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:
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Affirmed: The courts properly have jurisdiction over the declaratory judgment case.
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Reversed: Myriad's composition claims to isolated DNAs, including cDNAs fall within the scope of Section 101 patentable subject matter.
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Affirmed: Myriad's method claims directed to comparing or analyzing gene sequences are not subject matter eligible.
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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
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.
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.
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.
if you repeat a lie often enough
You’ve been asked before to identify one such alleged “lie”, suckie, and you failed miserably.
GFY
“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.
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.
“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?
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.
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?
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.
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.
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.”
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.
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.
“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.”
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.
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?
“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.
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.
“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.
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.
“your weird-arse paranoid suspicions”
Lolz, coming from the person who thinks anyone outside of the vocal minority is a ‘suckie.”
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.
“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?)
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.
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.
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.
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.
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.
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?
How would you perform the test Hans?
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.
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.
suckie, please ask Dennis to confirm or deny your weird-arse paranoid suspicions.
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.
“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.
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?
?? MM,
You want to explain how your post makes any sense (even assuming your tinfoil hat “everyone is suckie” conspiracy theory?
See what I mean, Ned?
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
“ Story said this a long time ago. It was accepted law ”
Citation please.
Malcolm, regarding the method claims they are glaringly wrong. Isolated DNA is a close case, so she decided to go with history.
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.
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.
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.
Lolz,
MM puts on his Hans Blix sockpuppet to talk to his Marryadd sockpuppet.
Although such claims would be worthless (one would never perform a test this way), the answer is yes.
“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?
“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)?
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.
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.
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?
“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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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)
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!
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.
“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?
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."
My oversight.
link to aclu.org
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?
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.
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?
I seem to recall that a Critique on Bryson Section II was on that thread.
Dennis, any luck on reviving the lost comments?
“I don’t know if this is entirely correct.”
I do know that it is entirely correct. I will agree to no less.
crelboyne, is sequencing one’s own genome an act of infringement?
If it is, then I have a big problem with Myriad’s patent.
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.
Mike, you even have me intrigued. Why don’t you provide a link to the brief?
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.
“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?
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.
anon, there are a couple of posts near the bottom of this page that merit your attention. See posts by crelboyne and by “not.”
“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.