by Dennis Crouch
In an important decision, the Federal Circuit has affirmed the invalidity of a number of additional genetic testing claims. Based upon this decision, the USPTO may need to again reevaluate its subject matter eligibility procedures.
In AMP v. Myriad (2013), the Supreme Court found that some of Myriad’s BRCA gene patent claims were valid – or at least that they did not violate the prohibition against patenting products of nature. Following the decision, several companies – including Ambry – began marketing BRCA genetic testing, and Myriad sued.
The new lawsuit – captioned In re BRCA1- and BRCA2-Based Heredity Cancer Test Patent Litigation (Fed. Cir. 2014) – was brought by Myriad (the exclusive patent licensee) along with patent owners University of Utah and University of Pennsylvania. The plaintiffs here assert a set of patent claims that were not previously a part of the Supreme Court or lower court analysis. Now asserted are U.S. Patent Nos. 5,753,441 (claims 7 & 8); 5,747,282 (claims 16 & 17); and 5,837,492 (claims 29 & 30).
The appeal here stems from the Utah District Court’s denial of Myriad’s motion for a preliminary injunction based upon its conclusion that the asserted claims are “likely drawn to ineligible subject matter.” On appeal the Federal Circuit has now affirmed and taken a step further by holding on de novo review that none of the asserted claims are patent eligible.
DNA Primers: The asserted claims from the ‘282 and ‘492 patents are all directed to DNA primers used to bind the chromosomal section of the BRCA1 gene during PCR (the DNA-amplification process). In reviewing these claims, the Federal Circuit found that the “primers before us are not distinguishable from the isolated DNA found patent-ineligible in Myriad and are not similar to the cDNA found to be patent-eligible.”
Now, although not particularly claimed, it appears that the primers are synthetically created through a lab process. In the appeal, the Federal Circuit rejected the importance of that distinction – holding that “it makes no difference that the identified gene sequences are synthetically replicated.” Rather, the rule of law is that:
[N]either naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible. . . . A DNA structure with a function similar to that found in nature can only be patent eligible as a composition of matter if it has a unique structure, different from anything found in nature. . . . Primers do not have such a different structure and are patent ineligible.
The difference here from the cDNA patents that were allowed in Myriad is that(a) the cDNA is structurally different from naturally occurring DNA because the introns had been removed leaving exons only and (2) the cDNA is structurally different from naturally occurring exon-only mRNA because cDNA is a different substance. “To the extent that the exon-only sequence does not exist in nature, the lab technician “unquestionably creates something new when cDNA is made.”
Method of Screening: The asserted ‘441 patent claims are directed to a particular method of screening for BRCA1 mutation by comparing a patient’s gene sequence with a germline BRCA sequence. Both claims 7 and 8 depend from claim 1 that the Federal Circuit found invalid in its 2012 decision as “a patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations.”
Following the two-step analysis from Mayo and Alice, the Federal Circuit first determined that the asserted claims embody an abstract idea through the comparison steps.
Here, under our earlier decision, the comparisons described in the first paragraphs of claims 7 and 8 are directed to the patent-ineligible abstract idea of comparing BRCA sequences and determining the existence of alterations. The methods, directed to identification of alterations of the gene, require merely comparing the patient’s gene with the wild-type and identifying any differences that arise.
Going to the second part of the Alice/Mayo test, the court looked to the claims to find any “non-patent-ineligible elements” sufficient to “transform the nature of the claim into a patent-eligible application.” Here, the claims require various physical transformations, including hybridizing the gene probe; amplification of the gene; and sequencing the gene. However, according to the appellate panel, those transformations are insufficient – primarily because those steps “set forth well-understood, routine and conventional activity engaged in by scientists at the time of Myriad’s patent applications” and are the activities that a scientist would have relied upon to achieve the goals of the invention.
The second paragraphs of claims 7 and 8 do nothing more than spell out what practitioners already knew—how to compare gene sequences using routine, ordinary techniques. Nothing is added by identifying the techniques to be used in making the comparison because those comparison techniques were the well-understood, routine, and conventional techniques that a scientist would have thought of when instructed to compare two gene sequences.
With the claims invalid, Myriad has now lost the case. In my view, an en banc reversal is highly unlikely.
At this moment, the CAFC opinion is not avaliable on their website. Curious.
Are you looking in the right spot?
It is there at the 12/17 date, under University of Utah (not Myriad).
Just to stirr this boiling pot with an analogy question, noting that now all human gene structures are now public info, like other known chemicals:
Would whomever first discovered [not that many years ago] that lead affects child brain development be able to get get a valid patent with generic claims broadly covering any conventional chemical test for lead content in children’s blood?
I think we know what the Supremes would say. [Please, no more comments by folks who think that posting their personal disagreement with decisions of the Supremes is of the slightest value or interest or carries any weight.]
Translation: bubble chamber comments only please
For posting with a name like “curmudgeon” that’s an odd request.
The answer is pretty clearly no, right?
The best method of rejection will depend on the wording of the claim.
As you stated, I could see 102, 103 or 101 applying.
If the claims are old or merely an new obvious use of using the old test (using a lead test to discover the concentration of lead…) I could see using 103.
But if the claims are worded in such a way so as to monopolize the (new) correlation between lead concentration and child brain development, I could see a 101. Depends on the claim.
>>to monopolize the (new) correlation between lead concentration and child brain development
You got love these words without any meaning. The judges just proclaim this with no evidence or without going through any type of analysis. Moreover, by its very nature one cannot be sure this is true.
I agree with Arthur. If the claim is generally drawn to the correlation between lead in the blood and brain development problems, there is probably a 101 issue. I think the wording of the claim is crucial.
Liekly ineligible under 101:
A method comprising testing blood for lead, wherein the presence of quantity X of lead indicates an increased risk for brain development problems.
Possibly eligible under 101:
A method comprising acquiring a sample of blood from a patient, subjecting the sample of blood to [the chemical test for lead], and inserting the product of the chemical test into [analytical lab equipment].
Note that the (possibly) eligible claim doesn’t say anything about the law of nature.
If you say so. Lots of conflation of different issues. To my mind, figuring out that correlation should be patent eligible. Those correlations are great to know and they only get it for 20 years. And they share it and there are lots of ways to use it without infringing or paying.
And exactly why do we want to not promote things like that again? Why is that? The only reason I can figure out is that Benson (the root of all evil) wanted to kill software.
RH “generally drawn to the correlation between lead in the blood and brain development problems,”
And what’s to prevent Judge Louries, Omalley, and Mayers from distilling the claims down to a gist/ concept of their own creation of say, a correlation between lead in the blood and brain development problems. Then simply say the claim is directed to the correlation between lead in the blood and brain development problems, and therefore ineligible subject matter. See how easy that it is? Just the way the anti lobby likes it.
I share the concern that claims not be distilled down to their gist, but I also think that drafting is important. Two claims which were intended to cover the same thing might be construed very differently!
In that second claim I proposed up at 18.2.1.1 (the possibly eligible one), there’s no law of nature recited (or other judicial exception) for a judge to distill the claim down to. So that kind of drafting might be more effective at avoiding this sort of claim interpretation.
After thinking about what I wrote, I think I can distill the distinction between the claims down to a piece of advice:
If the drafter thinks a law of nature would distinguish a claim over the prior art, there is probably a 101 issue. If the drafter does not think a claim needs a law of nature to distinguish over the prior art, then just leave out the unnecessary verbiage!
If the drafter thinks a law of nature would distinguish a claim over the prior art, there is probably a 101 issue. If the drafter does not think a claim needs a law of nature to distinguish over the prior art, then just leave out the unnecessary verbiage!
Good advice, with the additional reminder that “laws of nature” are just a subset of the larger universe of ineligible abstractions (like any other fact or “correlation”).
“might be construed differently”
And might not be.
Maybe you missed the combination of the Court criticizing the “scriviners” (you yourself mentioned that the two claims were meant to protect the same thing)…
As well as
…the unlimited “Gist/Abstract” sword which ‘magically’ slices through the words of Congress and disbands with any silly notion that your claim IS to an item stipulated as meeting one of the statutory categories (take your pick as any claim sounding in any of the four categories is not spared the limitless “Gist/Abstract” double blade.
With these combined, there is no ‘game’ you can come up with, and the only way whatever Manipulation you effect, the only guarantee you have that it will not be found invalid is if you have not yet appeared before the Court.
101, … distilling the claims down to a gist/ concept of their own creation of say, a correlation between lead in the blood and brain development problems. Then simply say the claim is directed to the correlation between lead in the blood and brain development problems, and therefore ineligible subject matter.
101, according to the new guidelines from the PTO, the “directed to” step of the analysis searches the claim for nonstatutory subject matter such as product of nature, laws of nature or abstract ideas, and for the latter gives enough cases and examples for the average person figure out what that is.
It is not in particular, at least according to the PTO, a search for an inventive concept or gist of the invention. Rather, it is a search of the claim for nonstatutory subject matter.
NWPA: “The judges just proclaim this with no evidence or without going through any type of analysis.”
This is exactly right. And the reason why you do not see any level of Integration Analysis in the majority of CAFC decisions, is that without the facts and the law, you can make up anything you want.
I’ll rephrase the question – let me know if I misunderstood you.
If a chemical test for lead in fluids (generally) was known, would a claim directed to this chemical test for lead in blood (specifically) be eligible under 101?
If a chemical test for lead in fluids (generally) was known, would a claim directed to this chemical test for lead in blood (specifically) be eligible under 101?
Absent any express teaching in the art that “blood is not a fluid” or that “the test cannot be used on blood” (and that doesn’t appear to be part of your hypo) the test would seem to fall in the category of “old technology applied to material that was contemplated by the technology”.
In other words, it’s old. There’s no “invention”. It’s tanked under 101 or 102 and it doesn’t matter which.
You can take it out of the medical field and (as usually happens) the result is more easily “digested.” Let’s say I invent a device for an amputee to hold a book up to his face. Now you come along and try to claim the identical device except that in your claim the device comprises The Flower Died Today (your excellent new book that nobody ever disclosed specifically before).
Do you deserve a patent? Of course not. Is this a question of “obviousness”? Nope.
Now, you can argue that chemistry is an “unpredictable art” and that argument will have weight in certain instances and change the analysis. But it doesn’t have weight in every instance. Your hypo suggests that the test for detecting lead in fluids generally was known. Given that blood is a fluid, where’s the “unpredictability” in that case and, more importantly, where does the solution to that “unpredictability” appear in your claim?
Malcolm, you simply are not correct to say that it does not matter between 101 and 102, as it mattering is very much the point of the coversation.
You have retreated to your old position of “WHATEVER”
Then to make matters worse, you drag out the canard of “book” something you know is not in the Useul Arts to begin with and cannot be used to make a point in law that must be made with the proper basis of being in the Useful Arts.
And it’s not as if this type of duplicity has not been pointed out to you previously…
You see PatentBob, this is precisely why the merry-go-round keeps on going around.
“something you know is not in the Useul Arts to begin with and cannot be used to make a point in law that must be made with the proper basis of being in the Useful Arts” (sic)
Given relatively recent supreme court decisions that are pushing software into non-statutory land, it doesnt sound like such a terrible analogy… Two non-statutory things.
Of course I am talking to the guy who will, with a straight face, argue with you that a light switch in the on position is a different light switch than the same switch in the off position.
Its been a hard day for you anon. Lots of people have been taking implicit and explicit swipes at you.
Have you considered going on a little holiday break from posting here? Maybe you could spend that time focusing on improving your “craft” at i.p.w a tchdog.
Dear Happy,
Thank you for your concern but let me assure you that this has not been a hard day at all.
People taking swipes at me (either implicitly, explicitly, or both) don’t bother me, as any one familiar with the law can readily see that the swipes badly miss.
Further, you again seem to miss the fact that I debunked the “light switch” mischaracterization – several times now.
And further still, your comment about the Supreme Court pushing software into non-statutory land is dreadful off. Surely you are not referencing the Alice decision, are you?
Please feel free to explicate and confirm how little you understand what is going in that decision.
And finally, “Have a nice day.”
“book” … cannot be used to make a point in law
Totally false and ridiculous on its face. But keep pounding the table anyway. You don’t look like a raving lunatic at all! You’re a very serious person.
mattering is very much the point of the coversation.
Indeed. That’s why subject matter eligibility is important and it’s why it can’t be disregarded as some sort of mere formality that can be addressed by mere wordsmithing. It does matter. It matters a lot.
Get used to it because it’s not going away.
RH Wrote: “If a chemical test for lead in fluids (generally) was known, would a claim directed to this chemical test for lead in blood (specifically) be eligible under 101? ”
Yes, if you can show a new use of the old test in combination ( Integrated ) with all the other elements. The claim as an integrated whole needs to be doing more than the individual sum of each part or element.
curmudgeon Would whomever first discovered [not that many years ago] that lead affects child brain development be able to get get a valid patent with generic claims broadly covering any conventional chemical test for lead content in children’s blood?
Methods of detecting lead in blood have been around for a long time, including detecting lead in children’s blood, so the answer is surely no.
A claim that would effectively amount to ownership of the discovery such that nobody could detect lead in children’s blood using the old techniques and then think about “what it means” and/or communicate that ineligible “meaning” to somebody presents severe subject matter eligibility issues.
Now, if someone were to develop some new technology for detecting lead in children’s blood (e.g., some method that unexpectedly results in improved measurements of lead levels) we’d have a completely different story and, depending on the details of the claim, a completely different outcome.
I guess talking about the breadth of the “Gist/Abstract” sword is out of the question…
(mayhap too curmudgeony)
This comment from Hans is worth elevating given what we’re guaranteed to hear over and over again from defenders of Myriad’s claims and similar claims that attempt to fence off “important” parts of the human genome:
[someone suggested] that you need FDA clearance in order to bring a genetic test to market? Um, not exactly. Myriad’s test is what is known in the industry as a “home brew” test. These are tests where everything is performed in-house. Although the FDA was theoretically given authority to regulate these tests in 1976 when the Food, Drug & Cosmetic Act was amended to specifically include in vitro diagnostics under the umbrella of a “medical device,” it has up to now chosen to not do so. Labs that offer home brews generally must follow a set of regulations known as the Clinical Laboratory Improvement Amendments which are implemented by the Center for Medicare and Medicaid Services. But that’s really it. There is a push to get the FDA to more aggressively regulate home brews, but naturally the labs that offer home brews resist this, and frankly for good reason (well, mostly). The bottom line is that there is absolutely no comparison in getting a drug to market versus getting a home brew test to market.
The notion that tests such as those offered by Myriad and Prometheus would not exist absent patent protection is offensive. I actually know what I’m talking about here. And I also know a thing or two about patents and genetic tests, having literally been on the front lines in this area for years. The term “gnostic” means “pertaining to knowledge.” This definition gives one a clue as to why the screening claims at issue in today’s decision were invalidated, and why the claims at issue in Mayo v. Prometheus were invalidated. Fundamentally they were efforts at patenting information. Don’t let anyone fool you about that.
If the FDA does decide to aggressively regulate home brews, then I would personally be in favor of a “marketing exclusivity” period for home brews just like occurs now for new drug products. That could provide the so-called necessary incentive for the development of home brew tests.
I’ll also take this opportunity to remind everyone that the alleged value to “science” of the correlations and information disclosed in the typical data-crunching correlation patent is infinitesimally small given (1) the lack of peer review of patent disclosures; (2) the lack of any incentive for patent applicants to highlight the shortcomings of their own data (in fact, the opposite incentive exists); (3) the well-known effect that “legalese” has on the comprehensibility of patent disclosures to skilled artisans; and (4) with respect to claims, the lack of any uniform standard for determining when a given “new” correlation between X and Y is sufficiently robust to be of any practical value to anybody.
…the lack of peer review…?
LOL – tell me how well that works in the cesspool of Ivory Towerisms
Peer review is just like what Winston Churchill said about democracy: it’s the worst system of advancing human knowledge, except for all the others.
I think, however, that MM is rather missing the point. Kary Mullis’s PCR patent is much less readable than his PCR papers. But we would not have the papers but for the patents. If Cetus had thought they could not have protected Mullis’ invention with a patent, they simply would not have disclosed the technique at all, and molecular biology would have advanced far more slowly.
No doubt MM will respond that someone else would have discovered (and disclosed) PCR anyway. That may well be true, but we should not be indifferent to whether the disclosure is made now or three years hence. We are each only going to be around for a finite time, and we all have, therefore, a real interest in seeing that as much progress gets made in the time we are still around to enjoy it.
Greg DeLassus: If Cetus had thought they could not have protected Mullis’ invention with a patent, they simply would not have disclosed the technique at all
This is a joke, right? Please tell me this is a joke.
No doubt MM will respond that someone else would have discovered (and disclosed) PCR anyway. That may well be true
It is true.
we should not be indifferent to whether the disclosure is made now or three years hence.
Try to focus on the topic of the discussion, Greg. Nobody here is suggesting eliminating patents on innovations like PCR. In fact, I made the opposite contention already in this thread (comment 9.1).
Please try to step it up, Greg.
Your problem is that you want to judge patents based on the gist how does it make me feel standard MM.
Shameful lack of discipline and understanding of how law should be applied.
Thanks Greg. I used to type out long answers and explain all the particulars on this board, but I tired of the endless nonsense. On the next thread it will be as if MM never read or responded to any of your posts.
Still your posts are great.
Greg DeLassus:
Peer review … is the worst system of advancing human knowledge, except for all the others.
Deep stuff. Very impressive. You gotta love these patent attorneys who aren’t afraid to speak their … well, “minds” really isn’t the right word here.
Meanwhile, the point made about the absence of peer review of patent disclosures stands unrebutted.
It stands unrebutted because it is a fair point. I agree with you that the level of science in patent writings is not always up to snuff, in large measure because of the lack of peer-review, as you point out.
To my mind the problem is the lack of modernization of the prosecution process. The PTO must be the experts. The MMs of the world constantly want to try to switch the burden from examining at the PTO to submitting papers that indicate your worthiness of getting a patent.
That makes no sense from any type of business or information processing point of view.
I guess that my point was that I agree that an argument that patent application disclosures somehow advance the state of the are is indeed flawed. They are not written to be read by other scientists. They are written to be read by judges and (to a lesser extent) other lawyers.
Moreover, as MM points out, any old fool can submit an application, and if one had to advance the state of the art by wading through all of that dross and picking the good stuff out from the wackadoodle, it would be slow going. Mercifully, no one does. The state of the art advances in practice by the communication of ideas in peer reviewed journals, and at conferences, and by competitors buying each others products and reverse engineering them.
To say, however, that therefore patents are dispensable (or even deleterious) to scientific progress rather misses the point. How much of the disclosure in journals and conferences and sales would we have without the patent system? I gather that MM believes that the answer to this question is “about as much as we have today,” but this seems rather naive to me.
Regrettably, while this is in principle an empirical question, I do not know how one actually does the experiment to answer it. Even if dispensed with patents for the next ten years and saw no change in the pace of innovation, you could not formally rule out the possibility that institutional inertia kept things going for a few years beyond the point at which the legal incentives that built that inertia left off. On the other hand, if you did away with patents and innovation tanked a year later, how would you know whether the observed effect was not some sort of supply shock or business cycle phenomenon?
>How much of the disclosure in journals and conferences and sales would we have without the patent system?
That is the key point. I do know with computers that we started down the road of trade secrets and secrecy in the early 1980’s when I was a developer. Companies would make you sign draconian agreements not to compete with them and not to disclose anything you have done.
And chip makers were building chips with built-in mechanisms to hide how the code was written.
I could go on….it was bad. We are going back there now.
Caught in the filter, but Greg long story short: your emperical experiment is called the Bayh-Dole Act.
Greg: To say, however, that therefore patents are dispensable (or even deleterious) to scientific progress rather misses the point.
Well they certainly are dispensible because “scientific progress” has been happening without patents for a long time. And I don’t recall anyone saying that patents are “deleterious to scientific progress” so whatever “point” is being missed there exists only in your mind, Greg.
How much of the disclosure in journals and conferences and sales would we have without the patent system? I gather that MM believes that the answer to this question is “about as much as we have today,” but this seems rather naive to me.
It’s you that’s being “naive” here.
Here’s a little thought experiment for you: take all the “disclosures in journals and conferences and sales” throught US history that were never patented and weigh them. Now subtract the weight of all the unique patent disclosures. Do you know what you are left with? About the same amount of disclosure.
And this is Malcolm being “pro-patent”…
As they say, with friends like this, who needs enemies?
“it’s you that’s being ‘naive’ here”
Naive…? Like the patent system is not under attack naive?
Like that?
Greg: if one had to advance the state of the art by wading through all of that dross and picking the good stuff out from the wackadoodle, it would be slow going. Mercifully, no one does.
You’ve clearly never worked in the medicinal chemistry arts. Medicinal chemists read as many, if not more, patents than scientific papers, because big pharma companies discourage (or prohibit) publications regarding small molecule drugs that are in development (i.e., undergoing clinical trails). While plenty of publications do reach the scientific journals, the most important compounds typically first show up hidden away in the midst of hundreds of compounds in published patent applications.
“anon”: this is Malcolm being “pro-patent”…
Because a “true” “pro-patent” belieber sticks to “anon’s” awesome script.
Yes, we’ve heard it all before.
Go ahead. Tell everyone that “MM must be an Examiner” or that I must be a “paid shill.” Or my personal favorite: “MM is Dennis’ sockpuppet.”
Super effective stuff. Very serious.
This cannot be correct. The Baye-Dole Act did not change the law in Europe, or Japan, etc. For the experiment to tell you anything, it would have to be worldwide, not US specific.
Besides, as I noted before, it is impossible to tease out what is “effect” and what is “coincidence” when legislation is changed. What you really need are two parallel Earths, one of which abolishes patents worldwide and the other of which retains them, and then compare the state of technology in each at the end of some arbitrary time period (10 years?). Suffice it to say, this is a hard experiment to run.
Actually Greg, since there is no “world patent” and all patent law is sovereign in nature, you cannot test this out on a worldwide basis.
Notwithstanding any operational difficulties the closest that you will come to a test is in fact the Bayh-Dole act.
Your “cannot be correct” is simply too presumptuous and ungrounded.
What also stands unrebutted Greg is that the mere idea of “peer review” does not stop a cesspool of CRP generation and such “being blessed” from a biased and agenda driven body of people having deleterious impacts on real innovation.
When meritocracy is replaced with “peer approval,” one cannot close one’s eyes to the effects of such.
a biased and agenda driven body of people having deleterious impacts on real innovation
Because “anon” is totally unbiased and has no agenda.
Try to believe it, folks.
When meritocracy is replaced with “peer approval,” one cannot close one’s eyes to the effects of such.
Fancy sounding but utterly devoid of meaning. Thanks for the warning, “anon.” Yay “meritocracy”, whatever that is supposed to mean.
Note too that there is no peer review of papers in law journals. So Lemley’s continued parade of judicial activism papers are only approved by Lemley.
Bingo.
Likewise see Bessen and the proliferation of rhetoric – even after his numbers have been thoroughly debunked.
If someone (SC, congress) decided to do away with “software” patents (assuming one could even define what those are), I see many of my clients ceasing to publish probably 90% of what they do. The clients that are involved in areas where publishing is mandatory for academic purposes would still publish, although I think the amount of publication would go down. I’m just not sure by how much.
These are all clients doing work with real computer systems (nothing “abstract” but likely would meet that “definition”), but the amount that published would decrease will depend on the specific areas the clients are in.
By the way, I wonder why I come here. 90%+ of the comments below are sniping between people, long rambling discourses that could be boiled down to a few sentences, etc. The amount of actual civility and interesting debate is too small. It also seems that the people asking true questions and posing good comments get immediately attacked and bludgeoned to the point they don’t come back. (I’m probably getting the same treatment, but I don’t have time to revisit any comments I make, so I wouldn’t know.) All the “old timers” here, who seem to be taking the same positions every time, seem like some kind of obdurate, masochistic yet cliquish group. Why do this? Why argue with people who refuse to even attempt to see your opinion or evidence? Life is to short to behave like this. I expect this for an article about the Newtown massacre and gun control, but I had assumed professional people with multiple degrees were somehow different. Perhaps I’m mistaken.
The simple answer PatentBob is that propaganda works.
Letting the one side have their drive-by monologues without rebuttal would be (and has been) used as propaganda.
What would make this a better and true dialogue would be the insistence of validly made counterpoints being integrated into the discussion.
As has been my stance since I first started posting here.
people asking true questions
Question for you, “PatentBob”: it’s 2014. Mayo v. Prometheus was decided 9-0 over two years ago, after years of debate about the correct outcome (calling it a “debate” is being generous because the losing side had only one “argument” that never made sense).
So … when do “questions” by alleged patent attorneys — patent attorneys who portray themselves as well-informed people — which betray a complete misunderstanding of the claims at issue, the eligibility issues presented, and the rationale underlying the decision become “true questions” for discussion, as opposed to attempts to derail the thread and/or tr0ll the blog and/or just introduce choking dust into the conversation?
It’s like having a blog about voting rights legislation where some guy keeps “arguing” that the “real issue” is that slavery shouldn’t have been abolished, therefore anybody who doesn’t “acknowledge that” is “biased.”
And we all know where the misinformation and confusion about subject matter eligibility is coming from. It’s right out there in the open. It’s *been* right out there in the open the whole time. It’s two blogs, primarily. And guess what? Invested patent attorneys behind both of them.
That’s actually not accurate any longer, I believe. FDA calls these “home brew” tests Laboratory Diagnostic Tests (LDTs) and recently indicated that they intend to take a much greater oversight role in them There is a new draft guidance dating from October. The definition of LDT is actually quite narrow now, too. The relevant FDA page is here: link to fda.gov
Trust me, it is accurate. There is no formal regulation by the FDA of home brew tests. And it is “laboratory developed test” not “laboratory diagnostic test.” What was published in October was a “framework” for regulatory oversight of home brews. This is light years from actual regulation. None of this is particularly relevant to the subject of the post. I only brought it up earlier to rebut the contention that home brews like Myriad’s BRACAnalysis test require FDA approval. That contention was made in support of a policy argument in favor of patent protection for these tests.
So, are the common-law exceptions to section 101 a matter of constitutional law? I cannot find a case that says that they are, and I note that even the scholars who really want the exceptions to be a matter of Con Law never cite a case, which tells me that there is no such case. See, e.g., Robert Kreiss “Patent Protection for Computer Programs and Mathematical Algorithms: The Constitutional Limitations on Patentable Subject Matter” 29 NM L Rev 31, 58 (1999).
So, what Con law jurisprudence do we have on the Patent & Copyright clause? Well, just two years ago in Golan v. Holder, 132 S. Ct. 873 (2012) the court considered whether it was constitutional for the Congress to extend copyright terms on works that had already lapsed into the public domain in the U.S. Congress had, pursuant to our Berne convention obligations, extended the copyright term on Dmitri Shostakovich’s works in the U.S. Lawrence Golan, a symphony conductor, sued the Justice Dept arguing that he had previously been able to perform Shostakovich in the U.S. without copyright clearance, and that he was harmed by the copyright revival because he would now need clearance to perform these works. He argued that the term extension was unconstitutional because the Constitution provides that patents and copyrights are authorized by Art. I, § 8, cl. 8 to “promote the progress of science and useful arts,” and that this term extension could not possibly promote Shostakovich to write new works, because he was dead.
The Supreme Court held that the standard for review of IP clause cases is “rational basis.” Golan, 132 S. Ct. at 889. Patent and Copyright statutes can survive constitutional scrutiny under the IP clause so long as “Congress rationally could have concluded that [the statutory provision] ‘promotes the diffusion of knowledge’…”
So, when considering whether the subject matter eligibility exceptions are a matter of Con law, the question to ask is “Could Congress rationally believe that extending patent protection to (e.g.) isolated nucleotides promotes the diffusion of knowledge?” Surely the answer to this question is yes. That is not to say that extending patent protection to isolated nucleotides does promote the diffusion of knowledge, but Congress could at least rationally believe as much.
In other words, Congress could revise the statute to reverse Myriad, Mayo, and/or Alice. That is a separate question from whether Congress should, but clearly Congress can.
Thanks Greg.
I would take this opportunity to point out to my loyal circle of naysayers that the reference that Greg puts on the table for discussion has previously been put on the table by yours truly.
Dialogue, gents, means actually engaging those counterpoints given to you, even as they wreck your little “opinion/policy” agendas.
I think you’re over reading the holding in Golan. The Court explained that they would not review the law in question specifically because the copyright act had built in safeguards to protect ideas.
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The idea/expression dichotomy is codified at 17 U.S.C. § 102(b): “In no case does copyright protec[t] … any idea, procedure, process, system, method of operation, concept, principle, or discovery … described, explained, illustrated, or embodied in [the copyrighted] work.” “Due to this [idea/expression] distinction, every idea, theory, and fact in a copyrighted work becomes instantly available for public exploitation at the moment of publication”; the author’s expression alone gains copyright protection. Eldred, 537 U.S., at 219, 123 S.Ct. 769; see Harper & Row, 471 U.S., at 556, 105 S.Ct. 2218 (“idea/expression dichotomy strike[s] a definitional balance between the First Amendment and the Copyright Act by permitting free communication of facts while still protecting an author’s expression” (internal quotation marks omitted)).
Given the “speech-protective purposes and safeguards” embraced by copyright law, see id., at 219, 123 S.Ct. 769, we concluded in Eldred that there was no call for the heightened review petitioners sought in that case.[30] We reach the same conclusion here.
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I’m not saying you’re wrong necessarily, but I don’t think Golan supports your position as strongly as you’d like. Especially where the Court has specifically held that the claims at issue in the cases you cite amounted to the protection of an idea itself.
Fair enough. Maybe, then, the abstract idea exception really is a part of Constitutional law. Consider me unconvinced, but I will agree to say “maybe.”
That really says nothing about Mayo or Myriad, however. There is nothing about isolated DNA claims that implicates the first amendment. Similarly, there is nothing about the first amendment that protects administration of drugs or measurement of drug metabolites. In other words, maybe the Congress has no power to legislatively overturn Alice, but I stand by the contention that Golan proves that they can overturn Mayo and Myriad. It is an open question whether they will want to, but they surely can.
I stand by the contention that Golan proves that they can overturn Mayo
You can contend whatever you want but you are dead wrong and you haven’t provided a remotely convincing argument for your position.
Nevertheless, enjoy the “freedom” to spout indefensible nonsense about Congress having the authority to override the First Amendment and grant patents on information. You are a very serious person with a law degree and everything and you make everyone blush with your deep insights.
there is nothing about the first amendment that protects administration of drugs or measurement of drug metabolites.
That’s nice. Nobody ever argued otherwise. Any other worthless strawmen you want to beat up on today?
So the community highly regards this blog, and whenever anyone recommends to another potentially interested party it is also with the caveat “don’t read the comments.”
It is comments like this that have made that necessary.
“You are dead wrong and you haven’t provided a remotely convincing argument for your position.”
Note that you had to qualify that with “remotely convincing,” because he at least put forth an argument. You have not, you simply accused him of being wrong because you didn’t like his argument. You didn’t respond to it. You didn’t attempt to counter it. You just called him wrong because you said so. And then you went on to personally attack him.
The world isn’t out to get you. When someone anticipates a counter argument and responds to it, that doesn’t make it a strawman and it certainly doesn’t warrant a personal insult.
It is comments like this that will insure that I and most readers will continue to visit only for the articles themselves.
There is nothing about isolated DNA claims that implicates the first amendment.
See my post at 16.5. DNA exists in nature. The structure of the isolated part exists in nature, it pre-existed the isolation of it, and actual newness is a constitutional requirement.
The process for isolating it is eligible. The actual structure is not.
I agree that novelty and non-obviousness are constitutional requirements, but as Judge Lourie noted, the bare novelty of isolated DNA comes from the chemical distinctions (free phosphates) between the isolated and in situ sequences. That Justice Thomas preferred to ignore the words of the statute (“composition of matter”) in favor of his own rough-and-ready understanding of the technology does not rise to a constitutional problem. Certainly Justice Thomas never referenced the IP clause in his opinion.
Greg,
If you adhere to the notion that non-obviousness is a constitutional requirement, are you saying that pre-1952 law (which lacked the explicit non-obviousness requirement) was unconstitutional?
Really?
(and please recognize your own citation to Rich and the history of Congress choosing non-obviousness instead of “invention”).
Hotchkiss was predicated on the idea that non-obviousness is a background supposition to the patent law, because Congress is not statutorily empowered to set up a patent system that would allow patents on obvious developments. Judge Rich certainly did not disagree with that point. Indeed, he says as much in the very first paragraph of the cited article.
The old “inventive step” common law was necessary in order for the pre-1952 act to be constitutional. That does not mean, however, that every jot and tittle of that pre-1952 jurisprudence was constitutionally necessary. Congress was free to prune out some of it (such as “flash of genius”), just as Congress is free to prune out some of the less savory recent developments (such as “inventive concept”).
Congress is free to prune out some of the less savory recent developments (such as “inventive concept”).
Please tell everyone how Congress can eliminate consideration of the inventor’s contribution to the art from the patent system and leave us with (1) a working patent system and (2) a Constitutional patent system.
You really do sound like you were born yesterday, Greg. Either that or you’re just a dishonest hack desperate for attention.
Somehow, I am reminded of Saki’s The Hen.
It is as if there is a contest to see how much ad hominem invective can be packed into a given number of words.
Two points Greg:
1) you fail to recognize the difference in the path chosen by Congress with non-obviousness INSTEAD OF inventiveness, and
2) you appear to be a relatively new poster to Malcolm’s tactics. Would it surprise you to learn (as I have recently learned) that Malcolm’s behavior has persisted in this very same manner for more than eight years and running?
Why do you think that Malcolm treads such a well worn path?
Possibly. Could you unpack this a bit? I am not clear on how your response relates to my earlier point.
In any event, I am not saying that the pre-1952 acts were unconstitutional, but only because Hotchkiss et al. redeemed them.
Meanwhile, as noted above, Judge Rich himself says in “Laying the Ghost…” that “it is §103 which brings about statutory compliance with the Constitutional limitation on the power of Congress to create a patent system” (emphasis in original). In other words, I am not saying anything particularly original or controversial.
Greg,
Are you saying that your point is not to the fact that there are differences in the law as written by Congress pre- and post-1952, but that both versions of the law served to make sure the system set up by Congress met with the constitutional strictures?
In that case, the emphasis of my post – the fact that Congress did act to make the change in 1952 is not germane to the particular point you are stressing (yet remains crucial for understanding what today’s law means and why the conflation of the Court in avoiding what Congress did with its action of distilling both 101 and 103 from the same pre-1952 paragraph means for both 101 and 103 jurisprudence).
My apologies. In re-reading my 4:02 post, I see that I could have been more clear.
It appears that we are in agreement, dear anon. I am saying that both the 1836 Act and the 1952 Act were constitutional. The 1836 Act would not have been constitutional if the Supreme Court had not read a requirement for “inventive step” into it, but that is neither here nor there.
As Judge Rich was careful to explain, “obviousness” is not the same thing as “invention,” but neither are the two concepts totally unrelated. Congress was free to modify the common-law doctrine of “invention,” but it was not free to do away with the core insight of the old “inventive step” jurisprudence—i.e., that patents may not be granted for improvements that are merely obvious developments on the state of the immediately previous art.
Meanwhile, I agree that the Supreme Court seems lately determined to revive the old “inventive step” standard, and to pack the 101 and 103 analyses back together. I agree that this is wrong, but regrettably it will likely require a new statutory revision to make the SCotUS give up this trend.
In other words, Congress could revise the statute to reverse Myriad, Mayo, and/or Alice.
Possibly something could be written to reverse Myriad or Alice.
But not Mayo. That’s never going to happen.
That is a separate question from whether Congress should, but clearly Congress can.
Clearly you don’t understand what you’re talking about, Greg, and we know that because you’ve indicated as much in very plain terms. It’s like you were born yesterday … when it comes to certain issues anyway (go figure).
Here’s the education received below and you have not acknowledged:
1. A method comprising the steps (1) drinking a cup of coffee and (2) thinking about whether a set of primers is identical to another set of primers.
Drinking coffee isn’t “abstract”. But the claim prevents me (and other coffee drinkers) from thinking about an abstract relationship between two primers. In other words, the claim protects the abstraction.
That’s Mayo, in a nutshell.
It’s really quite straightforward, Greg. Start with the fundamentals and learn to apply them and never forget them. It’s what the courts are doing and it’s what the PTO is doing. You need to learn to do it, too, if you want to taken seriously by anyone outside of the tiny circle of hacks who never saw a patent they couldn’t defend.
Your nutshell still revolves down to the b@nal “can’t patent unrelated aggregations” – with or without ANY elements of a claim sounding in ‘mental steps.’
Nothing more.
Let’s talk about learning lessons on basics, as you ever clench right your eyes to that basic lesson.
“Could Congress rationally believe that extending patent protection to (e.g.) isolated nucleotides promotes the diffusion of knowledge?”
Actually greg the question is “Could Congress rationally believe that extending patent protection to abstract ideas, natural phenom, and laws of nature promotes the diffusion of knowledge?” Since those are the three things currently excluded.