufficiently "changed in kind" to become eligible over an allegedly similar chemical found "in nature." I'll gladly refer to your magical phrase when you provide a coherent answer to this question.

"I find myself very skeptical with MM’s several stories."

And yet you were unable to refute a single fact or identify a single "canard" in my hypothetical. You just waved your hands around. I recall you behaving in identical fashion when we discussed Prometheus, which you managed to completely misunderstand and apparently still do.

Please tell us all, Skeptical: if I synthesize a novel polynucleic acid that is 100 nucleotides in length and show that it cures leukemia when administered to leukemia, can I get a patent on that chemical composition ("A nucleic acid composition consisting of 100 nucleotides in the sequence of SEQ ID NO: 1")? Assume there are no other relevant facts. Explain your answer.

Next question: if it is later shown, five years after I file my application, that a billion base chromosome comprising a stretch of nucleotides with an identical sequence exists in a yeast strain that has been used for barleywine making by Belgian monks for centuries, is my composition claim now ineligible because it is not sufficiently "changed in kind"? What facts would change your answer to this question?

I would be stunned if you are unable to answer these questions, since you seem very confident that you know "the answer." Please share your special knowledge with us all. This is exactly the sort of issue that is going to pop up routinely if your "change in kind" methodology is adopted. Give us a hint, at least, as to how you imagine this test being applied in the future.

[Keeping it Real]

Hibob: "Trees are products of nature. Notched logs, building cabins, etc are all well established in prior art. It's well known that different types of wood can be used for theirdifferent properties. Could someone, having noticed that Cedar trees are rot resistant, patent a cedar notched log for being rot resistant? Does the answer change if the cedar notched log is made from wood that was synthesized industrially (PCR amplicon) but is still absolutely identical to wood cut from a tree in every way?"

Those patents are invalid under 103. That's what 103 is for. It works perfectly to prevent patents of the sort you describe and is applied by the USPTO in the exact manner you suggest to reject claims every day.

The issues presented by the compositions in Myriad are trickier. At least for the moment (and this may change) it is understood that as of the filing date the claimed compositions were novel and non-obvious, with a substantial valuable utility.

[Skeptical]

I am skeptical that you understand the pertinent case law MM, at least including Chakrabarty and the notion that even later found Products of Nature can remove patent eligibility from an invention.

[Skeptical]

MM, you state: "if your "change in kind" methodology is adopted"

There is no "if" - change in kind is current law.

[Keep It Real]

Skeptical: "I am skeptical that you understand the pertinent case law"

Shall we re-visit your incomprehensible rants posted here regarding Prometheus v. Mayo and see who has a better understanding of "currrent case law"? Let me know.

Skeptical: "later found Products of Nature can remove patent eligibility from an invention"

Show me one example of ANY court upholding the ineligibility of a composition of matter where (1) the composition does not literally read on the "product of nature" and (2) where the "product of nature" did not exist prior to the filing of the application.

If you can't do this, then show me an example where only the fact in (2) was present (i.e., where the claimed composition did read literally on the later-created "product of nature").

I know you'll never be able to do either task, Skeptical. I just want to establish the fact that you were presented with a very straightforward opportunity to support your position and you failed miserably.

Skeptical: "change in kind is current law."

If you say so. I notice you haven't bothered to answer a single question that was asked of you upthread, in spite of the fact the questions arise from the straighforward consideration of your own statements. That's a sign that you don't really know what you are talking about but are instead simply waving your hands about, like any intellectual coward would when his unsupported beliefs are being challenged.

[Skeptical]

Thank you for confirming my skepticism MM. You really do accuse others of that which you do. Your grand, but empty conclusory statements really don't help you much. Have you read Chakrabarty lately? Do so again and especially note the verb tense used by the Justices when describing patent eligibility-denying Products of Nature. Obviously, it is not just I that understands this.

Good luck to you and your accusations. They play even more poorly in this forum than at your regular haunt.

[Keep It Real]

"empty conclusory statements"

LOL. This from the character who for some strange reason chooses to capitalizes "Judicial Exceptions" and "Product of Nature".

I knew you didn't have the chops to discuss the issues, Skeptical. Now everybody knows. Again. Keep running away.

[Skeptical]

The capitalization is appropriate, given the fact that the terms capitalized represent well known tenets of law (or are you really saying that you have never heard of the Judicial Exceptions to patent eligibility, or that Products of Nature fall under one of those Judicial Exceptions?).

I am not running at all. Please stop accusing me of things I am not doing.

How is your reading of Chakrabarty coming along?

[Skeptical]

MM asks: Please tell me exactly how we know when a claimed composition that is indisputably novel is sufficiently "changed in kind" to become eligible over an allegedly similar chemical found "in nature." [?]

The answer is that we don't always know. I think that you think that this somehow makes a point for your arguemtn, but it does not. There is no "time-dependency" to a Judicial Exception. We have covered this before. So rather than "running," my ignoring your questions is based more on the fact that I have already answered them. The fact that you don't like (or don't understand) and don't accept them does not detract from the fact that my answers are correct.

Again.

And skipping over your canard does not mean that I am "unable to refute a single fact," as you misrepresent, it means that I have chosen not to waste my time with your obvious strawman. It seems that misrepresentation is one of your favorte tactics. You should be aware that it is entirely transparent, and really fools no one.

Now your turn. Tell me how a patent can be enforced if it turns out later after grant that the claims read on a product that is freely available in nature? This is a question that you dodged with consistent and great effort at your usual haunt.

Perhaps here, you will finally grace everybody with an answer.

Me? I am skeptical.

[EG]

"Our famous O2 example for instance."

David,

Still bringing out that wearisome and antiquated "O2" hypo, eh. About on par with "earth, air, fire, and water" logic. BTW, we're talking chemistry here, not "philosophy."

It might surprise you but my degree in chemistry is a batchelor of arts (B.A.) from one of the finest small liberal arts schools around (Carleton College). So I'm quite familiar with "philosopical rhetoric" like yours, and I'm not impressed or persuaded by it.

[EG]

"I am skeptical that your view of 'SCOTUS has entered the legislative domain which is not theirs and gone far beyond their role in our constitutional framework' will stop SCOTUS from doing what they want to do."

Skeptical,

Unfortunately, you may be correct. Congress has had numerous opportunities to change the patent-eligibility standard as it relates to nucleotide sequences, including the Becerra bills (none of which made it out of committee), as well as the AIA, and did nothing; that should be enough to tell SCOTUS that Congress intended such subject matter to remain within 35 USC 101. But you're correct that that never stopped SCOTUS from "poking its nose" into matters belonging to the legislative perogative, not the judicial

[Keep It Real]

KIR: "Please tell me exactly how we know when a claimed composition that is indisputably novel is sufficiently "changed in kind" to become eligible over an allegedly similar chemical found "in nature." [?]

Skeptical: "The answer is that we don't always know."

LOL! More like you *never* know or at least you simply refuse to tell us. Except in this one case, of course, where somehow you do know but you can't explain your reasoning. Can you tell us why Myriad's composition is not "changed in kind" relative to the (allegedly) similar compositions found "in nature" which, quite unlike Myriad's claimed composition, never was useful and remains quite useless to everyone? Please explain, Skeptical.

Again, for the record, you stated quite proudly and plainly: "later found Products of Nature can remove patent eligibility from an invention"

I'm asking you again to provide us with one example of ANY court upholding the ineligibility of a composition of matter where (1) the composition does not literally read on the "product of nature" and (2) where the "product of nature" did not exist prior to the filing of the application.

If you can't do this, then show me an example where only the fact in (2) was present (i.e., where the claimed composition did read literally on the later-created "product of nature").

It's okay to simply admit that you can't do so. Absent that admission, we'll just have to assume the answer (i.e., that you can't provide the answer, you are making stuff up, and you are afraid to confront the inevitable, logical results that will flow from your made-up theory).

"Tell me how a patent can be enforced if it turns out later after grant that the claims read on a product that is freely available in nature?"

Please define "freely available in nature". I assume that "freely available in nature" does not include molecules that are discovered to exist as parts of other molecules "in nature". What does "frely available in nature" mean?

Or are you thinking of the situation where a lightning bolt strikes a field and a computer with some novel software suddenly appears there? Because I do see where that could be a huge problem for patent law.

[David Koepsell]

EG: you apparently forgot the distinction between logic and rhetoric. The law of identity (an axiom of logic) is what makes the O2 example so compelling, because despite their different origins, all O2 molecules are identical natural products ... only rhetoric and the worst sort of sophistry attempts to persuade that two identical O2 molecules are somehow different. No O2 molecule has ever been other than a natural product because none is the product of man's design.

[EG]

"you apparently forgot the distinction between logic and rhetoric."

David,

Once again, you miss my point. I'm not arguing there's a difference in O2 as the molecule. What I am saying is that O2 isolated/purified from air is a different COMPOSITION from O2 in air (by not including almost 80% additional nitrogen). Please again focus on the chemistry/science, not philosophy.

There is also no "sophistry" (or rhetoric) in what I say. What I am correctly pointing out is that the two compositions (purified O2 and O2 in air) are different compositions. Perhaps you (the philosopher) don't understand that, but any chemist would.

Your O2 example may be "compelling" to a philosopher like you, but it is completely bogus to a chemist like me.

[Skeptical]

Air: mere aggregation? (to play on the SC words...)

[Skeptical]

MM asks: "Please define 'freely available in nature' "

MM - use whatever definition you think appropriate and try not to sidetrack from the question. Use the simplest definition that you can merely pick up the item laying on the ground. Use something and stop running from the question.

You have had months to think about this question, and yet still no answer from you.

[Just Watching]

Skeptical: use whatever definition you think appropriate

Are you kidding? He/she asked you to clarify your definition so he could answer the question. He/she even gave you an example definition and asked you comment on whether it was accurate. Why would you refuse to do define the term? It seems like the definition of that term would embody most, if not all, of your philosophy on how to approach the Myriad case and cases like it. Why hide the ball?

[Skeptical]

Why would I refuse? Because all it is from him is a stalling tactic. A question instead of an answer. If you really believe he was looking for clarification, then you do not know who that poster is. (this question is one he has been dodging literally for months).

Besides, I did give a clarification - "you can merely pick up the item laying on the ground"

How is this hiding the ball?

[Just Watching]

Why does it matter "who the poster is"? He/she asked a question. I'm curious, too. What does "freely available in nature" mean?

You didn't offer the "clarification" as your definition. You said that he/she could use any definition, including that one. But what's the point if your definition is different? He/she asked you to define a term that you used in your question so that he/she could answer the question you asked.

Are you now saying that you define "freely available in nature" to mean "you can merely pick the item up on the ground"? That would simplify things, I think. I think we could all live with a rule that says you can't enforce a patent that covers something that "nature made" that you can pick up off the ground. I guess the other obvious question is whether nature had to make the thing from "scratch" (without any assistance from "man") or whether the rule applies to things that man mostly made but nature "finalized". What's your answer? I think if you exclude anything that man assisted nature with at some point, then everyone would agree that your rule regarding enforceability is pretty reasonable. What sort of compositions were you thinking of anyway when you asked the question?

[David Koepsell]

So you admit that O2 molecules everywhere are identical, right? Those made by photosynthesis are identical to those made by electrolysis of water , just to be clear.