Supremes Rule Isolated DNA and Some cDNA Patent Ineligible

Justice Clarence Thomas

UPDATED June 13, 8:24pm ET (see comment #15 & #19)

Earlier this morning the United States Supreme Court issued its much anticipated ruling in Association of Molecular Pathology v. Myriad Genetics. Justice Thomas wrote for a a nearly unanimous Court, only Justice Scalia wrote separately and he concurred in part and concurred in the judgment. The decision is not long, and approximately half of the decision is background, yet at the end of the day much damage has been done to the biotechnology industry, the medical industry and the patent system. Indeed, the assault on patents continues.

According to Todd Dickinson, Executive Director of the American Intellectual Property Law Association, the outcome was fairly predictable given the oral argument, although 9-0 was a bit surprising. Dickinson told me via telephone earlier today the the decision itself is disappointing because it “keeps framing an anti-patent narrative.” He went on: “Patents are terribly useful to incent innovation and necessary to provide funding. If we undermine the patent system further I think we will be shooting ourselves in the foot.” I couldn’t agree more!

[Bio-Pharma]

The Decision

Justice Thomas summarized the Court’s decision by saying:

[W]e hold that a naturally occurring DNA segment is a product of nature and not patent eligible merely because it has been isolated, but that cDNA is patent eligible because it is not naturally occurring.

Further, with respect to cDNA, Justice Thomas also explained:

[T]he lab technician unquestionably creates something new when cDNA is made. cDNA retains the naturally occurring exons of DNA, but it is distinct from the DNA from which it was derived. As a result, cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.

So, cDNA is patent eligible as long as the series is not too short. But wait, there is more. It is not correct to take form this decision any believe that cDNA is patent eligible. When you unpack the decision and apply it to the claims directly, which the Supreme Court did not do directly, it becomes clear that there are real and very significant limitations on patent eligibility relating to cDNA.

More on cDNA

Some are reporting that the Supreme Court split the baby, so to speak, finding isolated DNA patent ineligible and cDNA patent eligible. Not so fast!

Time and time again the Court explains that Myriad’s claims cannot be saved for one reason after another, but how is that possible if cDNA is patent eligible? You see, the claims at issue all incorporate cDNA into the claim itself, and the cDNA incorporated was a composite cDNA created from hundreds of individuals.

Justice Thomas further explained:

[C]laim 1 [of the ‘282 patent] asserts a patent claim on the DNA code that tells a cell to produce the string of BRCA1 amino acids listed in SEQ ID NO:2.

Justice Thomas then goes on to explain:

Like SEQ ID NO:2, SEQ ID NO:1 sets forth a long list of data, in this instance the sequence of cDNA that codes for the BRCA1 amino acids listed in claim 1. Importantly, SEQ ID NO:1 lists only the cDNA exons in the BRCA1 gene, rather than a full DNA sequence containing both exons and introns.

The Supreme Court ruling must mean that even though cDNA is patent eligible the presence of cDNA in the Myriad claims did not save those claims, although the point is not directly addressed. Thus, the statement that cDNA is patent eligible has real and significant limitations. Still, whatever the boundaries of the Supreme Court ruling, the ruling has to at least mean that a composite cDNA made from the hundreds of individuals in a lab setting is not patent eligible unless it contains both exons and introns.

Chakrabarty No Longer Relevant

The Supreme Court’s decision today obviously and seriously undermines the continued relevance of the Chakrabarty decision given that something (i.e., composite cDNA) created in a lab by man is not patent eligible. The very foundation of the Chakrabarty decision mandates a finding of patent eligibility when man has engaged in activity to alter something. Clearly a composite cDNA made up of hundreds of individuals was created by man and by and through the sequence listings incorporated into the Myriad claims. Thus, the very fabric of Charkabarty has been ripped to shreds, although the Supreme Court didn’t understand that this is the factual and scientific consequence of the ruling.

Not recognizing that the decision today undermines Chakrabarty, the Supreme Court sought to distinguish this case from Chakrabarty, explaining:

In this case, by contrast [to Chakrabarty[, Myriad did not create anything. To be sure, it found an important and useful gene, but separating that gene from its surrounding genetic material is not an act of invention.

Justice Thomas then wrote the nearly incredible statement:

Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.

Yes, the Supreme Court ruled today that innovative discovers are not patent eligible. No need to inquire whether they are new, non-obvious and adequately described. If you have an innovation no patent for you!

Thomas claims support for this ridiculous statement that innovative discoveries are not patent eligible is found in Funk Brothers Seed Co. v. Kalo Inoculant Co. Yes, the same Funk Brothers case from 1948, which gets used to kill software too! The same case that was decided by the Supreme Court some 65 years ago, which pre-dates both the biotechnology and computer industries.

Justice Scalia’s Opinion

As for Justice Scalia’s concurrence-in-part and concurrence in the judgment, it was very brief. Justice Scalia wrote only 1 paragraph, which in part explained:

It suffices for me to affirm, having studied the opinions below and the expert briefs presented here, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA (cDNA) is a synthetic creation not normally present in nature.

So if an invention is identical to what appears in nature the innovation is patent ineligible. That should fairly well kill any and all development in the medical field related to growing organs for medical transplantation since the entire point is to create something that is identical to the organ found in nature.

[Books-1]

Fallout from the Decision

This decision is really a huge blow for much of the biotech industry. You can expect stock prices for many biotechnology companies to crater, if that hasn’t already happened by the time you are reading this article.

Furthermore, you can expect a near complete cessation in many areas of personalized medicine. If creating something in a lab, such as a composite cDNA, does not make the underlying claims patent eligible because what results is indistinguishable from what appears in nature that means that the fledgling and potentially promising technologies to grow organs for transplantation will shrivel up and die. The whole point is to create an organ that is indistinguishable from what appears in nature so that it can be transplanted into a human body to prolong life. Given the breadth of this opinion and the uncertainty it will cause funding will dry up in the U.S.

Today is a big win for those who wish to copy innovators.

Today is a big lose for the advancement of science and even a bigger lose for people who rely upon the advancement of medical technologies to live longer, better lives. Thus, we all lose.

Today is also a big loss for the patent system. The United States Patent and Trademark Office has been issuing these types of patents for upwards of 30 years without challenge in the Courts and all the while Congress knowing that such patents were being issued. The settled expectations of corporations meant nothing to the Supreme Court, which continues to operate as if a patent is not a property right.

Will Congress step in and do anything? Who knows, but they should. Yesterday the Patent Trial and Appeals Board at the USPTO issued a ruling that as a consequence of the ruling makes software patent ineligble. So on back to back days we have decisions that will render many hundreds of thousands of patents void and render many hundreds of thousands of patent applications useless.

By the way, if you haven’t noticed, the software and biotechnology industries are the backbone of the U.S. economy. So while this decision was urged by the Obama Administration the impact will not be good news for the Obama Administration, which will watch numerous jobs vanish and the economy suffer as a result.

The war on patents continues!

Gene Quinn Gene Quinn is a patent attorney and a leading commentator on patent law and innovation policy. Mr. Quinn has twice been named one of the top 50 most influential people [...see more]

Warning & Disclaimer: The pages, articles and comments on IPWatchdog.com do not constitute legal advice, nor do they create any attorney-client relationship. The articles published express the personal opinion and views of the author as of the time of publication and should not be attributed to the author’s employer, clients or the sponsors of IPWatchdog.com.

Join the Discussion

159 comments so far.

Wayne Borean
July 17, 2013 12:09 am
@Mike,

Do a search on “HTML Mark Up Language” and check out BlockQuote. It’s very useful.

Not what I said. I said you haven’t created an entirely new SUBSTANCE. Your statue doesn’t exist in nature. I’ve already told you that it is patent eligible under 101. As you say, the appropriate rejection would be under 102. And I can certainly envision a number of wooden doorstops that would be patent eligible under section 102 as well. Probably not commercially viable, but I am fairly confident I could design something that would exclude the prior art.

Now here’s where we get into problems. I can’t see how a statue, which effectively does nothing, could be patentable. The same thing applies to the BRCA1 and BRCA2 genes. On their own, they don’t do anything, and are part of a pre-existing structure.

Compare them to a Wifi chip. it didn’t exist before it was designed, and produced.

Now the process to make the statue, or to isolate the genes, that would be patentable, assuming it wasn’t ruled out by 102 and 103.

I find your comment about the “inconvenience” of a change in the law and the comparison to Skype to be a little specious. This is not a prospective change in the law, it is entirely retrospective. As I said before, the Supreme Court dis explain how to claim new genetic material in a way that would be patent eligible, and most of the inventions that were properly claimed and properly granted under the previous rules would still be properly granted if they were claimed in conformance with the new rules. However, those inventions are now public property, since the Supreme Court has decided they were claimed wrong. This isn’t requiring a new feature in future releases. Imagine the effect on the pharmaceutical world if the Supreme Court reached a decision that made all pharmaceutical patents issued in the last 15 years invalid while permitting new pharmaceutical patents to issue. Every currently patented drug comes off patent, but new research can still be covered by patents.

I agree that changing the law is a nuisance to the people who depend upon it, but such changes are necessary sometimes. Consider Loving v. Virgina.

Truthfully it isn’t that bad, especially not for Myriad, but only because they had so many increasingly narrow claims built into their patent portfolio and only these very broad claims were limited out. They were fortunate that they were among the very early groups patenting in the field of gene research, before even the USPTO figured out how the claims should be written, and they wrote them every way they could. Once the USPTO did come to a decision on how these inventions should be claimed, however, the patents most frequently were only claimed in the specific manners recognized by the USPTO, and granted under that paradigm. Those are the people that will be hurt by this decision.

I’m of the opinion that the USPTO is totally incompetent, and has always been. If the USPTO wasn’t incompetent, we wouldn’t see patents like US Patent Number 4902487, which was totally ridiculous. If you don’t understand the technology, I’ll be happy to explain why the patent is ridiculous, but you need to be a fairly decent chemist for it to make sense.

Wayne
Mike
July 14, 2013 11:18 am
@Wayne (sorry, I’m not good with markups so I can’t do the nice quotes that you do)

You say “so you think the statute I’ve carved exists in nature?”

Not what I said. I said you haven’t created an entirely new SUBSTANCE. Your statue doesn’t exist in nature. I’ve already told you that it is patent eligible under 101. As you say, the appropriate rejection would be under 102. And I can certainly envision a number of wooden doorstops that would be patent eligible under section 102 as well. Probably not commercially viable, but I am fairly confident I could design something that would exclude the prior art.

You mention in two places, “is it eligible under 102 and 103?” You are right, I haven’t addressed that at all. And neither has the Supreme Court. That is EXACTLY my point. The entire focus of prosecution and patent eligibility of the Myriad patent should have been under section 102 and 103, and the Supreme Court has erroneously decided the issue on the basis of a 101 rejection based on a faulty understanding of the science, making it unnecessary to even consider 102 or 103 eligibility. And since the Supreme Court decision is the final decision on the topic, that faulty understanding of the science is now the law of the land.

I find your comment about the “inconvenience” of a change in the law and the comparison to Skype to be a little specious. This is not a prospective change in the law, it is entirely retrospective. As I said before, the Supreme Court dis explain how to claim new genetic material in a way that would be patent eligible, and most of the inventions that were properly claimed and properly granted under the previous rules would still be properly granted if they were claimed in conformance with the new rules. However, those inventions are now public property, since the Supreme Court has decided they were claimed wrong. This isn’t requiring a new feature in future releases. Imagine the effect on the pharmaceutical world if the Supreme Court reached a decision that made all pharmaceutical patents issued in the last 15 years invalid while permitting new pharmaceutical patents to issue. Every currently patented drug comes off patent, but new research can still be covered by patents.

Truthfully it isn’t that bad, especially not for Myriad, but only because they had so many increasingly narrow claims built into their patent portfolio and only these very broad claims were limited out. They were fortunate that they were among the very early groups patenting in the field of gene research, before even the USPTO figured out how the claims should be written, and they wrote them every way they could. Once the USPTO did come to a decision on how these inventions should be claimed, however, the patents most frequently were only claimed in the specific manners recognized by the USPTO, and granted under that paradigm. Those are the people that will be hurt by this decision.
Dale Halling
July 12, 2013 07:23 pm
Wayne,

You argument about novacaine does not follow. Did the Supreme Court know how to change those chemical bonds before the invention? Or anyone else for that matter? Did they know if would provide the same pharmacalogical effect? The difference between a drug that kills you and one that saves you may be that they are mirror images – same exact chemical elements having almost the exact chemical structure. Figuring this out and how to select the correct stereoisomer would clearly make the stereoisomer that provides therapeutic effect patentable. Small difference can have large effects. Looking at the small structural changes without looking at the affects is pulling a slight of hand to steal the inventors property. Edison’s light bulb had almost the same elements as Joseph Swans. But only Edison’s was a commercially viable invention, because it had a high impedance. According to your logic Edison’s invention was obvious. However, everyone knew that a high impedance filament was necessary, but no one knew hos to provide a high resistance long life filament.
Wayne Borean
July 12, 2013 05:50 pm
I think you’ve lost track of the point of your argument. Yes, a wooden doorstop is patentable. There are no issues with patent eligibility there.

Actually, a wooden doorstop isn’t patent eligible under Section 102.

What you haven’t done, and what Myriad has done, is great an entirely new substance which does not exist in nature. A new molecule was created in the lab that does not exist in nature. There is no more definitive description of a substance than the molecules from which it is made. And this new molecule was NOT made by taking a larger molecule and clipping off a piece of it, though that would not have changed the fact that it is a new molecule. It was synthesized in a totally different organism using an artificial set of directions.

So you think that the statue I’ve carved exists in nature? That’s a really interesting argument.

As to the ‘new’ molecule, is it patent eligible under Sections 102 and 103? You keep saying ‘new’ but just because something is new, doesn’t mean that it will be eligible for a patent. Congress decided that certain things would not be eligible.

In this case, the modification of an existing molecule is unlikely to meet the requirements for patent eligibility. The changes are minimal.

Look up the structures of cocaine and novocaine. (Unfortunately I can’t attach structures here, but you will find them on Wikipedia). Just like the Supreme Court justices did, you can overlay the molecules (you can even use those molecular model sets you had in college, or marshmallows and toothpicks), and decide which bonds would need to be broken to change cocaine into novocaine. Does that mean Novocaine is a natural product? No. Does it mean Novocaine can be made from cocaine by breaking the appropriate chemical bonds? Well, theoretically it might be possible, but I don’t see how. And yet Novocaine retains enough of the chemical structure of cocaine to interact with the same receptor and produce an anesthetic response. Does this mean it is a natural product, simply clipped out of cocaine? Absolutely not.

Cocaine acts as a serotonin–norepinephrine–dopamine reuptake inhibitor, also known as a triple reuptake inhibitor (TRI). Procaine aka novocaine is a sodium channel blocker. The two drugs have nothing in common in their manner of operation, though both can be used as topical anesthetics.

Myriad’s genes bear the same relationship to DNA as novocaine does to cocaine. The chemical structure of the gene might arguably be found in a subset of the population as a small part of enormously large and variable molecules, but those enormously large and variable molecules have far different properties than the particular construct Myriad synthesized. And once again, IT WAS SYNTHESIZED; it was not in any sense “clipped out” of, or purified from, any natural enormously large DNA molecule. It is a completely different molecule, a totally different substance, from anything found in nature. It is man-made, and therefore cannot be considered a product of nature.

But is it patent eligible under Sections 102 and 103? You’ve not addressed this at all.

Unless you’re trying to get a patent and the Supreme Court has decided otherwise.

The worst part of this decision is not that it will stifle this type of research; it won’t. The Supreme Court also very nicely explained to Myriad how to claim the exact same product and get a patent on it. After this decision, genes will be as patentable as they ever were, as long as they are claimed properly. The problem is that the language the Supreme Court wants is different from the language that the USPTO has required since they first decided genes were patentable. A tremendous number of patents will be invalidated, not because they covered non-patentable material, but because they claimed it using language which is no longer appropriate. It will have the same effect on biotech companies as deciding any automotive patents issued between 1980 and 2000 are invalid would have on automotive companies. Research won’t face any new patent hurdles, but the current product pipeline has just become totally unprotected.

While I agree that having the law change under you is inconvenient, it is part of the cost of doing business. Just look at poor Microsoft, having to build a back door into Skype so that the NSA would have access to everyone’s Skype conversations. I’ll bet the NSA didn’t cover the costs.

Wayne
Mike
July 12, 2013 04:44 pm
Wayne,

I think you’ve lost track of the point of your argument. Yes, a wooden doorstop is patentable. There are no issues with patent eligibility there.

What you haven’t done, and what Myriad has done, is great an entirely new substance which does not exist in nature. A new molecule was created in the lab that does not exist in nature. There is no more definitive description of a substance than the molecules from which it is made. And this new molecule was NOT made by taking a larger molecule and clipping off a piece of it, though that would not have changed the fact that it is a new molecule. It was synthesized in a totally different organism using an artificial set of directions.

Look up the structures of cocaine and novocaine. (Unfortunately I can’t attach structures here, but you will find them on Wikipedia). Just like the Supreme Court justices did, you can overlay the molecules (you can even use those molecular model sets you had in college, or marshmallows and toothpicks), and decide which bonds would need to be broken to change cocaine into novocaine. Does that mean Novocaine is a natural product? No. Does it mean Novocaine can be made from cocaine by breaking the appropriate chemical bonds? Well, theoretically it might be possible, but I don’t see how. And yet Novocaine retains enough of the chemical structure of cocaine to interact with the same receptor and produce an anesthetic response. Does this mean it is a natural product, simply clipped out of cocaine? Absolutely not.

Myriad’s genes bear the same relationship to DNA as novocaine does to cocaine. The chemical structure of the gene might arguably be found in a subset of the population as a small part of enormously large and variable molecules, but those enormously large and variable molecules have far different properties than the particular construct Myriad synthesized. And once again, IT WAS SYNTHESIZED; it was not in any sense “clipped out” of, or purified from, any natural enormously large DNA molecule. It is a completely different molecule, a totally different substance, from anything found in nature. It is man-made, and therefore cannot be considered a product of nature.

Unless you’re trying to get a patent and the Supreme Court has decided otherwise.

The worst part of this decision is not that it will stifle this type of research; it won’t. The Supreme Court also very nicely explained to Myriad how to claim the exact same product and get a patent on it. After this decision, genes will be as patentable as they ever were, as long as they are claimed properly. The problem is that the language the Supreme Court wants is different from the language that the USPTO has required since they first decided genes were patentable. A tremendous number of patents will be invalidated, not because they covered non-patentable material, but because they claimed it using language which is no longer appropriate. It will have the same effect on biotech companies as deciding any automotive patents issued between 1980 and 2000 are invalid would have on automotive companies. Research won’t face any new patent hurdles, but the current product pipeline has just become totally unprotected.
Wayne Borean
July 12, 2013 04:13 pm
Mike,

Unlike your wooden sculpture, the artificial xylem is (in my hypothetical) useful. As you say, the sculpture would be protected by copyright. If the sculpture had a useful purpose; for example, if it also functioned as a clock by projecting a shadow onto a delineated surface, then it is patentable subject matter under section 101. Maybe anticipated, maybe obvious, but it has met the threshold 101 patentablity requirement.

Or the wooden sculpture could be used as a door stop. The question is whether the ‘usable’ item is really patent eligible. In this particular case I would say it isn’t. There are more changes to the base material in my statue, than there are to the DNA section in Myriad’s process.

Wayne
Mike
July 12, 2013 01:41 pm
Wayne,

Unlike your wooden sculpture, the artificial xylem is (in my hypothetical) useful. As you say, the sculpture would be protected by copyright. If the sculpture had a useful purpose; for example, if it also functioned as a clock by projecting a shadow onto a delineated surface, then it is patentable subject matter under section 101. Maybe anticipated, maybe obvious, but it has met the threshold 101 patentablity requirement.
Wayne Borean
July 12, 2013 01:21 pm
Mike,

Rather like my wooden sculpture, which exists no where in nature?

Wayne
Mike
July 12, 2013 01:14 pm
@Wayne –

With respect, your analogy doesn’t even come close to capturing what Myriad has done. They are not simply extracting DNA and clipping off pieces. Imagine instead that you had developed a way to produce a single structure of a tree, let’s say a xylem, grown not in a tree but from bacteria in a laboratory. Further, this wasn’t the xylem of a specific tree, but the xylem of an idealized generic tree determined by isolating xylem from thousands of trees and finding out what they all had in common, then engineering the specific xylem you wanted to make. Finally, you produced it in large quantities. This artifical xylem has none of the associated molecules, cells, proteins, minerals, or any of the other structures that would be absolutely impossible to remove from the xylem found in nature, and because it has none of the associated natural structure of a xylem, you find it to be uniquely useful as a model for examining the xylem of plants that were actually present in natural trees, and your were able to use that as the key piece to a test for diagnosing and treating diseases of trees. Why shouldn’t your artificial xylem, bearing none of the characteristics of natural xylem except for an underlying structure that is impossible to isolate from natural xylem, be patentable?

“Isolated gene” is a terribly misunderstood construct, and is not what Myriad was trying to patent. “Gene” implies information, as the Supreme Court understood – what they didn’t understand was that Myriad was not trying to patent a gene but was trying to patent a MOLECULE, a specific chemical entity, that does not exist in the form which Myriad claimed anywhere in nature.

I am not arguing that the molecule Myriad claimed was patentable, and nobody else is arguing that point. What people are arguing is that it should not have been excluded from patentability by section 101. It still needed to surpass the very high hurdle of whether it would have been obvious over the truly natural form of the gene.
Wayne Borean
July 12, 2013 12:51 pm
Gene,

I agree and disagree with you. Thomas is wrong in what he wrote. That I agree on.

I do not however believe that isolating sections of DNA makes the DNA patent eligible. The technology to isolate the section of DNA might be patent eligible, the DNA itself would not be eligible.

Consider a tree. I cut it down, and slice a section of trunk out. Have I changed the tree? Yes. Is the section of trunk worth patenting? No. Now if I were to carve that section into a sculpture, the sculpture would then be covered by copyright law. If someone uses the sculpture as a trademark, it would be covered under trademark law. The method I use to cut the tree, to get the section of wood might be patentable though.

The section of a tree is not something new. It is a part of a pre-existing organism.

Wayne
Eric Johnson
July 12, 2013 12:18 pm
Gene,

Some very fair points. Thank you for clarifying your position.

My response is that you might be taking one passage in the Myriad opinion out of the context of the entire argument which, I’ll give you, would allow some attacks to the Chakrabarty holding. But I believe any such attack would be misguided and they would fail, and here is why:

The Chakrabarty court held that the exception of patent eligibility for a naturally occurring thing (in that case modified bacteria) was narrowed by the following factors:

1.) That the new composition of matter was not, in a strict sense, a naturally occurring thing (i.e., clearly by the facts of the case itself, a new composition could be made up of all natural components, but that there had to be some change such that the new composition was not one found in nature in that shape or form)

2.) The new composition had to have markedly different characteristics with a new utility. This comes from the following from the Chakrabarty holding (sorry I don’t have the citation):

“Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under 101.”

The argument in Myriad, form my understanding, centered in large part on whether the isolated gene sequences BRCA1 and BRCA2 had “markedly different characteristics from any found in nature and one having the potential for significant utility.” All Thomas was saying in his passage, if you read it in the context of the entire opinion, is that Myriad relied on a chemical change (if a scientist would really even call it that without laughing) to the genetic sequence, but that chemical change did not render the isolated BRCA1 and BRCA2 genes markedly different, and in fact they did not have any real new utility. The isolated genes were still the same store of genetic information as were native BRCA1 and BRCA2 genes. In fact if you read on, directly under the passage you quoted is the following:

“Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2 genes. If the patents depended upon the creation of a unique molecule, then a would-be infringer could arguably avoid at least Myriad’s patent claims on entire genes (such as claims 1 and 2 of the ’282 patent) by isolating a DNA sequence that included both the BRCA1 or BRCA2 gene and one additional nucleotide pair. Such a
molecule would not be chemically identical to the molecule “invented” by Myriad. But Myriad obviously would resist that outcome because its claim is concerned primarily with the information contained in the genetic sequence, not with the specific chemical composition of a particular molecule.”

So reading farther, it is clear that what Thomas said here is that the new chemical composition does not save Myriad’s claim because (and the because is real important here) in this case the chemical change was a mere tactic for separation of the gene and not a process to create a new utility of the isolated and “non-naturally occurring” composition of matter. In other words, the isolated gene does not have “markedly different characteristics from any found in nature.” And certainly, the isolated gene has no unique and special utility aside from that of its naturally occurring counterpart, the native BRCA1 and BRCA 2 genes.

I share the opinion of some that this is closer to a purification analysis rather then a new composition, because all that was done here was removal of substance, not addition. I know that should not be dispositive, but taking that fact into the context of all the facts leads me to frame it as a purification.

I also think from a pure policy standpoint here, this particular ruling will actually promote and not inhibit innovation. This is because gene patents cannot really be invented around. A correlation between a gene and a specific disease is the real utility here, and that correlation should not be limited via research to one entity under the guise of a gene patent. I think an alternate solution would have been to make a viable infringement exception for research activities (bringing it closer to copyright exceptions), but that is a different world.

Finally, I cannot comment on whether there are many judges who are in general unfriendly to the patent system as a whole. You would know much better than I as I am not a patent attorney. I do know that there are plenty of economists out there who believe that the patent system in its current state may not be the best and most efficient way to promote innovation. In fact, some economists disagree with the idea of a patent system altogether, again on grounds of efficiency and promotion of innovation. But, that is a whole other can of worms which should be debated by Congress and not activist judges (and I would guess that you and I are in perfect agreement on this last point). Have a great weekend Gene!
Gene Quinn
July 12, 2013 11:21 am
Eric J-

We are going to have to agree to disagree about Chakrabarty. I understand that I am in the minority, but in time I am 100% confident that what I am saying will be proven to be 100% true.

For reasons I just don’t understand, everyone is ignoring what Thomas says on page 14 of the slip opinion. He writes:

“Nor are Myriad’s claims saved by the fact that isolating DNA from the human genome severs chemical bonds and thereby creates a nonnaturally occurring molecule.”

I’m not actually making this up. This is what is specifically stated. This clearly says that isolated DNA is nonnaturally occurring. The fact that it is nonnaturally occurring does not mean that it is patent eligible. This directly undermines the holding in Chakrabarty.

I think anyone who is honest knows how this passage will be used by defendants and challengers at the USPTO and in the district courts. If the PTAB decision on covered business methods is any indication the PTAB is quite anti-patent. We also know that many, if not a majority, of district court judges are anti-patent as well. We also know that many judges on the CAFC are taking anti-patent positions. This will be offered by challengers and accepted by judges who do not like patents as meaning that something that is nonnaturally occurring and man-made is not necessary patent eligible. That fundamentally undercuts the ruling in Chakrabarty.

Soon we will see these arguments made and adopted. So patent owners had better figure out a response. It won’t be persuasive in court to simply pretend the Supreme Court didn’t say what they clearly said, or that such a viewpoint is “the sky is falling” paranoid nonsense.

-Gene
Eric J
July 11, 2013 10:17 pm
However, your analysis of the limitations on the cDNA is very thought provoking! I have to think about that one. Actually, I don’t agree with the second part of the opinion anyhow. Given the court’s logic on why isolated DNA is ineligible for patent protection, it makes little sense to me that cDNA can be eligible. It seems internally inconsistent to say both because cDNA does exist in nature to the same extent that isolated DNA does. The court essentially says as much when it realizes that there could exist a sequence so short that it would not have introns, and therefore it’s cDNA would be identical to itself, thus patent intelligible. To me, cDNA should have to have, again, markedly different characteristics and a new use from its counterpart that includes introns. Your thoughts? I am not a biologist, perhaps there is a great wonderful use for cDNA that the same natural sequence wouldn’t have, but if that is the case, shouldn’t that use need to be specifically stated in the patent application? Great discussion by the way, thank you for allowing these comments and discourse (some of which is intelligent, some not so much).
Eric J
July 11, 2013 10:03 pm
You have it wrong that Myriad undermines Chakrabarty, because in Chakrabarty, the patent claimant not only ADDED plasmids to bacterium which created a NEW composition with a
Markedly new characteristic and use, mainly the ability to break down oils.

In Myriad, respondents merely subtracted elements, or “isolated” a genetic sequence. MUCH MORE important is that this modification, this isolation, did NOT create markedly different characteristics and did not create an entirely new usefulness of the resulting “unnatural” composition. It is still simply an embodiment or store of genetic information. If you read the opinion carefully, the court mentioned as much when it states it’s reasoning behind why Myriad’s claims are not saved by the chemical differences between the isolated and naturally occurring DNA.

So please stop exclaiming that the sky is falling and that this decision is an attack on patents and Chakrabarty, because that is simply not true.
Anon
June 20, 2013 09:20 pm
“non-transferrable except by inheritance”

Goes directly against public policy that favors alienation of property.

Also, this would pose a huge detriment to actual monitization and implementation, as many patents cannot be put into commercial use on the basis of a single individual owner.

It is simply a bad idea all around.
Wayne Borean
June 20, 2013 07:38 pm
Recently I viewed a talk about how certain corporate powers want to “anonymize” inventors so that they don’t get any compensation for their work product and all the profit flows to the companies with the biggest servers. I think people are starting to sit up and take notice of this subversive campaign to rob inventors of the harvesting of the fruits for which they sowed, fertilized and irrigated over all those years. AMP v. Myriad is but another example of a company doing everything according to the rules, the books (35 USC 101: “Whoever … may get a patent therefor”) and then having it taken away from them without just compensation.

One suggestion I’ve made is to make Patents and Copyrights non-transferrable except by inheritance. Anyone wanting to use the material/patent would lease the rights for a limited time, with no automatic renewals. Only living beings (creators) would then be able to own Intellectual Property (except trademarks, which are really a consumer protection measure).

Needless to say, the Music Industry wasn’t happy with me. In fact they were bloody furious 🙂

Wayne
step back
June 19, 2013 02:13 pm
Dale @142 –COL (good one)

Yes. We need to keep the good fight going despite the overwhelming forces aligned against inventors and their property rights in their inventions.

I have repeatedly alerted you to how the word “innovation” is framed to take the inventor out of the picture.

Recently I viewed a talk about how certain corporate powers want to “anonymize” inventors so that they don’t get any compensation for their work product and all the profit flows to the companies with the biggest servers. I think people are starting to sit up and take notice of this subversive campaign to rob inventors of the harvesting of the fruits for which they sowed, fertilized and irrigated over all those years. AMP v. Myriad is but another example of a company doing everything according to the rules, the books (35 USC 101: “Whoever … may get a patent therefor”) and then having it taken away from them without just compensation.

((p.s. I’m caught again in your spam filter at State of “Innovation” 🙂 ))
step back
June 19, 2013 02:04 pm
Anon@ 141 –LOL (good one)
John-Paul Gignac
June 19, 2013 11:01 am
Dale-

Thank you for that thoughtful post. The fact that you and I are arguing a point back and forth like it’s in our genes to do so suggests that there must be some point to it.
Dale Halling
June 19, 2013 10:19 am
You are engineers and scientist who should know better than most,you mock reason. The amazing products of reason are around you everywhere, from the cell phone in your pocket, to the internet and the ability to send, message, audio, video around the world instantaneously, from steam engines, to trains, to cars, to planes, to jets and rockets that have left our solar system, to machines that can see the end of the known universe and others that can see inside an atom, the discovery of DNA and the ability to look inside that DNA and see which part of it is likely to result in breast cancer.
BUT YOU ARE RIGHT reason is a volitional choice and when people turn away from reason you get, North Korea, Pol Pot , Moa, Stalin.
All that is needed for evil to succeed is for good men to stand aside and do nothing.
Anon
June 19, 2013 06:50 am
(under my breath) and yet, invention still happens,
step back
June 18, 2013 09:45 pm
Anon @139,

Those of us who are intelligent enough to understand know that we are not.

Intelligence is but a momentary and fleeting illusion. 😉
Anon
June 18, 2013 09:32 pm
Wayne,

You left out the obvious question:
Are humans naturally intelligent?

Your premise above assumes this point – not a safe assumption.
step back
June 18, 2013 08:51 pm
Wayne, … or naturally irrational:

http://www.declineoftheempire.com/2013/06/when-will-homo-sapiens-go-extinct.html
Wayne Borean
June 18, 2013 07:10 pm
@Step Back

You are not being overly cynical.
Law is part of human-based power brokering.
Basically, who deserves what and when as based on their status in society.
For example, bankers who sell junk paper don’t go to jail while pick pockets who lift a few dollars do.

Cynicism is a natural state for intelligent humans. Me saying this gets me into arguments with a lot of people, who believe contrary to the evidence, that humans are either naturally good or naturally bad.

Wayne
Dale Halling
June 18, 2013 06:55 pm
Sorry for the delay

To get this back to US history and law, Natural Rights starts with the idea that you own yourself. We are talking about a logical system here, not about people’s specific actions. If you own yourself then you have a right to your life, but not at the expense of someone else life. You have a right to the product of your efforts (mental and physical). Blackstone’s commentaries on the law were based on Natural Rights and was the Declaration. And you can see that this axiom leads to most of our property laws and criminal laws.

Any action inconsistent with the logical system of Natural Rights leads to the idea that slavery or murder are okay. Yes, there will always be criminals, but the question is how we react to those criminals (private, and government) determines whether we are following a set of laws consistent with ownership in one self
John-Paul Gignac
June 18, 2013 05:43 pm
Dale-

Okay, I’m not sure if you’re still disagreeing with what I said in 125. You’ve admitted that the value of human life is not a universally accepted principle. Are you saying that lawmakers generally follow that principle even if they don’t agree with it?
Anon
June 18, 2013 05:20 pm
If the axiom of “value of human life” were applicable, we would not need the constitution.

Or government.
Dale Halling
June 18, 2013 05:19 pm
Well you either value human life or you don’t. Some people value it in some case and not in others. But as an axiomatic premise, if you value human life then there are logical implications as to which polices promote human life and those that do not. The evidence on this point is overwhelming. Man’s unique method of survival is his ability to think (and act on those thoughts) and those things that limit a person’s ability to think lead to death.
John-Paul Gignac
June 18, 2013 05:01 pm
Dale-

Sorry, I guess I should try to address your argument more properly. First of all, history (including modern history) demonstrates that not everyone values human life. I’m pretty sure you don’t need examples to demonstrate that. Secondly, even among those who value human life, there is disagreement on the relative value of different human life. Discrimination is a powerful political force. And it’s real and active. Finally, and I’m speaking as a mathematician, even if everybody agreed on some form of base valuation of human life, that single axiom is definitely not enough to build up a set of theorems approaching the complexity of anything resembling the laws of a country.
John-Paul Gignac
June 18, 2013 04:31 pm
Dale-

Value of human life as a shared axiom! LOL If only!!! Here’s some homework for you: Re-read the decision and dissenting opinions in Roe v. Wade and tell me which side is more logical. Then tell me whether one’s viewpoints are likely to be altered by that logic. Good luck!
Dale Halling
June 18, 2013 04:06 pm
Jean Paul,
I’m suggesting that the only axiom we need to share is that we value human life. then logic and reason apply.
step back
June 18, 2013 03:13 pm
John-Paul @ 125,

You are not being overly cynical.
Law is part of human-based power brokering.
Basically, who deserves what and when as based on their status in society.
For example, bankers who sell junk paper don’t go to jail while pick pockets who lift a few dollars do.

The AMP v. Myriad decision appears to be one based on the Supremes thinking they are being politically nice-guys(/gals) for women with propensity for breast and ovarian cancer. It has little to do with abiding by the promise that government originally made to the inventors ala 35 USC 101:

“Whoever invents or discovers any new and useful … composition of matte … may obtain a patent therefor, …”

Myriad did everything by the book. They discovered a non-naturally occurring molecule (the isolated DNA fragment) and a utility for it (using it as a probe). Rather than keeping it as a trade secret, they disclosed.

The ACLU had more political muscle. Therefore the ACLU won irrespective of what the science says.

I guess I’m cynical too. But why not? The evidence points in that direction.
John-Paul Gignac
June 18, 2013 02:57 pm
Dale-

I guess I’m missing something. Are you saying we do have shared axioms that everybody accepts, or are you saying we don’t need them?
Dale Halling
June 18, 2013 02:46 pm
John-Paul,

I disagree. Every animal has a certain set of conditions necessary for its survival. If you chose man’s life as your value, then there are objective criteria. This has been studied extensively. For instance, look at every index of economic freedom. This has been as well documented as evolution. Humans thrive under economic freedom, which is an awkward shorthand for Natural Rights, which the US was founded on.
John-Paul Gignac
June 18, 2013 11:54 am
PatentLovah-

Nobody cares about logic. This isn’t math. Logic requires shared axioms. In the realm of law and politics, everyone has their own beliefs which they use as their only axioms. Judges combine logic, written law and precedent as a facade for deciding what they ultimately think at the time is best for society moving forward.

Who thinks I’m being overly cynical?
PatentLovah
June 18, 2013 11:27 am
Gene does a very logical job of debunking the patent haters here:

http://libertarianstandard.com/2010/04/13/gene-patent-absurdity/
Woody
June 17, 2013 11:52 pm
So you are suggesting relying on “the draftsman’s art” to attempt to create patentability in the unpatentable?

If something is obvious “as a whole”, making the claims more granular (or adding obfuscating claims), isn’t going to change that fact.
Dale Halling
June 17, 2013 11:32 pm
So you are suggesting that adding additional limitations to a claim will not overcome an obviousness rejection?
Woody
June 17, 2013 10:10 pm
I wasn’t arguing novelty. I was arguing non-obvious. You were proposing that some arbitrary number of steps could magically confer patentability on something. Neither complexity nor tedium is a valid route to a patent.
Dale Halling
June 17, 2013 09:25 pm
Woody,

103 clearly states that you cannot look for a point of novelty. You are attempting to do exactly that. In addition, that approach is illogical. Every invention is combination of known things/steps – operative word is combination
Woody
June 17, 2013 07:23 pm
Dale,

There is no “number of steps” that will render something novel or non-obvious. It is the tangible outcome of those steps, or the device used in a step, that may be novel or non-obvious. An earlier decision rendered “obvious to try” by someone skilled in the art as a valid definition of obviousness.

The point here with the cDNA is that “a purified or isolated version of X.Y” isn’t non-obvious anymore if it can be achieved by someone skilled in the art with the conventional tools of the trade (granted, there was discussion of patentability in the context of 101 subject matter, but I suspect it was really the obviousness that got it kicked out. We’ll have to wait to see if the final registered opinion clarifies from the published slip). It doesn’t matter if X.Y is maple syrup, latex rubber, or cDNA.
Dale Halling
June 17, 2013 06:53 pm
Woody,

Of course an invention is always a combination of steps and those steps/elements are individually known (otherwise you end up with a 112 rejection). With that said I don’t think the adding the syrup to pancakes (buttered or not) is going to add to the novelty or nonobviousness, since that is a subjective choice/result.

I think the question is what is the minimum number of steps that would make a claim novel & nonobvious.
stan g
June 17, 2013 06:08 pm
Well, the isolated but otherwise unmodified leaves are clearly not eligible under Myriad, but looks like there may be other eligible inventions here.
Woody
June 17, 2013 05:05 pm
Here is a much closer analog to Myriad:
Collect a bag of undifferentiated leaves.
Based on expert knowledge, sort out all of the maple leaves.
Measure each maple leaf’s outline and vein structure, and create a mathematical model of an “idealized” maple leaf.
Create a template drawing based on the mathematical model of the idealized maple leaf.
Give the template to an arbitrary individual, along with some undifferentiated leaves.
Instruct the individual to collect the leaves which are a close match to the idealized leaf template.
Find the tree which produced the leaves matching the template.
Place tap in tree and collect the sap.
Boil the sap to approximately a 1:40 reduction.
Apply boiled sap to buttered pancakes
Quiz: Which of the above steps (or results thereof) are…
Patent Eligible subject matter
Novel
Non-obvious

(note: processes for isolating butter from cow’s milk, and creating pancakes are subject to other patent applications).
stan g
June 17, 2013 04:50 pm
“Leaf types”, sorry
stan g
June 17, 2013 04:42 pm
Let’s add a use, then, that makes the hypo like the Myriad case: the use of the bag of leaves is as a reference for identifying types of leaves. Now, would you still insist that a patent on that would entitle you to claims over the last types themselves, even though the leaves are present individually in nature?
Dale Halling
June 17, 2013 03:01 pm
Anon,

Good point http://en.wikipedia.org/wiki/Corrosion_in_space.
Dale Halling
June 17, 2013 03:01 pm
Stan g,

Good point. But in the case of the bag of leaves you have not described a use for them. Without a use it is a hypothetical that makes it difficult to evaluate.
Anon
June 17, 2013 02:45 pm
“O does not exist in nature by itself”

from the article that you said you read: “Atomic oxygen [O] is very reactive; on Earth’s surface it doesn’t exist naturally for very long, though in space, the presence of plenty of ultraviolet radiation results in a low Earth orbit atmosphere of about 96% atomic oxygen”

“they are always mixed with other gases”

Your pedantic request for an element to be considered in a vacuum has completed the decimation of your credibility. I hope you realize that anything you “isolate” as that term is used fails to be “isolated” according to your pedantic stance.

We are truly done now.
stan g
June 17, 2013 01:31 pm
Dale, you seem to be confusing the product with some accumulation of the product. Even if a bag of leaves, because that bag of leaves does not occur in nature, is inventive somehow, that would not give you a claim over the leaves themselves. At most you could claim the bag of leaves as a whole, but not any exclusive right to the leaves comprising it.
Dale Halling
June 17, 2013 11:49 am
Anon,

I never morphed into O, I never suggested that and it still does not prove your point. O does not exist in nature by itself. Whether it is O or O2 they are always mixed with other gases. A claim to the effect of a gas containing greater than 75% O2, would clearly not be a product of nature. It only exists because man created it.
Anon
June 17, 2013 10:36 am
No Dale. I was listening.

O2 may have been the start, but this quickly morphed to single O, and a discussion ensued about how single O was too reactive to exist on its own in nature.

Regardless of that point – each of O, O2 and O3 exist in nature – as the article I linked to demonstrated.

You have yet to acknowledge and concede this point.

If you are going to be further pedantic and ask for these items – by themselves and in a vacuum – you are showing to what lengths and how silly you are willing to go to attempt to preserve a losing argument.

I tire of the pedantic nature of your responses. You may have the last word.
Dale Halling
June 17, 2013 09:54 am
Mike,

Good points. But the Supreme Court is not consistent and laying out the logical reasons for why they were correct or incorrect in their decision is important.
Dale Halling
June 17, 2013 09:52 am
Anon,

No I was never dishonest you weren’t listening. How this conversation got started was “If I figure out how to separate out oxygen from other gases, why shouldn’t I get a patent on purified oxygen?” So it was you who assumed that it was about O1. I know in these long thread it can be easy to miss these points.

But even with that you have again assumed a different point. O1 exists, I never doubted that but not separate (not unmixed with) other gases and not for a very long time either.
Anon
June 17, 2013 09:39 am
Good post Mike, although your (more persuasive) argument was not the one before the court, perhaps it should have been.

Your position is the different in kind position that would overcome the product of nature doctrine.
Mike
June 17, 2013 08:58 am
Just to make a couple of points that get lost in the argument, and should act to distinguish both the O2 and the B12 examples. Large amounts of O2 molecules and B12 molecules do exist in nature, even if the concentrations are lower than we would like for specific purposes. As was pointed out at 94, purified B12 was awarded a patent.

However, the Oxygen and B12 molecules aren’t doing anything different than they do as they are naturally found, and one O2 molecule is the same as the next. Oxygen molecules in a mixture with air do what oxygen molecules do – combustible materials react with them and things burn. Concentrating the oxygen molecules and removing things that are not oxygen molecules do not change the reactions that occur, but they increase the speed and can make processes like burning acetylene far more useful. The same with B12 – it is absorbed in the intestines and acts as a vitamin whether it is coming from a pound of liver or a pill.

The DNA which is the subject of the Myriad patent is not found as separate molecules anywhere in nature, and one BRCA1 gene is most definitely not the same as the next. These genes aren’t “isolated” the way oxygen is; you don’t somehow purify a large amount of genetic material and separate out just the pieces you want. Hundreds of gene fragments were analyzed, an artifical construct was built, and this artificial construct was turned into a factory for preparing specific molecules which did not previously exist in nature. In no meaningful chemical or structural way are the sequences claimed by Myriad natural. Those molecules simply did not exist prior to Myriad’s work.

Is this enough to lift them over the “natural products” bar of 101? The Supreme Court says no and that is the law of the land, so, no. Unfortunately, it doesn’t provide much guidance for the next unforeseeable technology, and it guts a lot of inventions that would have had valid patents if this decision had come out before they went through prosecution rather than afterwards. About the only lesson we can draw is that inventions, especially for new technologies, must be claimed in every possible imaginable configuration, regardless of what the Patent Office currently considers patentable.
Anon
June 17, 2013 07:32 am
Dale,

You say that you have addressed my points, but you have not.

You say you do not see the problem with the article I linked to, but this is true only if you close your eyes and do not read the article I link to.

You said that single O did not exist in nature. The article clearly shows that in fact it does. You then attempt to move the goalposts to a welding bottle example. You attempt to move the goalpost from the existence of the pure item (be it single O or O2) to a capture of the pure item. I will not tolerate this intellectual dishonesty.

Sorry Dale, if you cannot honestly hold a conversation, honestly admit when the points you hold have been negated, you are no better than the mindless lemmings that stick to a pre-ordained script and there is no point in even trying to hold a conversation with you.
Dale Halling
June 16, 2013 03:36 pm
Good point Wayne
Wayne Borean
June 16, 2013 03:30 pm
@Dale,

You’ve missed on major point. The Oxygen (O2) that you find in a bottle from your local welding supply shop is not pure. It contains a wide range of trace substances, including metal filings, lubricating oil, Nitrogen (N2), Hydrogen (H2), and everything else you’ll find in the atmosphere, and everything else that can come from the purification and compression machinery.

It contains very low levels of those, and it takes really good instrumentation to detect the impurities, however there is enough that for certain processes the standard welding grade Oxygen supplied by companies like Linde is not pure enough.

Oxygen is sold in a variety of grades, or purity levels. Laboratory grade oxygen is very expensive compared to welding grade oxygen. Do a search on the term Laboratory Grade Gasses. Sit down when you look at the prices. From memory, a standard bottle, the same size as is used on welding rigs cost $400.00 Canadian for a refill five years ago.

Wayne
stan g
June 16, 2013 02:34 pm
Dale, be that as it may, until Congress says otherwise, the Supreme Court’s definition of invention is the law. I think we can understand it for the sake of predictability if we read it as I’ve described above.
Dale Halling
June 16, 2013 01:51 pm
Stan,

The Constitution controls, not the Supreme Court’s rulings. I am discussing logic, not the SCOTUS decision. To make sense of the constitution we have to define what an invention is. Just saying it is whatever SCOTUS or the statute says, leads to circular reasoning. If that is the case then an invention could be people who preserve the folk dance Halling and protecting their rights could be giving them a yearly stipend.
Dale Halling
June 16, 2013 01:47 pm
Yes, Myriad would be controlling now. I am not interested in what SCOTUS thinks. They can hardly be considered deep thinkers about patent law or technology.
stan g
June 16, 2013 01:44 pm
And Dale, suggesting Anon wants to steal other people’s inventions is the fallacy of begging the question, since the court has ruled that mere isolation of a natural product and even synthesis of that same product is not in itself inventive, even if the process for doing so may be in some cases.
stan g
June 16, 2013 01:36 pm
Moreover, the Myriad case deals with mere isolation, not purification, which might still warrant patent protection even with the Myriad holding.
stan g
June 16, 2013 01:34 pm
Dale, Merck v. Olin was 4th cir., was it cert denied to SCOTUS? In any event, the Myriad case would appear to be controlling now, and might very well warrant a different result regarding B12.
Dale Halling
June 16, 2013 01:21 pm
Anon ,

If you are a judge you lack of knowledge of patent law is shocking. You are either unaware or are ignoring the B12 example. As explained on Patent Docs

n 1947, Merck succeeded in identifying and isolating that component — vitamin B12 — and secured patent protection for isolated and purified vitamin B12. Dr. Sauer pointed out that in an infringement suit brought by Merck against E.R. Squibb & Sons, the accused infringer asserted that vitamin B12 was a “natural substance,” and therefore, not patentable. The court disagreed, finding that Merck had claimed an isolated and purified form of vitamin B12 that was not found in nature, and that Merck’s isolated vitamin B12 was better than the form found in nature since patients were spared having to consume a pound of liver in order to derive the same benefits.
Dale Halling
June 16, 2013 01:17 pm
Anon,

I have acknowledged that. I have also pointed out that this does not allow me to use it in my my acetylene torch. So clearly there is a difference. You have failed to acknowledge that O2 mixed with other gases is not the same thing is purified O2. This is exactly analogous to the vitamin B12 case where the court clearly said purified B12 was patentable.
Dale Halling
June 16, 2013 01:13 pm
If it is greed you are talking about, I would suggest you desire to steal other people’s inventions is the real greed here, not my defense of their property rights.
Anon
June 16, 2013 01:08 pm
More than that, Stan, as I point out that single O also exists in nature at earth’s upper atmospheric levels.

Not only does Dale not recognize this (and that is damaging enough to credibility), he continues to argue an example when the point is easily lost with any number of different examples.

I would not be kind to an attorney pressing this matter in my court.
dmc
June 16, 2013 12:57 pm
If isolation matters to you, then patent your isolation process. But, I repeat, keep your grubby greedy hands off the NATURALLY OCCURRING molecule.
Dale Halling
June 16, 2013 12:42 pm
It matter if I want to use it in my acetylene torch. So clearly you are ignoring that reality that O2 mixed with nitrogen etc. is not the same thing as purified O2.
dmc
June 16, 2013 12:38 pm
It doesn’t matter if its isolated or not. O2 is O2 is O2. If isolating it is so important, then patent your unique way of isolating it. But keep your grubby hands of the naturally existing molecule itself, dammit!
dmc
June 16, 2013 12:36 pm
Dale, your intransigence is pitiful. O2 molecules do exist in nature. That they are mixed in with other types of molecules (not through bonds, but simply bouncing off of each other) in the air does not, under any logic, mean they do not exist in nature. Your resistance to this simplest of facts is futile. Nobody with half a brain will corroborate your position here. Air is roughly 21% O2 (http://chemistry.about.com/od/chemistryfaqs/f/aircomposition.htm).
Dale Halling
June 16, 2013 12:28 pm
Yes, and isolated O2 does not exists in nature, neither to the genetic compounds Myriad to patented.
stan g
June 16, 2013 12:16 pm
I’d also point out Koepsell made an identical argument, using the O2 example, in numerous threads here. So perhaps he went further, but seems also to have anticipated the reasoning adopted, more or less.
stan g
June 16, 2013 12:14 pm
In other words, as Anon seems to be arguing, since O2 molecules exist in nature and are morphologically identical to synthesized O2 molecules, they are still considered natural products, albeit synthetically produced, as with the BRCA1 and 2 sequences. Looks like form is what’s important, not origin.
dmc
June 16, 2013 12:08 pm
The rule of patent law is that your claims are limited by (1) the prior art, AND (2) products of nature (arguably part of the prior art). If the “objective result” of your creation is a substance that occurs in nature, like O2 molecules, then your claims are limited by that fact and the prior art, in other words, limited to any process that is new and non-obvious. In contrast, if the result of your creation is a substance which does not occur in nature, then you can claim both the process and the result. This is logical, reasonable and good policy. No patent claim should EVER be able to preempt others from finding new ways to manipulate or synthesize naturally occurring substances.
Dale Halling
June 16, 2013 11:59 am
Stan g

I am not confused about what the Supreme Court said, but they have changed patent law on a dime multiple times – including 101 in software. It is important to define patent law in a logical context separate from what the Supreme Court states or we will never end up with logical patent system.
Dale Halling
June 16, 2013 11:57 am
dmc I understand your point, but I think it is inconsistent with the rule in patent law that your claims are only limited by the prior art. I think that is the correct rule. The product of nature rule if applied strictly adds nothing to the 101 statute – its redundant. An invention is a creation of man that has an objective result and you should be able to claim anything that fits that definition.
stan g
June 16, 2013 11:54 am
Analogues, I meant
stan g
June 16, 2013 11:53 am
It seems that the Supremes have agreed that synthetic, but morphological analogies of naturally-occurring products will not be eligible, so Dale, as much as you believe what you are saying is right, that won’t be the law of the land.
Dale Halling
June 16, 2013 11:53 am
Anon,

I do not see where you negated my view. I looked at the wikipedia article and do not see how that applies – Did you post something else I missed?
Anon
June 16, 2013 10:31 am
Dale,

You do not address the fact that I negated your view. Your post at 75 is simply wrong. You can just pick that up in nature (the fact that you need to approach the limit of the atmosphere, notwithstanding).

Again. You drown yourself clinging to the example, while not realizing that you have lost the point the example was introduced to make.

You are acting no better than the anti-software patent posters, and I am truly disappointed that you do not see and understand this.
dmc
June 16, 2013 09:51 am
Dale,

That is irrelevant to the question of whether O2 molecules exist in nature. They do. They just aren’t conveniently harvested and isolated without some effort. Patent the effort, not the result .
Dale Halling
June 16, 2013 09:41 am
As I said If I need oxygen for my acetylene torch. I cannot just pick that up in nature.
przemoli
June 16, 2013 04:17 am
@Genne

“It is, however, incorrect to say that the test costs $3,000, or at least misleading. Myriad never refused any individual the test even when they had no ability to pay anything. For reasons known only to Myriad they did everything in their power to hide that fact from ever coming out publicly in a meaningful way.”

Its not incorrect. Its Myriad own price tag.

You can not say that Myriad did not priced their tests as such if Myriad say they did. 😀

Though I would appreciate link to sworn statement from Myriad or anyone who got tested below that price tag.
Anon
June 15, 2013 09:42 pm
Dale,

https://en.wikipedia.org/wiki/Atomic_oxygen#Atomic_oxygen

Can we move on now?
Anon
June 15, 2013 09:27 pm
Dale,

You are being pedantic. Do you want to continue the conversation on the larger point, or do you want to wallow in your O2?

Seriously, I tire of trying to hold a conversation with you.
dmc
June 15, 2013 09:04 pm
Dale,

Are you trying to say that O2 molecules do not exist in the atmosphere? Or are you saying that doesn’t count as “pure” oxygen because air is made up of more than just O2 molecules?
Dale Halling
June 15, 2013 08:30 pm
Neither O2 or O exist in essentially pure form in nature.
Anon
June 15, 2013 08:11 pm
Sorry Dale, but why would you think I was limiting myself to breathing? There is a plethora of processes, and O is not created only in doubles.

As I said, single O is unstable, but it is created and it does exist in nature.

As I also said, I need not rely on that as the only example. If you want to get huffy about it, I can easily set that aside and defeat your viewpoint with something else. Why fight so hard for a relatively meaningless example that I can replace in a heartbeat to prove the larger point?

Shall we go there, then? Or do you want to step back, reason through this for a second and realize that you will most assuredly lose this larger point?

Your choice.
Dale Halling
June 15, 2013 08:05 pm
You also do not know your patent law – See B12 it occurs in nature and was patented.

I do not want everything to be patentable. A painting is not and should not be patentable. An invention is a creation of man that has an objective result. Anything that is an invention should be patentable. Purified oxygen, purified B12 does not exist in nature. They are products of man and have an objective result so they are in inventions and therefore should be patentable.
Dale Halling
June 15, 2013 08:00 pm
You do not breath pure O2 and you clearly do not understand chemistry. You breath in air, which is mainly nitrogen. It is your lungs that separate out the O2.

Pure O2 does not exist in nature PERIOD.
dmc
June 15, 2013 07:13 pm
Man did not create oxygen, therefore man cannot have created pure oxygen. What man created was a METHOD for isolating oxygen into a form that can be made more useful. Therefore, man deserves a patent for that method, provided the method meets other criteria. Man did not create iron, let alone pure iron, just because the only way (that I know of) to obtain pure iron is through a man-made PROCESS of extracting it from iron ore. Again, man might deserve process claims for new non-obvious ways of obtaining pure iron, but not composition claims for the product of nature which results.

All of this back and forth is inane and pointless. Some people, like Dale and Gene, won’t be happy until “anything under the sun that is made by man” is patent eligible, including the sun itself. (By the way, you know the significance of that quote was thoroughly debunked by Stevens in Bilski, right?) Other, more reasonable people, are just fine with some things – like products of nature – being relegated to method/process claims so that others can find different ways of synthesizing them. This distinction boils down to patent maximalism (Dale/Gene) versus patent reasonableness. Maximalists are not known for being reasonable. The only logic they understand is bigger stronger patent rights over more things, or bust. Arguing logic and reason will get nowhere with them. It’s a waste of time.
MDT
June 15, 2013 07:00 pm
You do realize that ‘pure oxygen’ is just O2 right? And that O1 is so reactive, that you can’t actually have O1 in a tank, because it combines with itself to form O2. O2 can be extracted from the environment, but it exists there naturally. The atmosphere is rougly 20% O2 and 80% nitrogen. Extracting O2 from the atmosphere is no different than extracting gold from the ground. You can’t patent gold, you can patent a new way of extracting it, but not gold itself. No more than you can patent O2.
Wayne Borean
June 15, 2013 06:51 pm
Dale,

I really hate running into someone who doesn’t know chemistry. Purified Oxygen, otherwise known as O2, is what keeps you alive. The other atmospheric gasses are not used by the aveoli in your lungs.

You do breath out Carbon Dioxide, but that’s only because you breath in Oxygen, and the chemical reactions in your body used Oxygen as an oxidizer.

If you don’t believe me, go see your doctor, and ask. Or ask any college level biology or chemistry student.

Wayne
Dale Halling
June 15, 2013 05:51 pm
Despite what Anon says you cannot find purified oxygen for Acetylene Torch just hanging out. It has to be purified. It is not a product of nature any more than a steam engine is a product of nature or if you know your patent law or purified vitamin B12. These things do not exist but for man. They are not products of nature they are inventions.

Quoting the Supremes – who have supreme ignorance of both science and patent law holds no weight.
Anon
June 15, 2013 12:17 pm
And Dale, purified oxygen does in fact occur naturally. It just is not naturally stable.

And Wayne’s point at post 59 is not a comparison between one method and another method. It is a comparison between the object and any and all methods.

And if oxygen is too difficult an example (if you get hung up on the O versus O2), the same line of thought explaining the product of nature exception can be generated with a whole world full of examples.

But let’s not become pedantic, shall we?
Anon
June 15, 2013 12:12 pm
Dale,

Because you would violate the policy directive behind the Supreme Court’s product of nature exclusion.

It’s that simple.

The how to grow part would be covered under a process patent – and you are correct in that no one seems to argue (not even the Supreme Court) that you can obtain such a patent.
Dale Halling
June 15, 2013 12:11 pm
Wayne,

You are factually incorrect. Purified oxygen does not naturally occur. It only exists because of man – therefore it is an invention.

As for blocking all other methods, that is a different argument. First of all patents do not last forever. Second it does not stop someone from obtaining a patent on a different method of purifying oxygen. This overlapping rights happen all the time in patents (as well as in art). The question is whether the person to discover a second way of purifying oxygen owes any attribution to the first person to invent a way of purifying oxygen. The real life example was marconi ( I believe) where he filed patent on all EM waves for communication. But for marconi would other people have come up with inventors. There is a question of enablement also. But the normal rule is that claims are only limited by the prior art as long as one embodiment is enabled.
Wayne Borean
June 15, 2013 11:50 am
If I figure out how to separate out oxygen from other gases, why shouldn’t I get a patent on purified oxygen?

Because Oxygen is a naturally occurring substance. You could however apply for a patent on the process.

Let’s consider your invention, as against electrolysis which produces Hydrogen and Oxygen from water. If we allowed you a patent on Oxygen, it would block all other methods of producing Oxygen whether they had any relationship to your invention or not, and since electrolysis produces Oxygen in an entirely different matter, using an entirely different base stock, why should we allow you to patent Oxygen?

Wayne
Dale Halling
June 15, 2013 11:44 am
Mike,

If I figure out how to separate out oxygen from other gases, why shouldn’t I get a patent on purified oxygen?

I think the question on the kidney is how the claims are structured. We all (or at least most) agree that you have invented something patentable if you figure out how to grow an artificial kidney. Certainly claims to the process for growing the kidney would be a patentable. But how about a kidney separated from a human body that is alive (functioning?). This would be like the case of purified oxygen. It does not exist separate from man’s actions and has an objective result, so it is an invention. So why can’t a write a claim to purified oxygen or a function kidney outside the human body?
Mike
June 15, 2013 11:10 am
I, too, think the artificial kidney example is a little hard to justify. If your artificial kidney is exactly the same as a natural kidney, and the only patentable distinction comes from the fact that it was man-made, then it is not patentable. That is a product-by-process claim, and if the product is identical to a known product, the process does not add patentability. However, your point is very well taken, if not explicitly laid out – that is not a 101 rejection! It is 102 anticipation! it wouldn’t matter whether the kidney you were matching was a natural kidney or some other inventor’s artificial kidney that was in fact not identical to a natural kidney. If you’ve made an identical object by a different process, you can’t get a patent on the object, but may be entitled to one on the process.

The same argument applies to the synthesis of gold or diamonds. It doesn’t matter whether you are copying gold, diamonds, or Ford F-150s. You don’t need a threshold determination as to whether you are making a natural product, because you are making something that already exists and is thus not novel. There is no need to make a threshold determination of whether something is a “product of nature” before deciding whether what you have made is identical to a preexisting product.

The Supreme Court seems to have said that no matter how you obtained the “gene”, the “gene” itself is not patentable, even if it is in fact chemically different from that found in nature. However, some of the intermediates along that process are patentable. Exactly where that line is in genetics will be difficult to determine, because a strict chemical structural determination of what exactly is a “gene” is pretty ambiguous. The decision is weak on a scientific basis. It does at least provide language that seems clear enough to guide future claim writing in the area. As you also point out, the truly unfortunate part is that almost all of the previous claim writing in the area has just been found to lead to invalid claims, and clearly patentable inventions which could have been protected by writing claims in accordance with this new decision have suddenly become public domain. Whatever the Supreme Court may think about clever claim drafting, they have just invalidated an entire technology area of patents due to the way the inventions were claimed.
MDT
June 15, 2013 09:25 am
Gene

You are the one who is, quite honestly, making incredibly arrogant statements.

You have stated, in the past, that the 9th Circuit should rule around the SCOTUS. That is quite frankly breathtakingly arrogant, in that it advocates that a US court should willingly and with knowledge subvert the SCOTUS. To me that is a breathtakingly arrogant, and to me at least, highly unethical stance. If you don’t agree with the SCOTUS rulings, the proper (constitutionally) method of correcting this is congressional action to clarify the law, not subversion of the justice system by intentionally trying to disregard legal precedent.

And yes, you have repeatedly said that the concept should be patentable. You claim the artificial kidney itself should be patentable, not just the specific way of making it. Per your own posts above, if someone figures out how to make an artificial kidney, they should have a patent on artificial kidneys. Not that way of making a kidney. Under your preference, the act of making the first artificial kidney precludes anyone else from being able to make an artificial kidney, no matter how they go about it.

I am not a lawyer, but I do try to ‘educate myself’. Everything that I have read indicates that such a stance is an overly broad attempt at a patent. You can’t patent every possible method of ‘artificial kidney’, only the one you actually created. Otherwise, you couldn’t design around the patent. If this were true, then we would only ever have had one type of internal combustion engine, only ever had one company making microchips, only ever had one type of laser. That is not the intention or the legality of patents.

Here is a question for you then, with your claims.

1) Researcher A patents making an artificial kidney by using stem cells in a culture, which is then implanted in a human body.
2) Researcher B comes along 6 months later, and has figured out a way of making a kidney inside your body by injecting specific RNA and chemical mixtures into the human body, and then transplanting that new kidney from where it’s growing into the same patient’s body.

From your statements above, Researcher B would violate Researcher A’s patent. He is not creating the kidney in the same way by any stretch of the imagination. But you would give A a patent on the human kidney, not on the method he used to create it, based on your comments above, is this correct? If it is, I repeat my statement that you are advocating for the patenting of Gold, since there is no functional difference between the kidney and gold. If you are not advocating this, please explain the functional difference between your advocacy of being able to patent the gene, no matter how it’s derived, and not advocating for the patentability of the kidney, no matter how it’s derived.
EG
June 15, 2013 09:24 am
“It does not do well to withhold credit where credit is due. Yes, Mr. Koepsell did argue for more, but that does not diminish the products of nature doctrine.”

Anon,

Koepsell is frankly entitled to NO CREDIT whatsoever because he based his reasoning on philosophy, not on the science or the relevant patent law. As my upcoming article for IPWatchdog will acknowledge, the reasoning in the Myriad opinion for why the “isolated” DNA sequence was patent-ineligible can be squared with the “product of nature” doctrine.

Also remember that Koepsell authored the book “Who Owns You” which disingenuously suggests that what Myriad did in patenting such “isolated” DNA sequence meant they owned you, me, and everyone else which is stuff and nonsense. Also, and contrary to all the media and ACLU hype and hyperbole, research on the BRCA gene wasn’t retarded in any significant way. Sorry, I’m not going to give credit to anyone who engages in such disingenuous sophistry.
Wayne Borean
June 14, 2013 11:47 pm
Gene,

Please delete this, forgot to check the box 🙂

Wayne
Wayne Borean
June 14, 2013 11:47 pm
The Supreme Court’s decision today obviously and seriously undermines the continued relevance of the Chakrabarty decision given that something (i.e., composite cDNA) created in a lab by man is not patent eligible. The very foundation of the Chakrabarty decision mandates a finding of patent eligibility when man has engaged in activity to alter something. Clearly a composite cDNA made up of hundreds of individuals was created by man and by and through the sequence listings incorporated into the Myriad claims. Thus, the very fabric of Charkabarty has been ripped to shreds, although the Supreme Court didn’t understand that this is the factual and scientific consequence of the ruling.

This is a silly analogy, but you seem to be saying that an apple would not be patentable, but a peeled apple would be patentable. Yes, I know I’m over simplifying things, but that’s the way I read it Gene.

Composite DNA made up from hundreds of individuals isn’t man-made. If on the other hand you designed bioluminescent DNA and made a glow in the dark child, that might be patent eligible. Make it a lot easier to find your kids, when they decide to sleep under the bed instead of on it…

So if an invention is identical to what appears in nature the innovation is patent ineligible. That should fairly well kill any and all development in the medical field related to growing organs for medical transplantation since the entire point is to create something that is identical to the organ found in nature.

No. The process used, and the equipment designed for it could be patented, assuming that they meet the requirements.

Besides, all the patents on incandescent light bulbs expired years ago, and they were available for years. It depends on whether or not there is a viable market.

Or consider radial tires. The patents expired in 1949, and radial tires didn’t become common on cars until twenty years later.

Wayne
Douglas L. Rogers
June 14, 2013 08:41 pm
Gene

I agree with your point that in the Myriad Genetics decision “there are real and very significant limitations on patent eligibility relating to cDNA.”

On the other hand, your assertion that “the Chakrabarty decision mandates a finding of patent eligibility when man has engaged in activity to alter something” overstates the holding in Chakrabarty. The Supreme Court in Chakrabarty explained its reasoning for holding the plasmid-enhanced bacteria to be patentable (in contrast to its holding in Funk Brothers) in the following two sentences: “Here, by contrast, the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility. His discovery is not nature’s handiwork, but his own; accordingly it is patentable subject matter under § 101.” 447 U.S. 303, 310. Although in Chakrabarty the Supreme Court did say – 447 U.S. at 313 – “Congress thus recognized that the relevant distinction was not between living and inanimate things, but between products of nature, whether living or not, and human-made inventions,” it added in the next sentence that Chakrabarty’s invention was “the result of human ingenuity and research.” In other words, the Court indicated a number of times in Chakrabarty that not any human activity would turn a product of nature into a human-made invention. I believe Myriad Genetics is fully consistent with Chakrabarty, and indeed Justice Thomas relied on the “markedly different characteristics” holding in Chakrabarty for the decision in Myriad Genetics.

You state that the Myriad Genetics decision “is a big loss for the advancement of science.” Although I am sure many persons agree with you, I call to your attention that in an editorial today the very pro-business Wall Street Journal praised the decision in Myriad Genetics. You might respond correctly that the WSJ editorial writers are not scientists or lawyers, but at least this leading representative of the business community has a positive opinion about the impact of this decision. Also, in a press release today, Myriad Genetics pointed out that after the Court’s decision it still had over 500 valid patents in this area, it gave no indication that the decision would have a negative effect on its future business or research and said, “Myriad will continue to encourage and support academic research studies conducted on the BRCA genes.”

Thanks for your interesting blog and your observation in the blog today about the limitations on the Court’s ruling about cDNA.

Doug Rogers
Anon
June 14, 2013 04:18 pm
Gene,

I will touch upon the kidney with a short note: My response to “The fact that the man-made kidney is identical to the natural kidney is what is the innovation” is to say that you are asking for a patent on the wrong thing. You found a way of duplicating something? Great – you get a patent for the method. You do not get a patent for something already (in this case – and I hesitate to mix the 102 with the 101) existing.

“Identical result” simply is not innovation. Getting there, different story. Doing something man-made that presents the results of an identical thing of nature: the process is the innovation.

And sorry – I do not think that you are reading Chakrabarty properly. It is NOT merely that man made something that won the day there. It was that man made something that was NOT in nature. Your man-made kidney would fail under Chakrabarty. As Mal Reynolds would say, you have this all crabbed.

As to the altering – I think you miss that a line has always been there – even in Chakrabarty. As I posted, there is legal history for ‘difference in kind – not degree.’

I will agree that this notion of “conventionalness” of steps rubs me the wrong way. To me, this is misaplying pre-1952 “invention” analysis which was re-codified into 103, which, when codified was done so with the express addition of “Patentability shall not be negated [AIA] by the manner in which the invention was made.

But I think that separate from any other consideration, and predates Chakrabarty – tracable to Graham.
step back
June 14, 2013 04:12 pm
The bottom line is that the government makes promises to the inventor community:

“Whoever invents or discovers any new and useful … composition of matter … may obtain a patent therefor, …”

And then (warning SPOILER alert) … reneges on that promise.
John-Paul Gignac
June 14, 2013 03:57 pm
Gene-

I see what you mean regarding newness in §101 making novelty in §102 superfluous. But the word new is indeed present in §101, and it seems like the current approach is to let the law of nature exception fall under §101, which is consistent with my point.

In any case, I think the complexity of the situation (which I didn’t previously realize) entitles you to what I still consider minor hyperbole. Thanks for the lesson. 🙂
Gene Quinn
June 14, 2013 03:24 pm
John-Paul-

Unfortunately, 101 doesn’t have a “newness” component. Please check historical 101 jurisprudence vis-a-vis 102.

101 has never been used in any way, shape or form to address newness until at least Mayo v. Prometheus. If newness is now determined under 101 then 102 is superfluous. I’d be very grateful if the Supreme Court intends to ignore 102 and rule it unnecessary and superfluous and just ignore the new law past by Congress. But the Supreme Court has always said that statutes cannot be construed to make another statute superfluous. So either the Supreme Court statutory interpretation law has been jettisoned, several hundreds of years worth of patent law precedent has been jettisoned, or the Supreme Court doesn’t know what they are saying or what they are doing.

Novelty, or newness, is addressed under 35 USC 102, not 101.

-Gene
John-Paul Gignac
June 14, 2013 03:17 pm
Gene,

Groundbreaking, innovative, or even brilliant discovery does not by itself satisfy the §101 inquiry.

It’s completely unfair to characterize Justice Thomas’ statement as saying “that innovative discoveries are not patent eligible”. The statement was clearly intended to emphasize §101’s requirement that the discovery be new. Although one might attempt to interpret the terms “groundbreaking” and “innovative” to imply newness, the context of the statement decidedly precludes that interpretation.
Gene Quinn
June 14, 2013 02:18 pm
Anon-

I didn’t intend to try and dismiss your position glibly, so apologies if it came off that way.

You want a rational explanation about differentiation in order to have a claimable difference. The problem is that with my hypothetical about the kidney, which folks don’t seem to want to address, rests on the premise that there will be absolutely no claimable difference as to the structure. All that will be different is one was made by God (or through natural processes) and one will be made by man in a laboratory. The fact that the man-made kidney is identical to the natural kidney is what is the innovation. How is it possible that man could replicate body parts that are identical to what appears in nature and that not be considered anything other than an extraordinary innovation?

Should such an extraordinary innovation be patent eligible? I say absolutely. The claim would have to be to a man-made kidney. You could certainly get product by process claims and method claims, but why not a claim to the kidney itself?

Chakrabarty is overruled because it stood for the proposition that if there is human intervention then the resulting “thing” is patent eligible. As a result of the Myriad decision human intervention is not enough to result in patent eligibility… see the aforementioned kidney discussion. Under Chakrabarty a man-made kidney would certainly be patent eligible. Not so any more.

Further, Chakrabarty also stands for the proposition that if human intervention alters the natural state of the “thing” then the thing is patent eligible. The Myriad Court acknowledges that the claims do not cover DNA that naturally occurs, but still they find it to be a product of nature. Thus, Mayo v. Prometheus is extended. In Mayo the Court recognized there were extra steps that take the claimed method outside of a law of nature, but the steps are conventional, so the claim covers a law of nature. Now in Myriad they say the claims cover something that does not occur in nature (i.e., the bonds) but it is still a product of nature.

In Chakrabarty the science mattered. In Mayo and Myriad the science doesn’t matter. Even things that do not naturally occur are patent ineligible as products of nature. These statements from Mayo and Myriad that relate to the science are mutually exclusive and internally inconsistent. They are also wholly inapposite to the holding in Chakrabarty. Thus, regardless of what the Supreme Court says, Chakrabarty is effectively overruled.

What say you?

-Gene
Gene Quinn
June 14, 2013 02:08 pm
Stan G-

I had many e-mail communications with Koepsell and I’m sure if you search IPWatchdog he has made those statements in the comments. I know he has made those statements in interviews he has given, and I thought he also made those types of statements in his book.

That is the problem I had with Koepsell… hyperbole. Initially I thought we could have an intellectual discussion on the issue, but it soon became clear he wanted to have a philosophical discussion, which he has said specifically. That is fine, but don’t couch it in terms of a patent legal argument then.

Koepsell said numerous times that the Myriad claims protected what occurred in nature. That was also what the ACLU et al argued. Surprisingly the Supreme Court disagreed with that, specifically stating that the claims do not cover what appears in nature, but finding that the claims are still, nevertheless, a product of nature. A true logical inconsistency. Sadly I doubt the Supreme Court understands the inconsistency at all.

Cheers.

-Gene
Anon
June 14, 2013 01:26 pm
Gene,

Not so fast with the “confuse infringement” line of thought.

The infringement angle is not a sign of confusion. Rather, it highlights one very real difficulty with allowing something that nature can also provide – and quite in fact makes a mockery of the patent’s exclusive rights.

So please, take a moment and think through the points I make. Do not dismiss them glibly.

As for gold – I would love to see a rational explanation and differentiation for a stable element to somehow have a claimable difference.

Also, please explain your view of Chakrabarty – You have now repeated that you think it overruled – and I simply cannot see why you think so. If anything, I see Chakrabarty completely in line with Myriad. This may be due to some lack of understanding I have with the cases, but I just cannot see it. If there is a legal basis for what you say – I very much want to understand it.

If you are thinking that the ability of man to make something that nature also can make overrides the warehouse of nature concept, then you have an exception that destroys the rule. The rule would make no sense whatsoever. The rule only makes sense when the set of what man makes and the set of what nature makes overlaps. If there was no overlap, there would be no need for the rule, as man would never be able to impinge on the warehouse of nature.
Gene Quinn
June 14, 2013 01:25 pm
MDT-

You say: “What I do know is that certain things should not be patentable.”

That is an extraordinarily arrogant statement. Who made you King and capable of deciding what can and cannot be patent eligible? Seriously, you admit that you don’t understand the law but you feel qualified to decide issues of patent eligibility? WOW. Amazing confidence in yourself without even a basic understanding of the area. That is practically comical!

I also find it amusing that you admit to not understand patent law and then proclaim I am conflating the kidney with a method of making a kidney. Please, if you are going to comment here take the time to inform yourself!

It will likely come as a shock to you but the patent laws allow for the patenting of (1) a thing (i.e., machine or compound); (2) a method of making a thing; and (3) a method of using a thing. The fact that you are unfamiliar with the patent laws and think it is enough to protect a method is your opinion, not fact. It isn’t even an opinion based on fact.

You also say: “I believe you could absolutely patent the specific method of cloning a human kidney. What I don’t think is valid is the concept of cloning a kidney.”

And now we come to the crux of the issue. You are so unfamiliar with any of this that you seem to really believe that concepts are patentable. Concepts are not patentable at all. They never have been patentable and they never will be patentable.

Finally, I have never said gold should be patentable. So you can keep saying that if it makes you feel better about yourself, but there is definitely a difference in natural gold and synthetic gold. If one can make synthetic gold then synthetic gold should be patent eligible. Whether it is new, non-obvious, useful and adequately described are open for discussion.

The trouble seems to be that you think that because something is patent eligible that means a patent should issue, which is simply false. With such fundamental mistakes in your analysis and understanding t is really hard to take anything you say seriously. You are trying to debate a legal issue and you admit to knowing absolutely nothing about the law generally or patent law specifically. If you want to have a philosophical discussion let’s have it. But further discussion about the law and what the law is or should be is really a waste of time until you first obtain a functioning understanding of patent law.

-Gene
stan g
June 14, 2013 01:18 pm
Gene, Looking back on his guest post on your blog, Koepsell doesn’t make the claims you allege, nor can I find him saying anything like that in his book (I have the kindle version). Can you provide a citation to him saying those things? Obviously such claims would be hyperbole if he made them.

Best,
Stan
Gene Quinn
June 14, 2013 01:07 pm
EG-

We should also point out that Koepsell was incorrect when he said that the Myriad DNA claims cover only what occurs in nature. SCOTUS recognized that the claims did not cover anything that actually occurs in nature, but declared it a product of nature nevertheless since they didn’t think breaking bonds was enough.

So on the science we were right and he was wrong. Where we were wrong was with respect to believing that the Supreme Court might follow their own precedent and actually apply science to the decision.

So now we have the Supremes saying form on high that something that does not occur naturally in nature is a product of nature and therefore not patentable. This is too bizarre to make up and it is sad even coming from the Supreme Court.

-Gene
Gene Quinn
June 14, 2013 01:04 pm
Anon-

Don’t confuse the ability to prove infringement with whether something should be patent eligible under 101. Based on the long history of patent law in the US there is no reason why man-made gold shouldn’t be patentable if the claims are narrowly tailored to protect the man-made version. The fact that the man-made version is indistinguishable from what appears in nature wouldn’t have mattered under the now overruled Chakrabarty decision.

When you say “gold is gold,” we will just have to disagree.

If you are right then a man-made kidney that is identical to a nature made kidney isn’t patent eligible. That would be a comical farce. An artificial kidney could be patented but if we can ever replicate nature then no patent for that extraordinarily valuable innovation.

Have we really come to the point where the most breathtaking innovations aren’t patentable? The Star Trek computer is not patent eligible and neither is an artificial kidney that is identical to a natural kidney. Sad. I thought the Supremes said in KSR they didn’t want “common sense” innovation and wanted a patent system to foster the truly innovative. I guess they don’t want trivial innovation and they don’t want groundbreaking innovation. They want sorta interesting and not too commercially valuable innovation.

Somehow I am sure that wasn’t what Madison, Washington et al had in mind.

-Gene
MDT
June 14, 2013 12:04 pm
Gene,

I have never claimed to know about the law. What I do know is that certain things should not be patentable. Or rather, patents should not be overly broad. Any patent on a man-made human kidney that patents ‘human kidney, man made’ is too broad. And again, you are conflating the kidney with the method of how it is made. That is the mistake you are making. I am perfectly happy (nay, thrilled) if someone comes up with a way to clone a human kidney or grow it, or what have you. Let us look at this…

1) Extract DNA from Human A
2) Extract DNA sequence governing Kidney from DNA
3) Extract Stem Cells from Human A’s bone marrow
4) Culture Stem Cells from Human A using a growth medium of one of the following makeups based on ethnographic makeup.
5) Using Extract from Step 2, mix with cultured Stem Cells from Step 4. Apply a chemical treatment using for X days, then switch to for Y days. Ensure cells are incubated between M and N temperatures during incubation, and supply cells with growth medium.
6) Implant Kidney obtained from Step 5 in Person A.
7) Monitor Person A’s urine for X days to ensure kidney is functional. Daily blood tests should be done to ensure filtration is working.

Now, the process of creating the kidney, absolutely patentable IF IT IS NOT ALREADY FULLY UNDERSTOOD AND EXPECTED that it should work that way. So let’s look at the steps above.

1) This process is already understood, and already either patented or out of patent (I suspect the latter). Not patentable as part of Kidney.
2) This process is already understood, and already either patented or out of patent (I suspect the latter). Not patentable as part of Kidney.
3) This process is already understood, and already either patented or out of patent (I suspect the latter). Not patentable as part of Kidney.
4) This may be a new patent here, if the growth medium is a new and previously unpatented method of growing the stem cells. Culturing cells is a very old process, but if this is a new way of doing it, or a special and new and previously unused growth medium formulation that faciliates the cloning, then you’re golden for a patent. Good for you, you came up with something nobody else did, and it’s a physical thing and limited by the formula you supplied. You didn’t go overbroad and say ‘patent all culturing of stem cells’.
5) THIS is the part that is patentable. The very specific method of inducing the cells to grow into a kidney. Not the entire concept of growing a kidney. That is where I believe (and apparently SCOTUS also believes) you are overreaching. You are trying to lay claim to the concept of a man-made kidney, rather than the specific method used to make the kidney. This would be the equivalent to laying claim to the concept of SUV, not a specific implimentation of the SUV. Or the concept of ‘Internal Combustion Engine’ rather than a specific design of ICE.
6) Not Patentable.
7) Not Patentable.

So to answer your question, I believe you could absolutely patent the specific method of cloning a human kidney. What I don’t think is valid is the concept of cloning a kidney. You seem to want to patent the kidney, not the process of making it. That would, again, be like patenting GOLD rather than patenting ‘method of making gold’.
Anon
June 14, 2013 11:16 am
Sorry Gene,

I should have included this comment above.

Your reasoning about proof is a fallacy. Gold is gold and does not lend to proof about ‘making.’ You also run into the legal difficulty with the concept of product-by-process. Finally, you ignore the legal basis as to why the exclusions are there to begin with. In essence, a patent on something that fits the exclusion is a legal nonsense. Either have the patent or have the exclusion, but you CANNOT have both.
Anon
June 14, 2013 11:13 am
EG,

It does not do well to withhold credit where credit is due. Yes, Mr. Koepsell did argue for more, but that does not diminish the products of nature doctrine.

I would defiinitely draw the line between a product of nature and a product of man that is not a product of nature. But man being capable of duplicating a product of nature should not give rise to a right of the product – as the example of gold aptly illustrates, this violates the Court’s implicit finding in the words of Congress.
Anon
June 14, 2013 11:10 am
Gene,

I think some talking past each other is going on.

You state: “Of course, the claim would have to include appropriate limitations narrowing the claim so that it would not capture naturally occurring gold, in your hypothetical”

The problem, of course, and aptly illustrated in the example, is that no such “appropriate” limitations are possible with gold. Gold is gold. Period.

This too ignores the reason for the judicial exception under 101: the implicit (or at least the Court says so) writing of 101 that certain exclusions apply.

I have always believed (and find this case vindication of that belief), that IF the judicial exception of phemona of nature is allowed, THEN that exception necessarily includes products of nature. By the way, this is the ONLY way to read Chakrabarty.

The distinction being made in this case – and is a natural outgrowth of the Prometheus case, is the drawing of the line around just what is a product of nature.

There is legal pedigree for this line (difference in kind rather than degree).

To me, this case is much more palatable than the Prometheus case. And really, I do not think that the product of nature doctrine is nearly as apt to be bent and reshaped like a nose of wax anywhere near as much as the concept of ‘abstract.’ may/is. Understanding what is actually there in nature can be quite objective, even if at the edge the calls will naturally be tougher.
EG
June 14, 2013 10:51 am
To All,

Before we let Koepsell “crow” about what the Supreme Court ruled to be patent-ineligible, he also said that Myriad’s claimed cDNA should likewise be considered patent-ineligible. But notice that 9 Justices of the Supreme Court went exactly the other way on the patent-eligibility of the cDNA. Do remind Koepsell of that fact if he does start to “crow.”
Gene Quinn
June 14, 2013 10:29 am
MDT-

I just don’t see any reason why something that is man-made shouldn’t be patentable. Of course, the claim would have to include appropriate limitations narrowing the claim so that it would not capture naturally occurring gold, in your hypothetical.

Then your question turns ridiculous by saying that with a claim to man-made gold you could sue everyone who owns natural gold because there would be no way to know whether it was natural or man-made. That is simply not true. Clearly you are unfamiliar with the law and don’t understand about basic issues of proof. If the owner of the claim to man-made gold couldn’t show that the gold was man-made then there would be no infringement. If they could prove that the gold was man-made gold then there would be infringement. Pretty simple really.

I also notice that you and others don’t want to address the hypothetical I raise about a kidney because you know you can’t in any honest way win that debate. A man-made kidney that is identical to a kidney found in nature would be an extraordinary achievement. In order to be useful in any sense of that word it would necessarily have to be identical. So it seems that the Supreme Court… and you and others like you… would prefer science cease trying to invent man-made organs for transplantation to save lives. Now that is sick!

Without exclusive rights funding dries up. It is that simple.

-Gene
Gene Quinn
June 14, 2013 10:19 am
Etaoin-

See: https://ipwatchdog.com/2013/06/12/did-the-ptab-just-kill-software-patents/id=41693/

-Gene
Gene Quinn
June 14, 2013 10:16 am
Stan G-

That the Supreme Court agreed with the outcome that Koepsell advocated doesn’t make either of them right. The Supreme Court is wrong to say that a man-made item is naturally occurring. They are scientifically wrong when they say that, which should be clear to everyone who cares to be honest.

When Koepsell says that the USPTO was granting patents on body parts and Myriad could sue anyone alive he was being hysterical and objectively incorrect.

So if you want to ignore scientific reality, as the Supreme Court did, then you could suggest Koepsell was right.

-Gene
Dale Halling
June 14, 2013 10:14 am
At the very least patent holders should have a chance to modify their claims after decisions that effectively change the law.
Dale Halling
June 14, 2013 10:08 am
Gene is right that this will wipe out the value of thousands of patents, destroying property rights of thousands of inventors in a post hoc way. In that sense there is a question whether the court’s decisions such as this are a 5th amendment taking. The last time this happened was probably the means plus function claiming issue in Texas Instruments vs ITC.
ceejay
June 14, 2013 09:36 am
Following up on what Gignac was saying, if structure A is not novel or nonobvious compared with structures in nature then structure A is not patent eligible. That does not mean that unnatural methods for making the structure cannot be patented.

If an inventor comes up with a way to quickly and easily make diamonds then we may call those diamonds “synthetic.” The diamond structure is not new; it’s the process that’s inventive–not the product of the process. Thus, while I don’t think a “synthetic organ” is patent eligible, I’d expect a process for making synthetic human organs to be patent eligible.
Alan Stewart
June 14, 2013 08:42 am
This is a slippery slope but I am generally in agreement with the premise of the decision. The devil is certainly in the details, but the premise matches my thoughts on this case. If you were to create a kidney that is identical to a naturally occurring kidney, then the human created kidney by itself should not be patentable, without the limitation that the kidney must be the product of a non-naturally occurring process. It may be more easily understood when we deal with an object the size of an organ than when dealing with an item at the molecular level.

And come on Gene. Hyperbole is great but lets keep the dialog professional and not sensational. There has to be something that is NOT patent eligible at a base level. Natural phenomena have not been patent eligible for a long time. The “discovery” (to use the language of the Constitution) or more precisely, the recognition of the existence, of a natural phenomenon is not and should not be patentable. The method used to discover the phenomenon is and should be patentable. The object created by man that is identical to the natural phenomenon should not be patentable but the method discovered to create that identical object should be patent eligible.

So, reading you more sensational statements, you are saying that the first company to produce a kidney should be able to patent a kidney produced by something other than the human body and prevent all others from patenting or producing kidneys. Because if you divorce the object-identical-to-the-natural-object from the way it was created, then you are preempting all others from coming up with new and different methods of producing the same thing.

I am perfectly OK with requiring a patent claim to do more than just call out an artificial kidney that is functionally identical to the naturally occurring kidney of a patient. I am perfectly OK with requiring a patent claim to give some more of the detail of how this modern marvel was created. I am perfectly OK with this as it leaves room for other companies/individuals/labs/universities to practice their creativity and possibly secure limited exclusive rights to their discoveries of other ways to produce this modern marvel. Protecting creativity and promoting creativity at the same time. And this seems to be what the founders were intending when they drafted Art. 1, Sec. 8.
stan g
June 14, 2013 07:13 am
So… Basically, Koepsell was right.
EG
June 14, 2013 07:05 am
“The problem is Thomas didn’t say that cDNA is patent eligible.”

Gene,

I would also be careful in reading too much into Thomas’ comment (which is dicta) about “very short series of DNA which may have no intervening introns to remove in creating the cDNA.” By definition, cDNA (complementary DNA) is a DNA molecule which is created from mRNA (messenger RNA) and therefore lacking the introns in the DNA of the genome. Thomas (or his clerks) may not have realized that what they were talking about isn’t what would be defined as cDNA.
Karthik Kumar
June 14, 2013 07:01 am
Could someone please show me where I can pick up some free naturally-occurring isolated DNA? Need to get some experiments done asap.

Thx.
Etaoin Shrdlu
June 14, 2013 05:52 am
@Gene – got a link or a case number on that PTAB decision?

@Gary — yes, the diagnostics companies will “thrive” for a time, until they’re all offering the same tests for whatever pittance Obamacare will pay them (probably below cost, based on the current situation), and few new tests are coming out that they can try to scam premiums for.
dmc
June 13, 2013 10:22 pm
I look forward to the plethora of literature in the coming years that will use today’s ruling as a basis for mocking the type of ridiculously hyperbolic disingenuous sky-is-falling nonsense Gene spews here (and elsewhere). Patents certainly play an important role in innovation, but too much of a good thing turns it into a bad thing. The nonsense of Gene’s brand of nothing-good-can-ever-come-from-limiting-IP will soon be apparent. There is still PLENTY of incentive to invest in and protect new, non-obvious man-made creations in biotechnology, even related to genes, just not the genes themselves.
Dale Halling
June 13, 2013 08:58 pm
ptzemoli,

The Constitution did not give Congress a RIGHT, it did not give Inventors RIGHTS – it told Congress to secure those RIGHTS. i.e. the rights of inventors. The power given to congress was not to decide if inventors have rights, or whether they should be secured, but the process for how they are secured. This was a straight forward division of power question. The states were no longer allowed to have patent systems, the president cannot legislate and neither can the courts, so it was up to congress to provide the structure of the property right system for inventors, just as states provide the property rights structure for land. Congress does not have rights, but inventors do.
MDT
June 13, 2013 08:32 pm
Quote : Gene Quinn June 13th, 2013 8:21 pm
“Myriad never refused any individual the test even when they had no ability to pay anything. For reasons known only to Myriad they did everything in their power to hide that fact from ever coming out publicly in a meaningful way.”

Simple, if people knew Myriad would not charge if you couldn’t afford it, they’d get 100 million applications for tests from people who can’t afford it. They knew this, so they kept it as quiet as possible to keep how many people they tested for free to an absolute minimum. Bottom line thought.
MDT
June 13, 2013 08:29 pm
Article: “A man-made thing that is identical to something that occurs in nature is by definition new. This is why the ruling today overrules Diamond v. Chakrabarty.”

So, if I manage to figure out a way to turn lead into gold, I can not only patent the process of turning lead into gold, but also the gold itself? Because, I have now duplicated something that occurs in nature. My gold is not natural gold, but it is molecule for molecule indistinguishable from naturally occurring gold. In which case, I can now sue people for owning gold, because it might have been created using my process, yes?

I know, hyperbole, it’s actually easier to turn gold into lead via neutron capture and beta decay. 🙂 It’s easier to make gold from liquid mercury using a neutron accelerator or with mercury or platinum in a nuclear reactor (if you don’t mind your gold being irradiated that is). 🙂
Gene Quinn
June 13, 2013 08:21 pm
przemoli-

You are correct about Myriad not licensing, and I will modify that statement.

It is, however, incorrect to say that the test costs $3,000, or at least misleading. Myriad never refused any individual the test even when they had no ability to pay anything. For reasons known only to Myriad they did everything in their power to hide that fact from ever coming out publicly in a meaningful way.

-Gene
John-Paul Gignac
June 13, 2013 08:11 pm
Gene,

The main problem with Myriad’s patents on the BRCA1 and BRCA2 genes is that they had no language to limit their scope to synthetically created instances. In fact, as I understand, they couldn’t, since Myriad never created those genes. They only extracted them.

If you want to patent a kidney which is identical to a natural kidney, limiting the scope to synthetically created instances might be a good start. But, assuming the claims aren’t so broad as to include *every possible* present and future way of creating such an object, the patent is effectively on the method, not on the object itself.

The method by which something is created is just history, not a property inherent in the object. If it’s truly identical to a natural object, then it isn’t novel. But the method might be.
Matt
June 13, 2013 07:38 pm
when you overreach for years with patents by patenting blatantly obvious things under the guise of “promoting progress” when science and history show that patents neither promote nor promote progress, it’s going to result in a smackdown.

if an industry was propped up on a bubble like this, then let it hang. All the better for the benefit of society over a single corporation which has managed to put an entire society at risk due to greed. If companies were propped up off of patent trolling, all the better for them to fall from it. Live by the sword, die by the sword.

The patent system doesn’t have to be gone, but this excessive overreach that’s been going on for 10+ years? that needs to die off 10 years ago, and only now are we catching up. Things need to be fixed.
przemoli
June 13, 2013 07:31 pm
BTW

US constitution Article I, Section 8, Clause 8 says,

“””Congress shall have power … To promote the progress of science and useful arts, by securing for limited times to authors and inventors the exclusive right to their respective writings and discoveries;”””

“inventors” have no right here… Its Congress right to grant some rights, nothing more.
przemoli
June 13, 2013 07:29 pm
Myriad

DID NOT LICENSED their patent.

Nor Myriad allowed for independent RESEARCH.

So its not just “Thus, we all lose today so that a handful of companies don’t have to pay Myriad a royalty.” … Because Myriad was unwilling to cash on it by licensing…
And since majority of US citizens earn less than 3 000 $, and prices can go as low as 300$… We all benefit.
Gene Quinn
June 13, 2013 07:01 pm
John-Paul-

Please explain why you shouldn’t be able to receive a claim covering synthetically created diamonds?

Sure, your synthetic diamonds shouldn’t entitle you to a claim that covers naturally occurring diamonds, but you should be able to claim synthetically created diamonds.

I notice you changed the hypothetical. So is your position that a claim on a man-made kidney that is identical to a natural kidney shouldn’t be patented? No one in their right mind would say that.

-Gene
John-Paul Gignac
June 13, 2013 06:34 pm
If I invent a way of producing synthetic diamonds which are identical to natural diamonds, should that entitle me to a patent on diamonds? Nope. Should it entitle me to a patent on my method? Sure. That’s what this decision is about.
Gene Quinn
June 13, 2013 04:47 pm
Dale-

I guess you had a very bad prediction about how this case would turn out if you think this is better than expected. I think it is worse than expected.

This is being portrayed as a statement that at least cDNA is patent eligible, but that is not what the case says. If cDNA were patent eligible then Myriad would have been victorious since their claims incorporate a composite cDNA sequence made up of hundreds of individuals. So the inclusion of synthetic material that is made from hundreds of individuals in a lab does not render the claim patent eligible. That means there is no longer any vitality to Chakrabarty. Man-made is not enough. That which is made by man cannot be the same as what is made in nature. So the pursue of synthetic, man-made equivalents to what appears in nature will not result in a patent.

Although I haven’t yet written about this, notice also that many (if not most) antibiotics occur in nature and what is patented is a synthetic version of nature. So there will be a number of pharmaceuticals that will be challenged based on this ruling and we all know that many district court judges do not like patents. Any guess how that will turn out when the argument is made in the district courts? Any guess how it will turn out when the arguments are made to the PTAB, which after the CBM decision the other day seems extremely anti-patent.

-Gene
Gene Quinn
June 13, 2013 04:34 pm
EG-

The problem is Thomas didn’t say that cDNA is patent eligible. He wrote:

“cDNA is not a “product of nature” and is patent eligible under §101, except insofar as very short series of DNA may have no intervening introns to remove when creating cDNA. In that situation, a short strand of cDNA may be indistinguishable from natural DNA.”

Therefore, even though the Court says that cDNA is synthetic not all of it is patent eligible. To ignore this part of the ruling is a big mistake. What they are saying is that if the result is the same as nature then it is not patent eligible even if it is synthetic. That means no patents on synthetic, man-made body parts, such as organs for transplantation.

Further, each of the Myriad claims incorporated cDNA. Not any cDNA, but composite cDNA made up from scratch out of hundreds of individuals. So the composite, synthetic, man-made cDNA in each of the claims was not enough to save the claim.

So exactly what cDNA is patent eligible? It is not at all a blanket statement and hidden in that statement is the real negative consequences of the decision.

-Gene
EG
June 13, 2013 04:24 pm
Gene,

I don’t view this opinion as being as depressing as you do. It could have been far worse At least Justice Thomas wrote it in a way that at least kept the patent-ineligible part of the holding tightly cabined, more so than you might think.

Also, besides saying that cDNA was patent-eligible (versus “isolated” DNA that wasn’t) are these sentences at pages 14-15 of the slip opinion: “Myriad’s claims are simply not expressed in terms of chemical composition, nor do they rely in any way on the chemical changes that result from the isolation of a particular section of DNA. Instead, the claims understandably focus on the genetic information encoded in the BRCA1 and BRCA2.” In other words, Myriad’s claimed “isolated” DNA sequences didn’t look enough like a chemical molecule divorced from the native DNA. That’s also somewhat of a “jab” at Breyer’s derogatory statement in Mayo about not letting patent-eligibility under 35 USC 101 depend on the “draftsman’s art.”

Further, as I and others know, the Myriad opinion is essentially applicable only to that 2% of the human genome that follows the pre-ENCODE approach to genetics. That means that the Myriad opinion is really inapplicable (i.e., not on point) as to 98% of the human genome that doesn’t follow the pre-ENCODE approach to genetics. So the “game” isn’t over yet by a long shot.
Anon
June 13, 2013 04:17 pm
Gene states: “A man-made thing that is identical to something that occurs in nature is by definition new. This is why the ruling today overrules Diamond v. Chakrabarty.”

Sorry Gene – completely wrong. By definition, a man made thing that is identical to something that occurs in nature is not new. And while that is a 102 argument, the rationale for Chakrabarty remains sound explicitly because the invention in Chakrabarty was not a product of nature – a 101 argument. The 101 Product of Nature exclusion is not, nor ever has been, time dependent. It is policy driven and simply a part of the Judicial Excemption of the exclusion for phenomena of nature. The reason why it is a 101 and not 102 issue is because, or rather, NOT because of ‘new’ness, but because anything that can be classified as a Product of Nature falls outside the scope of patent law.
Dale Halling
June 13, 2013 04:03 pm
Gene,

While I disagree with the decision, I actually think it is better reasoned than we could have expected. I think it provides a fairly clear line for patent attorneys. There was little talk about monopolies and other anti-trust nonsense. There was little attempt (some) to incorporate 102 & 103 issues into the decision. However, there was nonsense about patents being a balancing act and clearly an idea that you can ignore certain parts of the invention and say the rest is old or natural and therefor not patentable. And inherently there was the statement that somehow knowing the parts were individually old tells you something about whether the invention is patentable.
Gene Quinn
June 13, 2013 02:51 pm
Woody-

You say: “If it exactly matches the natural sequence, you haven’t made anything new; so no novelty…”

That is certainly what the Supreme Court said today, but that does not make this a factually correct statement.

You have created something new. A man-made thing that is identical to something that occurs in nature is by definition new. This is why the ruling today overrules Diamond v. Chakrabarty. Something modified by man has until today been patent eligible. Here Myriad’s claims incorporate cDNA, which is man made, and yet the claims fail. So that which is made by man is no longer patent eligible in all cases.

This will have enormously negative consequences with respect to medical research and development. The point of growing an organ, for example, is to make it identical to the organ as it exists in nature. If it is not equivalent to the organ that exists in nature then it is useless. So an entire category of life saving innovations dies today because no patent can be obtained on a man made organ. Breathtaking!

Investors would be foolish to provide funding for research and development in many medical areas after this decision. No patent means no means to recoup the many billions of dollars required for R&D. Competitors will be able to copy without paying a dime of R&D. That means no one will fund the innovative and groundbreaking discoveries that SCOTUS says are not patent eligible.

-Gene
Woody
June 13, 2013 02:22 pm
Just because something is patent “eligible” does not mean that it is patent “worthy”. Naturally occurring DNA is not eligible, even if you work really hard to isolate and/or extract it. (Though if you use some new device or process, that may be eligible).

Manufactured cDNA is eligible because you made it. Now it has to pass the novelty and non-obviousness tests.

If it exactly matches the natural sequence, you haven’t made anything new; so no novelty, no patent. Anybody is allowed to duplicate a naturally occurring object. (Whether they have the means to do so, or the market for the results is another story…)

If it is derived from the natural DNA, but the sequence but has some evolutionary flotsam and jetsam removed, you have a new molecule, so you pass the first test. But, it is still a gene, and its effects are meant to be the same as the natural DNA’s effect once implanted. Everyone knows it can be done, and if the effect is desirable, then it should be obvious to anyone skilled in the art of genetic manipulation that you can create said molecule, so again, no patent.

So now you create a gene based on a natural gene, but through careful design you create a gene that actually does something other than the original. Let’s say it lets you grow Blue hair. That’s created, novel, and nobody else knows what goes into a gene to create blue hair. Now you’ve got a gene you can patent. But…
You have to be specific: “Creation of a gene to allow growth of hair of a particular color” is too abstract for a patent. You have to detail YOUR gene.
Someone else could create a different gene that also happens to have the effect of growing blue hair.
Someone could create a gene similar to yours (maybe also derived from the same natural “hair color gene”), that happens to create green hair.
Garrett Wollman
June 13, 2013 02:21 pm
So will this finally be the incentive Congress needs to intervene? And if so, will they end up making matters better or worse? I’m generally sympathetic to the anti-patent argument here, but there has to be *some* mechanism to reward the companies that invest in bringing this technology to the market. If they can’t agree on fixing patens, perhaps some more limited sort of exclusive marketing right.
Gary
June 13, 2013 02:06 pm
Oh Gene. How I wish I had taken you up on your “friendly” wager offer. Your analysis that this ruling is somehow bad for the industry is completely wrong. Diagnostic companies will thrive now that they are no longer hindered by outrageous royalties and licensing fees.
Gene Quinn
June 13, 2013 01:18 pm
Daniel-

The Myriad case has nothing to do with mathematical algorithms, so your comment completely misses the point altogether.

Whether you want to accept it or not, what Justice Thomas wrote and all the other Justices agreed with was: “Groundbreaking, innovative,
or even brilliant discovery does not by itself satisfy the §101 inquiry.”

I didn’t misconstrue anything. You obviously didn’t read the decision or didn’t understand what you read. Please read the decision and inform yourself. In the future please refrain from making an irrelevant, misleading comments that misrepresent what I write.

-Gene
Daniel Cole
June 13, 2013 01:11 pm
No what they said that innovative, and ground breaking discoveries of products of nature, or abstract mathematical algorithims are not patent eligible…which is how it has always been. E=mc squared was certainly ground breaking or innovative, but it shouldn’t be patent eligible. Misconstruing the decision for hits and to create controversy isn’t really a good idea. Section 101 is a real limit on patentability and should be treated as such.