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Hakuna Matada, the ACLU Gene Patent Victory Will Be Short Lived


Written by Gene Quinn
President & Founder of IPWatchdog, Inc.
Patent Attorney, Reg. No. 44,294
Zies, Widerman & Malek
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Posted: March 31, 2010 @ 6:50 pm
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It will likely come as a surprise to many, but I really don’t think the ACLU victory in the Myriad Genetics litigation is a big deal.  Hakuna Matada is what I say.  It’s actually a wonderful phrase. It means no worries for the rest of your days, and is a problem-free philosophy… blah blah blah… Picture begins to wiggle out of focus and fades to black in three… two… one… You are about to begin a journey through space and time, into another dimension.  On this odyessy into a wondrous land whose boundaries are that of the surreal, the vastness of the timeless infinity forms a middle ground between light and dark, between science and superstition, and it lies at the heart of humanity’s fears and the pinnacle of understanding.  You are about to enter the Twilight Zone…

As most undoubtedly know by now, Judge Robert W. Sweet, the 88 year old liberal jurist from the United States District Court for the Southern District of New York, on Monday issued an opinion that invalidated Myriad’s gene patent claims, and the decision was the lead case in the Docket Report e-mail sent out earlier today.  Essentially the opinion says gene patents, pretty much all of them, are not patentable subject matter because genes exist in nature.  Never mind that the genes that exist in nature are not isolated, the isolation step is really of no consequence (and I mean that literally).  If you can believe it, the term “isolated” was interpreted through one of the most tortured claim constructions I have ever seen to mean nothing.  Yes, the word apparently has no meaning whatsoever, almost as if it were a null set or the linguistic equivalent of a black hole.  Sadly, you can’t make this stuff up!

Unfortunately, the outcome in the case now styled Association for Molecular Pathology v. United States Patent and Trademark Office, which is likely known as ACLU v. Myriad Genetics by most observers, was foreseeable and predictable.  Anyone who has followed the case knew Judge Sweet would rule against Myriad, and many predicted that gene patents and perhaps the entire patent system would be ruled unconstitutional.  At least we should commend Judge Sweet for not ruling the entire patent system unconstitutional and only finding the claims at issue invalid.  The fact that all of the evidence demanded a different ruling and the fact that there was no standing be damned!  At least Judge Sweet deferred, finding it unnecessary to reach a constitutional issue after shooting the gene patent claims dead under 35 USC 101.

In Act I, which begins some 92 pages into the decision after an enormously long identification of the parties and recitation of the facts, in construing the claims Judge Sweet explained:

The term “isolated DNA” is defined by Plaintiffs as “a fragment of DNA substantially separated from other cellular components and other DNA.”  Myriad disputs Plaintiff’s definition insofar as it implies that fragments of DNA exist free-floating in the cell, separate from other components, such as proteins and the other DNA in the chromosome.  The patent specifications expressly define “isolated DNA” as a DNA molecule “which is substantially separated from other cellular components which naturally accompany a native human sequence [such as] human genome sequences and proteins’ and “includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.

“Isolated DNA” is therefore construed to refer to a segment of DNA nucleotides existing separate from other cellular components normally associated with native DNA, including proteins and other DNA sequences comprising the remainder of the genome, and includes both DNA originating from a cell as well as DNA synthesized through chemical or heterologous biological means.

Of course, the handwriting was on the wall well before this point, but once Judge Sweet construed “isolated DNA” to mean “DNA originating from a cell” the fat lady was already warmed up and well into the chorus.  To break this down to its most basic level, this construction by Judge Sweet was this: the term “isolated DNA” means “DNA.”  As it turns out the word “isolated” was just superfluous and Myriad was just trying to patent DNA, which happens to naturally occur, so that must mean they were trying to patent humans and exercise exclusive control over every human within the geographical boundaries of the United States.  Give me a break!

In any event, once again, Judge Sweet went through all the right paces and at the end engaged in almost unfathomable intellectual dishonesty.  Why kill so many trees with a 152 page decision just to analyze things, take the time to carefully set everything up and then so obviously ignore facts, law and logic?  Environmentalists everywhere should be appalled!  He could have just issued a one page decision, or one paragraph decision that said:

La la la la la la la… I’m not listening… la la la la la la… I’m not listening… this invention is far to fundamentally important and valuable to allow for a patent to stand… la la la la la la… there are people who need a second opinion and want a second laboratory to run the test… la la la la la la… so we need to confiscate this patent and ensure that no biotech company will ever seek to commercialize an invention that would become free to the public once the patent term runs out… la la la la la la… we are better off without innovation and better off had there been no economic incentive… la la la la la… I’m not listening… la la la la la la la… the patent is invalid… la la la la la la… I mean the claims are all invalid… la la la la la la… I understand patent law… I’m not listening!

Even with the case heading this would have used only one page and killed far less trees, proving that Judge Sweet is a proper environmentalist.

Yes, I am in rare form, but wait… there’s more!  If you can believe it things get even more comically tragic.  It wasn’t enough to spit on the biotechnology industry, which happens to be one of the growth industries in the US at a time when growth, and jobs, are scarce.  Judge Sweet couldn’t help himself.  He had to point out that the depths of his intellectual dishonesty directly and specifically.  To set up the sad but true punchline, on page 121 Judge Sweet summaries his position on patentable subject matter by explaining:

In sum, the clear line of Supreme Court precedent and accompanying lower court authorities, stretching from American Wood-Paper through to Chakrabarty, establishes that purification of a product of nature, without more, cannot transform it into patentable subject matter.  Rather, the purified product must possess “markedly different characteristics” in order to satisfy the requirements of § 101.

This ignores at least one CCPA case, and Federal Circuit precedent on point, but like so many of the things Judge Sweet has said in this case, that statement is largely unassailable as a naked and disembodied statement of law, at least with respect to Supreme Court precedent.  What Judge Sweet refused to acknowledge, however, was that the isolated genes in question do indeed “possess markedly different characteristics” because they do not exist in isolated form in nature.  You see that is where the human interaction comes in, and pursuant to Supreme Court precedent interpreting the 1952 legislative history of the patent act anything made by man under the sun is patentable.  So Judge Sweet selectively applies the law and carefully words things as if he were an advocate, not a judge, which allows him make correct statements of law while still reaching a tortured conclusion.  That is advocacy 101 and unbecoming of a member of the Federal Judiciary.

Now the punchline — Judge Sweet acknowledged his own bias and intellectual dishonest on page 125 when he admits his “conclusion is driven by the overriding importance of DNA’s nucleotide sequence to both its natural biological function as well as the utility associated with DNA in its isolated form.”  So in other words, this Myriad invention is far too important and fundamentally innovative to award a patent on.  You’ve got to be kidding me!  Really?

Let us be honest with each other, shall we?  Many in the liberal elite have never liked patents, exclusive rights and/or capitalism.  Add to that Judge Sweet’s view that an invention that is of “overriding importance” cannot be patented under 35 USC 101, and it is easy to see the real agenda of many liberal activists, like Judge Sweet.  This was supposed to be a judicial opinion, not a magnum opus or swan song!

The reality, however, is this is NOT a liberal left only problem.  The conservative leaning Supreme Court just a few years ago gave us the KSR monstrosity, which is anti-business, anti-invention and just plain ridiculous.  Taken as written, under KSR if you set out to solve a problem that is proof that the resulting invention is obvious, because the problem defines the solution and if it weren’t obvious you wouldn’t have been successful.  So in order to be an inventor you need to expect to fail, but nevertheless proceed.  For crying out loud, that doesn’t even make sense in the different dimension of the Twilight Zone!  Thank goodness the Federal Circuit and the Patent Office (for the most part) are not interpreting KSR as written, more focusing on the spirit of what they must have meant instead.

When you combine the liberal anti-patent view, with Judge Sweet’s intellectual dishonesty and the patently clueless Supreme Court, you are left with this sad state of affairs — You can’t have a patent if it is not important enough to be considered anything but trivial, you cannot have a patent if you actually set out to invent something because what results would be common sense and you cannot have a patent if your invention is enormously important and foundational.  This last point was obviously taken from Judge Sweet’s opinion, but it could have just as easily been taken from the Supreme Court decision in Gottschalk v. Benson, where the invention was too important to be patentable subject matter because it would be used in every digital computer.  Now you see why there is great concern over the imminent Bilski decision.

Newsflash!!!!!!!!!!!!!!!!  The United States Constitution and the patent laws of the United States are intended to encourage inventions that are of “overriding importance.”  The goal is to encourage innovation, not to take it out behind the wood shed and shoot it in the head, then stomp on it, then light it on fire and shoot it again before burying it in a shallow grave.

Newsflash!!!!!!!!!!!!!!!!  Innovation is encouraged by providing incentive, not by providing disincentive.  And, by the way, we tolerate incremental innovation and advance because we know that if there is not tinkering and attempts to advance the likelihood of a achieving a pioneering invention that is fundamental and foundational is pretty well zero.  And, by the way, what we want are those pioneering inventions; as many as possible in fact.  Those pioneering inventions we want, like cures for cancer, new antibiotics that kill antibiotic resistant bacteria, life saving medical devices and so many other enormously desirable inventions are by definition of “overriding importance.”

For crying out loud, WAKE UP people!!!!  Where and when will this assault on the patent system stop?  Do we have to drive our economy straight into a ditch and declare war on what little industry we have left and every high tech, research based, intellectual property driven industry as well?  Try and pay attention enough to not destroy the patent system.  At least try and not shred the Constitution, OK?  And can we please stop trying to execute our economic future as if it were a homicidal, maniacal killer on a multi-state shooting spree having finished and gotten caught in Texas?

Our founding fathers seemed to have done quite well with this “American experiment” and one thing is certain, they knew a thing or two about incentivizing people in the face of long odds.  They also felt it necessary to mention intellectual property, specifically patents, in the Constitution, which is an almost unbelievably short document that does little more than announce fundamental principles.  For those who have trouble keeping up, this means the US patent system was considered of FUNDAMENTAL IMPORTANCE by the likes of Jefferson, Madison, Washington and all the others in the starting a thriving and sustaining democracy Hall of Fame!

Gene… Gene… snap… snap…

Picture begins to wiggle out of focus and fades to black in three… two… one… Hakuna matada, that’s the motto.  It isn’t just a passing craze.  Hakuna matada, its just a matter of time before the United States Court of Appeals for the Federal Circuit reverses Judge Sweet, because word on the street is Myriad WILL appeal (surprise surprise).  Hakuna matada.  You may now return to your regularly scheduled lives, and while your at it, keep an eye on Myriad Genetics stock, those who foolishly dumped on this news have created a very nice entry point for you!  Hakuna matada everyone!

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Posted in: Biotechnology, Gene Patents, Gene Quinn, IP News, IPWatchdog.com Articles, Patent Litigation, Patents

About the Author

is a Patent Attorney and the founder of the popular blog IPWatchdog.com, which has for three of the last four years (i.e., 2010, 2012 and 2103) been recognized as the top intellectual property blog by the American Bar Association. He is also a principal lecturer in the PLI Patent Bar Review Course. As an electrical engineer with a computer engineering focus his specialty is electronic and computer devices, Internet applications, software and business methods.

 

131 comments
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  1. It’s Hakuna Matata*

    http://en.wikipedia.org/wiki/Hakuna_matata

    :)

  2. Well, we all knew this was coming. Let’s hope SCOTUS doesn’t get a hold of this thing. Hopefully the CAFC can craft an opinion that will not raise any issues for SCOTUS so as to result in another WWF CAFC smackdown. Here is how to do it: only cite SCOTUS precedent in the CAFC opinion. Chakrabarty, alone, ought to do it. If ever there was the “hand of man” being clearly evident, it is in the creation of something that doesn’t exist in nature; namely “isolated” DNA. See if anyone, even the ACLU, can show you any person’s isolated DNA without, of course, isolating it first. Hmmmm. Even the popular press articles in favor of this opinion have said useful things in this regard: “it is like patenting your thumb by itself.” This quote was meant as a negative, but, inasmuch as I’ve never seen a working thumb not attached to the human whose thumb it is, this is a useful example of what a patent ought to cover; a thumb by itself that still works and can be tested for stuff. If not the “hand of man” at least it is the “thumb of man”.

  3. Gene
    I like this style of writing. While I have my problems with the patent system, I never understood the “It’s too important to patent” argument. If medically related patents were eliminated I’m sure the cost of existing drugs would go down. But we better be happy with the existing state of medical technology because what company would spend millions creating, testing, going through approval, and marketing a product that can copied as soon as it hits the shelf?

    Stephen

  4. Really, Gene, you are in rare form, but you continue to mystify me. So, using your reasoning, “isolated” oxygen, separated as it is from its naturally-occurring form as a component of air, and not found “isolated” as it can be by humans until Joseph Priestley figured this out in 1774, should be patentable. Oxygen could have been patented by Priestley? Why or why not?

  5. DK,

    You rascal, your appeal to purified raw emotions (and total lack of reason) is duly noted.

    Now of course, back in 1774, not only had the Declaration of Independence not yet been signed but the 1952 USA Patent Act had also not yet been passed into law.

    However assuming that someone today “discovers” an elemental or molecular component of air that had not yet been recognized and figures out how to produce it (manufacture it) in purified form where that purified form had previously not existed as such in nature, then the answer is yes, he can patent that new, novel and useful (utility is assumed here since purified O2 also has utility) composition of matter.

    Why do you have a problem with such a simple and basic notion? Under USA Patent law, “invention” includes “discovery”.

  6. My appeal was to logic, and to the “product of nature” exception in patent law. Because, I can think of no clearer product of nature than an element on the periodic table of elements.

    Moreover, Priestley was in England, and there was a patent act in effect, upon which the colonial patent acts, and eventually the federal act, were based.

    So, according to Step Back, Priestley would have been justified in getting a patent on oxygen, just to be clear. Gene, do you accept that?

  7. There’s a fascinating take on this at the Skeptic’s Health Journal, sort of provides some of the background to the debate, if interested you can read on it here, http://healthjournalclub.blogspot.com/

  8. “So, according to Step Back, Priestley would have been justified in getting a patent on oxygen, just to be clear. Gene, do you accept that?”

    Why not? Of course, but how would you claim O and get around the prior art of O2, O3, Fe3O4 or the bazillion other molecular compositions involving oxygen?

    Is there a man-made process that involves O alone and not O2? I don’t know. Chemistry was too long ago for me.

    Regardless, this little strawman you are trying to set up is going nowhere. Even if elemental oxygen could have been patented, the scope of the claims could not cover any pre-existing process, article, machine, etc. involving elemental oxygen.

    Turning to gene patents, the same concept applies — i.e., the scope of the claims could not cover any pre-existing process, article, machine, human, etc. involving the isolated DNA.

    As such, anybody who asks the question “who owns you?” with the implication that you could be “owned” because of gene patents is a fear mongerer — nothing more, nothing less. It reminds me of the local news advertising byline of “what you don’t know about household products could kill you — tune in at 6PM to learn more” or “danger at the shopping mall? learn more by tuning in tonight on the 11PM new.” Crap like that makes me puke.

  9. Regarding the statement “Because, I can think of no clearer product of nature than an element on the periodic table of elements.“:

    Indeed, there is even a chemical element, Americium, that has been the subject of a patent, because the element is unknown in nature and produced only in a nuclear reactor (and provides one embodiment of smoke detectors found in most homes.

    from Dr. Noonan’s article “Falsehoods, Distortions and Outright Lies in the Gene Patenting Debate” as accessed today from http://www.theamericanmuseum.org/august.09.second.html

  10. David-

    Of course that should be patentable. You really should read US Supreme Court cases on patentable subject matter, the 1952 legislative history to the Patent Act and pretty much every non-software patentable subject matter decision from the Federal Circuit. If you do then you would much better understand the law. I would also recommend that you stop listening to scientists about the law. Listen to them about science, not about the law. They know nothing of the law, so their opinions on what does and does not meet legal standards is really uninformed.

    -Gene

  11. David-

    You are right. There is no clearer product of nature than an element on the periodic table.

    What you are missing, ignoring or refusing to accept is that what is patented is not something that in its current state exists. There needs to be human activity to create what you so correctly point out is an element on the periodic table. So clearly the process that Priestley used would be patentable, and the resulting composition that in and of itself did not exist on its own and would not have existed on its own without human interaction is patentable.

    You continue to want to shoot the messenger it seems. We are just telling you what the law is, and what the Federal Circuit will hold. The Supreme Court will likely take the case, and they will hold the same thing. The only time the Supreme Court has ever limited patentable subject matter is with respect to software. Every other time throughout history they have had an expansive view of what is patentable subject matter, and they will in this case. This case doesn’t even present any difficult legal issues, and the moral argument and the greater good is clearly on the side of granting the patent. Why anyone would advocate a position that would strip research and development down to almost nothing, relying on the US government for funding when the government faces $50 trillion in unfunded liabilities just with Social Security and Medicare, is beyond me. If you don’t lock up the rights for a limited time the invention will never be made, or we will at the very least get far less invention. How does that help the billions and billions of people who would benefit in less than half a generation once the patent expires? You do realize that from the expiry date of the patent forward it would be freely used by anyone, right? That means billions and billions of people in the future derive the benefit.

    What amazes me is that the same people who seem to be so willingly advocating redistribution of the wealth and turning the US into a Western European type socialist democracy are the same ones who hate redistribution of wealth for the purpose of encouraging innovation, which clearly has a great good.

    -Gene

  12. John-

    A thumb by itself without more would definitely be something patentable. In fact, a lot of medical research is going into just that, which will clearly produce all kinds of patents and life saving innovations. Not so much with a thumb, but growing body parts for the purpose of using them for transplantation in a real and meaningfully useful was seems to be on the horizon. Unless, of course, the likes of Judge Sweet kill scientific research that is the precursor to innovations that extend life and provide a better quality of life.

    It is not often that the law actually supports the greater good argument, but in patent law it clearly does. It is almost mind numbing that the so-called elite are so myopic that they cannot see the enormous negative impact their ideology would cause if adopted. And so many of these people made fun of George Bush for not funding stem cell research and being averse to science. Oh the hypocrisy!

    -Gene

  13. “Because, I can think of no clearer product of nature than an element on the periodic table of elements.”

    DK,

    Actually, Seaborg got patents on “new” atoms. See In re Seaborg, 140 USPQ 659 and 662 (CCPA 1964).

  14. U.S. Patent 3,156,523 covers element 95 (now called americium), while U.S. Patent 3,161,462 covers element 96 (now called curium).

  15. fascinating…

    I think that your unwavering support for the patent-eligibility of something like Oxygen explains why most people are repulsed by gene patents.

    Anyway, enjoy your Zen-like calm. Hakuna matata!

  16. Growing body parts… Now we’re all going to burn.

    You have now tied patent practitioners, the unholy people who would have you believe that isolating a new and complex chemical from it’s natural environment is something patentable, with stem cell research, the unholy science of ground baby goo. Add in lawyers fees, i.e. unabashed greed, and you now have the trifecta of evil. EEEEVVVVIIIILLL I tell you.

    Everyone, turn off your laptops, cars and cell phones – Nothing new has been created since approximately 4000 BC. Everything after that should be free. There should be no money exchanging hands and we should all be equal – don’t they call that socialists. This would probably work better if we broke it down into two classes instead of one, we can’t just all be equal, thinkers and providers. There should be free open source thinkers that make everything better and the rest of us to work day and night to provide for the free thinkers. We should deliver food, shelter, and mates (three basic needs), then they can focus solely on the betterment of the free thinker world.

    We have explained again and again that just giving stuff away doesn’t work. Some things require money and resources to develop. The Cancer Institute, who discovered BRCA1 and BRCA2, apparently can sleep well at night while their inventions are exclusively licensed to Myriad. The royalties earned pay for a lot of additional cancer research and development. Myriad took the gene and invested tons of time and money to develop an FDA approved assays for breast cancer (technically a probability of breast cancer). Myriad should have some, “Can’t afford the test” program like Pfizer, Merck, Sanofi, etc. I am not in charge of Myriad. They paid a lot, they also got have very good patents with some very broad and narrow claims. The patents start expiring soon, couple of years from now.

    Why start this now? The ACLU is fighting what they feel should not be patentable subject matter. They are making an emotional plea, “Its not fair.” “It’s not fair,” is not a rule of law. Otherwise there would be no bankruptcy, no taxes, nobody fired from their job, etc. If you want to change the law, to exclude certain inventions from patentability, it should be done through Congress. A new law should be passed that best represents the country as a whole.

    Remember, for years inventions floundered in the hands of universities and research institutes. Universities do not have the expertise to achieve FDA approval, universities do not have manufacturing facilities, and universities do not have any distribution network. Small biotechs and big pharma are required to get the discovery to the patient in a safe and FDA approved manner.

    PS. An isolated DNA is a specific chemical entity with a unique chemical structure, series of atoms, that is not found in nature because DNA does not exist isolated in nature. It has a series of operators before and after the isolated sequence, it could not replicate on its own and would never exist outside the chromosome, nucleus, or cell. NEVER, because it does not exist in isolated form without the hand of man.

  17. DK,

    Your appeal to irrational emotion know no physical science bounds.

    Suppose I uncover a chemical compound that super-conducts at room temperature and I choose to call it: Koepsellium.

    The word “uncover” is a synonym here for “discover”, meaning revealing something that was previously unknown to the public.

    Now, of course, my newly uncovered/discovered chemical compound (Koepsellium) is composed of elements found in nature, like oxygen, carbon, and so forth. It has to be made of “stuff”. People schooled in science know that “stuff” is generally formed of basic elemental things found in nature but usually in need of “purification” and recombination because the way they exist in nature is different.

    So what you are saying is that I should not be entitled to a patent for Koepsellium because? because it is composed of stuff found in nature, namely, elements?

  18. Step Back, et al,

    Discovery and invention are two different activities, and I am aware that the Patent Act makes “new” discoveries patentable. But the BRCA1 and 2 genes, and oxygen for that matter, are not in any sense “new.’ My point is simply this: the gene sequences that compose the BRCA1 and 2 genes have been around for eons, and involved putting nothing new together out of old things. Instead, it was a matter of identifying the beginning and end of a gene (RNA does this nicely in our cells already, reading the promoter and stop codons, switching on and off protein synthesis) and identifying a common mutation in that pre-existing gene responsible for an increased incidence of cancers. Where’s the inventive step? Distant galaxies were unknown to us too until we developed tools that allowed us to see them, and no one would claim that acquiring the ability to see them now gives any intellectual property protection over their discoverers (or maybe you think it should?). Oxygen has existed for billions of years, and discovering that it exists in air combined with other elements could not reasonably confer some right to monopolize it, except that I think to most of you here it does, which is why many of us think you are being unreasonble. You’ve jumped the shark on this issue and don’t know how to back-pedal. Most scientists agree with my standpoint, and dozens of elements have been discovered since Americium and Curium, and no one but Seaborg ever patented any of the newly discovered elements. All patent attorneys see from this is the lost profits, whereas scientists understand that patenting too far upstream hinders the basic research. I have argued that it infringes on our common rights to natural laws. No one here buy that, and that’s fine. Most lawyers are positivists these days, unfortunately.

    This is why you guys have long ago lost the PR war on this, and why the courts and legislation will continue to shift away from patent-eligibility for gene patents.

    Best,
    David

  19. “This is why you guys have long ago lost the PR war on this.”

    DK,

    That’s a pretty tall statement to make. Could it be that this “PR war” is based on a media who long ago “lost” all concept of what journalism means? The media coverage of this case shows how clueless those writers are about the subject they’re writing about. Sort of on par whit how clueless Judge Sweet is about the “products of nature” doctrine specifically, as well as the law of 35 USC 101 generally. Also, as I recall, the Becerra bill that supports the position taken by the ACLU/Sweet never passed. Does that support your statement that the “legislation” has shfited away from patent-eligibility for gene patents?

    When it comes to legal issues, be it patent law or otherwise, what I see in the media generally disturbs me from the standpoint of how factually incorrect and intellectually dishonest it is. I frankly have no interest in wining a “PR war” based on such a disingenuous approach. Unfortunately, the policies of our current president and Congressional majority, are rife with this approach, the recently passed health care bill being my poster child for such malarkey.

    The fact is, and contrary to the deliberate distotrion by the ACLU, Myriad’s patents don’t cover these genes in their native state. The fact also is that the ACLU may have won this “battle” but they’re going to lose this “war” in the end. Why? Because the facts and law (correctly portrayed) are against them once this decision reaches the Federal Circuit. If you don’t believe me (or don’t want to believe me), wait for Sweet’s decision to be trounced in the judicial version of a verbal “blood bath.” And if what I say is “jumping the sharK,” so be it.

  20. DK,

    I forgive you cause clearly you’re no chemist and you know not what you do when you spake forth such unscientific nonsense.

    Myriad was not patenting the pure information part of the “sequence”. You cannot patent an “idea”. Generally ideas are set forth in the form of “information” (although “knowledge” would be a step up, if perchance you can grok that concept). Myriad made a claim to a purified, isolated composition of matter, not to an idea (a.k.a. information).

    Obviously, it greatly upsets you that the US Congress deemed it proper for “discoverers” to patent, ANY new, nonobvious and useful composition of matter in law section 35 USC 101. But then again we should remember you are an anarchist and you don’t believe in having any laws whatsoever. :-)

  21. so the patent on oxygen is not on the concept oxygen (the type, as we call it in logic), but only each instance of oxygen atoms? Well, that’s reassuring! Phew!

    The end result of Myriad’s claim over the sequence (which is the actual claim, over the sequence) is that others cannot use that sequence, cannot reproduce it in the lab (even while we do so in our cells), and cannot sequence it themselves in a clinical setting. As the recent Cook-Deegan et al. article found, the claim is far too broad because parts of the sequence recur throughout the genome.

    step back: I value your forgiveness :-)

    we’ll see how this all boils down eventually, I look forward to years of discussion and debate.
    best,
    David

  22. “So, according to Step Back, Priestley would have been justified in getting a patent on oxygen, just to be clear. Gene, do you accept that?”

    No, he would not. He would be able to patent isolated, purified oxygen, but not “oxygen.” Your whole argument is based on this equivocation between the two. You’ve been following this debate long enough to know the distinction.

  23. David-

    I have to agree with YA Examiner. You play all kinds of games with language. It is as if you are only concerned about the PR battle, which you more or less admit above. You are engaging in tremendous intellectual dishonesty, and I know you know it, which makes it all the more insulting. And from someone who should know better, someone who is educated in the law no less.

    You can say all you want that oxygen can be patented, but that is not what anyone of us have said. You know it, I know it, everyone reading knows it. Why you would tarnish your reputation with such intellectual dishonesty is beyond me. Why you would punish the billions of people who will benefit for practically free after biotech innovations go off patent is beyond me.

    As far as your constant reliance on scientists for interpreting claims, that is rather pathetic. Why not actually rely on lawyers for legal advice? Your intellectual dishonesty knows no bounds.

    We will indeed see what happens in the long run. We all know what will happen, and so do you. I know you can read, and I know you understand patent law enough to know that Judge Sweet is wrong and will be reversed.

    -Gene

  24. “I think that your unwavering support for the patent-eligibility of something like Oxygen explains why most people are repulsed by gene patents.”

    Strawman set up … and now David takes his wack. God … how freak’n predictable.

    Next, he’ll be posting on his website how patent attorneys think that oxygen should have been patentable in the 1800s. The term intellectually dishonest comes to mind … but that is probably too nice of a description.

  25. “Why you would tarnish your reputation with such intellectual dishonesty is beyond me.”

    FYI — I didn’t read read Gene’s comments before I posted mine. At least Gene and I can agree on one thing. :-)

  26. clown feet come to mind.

  27. The intellectual dishonesty is clear in your statement, Gene, and others: “He would be able to patent isolated, purified oxygen, but not “oxygen.” ” as though that makes any sense at all. Consider then, he gets such a patent, he gets the process and product patent of course. Then along comes another scientist who develops another way to isolate and purify oxygen. Now we have two scientists turned entrepreneurs peddling their purified oxygen, each selling tanks with their O2 inside. Are you honestly saying that each tank’s volume of O2 is somehow dissimilar because the process of purifying it was different in each case? The process claims should be allowed, but not the product claims. Otherwise it’s madness, and the sort of “lawyers trick” that Judge Sweet spoke of to claim that in this case differing processes result in a different product. The product patents on sythesized, otherwise natural products are what are at issue here, and that make no sense at all. The “isolated” genes are the same as the naturally-occurring genes (in the case of the BRVCA1 and 2 genes, there’s no purification at issue, only isolation), and you cannot get out of this by claiming that the patent applies only to the tokens and not to the types because here, as in the O2 example, the token claims encompass all of the type, which you readily admit is unpatentable.

  28. …when even Forbes agrees with me, then you know the end of gene patenting is nigh:
    http://www.forbes.com/2010/03/31/gene-patent-myriad-business-healthcare-dna-biotech.html

  29. but not “oxygen –as though that makes any sense at all

    Koep-seller,

    It does make sense –to scientifically trained people– a class from which you are obviously excluded.

    Once again I forgive you because you come from a Brawno sipping Idiocracy world and thus you know not of your own ignorance.

    The word “oxygen” refers to a broad class of possible materials.

    1) You could have “liquid oxygen” which could be the purified substance at temperatures low enough to cause it to change from the gas phase to the liquid phase. No one would laugh if someone said that steam and liquid water and ice are not all exactly the same thing. No one would laugh if someone said that deionized water is not the same as mineral water. However, your self-indulgent hubris makes you believe that you are some super intellectual being with powers of understanding far greater than, chuckle chuckle, all the nerd patent lawyers lurking here. Grow up and face the clown that stares back at you from the mirror.

    2) You could have molecular oxygen (O2) which is not the same thing as ozone (O3) or ionized atomic oxygen (O-2)

    3) You could have chemically bound oxygen (e.g. Fe2O3 aka rust) which is not the same as chemically free oxygen

    4) You could have various isotopes of the oxygen atom (forgive me, I’m not a nuclear physicist and thus can’t name the isotopes off the cuff here)

    There are probably people out there who are oxygen experts (not me, I don’t pretend to be) and who can teach the rest of us way more than we ever wanted to know about “oxygen”. Just don’t get cocky and fool yourself on the 1st of April into believing you are one of those experts. It is clear to the rest of us here that you are merely a political hack who has put on a purloined white lab coat with pens in pocket protector so that you could “act” the part of someone possessing “intellect”. OK. You got your 15 minutes of notice up on stage. Now it’s time for you to exit and let someone else have a chance at playing the village idio*.

  30. step back: your vituperations merely make you look bad. Sorry you feel the need to lash out like that. Stick to the example of Priestley and his oxygen synthesizing competitor, and tell me in what way to two products differ. And then contrast that with a third entrepreneur who discovers a rich, naturally-occurring vein of pure oxygen trapped in some natural, underground vault, and then who bottles it up and tries to sell it. Will Priestley’s patent on O2 preclude the prospective competitor’s sales? If not, then what good is the patent on “synthetic” O2?

    finally, Sir John Sulston and numerous other scientists, who presumably understand the science better than I do, completely agree with my analysis.

  31. breadcrumbs,

    I did not find your dialogue with David when you took him to task for his methods of debate, but I did find the following at http://www.ipwatchdog.com/2009/06/13/the-case-against-gene-patents/id=4102/

    It bears repeating since David employs the exact same tactics of poor legal/technical understanding, hit/skip soundbyting, and your-attacking-me-makes-you-look-bad that he did more than nine months ago. In truth, David’s arguements are as vapdi now as they were then.

    David,

    If your only purpose is to stir the pot,… well then you really aren’t listening to what is being said and no argument will make a difference to you.

    This appears to be the case, especially since you take comments directed to your lack of understanding of the legal ramifications of your sloppy logic in the intellectual property world as personal attacks (they are not, nor are they “cheap swipes”). Wearing “thin skin” as a shield to deflect actually answering the points and rebutting arguments may be a clever lawyer’s tactic, but upon review, it only shows that you have not fully answered the questions put to you.

    Granted, you are dealing with people who have both technical understanding and very specific legal understanding – having feet in Both worlds is what drew me to this particular profession. The questioning may indeed appear brutal, and this is what I alluded to with the public perception battle, as just as the questions are being put to you, “sound bytes” are also being put ot the audiances at large. If you want to lesson the sting of the soundbytes, focus on the legal logic. But then again, your particular legal logic in this arena is weak.

    There is more to this exchange than merely “making your points” and running away. As several have pointed out, your points are found wanting and you have not answered the deficiencies.

    To borrow from “breadcrumbs”, you are dancing with clown feet, and the camel is refusing to drink at the oasis.

  32. Noise,

    May 28th, 2009 4:17 pm – http://www.ipwatchdog.com/2009/05/24/san-francisco-chronicle-thinks-gravity-is-an-idea/id=3733/

  33. “The intellectual dishonesty is clear in your statement, Gene, and others.”

    DK,

    Continuing to drink your “Kool-Aid,” are you? The only “intellectual dishonesty” here is that expressed by the ACLU, Judge Sweet and others who simply distort the scientific facts (“isolated” genes are functionally distinct from the native DNA), as well as the controlling legal precedent (which Judge Sweet mystifyingly did in misrepresenting the holding in In re Bergy). That Sweet Ill-advisedly relied upon the Bilski test (which will almost certaintly be overturned by SCOTUS) to invalidate the method claims is shows no “common sense,” much less legal sense.

    The “victory” by the ACLU and it’s clients will be very short-lived. Sweet’s ruling has a “snow ball’s chance in hell” of being upheld by the Federal Circuit. As I warned, get ready for a judicial version of a “verbal blood bath” when the Federal Circuit get this appeal. So continue to drink your “Kool-Aid” because the end of this rhetroical nonsense will come, in due course.

  34. EG: interesting, and what is that functional difference? Is isolated O2 functionally distinct from naturally-occurring O2? I’m still trying to grasp this vital distinction, because it seems that you’d be willing to patent Priestley’s O2 (because up until his discovery, we had not found “isolated” O2 in the environment. Now, he did his isolation by heating mercuric oxide in 1774, whereas in 1789, Anthony Carlisle, also of England, produced pure oxygen by electrolysis. Assuming we had followed Gene’s advice an allowed Priestley the patent on not just the process, but also the product O2, then would Carlisle have been infringing on the patent by using a new process to isolate the O2? I don’t know enough about oxygen to say with certainty, but I’d be willing to wager that the O2 produced by either process is functionally equivalent, and atomically identical to O2 produced by any method, including by photosynthesis, which has been going on for eons. I’d say that O2 is one of those “products of nature” that ought to be excluded from patent-eligibility. Please, tell me where I’m wrong in the O2 example.

  35. Original assertion:
    “So, using your reasoning, ‘isolated’ oxygen, separated as it is from its naturally-occurring form as a component of air, and not found ‘isolated’ as it can be by humans until Joseph Priestley figured this out in 1774, should be patentable.”

    Oxygen’s naturally-occurring form as a component of air is O2. As such, your hypothetical did not originally refer to O2 — but some “‘isolated’ oxygen.” However, your last post is now littered with references to O2 (e.g., “we had not found ‘isolated’ O2 in the environment.”) When you change your hypothetical, our answers change.

    In my response to your hypothetical, I asked the question of “Of course, but how would you claim O and get around the prior art of O2, O3, Fe3O4 or the bazillion other molecular compositions involving oxygen?” — that question implying that, based upon your original hypothetical, we were referring to isolated oxygen (i.e., O) and not O2.

    FYI — anybody standing next to a still pool full of aquatic plants and observing little bubbles coming from those plants has found isolated O2 in the environment. As such, isolated O2 is a product of nature and not eligible for patentability. However, this was not the hypothetical you originally presented to us.

    Next time, try to be a little more precise when presenting your hypothetical. Details matter.

  36. ” the sort of “lawyers trick” that Judge Sweet spoke of to claim that in this case differing processes result in a different product.”

    DK,

    Normally, I don’t take umbrage at statements like this, but I will regarding the comment about “lawyer’s trick.” I find Judge Sweet’s use of that phrase to characterize claim drafting extremely offensive. I’ve also seen SCOTUS use similarly perjorative references to patent law doctrine (for example, Scalia’s reference to the TSM test as “gobbledygook” and Breyer’s “racoon invention” nonsense at oral argument in KSR) and it doen’t advance the debate one iota. I also don’t think the Federal Circuit is going to find the “lawyer’s trick” reference very amusing either, so I would suggest not going there.

  37. Just Visiting: I assumed you knew Priestley isolated O2. I’ll be more precise in the future. I’m glad you don’t think that Priestley could have gotten a patent on O2, then.

    EG: I’d say that essentially saying “X is not X” is as lawyerly a trick as one can imagine, and kudos to Scalia and Breyer for calling it like it is.

  38. David-

    Believe whatever you want. If it makes you feel better to believe your intellectual dishonesty by pointing to others who agree with you, then be my guest. Most who appreciate debate and logic would rather make cogent arguments based on facts, law and logic, rather than merely point to others who share their own misguided and wholly incorrect beliefs. But if it helps you to get up in the morning and look yourself in the mirror knowing that you are incapable of fair, logical and intellectually honest debate, then by all means proceed.

    You know as well as I do what will happen. The more you push your illogical and intellectually dishonest agenda the more I will relish telling you “I told you so.”

    -Gene

  39. “EG: interesting, and what is that functional difference?”

    DK,

    You misread my comment. I wasn’t addressing the “O2″ example that you and JV are going back and forth on. I was addressing the subject matter in the gene patent case.

    By the way, now that you’ve drawn me into the “O2″ debate (I’m an undergraduate chemist), “Isolated” O2 is different from O2 in air (which is over 80% N2). Fortunately, we’ve got that over 80% N2 in our ari or our atmosphere would be higly flammable.

  40. DK,

    Bless your simple minded heart that you believe all “oxygen” is “oxygen” no matter what the form.

    However, should you awaken one day in a hospital just as a pretty little nurse is bending over to insert an “oxygen” tube into you nostrils, please don’t fight against her and start insisting on getting your “oxygen” the natural way as nature intended rather than getting “synthetic” oxygen from some patent-fangled contraption.

    The nurse is trying to save your life. In all probability you have a respiratory infection and the concentration of oxygen that is reaching the alveoli in your lungs –so that it can then enter the blood stream– is reduced. In this case there is a difference between “oxygen” and “oxygen”. Natural oxygen comes intermixed in low concentration in the atmosphere together with many other molecules and particles, including dust particles, microbes and so forth. The “purified” oxygen the nurse is trying to give through the tube comes in the form of higher concentration of O2 and lower concentrations of dust particles, microbes and so forth. Drink the Brawno in this case. It’s good for you. :-)

  41. “Is isolated O2 functionally distinct from naturally-occurring O2?”

    Priestly sure thought so. He darn near killed himself testing the combustion properties of his pure O2. He was also astonished to find that if you purify the main component of air, it will suffocate animals.

    “Assuming we had followed Gene’s advice an allowed Priestley the patent on not just the process, but also the product O2, then would Carlisle have been infringing on the patent by using a new process to isolate the O2?”

    No, Priestly gets the patent on purified O2 and his method of making it. Carlisle gets a patent on his alternative method of making purified O2, but not the product itself. Carlisle gets an experimental use exception so Priestly can’t sue. Pretty simple.

    “Please, tell me where I’m wrong in the O2 example”

    You keep switching between O2 and purified or isolated O2. Plants don’t generate O2 in a way that keeps the O2 separated from other gases.

  42. Just Visiting says “FYI — anybody standing next to a still pool full of aquatic plants and observing little bubbles coming from those plants has found isolated O2 in the environment. As such, isolated O2 is a product of nature and not eligible for patentability. However, this was not the hypothetical you originally presented to us.”

    I totally agree, although because I was discussing Priestley’s discovery, it was exactly what I was raising… no matter.

    Now, if nature isolated genes in some analogous way, perhaps as Judge Sweet found and I have argued many times here and elsewhere is the case in protein synthesis, how is this not like the O2 bubbles, making the gene also a product of nature? It is the gene’s promoter and stop codons, marking the beginning and ending of the gene, and the process of protein synthesis, which omits the introns naturally, that makes gene functional in the first place.

  43. (BTW, I don’t take any offense at all to ad hominem claims regarding “clown shoes,” being “simple minded” etc., I just don’t see it advancing the debate at all, nor helping your cause.)

    I am really very interested in seeing how what I and so many others see as being a product of nature is not, and I think I have learned quite a bit from you all about how you characterize products of nature vs. anything else under the sun made by man. I am still puzzled, though, so please bear with some more questions:

    Returning now to EG, tell me please how the “isolated” BRCA1 gene, for instance, is functionally distinct, as you put it, from the naturally-occurring form of the gene. If there were no functional distinction, you would agree that the BRCA1 gene, for instance, was not patent-eligible?

    And for YAPE: so, if Carlisle gets a patent only on the method, and only an experimental use exception for the product, he and anyone else cannot isolate O2 by his differing process? What if someone could “harvest” O2 from natural plant photosynthesis, would selling that harvested O2 infringe on Priestley’s patent? What about someone who discovers a pocket of naturally-occurring pure O2 in some subterranean vault. Can that be mined and sold, even though it is molecularly identical to Priestley’s O2?

    And for JV: so, you disagree with YAPE?

    thanks,
    David

  44. And Gene: I am curious, why isn’t the determination of what constitutes a “product of nature” a fair subject for a scientist to decide, or at least to opine about? Isn’t it a scientific question more than a legal question? Isn’t the job of scientists to uncover the laws of nature, and doesn’t that then make those laws an area of his or her expertise?

  45. “tell me please how the “isolated” BRCA1 gene, for instance, is functionally distinct, as you put it, from the naturally-occurring form of the gene”

    DK,

    Surprisingly enough, there are some things that you would have to go to school for and study a long long time before you have any chance of understanding it.

    I have no freakin’ idea what the word “gene” models as inside your brain or how the word “isolated” translates inside you cranium.

    Let’s start with something way simpler. You’re in a life boat out in the middle of the ocean and you are surrounded by “water”. After a few hours you feel thirsty and so you decide to drink the “water”. Soon after, you die of dehydration. Most chemistry 101 students will be able to quickly tell you why that happened. You put “water” into your body and yet the water got sucked out of your body (dehydration) and you died.

    A simpleton would say “water” is water in the same vein that you say BRCA1 is BRCA1. You both just happen to be wrong. Dead wrong.

    Rumor has it that Judge Sweet is a sweet 88 year old man. Perhaps in his heart of hearts he truly believes that he has grasped the fundamentals of biochemistry with just a mere few hours of tutorials even though younger people spend many years of studying to get to the point where they are barely competent in understanding what a BRCA1 sequence is. In your case, it sounds like you come from a purely poli sci background where jargon is just jargon and you throw words around willy nilly without having any true sense of what they might mean to people skilled in the scientific arts.

    These are not ad hominem attacks. No one is calling you stoopid. We’re just trying to communicate to you that you are uneducated when it comes to basic science and that this lack of education comes across in the questions you keep posing.

    By way of analogy, you’re like the walk in at the geographer’s society who keeps asking: Why can’t you guys just tell me how flat the flat Earth really is? We keep telling you it’s not flat at all and no matter how many times we tell you, you still don’t get it.

  46. “why isn’t the determination of what constitutes a “product of nature” a fair subject for a scientist to decide, or at least to opine about?”

    DK,

    There you go again, asking how flat the flat Earth is is.

    Everything is a “product of nature” because mankind is a “product of nature”.

    There is no “product of nature” mentioned in the law about patent eligible subject matter (under the section 101 rubric as we obviously-evil and devious lawyers would frame the issue).

    The subject matter defined by the Myriad patent claims includes so-called compositions of matter. Compositions of matter are clearly patent eligible subject matter under 101 (no matter what sweet Judge Sweet believes).

    Perhaps you are barking up the “anticipation” tree (section 102) and you just don’t know that this is what you are attempting to do? In the latter case, the burden is on you to prove that the claimed composition of matter pre-existed on this planet in a manner such that it was already available to the public before Myriad “isolated” the sequenced composition of matter and demonstrated utility for the same.

  47. Oh great, “60 Minutes” is about to churn more mud into the muddied waters.

    Hat tip to Patent Docs:
    “60 Minutes” Examines Gene Patenting Issue on Sunday, April 4th — Patent Docs Author Kevin Noonan to Appear on Program

    link: http://www.patentdocs.org/2010/04/60-minutes-examines-gene-patenting-issue-on-sunday-april-4th-patent-docs-author-kevin-noonan-to-appe.html?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+PatentDocs+%28Patent+Docs%29

    Hakuna Matada indeed.

  48. Step Back: The “products of nature” exception is precedent, and arises in Chakrabarthy among other places: “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. Here, respondent’s microorganism is the result of human ingenuity and research” and thus it was patentable, because it was not a product of nature. I am relying on the PTOs own analysis of patentable subject matter, the link I used is to a document there called “2105 Patentable Subject Matter – Living Subject Matter [R-1] – 2100 Patentability” and you can click through my name here above for the page. The PTO says:

    “The tests set forth by the Court are:

    (A) “The laws of nature, physical phenomena and abstract ideas” are not patentable subject matter.

    (B) A “nonnaturally occurring manufacture or composition of matter – a product of human ingenuity -having a distinctive name, character, [and] use” is patentable subject matter.

    (C) “[A] new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated E=mc2; nor could Newton have patented the law of gravity. Such discoveries are ‘manifestations of… nature, free to all men and reserved exclusively to none.'”

    (D) “[T]he production of articles for use from raw materials prepared by giving to these materials new forms, qualities, properties, or combinations whether by hand labor or by machinery” [emphasis added] is a “manufacture” under 35 U.S.C. 101.”

    I assume the PTO knows something about patentable subject matter, but maybe they are wrong?

    Now, your example of seawater is inapposite since seawater is a solution of H2O and numerous minerals, etc. So, let’s stick either the the O2 example, or the BRCA1 example (since that’s what is at issue. I am still unconvinced that the isolated gene, which can be used to replicate that gene (as it does in nature) or to synthesize a protein (as it does in nature) is functionally distinct from the gene as it appears in nature.

  49. “And for YAPE: so, if Carlisle gets a patent only on the method, and only an experimental use exception for the product, he and anyone else cannot isolate O2 by his differing process? What if someone could “harvest” O2 from natural plant photosynthesis, would selling that harvested O2 infringe on Priestley’s patent?”

    Yes and yes, if the product is the same as Priestly’s.

    “What about someone who discovers a pocket of naturally-occurring pure O2 in some subterranean vault. Can that be mined and sold, even though it is molecularly identical to Priestley’s O2?”

    Carlisle hires Gene to start a reexamination of the Priestly patent. Don’t think anything like this has ever happened in the history of patent law. Tough break, Priestly!

  50. “And for JV: so, you disagree with YAPE?”

    Only on matters of botany, which I know nothing about. If plants really do produce O2 in a pure form that can easily be collected in a bottle, then that changes the premise of the situation.

  51. I assume the PTO knows something about patentable subject matter, but maybe they are wrong?

    Now there’s a nice lawyerly trick.

    If the answer is “yes, the Office knows something about patentable subject matter“, then although the fact that the Office DID decide that the Myraid application deserved a patent (and the BRCA1 as claimed) is patentable subject matter, the Office is de facto fallible and the BRCA1 as claimed is not patentable subject matter.

    If the answer is “no, the Office does NOT know something about patentable subject matter“, then the Office has no business giving out patents of any kind to anybody and the BRCA1 as claimed is not patentable subject matter because patents shouldn’t exist at all.

    David,

    You present a loaded question that presupposes the answer you want it to have. The whole point here is that the “maybe they were wrong” needs to be proven and cannot be merely taken as an assumption. You probably are aware that the Law does state that a granted patent has the presumption that it is correct – this presumption not only applies to 102 and 103, but to 101 as well. It is incumbant for you (the royal you) to prove that the Office made a mistake as to patentable subject matter. The “Sweet” methodology of misquoting and ignoring precedent will fail as such proof.

  52. Noise: The PTO was quoting SCOTUS, so it’s not like the PTO made it up. Here’s the language directly from SCOTUS:

    “This is not to suggest that 101 has no limits or that it embraces every discovery. The laws of nature, physical phenomena, and abstract ideas have been held not patentable. See Parker v. Flook, 437 U.S. 584 (1978); Gottschalk v. Benson, 409 U.S. 63, 67 (1972); Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127, 130 (1948); O’Reilly v. Morse, 15 How. 62, 112-121 (1854); Le Roy v. Tatham, 14 How. 156, 175 (1853). Thus, a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter. Likewise, Einstein could not patent his celebrated law that E=mc2.; nor could Newton have patented the law of gravity. Such discoveries are “manifestations of . . . nature, free to all men and reserved exclusively to none.” Funk, supra, at 130.”

    YA: photosynthesis does produce pure O2 molecules as CO2 is broken down, the carbon utilized for sugar, and the O2 release as waste. Which does indeed alter the analysis, because it seems to me that O2, like a “new mineral discovered in the earth” is a product of nature, under Chakrabarthy and thus not eligible under 101. Moreover, the process of protein synthesis I keep referring to relies upon the natural delineation of the beginnings and endings of genes to create proteins, omitting the introns, thus both purifying and isolating the gene through natural processes which I would say are directly analogous to photosynthetic natural production of O2.

  53. Note: if anyone wants to try, you can do a little science fair type project which will produce O2 if you put a little water plant in a test-tube full of water. Click my name above for the web link. This makes O2 which is molecularly identical to Priestley’s or Carlisle’s O2.

  54. DK,

    I’m impressed that you know how to dive into the MPEP –which BTW, if you are truly a scholar, you would know are mere internal guidelines within the USPTO and are not statutory law or case law or promulgated rules. Any of the latter three trumps the MPEP.

    So let’s leap forward into the dark heart of the matter, 35 USC 101:

    § 101. Inventions patentable
    [[ a ]] Whoever
    [[ b ]] invents or discovers
    [[ c ]] any
    [[ d ]] new and useful
    [[ e ]] process,
    [[ f ]] machine,
    [[ g ]] manufacture, or
    [[ h ]] composition of matter,
    [[ i ]] or any new and useful improvement thereof,
    [[ j ]] may obtain a patent therefor,
    [[ k ]] subject to the conditions and requirements of this title.

    Firstly, if you are going to insist that 101 is the “exclusive” provision governing what can or cannot be patented, here is a little monkey wrench for inclusion in your notions:

    § 161. Patents for plants Whoever invents or discovers and asexually reproduces any distinct and new variety of plant, including cultivated sports, mutants, hybrids, and newly found seedlings, other than a tuber propagated plant or a plant found in an uncultivated state, may obtain a patent therefor, subject to the conditions and requirements of this title. The provisions of this title relating to patents for inventions shall apply to patents for plants, except as otherwise provided.

    Careful attention to language will show that 101 establishes an open-ended class of people, the “Whoever” [[a]] who “may” obtain a patent.
    101 does not say these are the only people. It says, at least these people who have performed one of an enumerated set of acts [[b]], is a person who may obtain a patent. 101 does not say anything about claims. It does not say what an inventor may not claim. It merely says that a “Whoever” who performs the act of inventing or discovering [[b]] certain patent-eligible subject matter [[e]]-[[i]] may obtain a patent for having done so. The act is that of inventing or discovering “any” process, “any” machine, “any” manufacture, or “any” composition of matter or “any” improvement thereof (not “therefor”) that is new (novel) and “useful”.

    No matter what the USPTO guidelines (MPEP) say, 101 trumps them.

    The isolated BRCA1 is a new and useful composition of matter [[h]]. End of story.
    As you can see by careful review of 101, there is no “products of nature” in it’s language.

  55. Noise: The PTO was quoting SCOTUS, so it’s not like the PTO made it up. Here’s the language directly from SCOTUS:

    Except David, your post has nothing to do with what I posted.

    Perhaps you are confused with whm you are addressing. Perhaps you are not confused, but trying a cheap lawyer trick.

    It’s hard to tell since real answers do not appear to be your specialty.

  56. Surely, Noise, the PTO is fallible, yet SCOTUS (not the PTO) created the rule that Sweet followed in his decision regarding the patent-elligibility of the BRCA genes, which he decided were products of nature, and thus not patent-eligible under Chakrabarthy. SCOTUS is the ultimate arbiter of the rules of patentability, and despite the contention by Step Back that “everything is a product of nature,” the Supreme Court clearly disagrees, and thinks its a meaningful limit to patent-eligibility whether something is a product of nature or anthing else under the sun that is made-by-man. In this case (the Myriad case), the court decided that yes, the PTO was wrong in granting the patent, which answers your question completely. The proof comes through summary judgment in this case, the presumption of proper granting is defeated for now, and it may or may not be upheld in subsequent appeals, we’ll see.

    Now which real answers do I still owe you? I’d hate to leave you hanging.

  57. “Note: if anyone wants to try, you can do a little science fair type project which will produce O2 if you put a little water plant in a test-tube full of water. Click my name above for the web link. This makes O2 which is molecularly identical to Priestley’s or Carlisle’s O2.”

    This would seem to make pure O2 gas a natural product then.

    “thus both purifying and isolating the gene through natural processes which I would say are directly analogous to photosynthetic natural production of O2.”

    No, because the genes aren’t ever purified or isolated or even removed from the cell. You can’t simply harvest them in the same way you can with the O2 gas bubbles afaik. Unless there’s some plant out there that’s excreting pure gene fragments.

  58. YA: the gene is copied within the cell, as translation is the expression of the gene sequence into mRNA which duplicates the gene replacing uracil for thymine. So the functional part of the gene is effectively cut out and moved to the ribosome within the cell where protein synthesis can now occur. So, must the excretion of the isolated and purified product move out of the cell before you will grant that the analogy is sound? What’s so special about the cell wall?

  59. the rule that Sweet followed

    Except he didn’t.

    And you still played the lawyer’s trick of asking a loaded question with an assumed answer that is the answer that you need to prove. The answer you have left out there is the actual proof – not the reliance on a Judge that has misquoted precedent. “The proof comes through summary judgment ” is notproof. It is a lawyer’s circular reference. A lawyer that has nothing else but clown feet.

    Your current “answer is a non-answer by another, which you parrot thinking that the law has been applied correctly “because a judge has said so”.

    Is ignoring what people have posted showing exactly why the judge is in error and why the inevitable reversal will come the answer you want to bank on? Really?

    the court decided

    Except the “court” is not finished – Judge Sweet is (and in more ways than one).

  60. “What’s so special about the cell wall?”

    It’s neither purified or isolated at any point when it’s in the cell.

  61. YA: I guess you missed the point about mRNA and translation. It is both isolated and purified in this process.
    Noise: the court rules upon the uncontested material facts, and found as a matter of law that the presumption of validity was overcome . It could be overruled, but in this case, given there is yet no stay pending appeal, the patent is currently held invalid. The court was trier of fact and law, and the effect is thus, for now.

  62. YA: sorry, I meant transcription, in which mRNA is created, copying the sequence of the gene, omitting the introns, for delivery to the ribosomes. This mRNA is the functional equivalent of the gene itself, now both isolated from the DNA and purified through the omission of the introns. It the travels through the cytoplasm to the ribosomes where the protein is synthesized.

  63. Was mRNA what Myriad claimed?

  64. “Click my name above for the web link. This makes O2 which is molecularly identical to Priestley’s or Carlisle’s O2.”

    Jesus f’n Ch*&t. The isolation of O2 was NOT your original hypothetical. I think we can all agree that O2 is a naturally occuring product, and as such, cannot be afforded patent protection. However, that wasn’t the hypothetical you originally posed.

    Why do you keep pushing this hypothetical when you screwed it up from the very beginning?

  65. “It could be overruled”

    Stop day-dreaming. It will be overruled. Moreover, there is a far greater likelihood that it will be a unanimous decision than it will be that it won’t be overruled.

  66. “YA: I guess you missed the point about mRNA and translation. It is both isolated and purified in this process.”

    It is not either, not by any recognizable definition of “isolated” or “purified.” It’s in a complex matrix of thousands of different chemicals and trapped within the cell; at no point is it separated from other molecules. You might as well say that our atmosphere is purified Xenon.

    You don’t have to explain how transcription works. I understand it quite well.

  67. My hypothetical involved Priestley, who isolated only one form of oxygen, gaseous: o2. Look back, the recordis clear as to what I was referring. Your unfamiliarity with Joseph Priestley’s discovery is not my resposibilty. Next time, I won’t assume basic knowledge. And really, JV, such language, on Easter?

  68. YA: you seem to think the scale of the isolation and purification matters somehow, which is interesting but not convincing. Photosynthesis occurs at the molecular level too, in the matrix of complex solutions of H2O and plant matter, but it does result in splitting O2 molecules from CO2, just as the process of transcription creates a mRNA copy of the gene.

    anon: the claims are available from reading Myriad’s patent, click my name for the link. Among the numerous product claims are:

    1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.

    2. The isolated DNA of claim 1, wherein said DNA has the nucleotide sequence set forth in SEQ ID NO:1.

    5. An isolated DNA having at least 15 nucleotides of the DNA of claim 1.

    6. An isolated DNA having at least 15 nucleotides of the DNA of claim 2.”

    It’s interesting to read Judge Sweet’s opinion at page 127-130, because he addresses the role of mRNA in transcription, and the dual-nature of DNA as both a medium for storing information, and as a molecule in itself, isolated genes of which can be used in diagnostic screening. He found that the law of Chakrabarty, inter alia implies that man must change something naturally occurring into something “markedly different,” having some “new or distinctive form, quality, or property” [further cites omitted] The specific language from Chakrabarty is:

    “Guided by these canons of construction, this Court has read the term “manufacture” in 101 in accordance with its dictionary definition to mean “the production of articles for use from raw or prepared materials by giving to these materials new forms, qualities, properties, or combinations, whether by hand-labor or by machinery.”

    So, it’s an interesting question as to whether mRNA, which is the functional equivalent of a gene, is “markedly different” from cDNA. But in the Myriad case, the claims cover actual DNA nucleotide sequences identical to the gene itself, not even that of mRNA, since the diagnostic screening was directed at finding the specific mutation of the gene. My point in raising the issue of mRNA is to point out that nature isolates genes, and purifies them, in a process which I believe is analogous to the isolation and purification of O2 from C02 in photosynthesis, which in the case of O2, everyone agrees renders O2 patent-inelligible.

  69. DK,

    The issue was that of patenting “purified O2″ where such a composition of matter had previously not been available to the public.

    FYI, here is 35 USC 101:

    § 101. Inventions patentable

    [[ 1 ]] Whoever
    [[ 2 ]] invents or discovers
    [[ 3 ]] any
    [[ 4 ]] new and useful
    [[ 5 ]] process,
    [[ 6 ]] machine,
    [[ 7 ]] manufacture,
    [[ 8 ]] or composition of matter,
    [[ 9 ]] or any new and useful improvement thereof,
    [[ 10 ]] may obtain a patent therefor,
    [[ 11 ]] subject to the conditions and requirements of this title.

  70. Step Back: you do know precedent is also law, right? So you can’t just read sec. 101 and say you’re done, you have to read it in light of SCOTUS decisions, including <Chakrabarty, which, among other cases, invokes the “product of nature” exception you claimed is no exception at all, but it is. Everyone here now seems clear on the patent-inelligibility of Priestley’s isolation of O2 now, do you still disagree?

  71. DK,

    Careless tossing about of buzz words like “gene”, DNA and RNA does not win you points with this crowd.

    Let’s switch to a simpler “sequenced” composition of matter:

    CH3-(CH2)n-CH3

    As any beginner in organic chemistry knows, this is the formula for a straight chain, fully saturated hydrocarbon.

    Let’s say the the following sequence already was known and available in its purified form:
    CH3-(CH2)4-CH3

    But along comes a chemist and for the first time figures out how to produce the purified form of:
    CH3-(CH2)11-CH3

    This is a “composition” of matter. This specific isolated sequence did not exist before in purified form.
    It is new and useful and let’s say for argument’s sake that its synthesis was not obvious (although obviousness is not part of the 101 test).

    Then under 35 USC 101, it is patent-“eligible” subject matter.
    It may fail under section 103. But that is an entirely different issue.

  72. No one here, except the isolated DK, agrees on the patentable subject matter eligibility of purified O2.

  73. that should have said “ineligibility”

  74. YA and JV seem now to agree that isolated O2 was inelligible, I agree with them (see comment 4, et seq.)

    Step Back: I’m clearly not interested in “points with this or any crowd,” I am simply trying to figure out why some believe that the BRCA genes, which are to me clearly products of nature, would be considered otherwise. Your example is of a clearly new composition of matter, which is inapposite to the Myriad case, which the court found, as I am convinced, and most scientists are convinced, do not involve any new compositions of matter at all, but rather “products of nature” which have long existed, been isolated and purified for eons during proteins synthesis, and according to the Chakrabarty court and other controlling precedent, ought not to be considered patent-eligible.

  75. “YA: you seem to think the scale of the isolation and purification matters somehow, which is interesting but not convincing.”

    I think a chemical that’s in a complex matrix of other chemicals and interacting with those chemicals can’t possibly be considered to be isolated by any normal definition of the word. That’s not what the applicants mean by “isolated,” that’s not what a normal person would call an isolated or pure chemical.

  76. not convincing

    David, You have shown that you have no interest in being convinced. Your mind is completely closed and even when the current court decision is reversed, you will not be convinced.

    A discussion with you is a waste of time. I will only be interested in your concession after all is said and done by the courts.

    Have a nice Easter (if you choose to do so).

  77. “YA and JV seem now to agree that isolated O2 was inelligible, I agree with them (see comment 4, et seq.)”

    What do you mean seem “now”? My very first comment as to your hypothetical was “Why not? Of course, but how would you claim O and get around the prior art of O2, O3, Fe3O4 or the bazillion other molecular compositions involving oxygen?” As such, AT THE VERY F’ING BEGINNING I was assuming that O2 was prior art.

    Your failure to recognize this (or at least clarify your hypothetical) speaks volumes to your intellectual dishonesty. You don’t care about getting the facts right. You just care about making your point.

    The fact that you continue to miscontrue what I have written is a clear indication to me that you don’t want to engage in a debate — instead, you have an agenda that you are sticking to regardless of the facts.

  78. You’re right, JV, sorry to imply you didn’t think O2 was patent eligible, but I think you called it prior art, whereas it is a product of nature. That’s an important distinction since the whole discussion and the decision turn on what constitues a product of nature.

    Anyway, I learned a lot, thanks, and good Easter to you too.

  79. Keep Your Greedy Dirty Patent Hands Off mY Genes”

    Not only did CBS 60 Minutes use the ‘ownership of genes’ meme, but now newspapers are picking up on the same name calling:

    Hands Off Our Genes!
    http://www.beyondchron.org/articles/Hands_Off_Our_Genes__7982.html

  80. SB,

    I had to bite my tongue as I watch the 60 Minutes segment on the gene patent case. That 60 Minutes segment was a travesty in providing a one-sided debate (if you can even call it that) and illustrates why journalism, as we once knew it, is “dead” in the news meda. That 60 Minutes segment was solely concerned with vilifying the patent owner (Myriad), and paid no attention to whether the facts, science, and law were portrayed accurately or objectively. Again, the popular media, along with the ACLU, will soon be brought out of their short-lived “europhia” and down to “reality” when the Federal Circuit dissects (and demolishes) Sweet’s inane ruling.

  81. EG,

    There is no way of guaranteeing what various political hacks on the CAFC will do. I no longer expect well thought out and rational decisions from the CAFC. Those days are gone.

    As for biting the tongue that was almost jutting out through my cheek as I watched the 60 Minutes episode, I must agree. Responsible journalism is dead. We live in the mis-info-tainment era. Like many a tabloid magazine, CBS is apparently all too happy to dish out whatever sensation making material they can so as to garner eyeballs. The public has once again been well mis-informed. It did not seem like they gave Kevin Noonan much of a chance to present a counter position.

  82. A prescient article from 2003 (link below) has the following conclusion – recommended reading.

    “Accordingly, there is no warrant in the history of the product of nature doctrine for allowing
    it to be circumvented by the mere incantation of some combination of the words “isolated,”
    “purified,” and “synthesized.” Instead, what is required is a detailed factual assessment of the
    specific ways in which the claimed invention differs from its natural counterpart. When that analysis
    is performed against the background of the case law, substantial questions arise about the
    patentability of a good deal of subject matter whose statutory status is now taken for granted. All
    of the inventions we discuss may well survive, but they should survive after a process of rigorous
    scrutiny, not blithe assumption. At a minimum, it is time for litigants and courts to revisit the
    product of nature doctrine as it has actually been handed down. The results could prove surprising.”

    http://www.genomicslawreport.com/wp-content/uploads/2010/04/Conley-and-Makowski-Product-of-Nature-Article.pdf

  83. Thanks Gene: Ultimately, a patent should issue when a person uses technology to produce a useful product that has not been done before – that is what an invention is. If someone figures out how to isolate oxygen when it has never been done before, then they should obtain a patent on isolated oxygen.

    Judge Sweet’s argument is another version of the fallacy that an invention that is a combination of known elements should not be patentable. All invention is the history of the world are combinations of known elements. They also all obey laws of nature and are made from naturally occurring substances.

    I am glad to see someone else point out the absurdity of the KSR reasoning.

  84. “I am glad to see someone else point out the absurdity of the KSR reasoning.”

    Dale,

    The late Chief Judge Howard Markey pointed out that absurdity long before KSR Internationa:

    “v[V]rtually all inventions are ‘combinations’, and . . . every invention is formed of ‘old elements’ … Only God works from nothing. Man must work with old elements.” H.T. Markey, “Why Not the Statute?,” 65 J. PAT. OFF. SOC’Y 331, 333-34 (1983).

    Good to hear from you again. BTW, I need to read your book one of these days: the title alone speaks volumes. My younger patent attorney brother Mark spoke very highly off it and that counts much with me.

  85. Gene, I am always happy to hear someone liked my book – it is a pretty quick read. Of course since writing it I have come up with a number of additional issues. One idea that many people seem to like is a state stock market to circumvent Sarbox. If you are interested, I am happy to torture you with the details.

  86. Dale-

    Go ahead and torture away!

    -Gene

  87. All invention is the history of the world are combinations of known elements

    One small quibble Dale – an element was actually created by man and patented (although it is true that the building blocks of the element were old themselves)

    You can lead a horse to water….

  88. Not only did Myriad have claims to the “isolated” DNA, they also have claims to the methods of diagnosis. The statistical analysis, clinical data, and certainty afforded by FDA approval would not have been available if Myriad could not have an exclusive right to use their test. There would be no statistically significant BRCA test without patent protection. Now everyone with a boo-hoo story wants the test for free. That is not a part of the patent incentive. Yes big business is nasty, no it’s not always fair, but in a short period of time, people will be able to freely practice the method that Myriad developed. IF it werent for patents, Myriad may never have done the research, the Cancer Institute wouldn’t be earning royalties, and the field would stagnate. NAME ONE DRUG that is currently produced and marketed by a university. Yes, they can and did sequence the BRCA for minimal cost using a basement DNA sequencing system at many universities AFTER Myriad spent the time and money to prove that BRCA was a significant marker for cancer. So Myriad chose to enforce their patent rights, it is only for a limited time.

    Why doesn’t someone just design around the test, or sequence the whole genome then just happen to see if they have a BRCA mutation? You could also do the test Algeria, Kazakhstan, Indonesia, or other country where patent protection was not sought. Quit whining, work around it, it will be over soon.

    Or change the political structure in the US. Have the government fund all research, drug development, and distribution. I am sure that our medical system wouldn’t be sidelined so that a few senators could make a buck or two.

  89. Breadcrumbs,

    A chemical element was made, but it was made from the known elements of neutrons, protons and electrons. So it is still true that all inventions are a combination of known elements (patent elements – not chemical elements).

  90. Dale,

    I guess that goes to the saying, “There is nothing new under the sun.”

  91. Breadcrumbs,

    I guess it depends on how you define new (or novel or non-obvious)?

  92. I think most of you who support gene patents simply don’t understand the science behind it and therefore make claims that are unreasonable and unfounded. Myriad did NOT invent the method of isolating the DNA, nor did they alter it in any way. What gives these genes their unique predictive property is not the fact that it’s in an isolated form at the Myriad labs, but the fact that it contains a specific sequence that is associated with cancer. That specific sequence is not due to anything Myriad does, but simply a product of nature.

    By the way, DNA can and does exist outside of cells. Cells, especially tumor cells, shed DNA into the plasma, which can be used to detect certain mutations, etc.

    I’m not against patents, but let’s be reasonable here. If you invent a new technology to isolate DNA, fine go ahead and patent that technology. Myriad did not invent the technology for isolation, nor did they invent the technology to determine the sequence of that isolated gene. They found the association between a specific sequence (that is naturally occurring) and the risk of developing breast cancer. If they have their own way of isolating and detecting, they should patent just that. If I’m using a commonly known technology to isolate and sequence the DNA, they should not be able to stop me from doing so.

  93. Gary-

    You say: “Myriad did NOT invent the method of isolating the DNA, nor did they alter it in any way.”

    So it is your learned opinion that isolated DNA naturally occurs? So the human act of intentional isolation occurs in nature?

    Whether or not Myriad invented anything is not a part of the lawsuit. In its infinite wisdom, and because the ACLU isn’t familiar with patent law, they decided not to challenge whether the gene patents represent an invention, but rather chose to say that no gene patents should ever issue whether they are inventions or not.

    -Gene

  94. Gary,
    Myriad did not invent a method of isolating DNA, but they did isolate a new chemical entity consisting of the molecules required to make the BRCA1 and BRCA2 encoding sequence. So technically speaking they did isolate a new gene (not GENE, ha, ha, Ok not that funny). This gene does not exist as a separate molecule from genomic DNA so it is technically an entirely new isolated compound. If you are concerned about Myriads investment in this gene, why not review the whole list of clinical studies they did to prove that a mutation in one or both of the BRCA genes led to an increased risk of cancer.

    Myriad may or may not have a good business model. But neither do other businesses, should we shut down all banks because Lehman Brothers turned our retirement accounts into their bonuses? Maybe that wasn’t a good example. You cannot shut down all biotech research because of Myriad, and I do think that Myriad did the research and put in the time to own patents to the BRCA1 and BRCA2 tests. You do realize that they pay royalties on some of the portfolio to the National Cancer Institute? That cancer research institution doesn’t seem to concerned about the availability of the DNA test.

    FOR THOSE OF YOU WHO CLAIM THAT THIS INTERFERES WITH RESEARCH, THAT IS NOT TRUE. There have already been 17 papers published in this month alone by different research institutions on the BRCA genes. FACT, research in BRCA continues without hinderance.

  95. Gary,

    You ignore that Myriad was the one that determined that BRCA1 and BRCA2 are indicators for breast cancer. Inventions are always new combinations of existing element (processes) – its called conservation of matter and energy. If you look at each element individually, they are always old (known), but no one isolated a gene that indicates a predisposition to cancer.

  96. Breadcrumbs and Dale,
    Vacuum tubes and light bulbs existed before Edison invented the light bulb. Everyhting is built off of the work of our forefathers. That is how innovation works. The sequence of the BRCA genes was unknown prior to Myriads work. Myriad discovered the gene sequence that encodes BRCA1 and BRCA2 (through a license). They took these promising genes and dumped a ton of money into FDA approval, clinical testing and determining statistical significance. They have patents to the isolated genes and methods of diagnosing as well as other aspects and variations. The gene as it sits in your body is free from patent protection.

    Purified compositions that are new and novel are patentable. The first one to isolate purified penicillin received a patent. That patent has long since expired. The first one to isolate insulin received a patent. It too has expired. These compounds and proteins are now available for public use. The Myriad patents will start to expire in 2014/2015. You can try to design around but it may take about 3-5 years to develop a good test, clinical trials, etc. This is really about the other testing labs wanting to offer generic tests without paying for research not “freedom of the genes.”

  97. Mike,

    Well said

  98. Mike, that’s where you’re wrong. Myriad did not isolate a new gene/chemical entity. The process of determining the sequence of a gene (any gene, not just BRCA1/2) is to isolate genomic DNA (which include all genes, coding and non-coding), amplifying the specific region of interest, then performing the sequencing reaction on this amplified material. They should patent the steps/methods for determining the sequence (if they invented it) and not claim that somehow this “gene” they isolated is novel and not naturally occurring. It’s a completely ridiculous claim.

    Dale, I never ignored the fact that Myriad identified the association. Read my comments carefully and you’ll see that I give credit to Myriad for doing so.

    Gene, isolated DNA, as it appears in a test tube at Myriad laboratories, does not occur naturally. But if this is what they claim as their IP, then they own the whole genome, because that test tube contains all genetic material, not just the BRCA1/2 genes. i personally don’t care how the ACLU approached this issue. It’s my personal opinion as a scientist that what Myriad had patented should not have been granted simply on the basis that the genetic material occurs naturally.

    I’d like your opinion on the following example. Let’s say I invent a method of determining the sequence of DNA without having to isolate any genetic material from cells. Would I still be infringing on Myriad’s patent?

  99. In the last paragraph, by “the sequence of DNA” I meant BRCA1/2 specifically.

  100. Gary-

    You say: “Gene, isolated DNA, as it appears in a test tube at Myriad laboratories, does not occur naturally.”

    And that is really all there is to the debate. Debate over. If it does not naturally occur then it is patentable.

    You say: “But if this is what they claim as their IP, then they own the whole genome, because that test tube contains all genetic material, not just the BRCA1/2 genes.”

    This is clearly incorrect. If you read the Myriad claims they are limited to the BRCA1/2 genes. You really need to read the patent and read the claims. The claims define the exclusive right. So you can look to the test tube if you like, but the law looks to the claims. Facts do matter.

    You say: “i personally don’t care how the ACLU approached this issue. It’s my personal opinion as a scientist that what Myriad had patented should not have been granted simply on the basis that the genetic material occurs naturally.”

    See this is why scientists drive lawyers crazy. You admitted that it is not naturally occurring, your comments demonstrate you have not read the claims (because if you did you would know they are quite limited) and yet even in the face of but one logical conclusion you reach the only illogical and emotional conclusion possible. What was patented does not naturally occur, and the approach to law does matter, just like an approach to science matters. You can argue until you are blue in the face about what should be, but if you don’t make the right legal presentation you are wrong and lose. Much like there being one way to successfully engage an experiment and many incorrect ways to engage said experiment.

    -Gene

  101. Your ignorance and disrespect for scientific definitions are clearly trying to support an argument that is not correct.
    1) Isolated oxygen does not exist anywhere in nature. There is no bubble of 100% Oxygen (O, O2, O3 or other form) within the earth anywhere. There will be other gases mixed in with it- everywhere. IF you do find 100% Oxygen in any form in a pool somewhere, you have found the greatest wonder in the world.
    Chemists work very hard to “isolate” dried chemicals, pay a lot of money to get 100% nitrogen or other noble gas for specific reactions that require extremely inert environments. Yet you trivialize this work as ‘gas bubbles emitted from underwater plants.’ The synthesis of urea that came from neither man nor dog was a tremendous breakthrough for chemistry, but no big deal for DK because his dog can take a leak. Your scientific arguments are factually incorrect and dishonest. The separation of O2 from the air (where it is normally only about 16%) and increasing the concentration several fold was sufficient for patentability of purified isolated O2 as a composition. So yes “Oxygen” as a novel composition above a certain concentration is patenable, just as aspirin, penecillin, and other compositions isolated from their environment have been patentable. Finding the active ingredient from a homeopathic plant and isolating the active compositions provides patentable subject matter, even though sucking on a mushroom can make you a little daft.

    2) Isolated DNA does not exist in nature. If you’ve ever purified DNA and/or RNA after the microtubes were contaminated (not sterilized) then you’d know that DNAses, RNAses, and other enzymes degrade DNA and RNA very rapidly. The gene when its transcribed is bound by proteins that separate the DNA into two strands that are still incorporated in the genome, they are merely untwisted. The transcription begins and the RNA (not DNA by the way) is synthesized to create an mRNA within the transcription complex. As the RNA exits the transcription complex it is bound by protein synthesis complexes that begin assembling the protein based on the mRNA codons. The protein is synthesized several times or many multiple times based on the stability of the RNA and then the RNA degrades, stopping protein synthesis. If you did grind a cell in a DNAse inhibiting micro-blender, you would still not get an isolated BRCA1 gene, you would get a pool of mixed length DNA sequences without any sequence recognition, function, or activity. The isolated BRCA1 or BRCA2 gene did not exist prior to the work done by Myriad. That is not a lawyer trick, that is an accurate description of a chemical entity encoding a BRCA1 or BRCA2 protein. Review the scientific literature at http://www.ncbi.nlm.nih.gov/ to see how scientists discuss these and other compositions that they study.

    A proper example of a “law of nature” is the codons DNA -> RNA -> protein via codons. Those exist, an isolated codon could be patented, but nobody would ever use a single isolated codon. The information encoded in the gene is not patented.

  102. Gary,

    You fail to see what Myriad really patented. When they say isolated, they mean isolated. A test tube full of nucleotides encoding only BRCA1 (or BRCA2, they would not be together). When you use the DNA for any purpose you have to isolate it, cut it from the genome, separate the DNA based on size and or sequence, and isolate it. Frequently only a specific sequence is amplified by PCR. Using the Myriad method, the isolated BRCA gene is amplified by PCR to give a tube of only BRCA sequence. That sequence is then sequenced to identify mutations. Those mutations are correlated to an increased chance of breast cancer. PCR and sequencing are very cheap, I wouldn’t have said that 20 yrs ago, but now it is cheap and easy to amplify and sequence the BRCA gene. That is what is claimed.

    THE CLAIM DOES NOT EVER READ ON THE SEQUENCE AS IT EXISTS IN THE GENOME. One possible design around is to amplify and sequence a larger section of the genome rather than just the BRCA genes, but their claims are crafted very well and you would likely still infringe the ‘diagnosis’ claims.

  103. while i have been greatly fascinated with the discussion on this issue (it seems DK that patent law would deem this judges ruling wrong) I think we are all forgetting something even more basic. should we really as a society go to this new frontier, I love our capitalist society but sometimes capitalism goes too far. this would seem to be one of those times. is there nothing sacred? nothing that we has human beings deem too important to have a hands off approach about? really according to our patent law if there was a worldwide epidemic tommorow that would wipe out the human race. you still would have people arguing that whatever cure found is patentable and cannot be sold by anyone but the company who finds it. does know one see where this is going? according to how the law works now the scientists who were able to create an embryo with 3 sets of dna can patent the resulting child of that embryo, if they took it to term. is that really where we want to go? sadly it seems all too often that conversations arent about if things should be done but only about how much money we could make.

  104. A) If there were an epidemic, according to several different processes, the government can and has stepped in to provide services where needed (e.g. penecillin was distributed by the government during WWII).
    B) We need to investigate the morals and or process that would allow a scientist to create an experimental human, although I wouldn’t put it past some flagrant people. Of course there are no laws to prevent Wall Street from pilfering my retirement either? How moral is that? The clone is to generate tissues and likely would never be used to generate a body.

    As emotional as your plea is, it does not foster the development of new technologies. There would be no BRCA test if they didn’t get a patent. Pharmaceutical companies have turned down many drug prospects because there was no patent protection, no way to recoup the boatloads of money required to get FDA approval. A whole industry is now trying to sift through the trash and find those hidden treasures.

    I understand your concerns and feelings. If that were the system you wanted, we would have to convert all of the medical institutions into government sponsored treatment centers. Universities would have to get volunteers in order to conduct clinical trials, and the whole system would be funded from research to distribution by taxpayers. The doctors would be the only ones who could ever tell you what drugs treat certain systems because the available drugs would no longer be advertised (that may be a good thing). As a country we need to decide if we want an entirely 100% government based system or a regulated free market system.

  105. Personally, I see no reason to limit our research arbitrarily. Any general prohibition would have to be government enforced and this would be a clear breach of other people’s freedom.

  106. “The isolated BRCA1 or BRCA2 gene did not exist prior to the work done by Myriad.”

    That’s a ridiculous claim Mike. See http://www.ncbi.nlm.nih.gov/pmc/articles/PMC1682570/?page=1 as one example of what was known about these genes prior to Myriad’s work or publications.

    FYI, Myriad does NOT isolate BRCA1 and BRCA2 genes only. That is not possible. They isolate genomic DNA, which contains all genetic materials, coding and non-coding.

    I do not need a lesson in transcription/translation. I’m a molecular biologist and understand these processes quite well. From your attempted explanation, it’s obvious that you need some lessons yourself.

    Gentlemen, it’s clear that I will not change my opinion about this and neither will you. All I can say is that in a few years, if this blog is still functioning, I will be back to gloat the reversal of the many gene patents that were erroneously granted protection under outdated laws.

    So long…

  107. Gary says: “in a few years, if this blog is still functioning, I will be back to gloat the reversal of the many gene patents that were erroneously granted protection under outdated laws.”

    You can count on the blog still functioning. I am just getting started and warmed up. Readership is dramatically up. Thanks to all!

    As for gloating. Would you care to make a friendly wager? I guarantee that it is you who will be eating crow. I think in a private moment of quiet you know that too!

    -Gene

  108. Depends on what a patent attorney considers a “friendly wager”. :)

  109. How can you say the gene is not isolated. They do not have the entire genome when they amplify the BRCA1 or BRCA2 gene. They have claims a sequence with 100% identity to the sequence located at:

    NT_010783.15

    The Myriad patent:
    US5693473, “Linked breast and ovarian cancer susceptibility gene” SHATTUCK-EIDENS et al., MYRIAD GENETICS INC, RECH DU CHUL CENTRE [CA] Issued: 1997-12-02, Priority: 1994-08-12

    1. An isolated DNA comprising an altered BRCA1 DNA having at least one of the alterations set forth in Tables 12A, 14, 18 or 19 with the proviso that the alteration is not a deletion of four nucleotides corresponding to base numbers 4184-4187 in SEQ. ID. NO:1.

    The following references were before the Examiner that allowed the claims:
    Castilla, L. H. et al. (1994). “Mutations in the BRCA 1 gene in families with early-onset breast and ovarian cancer,” Nature Genetics 8:87-391. .
    Friedman, L.S. et al. (1994). “Confirmation of BRCA 1 by analysis of germline mutations linked to breast and ovarian cancer in ten families,” Nature Genetics 8:399-404. .
    Goldgar, D.E. et al. (1994). “A Large Kindred With 17q-Linked Breast and Ovarian Cancer: Genetic, Phenotypic, and Genealogical Analysis,” J. Natl. Cancer Institute 86:200-209. .
    Liang, P. et al. (1992). “Differential Display and Cloning Of Messenger RNAs from Human Breast Cancer versus Mammary Epithelial Cells,” Cancer Research 52:6966-6968. .
    Neuhausen, S.L. et al. (1994). “A P1-based physical map of the region from D17S776 to D17378 containing the breast cancer susceptibility gene BRCA 1,” Hum. Mol. Gen. 3:1919-1926. .
    Sato, T. et al. (1992). “The Human Prohibitin Gene Located on Chromosome 17q21 is Mutated in Sporadic Breast Cancer,” Cancer Research 52:1543-1646. .
    Stampfer, M.R. et al. (1993). “Culture Systems for Study of Human Mammary Epithelial Cell Proliferation, Differentiation And Transformation,” Cancer Surveys 18:7-34. .
    Wooster, R. et al. (1994). “Localization of a Breast Cancer Susceptibility Gene, BRCA2, to Chromosome 13q12-13,” Science 265:2088-2090.

    ONE ESSENTIAL REFERENCE THAT WAS NOT CITED DURING PROSECUTION WAS:
    Narod, et al., “Familial breast-ovarian cancer locus on chromosome 17q12-q23,” Lancet 338 (8759), 82-83 (1991)

    The claims recite specific mutations in the BRCA1 gene, that may be what is the distinguishing feature. I have not reviewed the entire file history, just the claim language. IF I had a week and no work to do, I could review in detail and identify exactly what Myriad claims, What they can exclude, and what is in the public domain. It is a factual analysis, not an emotional argument. It does not appear that Myriad is able to stop anyone from using the genomic DNA. Which is exactly why we say, THE CLAIMS DO NOT READ ON THE GENOME.

  110. A proper example of a “law of nature” is …

    according to Mike @comment 101

    But actually Mike, there is no such thing as a “Law of Nature”.
    They are all merely the ideas of men.

    Mother Nature does not descend from the mountain with a set of stone tablets clutched to her chest and with a loud and boisterous proclamation: “These are my top ten laws”.

    No.
    Men come up with ideas, with theories, of how they think Mother Nature operates. Time and again it has been shown that our theories are imperfect. They are theories (ideas) of men and not laws of Mother Nature.

    The fact that some black robed Supreme Court judges validated this crazy notion about Laws of Nature does not make it so. Heck. They don’t even know the difference between a pager and an email. ;-)

  111. wow, step back sounds like a post-modernist. There’s nothing but what man makes up? Hillarious!

    It’s amusing to watch real scientists like Gary disembowel the engineers and attorneys here.

    I’ll make a wager right now, gene, on Bilski since you said you are certain that SCOTUS will overturn. What’s the bet?

  112. Actually, “law of nature” as a legal description of laws man places on nature is not correct.

    A “Law of Nature” is an observed physical property, that through empirical evidence was thought to be universal.

    I think what the Supreme Court intended was more of a physical law, such as Newton’s laws of gravity, or other physical property. Although a “Law of Nature” as a physical property observed through empirical evidence is not patentable subject matter.

    For more info see:
    http://plato.stanford.edu/entries/laws-of-nature/

    I agree with you that in the grand scheme of things, there are truly no legal rights we can place on the physical world with either real or intellecutal property. I don’t think the Earth, Sun, Moon, planets, stars, or galaxies give a crap what Caesar ruled or when. Although if we transmit our blogs into space with the write trajectory in a focused beam (to avoid diffusion) our bitches, gripes, complaints, and moans may travel on for nearly an eternity.*

    There are no property rights on eternity either, except maybe copyrights…

  113. It’s amusing to watch real scientists like Gary disembowel

    What’s amusing is that Gary parades around in ignorance of what the Law actually says, what is actually patented and what that means.

    What’s amusing is that you glorify in someone else’s ignorance, thinking Gary triumphant. If your idea of “triumphant” is to proclaim my view is right and refuse to even understand the context of the discussion (law), then you are quite literally in a fool’s paradise. More power to you – enjoy your little made-up world, but do not try to impose that fantasy on me.

    What’s amusing is that Gary announces that he will not change his views, no matter how ignorant he is on the law.

    At least Gary isn’t trained in the law – he has an excuse for his ignorance. David, you have no excuse. Just an agenda.

    I believe that step back is echoing the semantic discussion that breadcrumbs had with you quite a while back. – see comment 32 on this thread for a link.

  114. Mike,

    Thanks for the link to the Stanford Philosophy site.

    Actually, what I was trying to say is that the so-called “Laws of Nature” (LoNs) are nothing more than man’s “ideas” of how the Universe works and as such, LoNs become subsumed under the more general class of mere ideas.

    I don’t have a beef with the US Sct proclaiming that mere ideas are not patentable. That has been the law from the inception because mere ideas are not by themselves part of the “useful arts”.

    I do have a problem however with the SCt saying that these LoNs are the “basic building blocks” because that invites all sorts of mischief. People can then extend the logic and proclaim all manner of things to be “basic building blocks”. Take isolated DNA fragments for example. Why aren’t they “basic building blocks”?

  115. I think there is a key distinction in that LoNs exist regardless of what man does. For example, I think much of the current debate stems from two different views of DNA. 1) The information encoded in the DNA, the sequence of ACTG exists in the genome no matter what man does. That information has not and cannot by itself ever be claimed in a patent application. That information would be considered a product of nature that exists. 2) The patentable part of the invention comes in identifying the relevant sequence, isolating a new and useful DNA sequence, and manipulating the DNA sequence to get a diagnosis (or expressed protein, target DNA, etc.). The patent claims in Myriad clearly make this distinction for those of us who read and interpret claims every day. Conveying to others the unique language used in patent law and how the claims distinguish themselves becomes more difficult.

  116. Mike, well said.

  117. LoNs exist regardless of what man does

    Mike,

    That may not necessarily be so (despite it sounding like sound logic in most people’s forests).

    It gets us into the metaphysical issues of quantum entanglement and the age old question about the tree falling in the forest where no person is there to detect the alleged sound that the falling tree is supposed to make.

    As you know, any time we measure something, we change it by the act of our measuring it. The Laws of Nature (LoNs) that we perceive may be functions of how we choose to measure them rather than being absolute universal truths.

    But that is probably not a topic to be discussed in a patent law blog.

  118. But if I am here, for how long?

  119. Mike,

    re “if I am here …?”

    Time and existence are merely illusionary, probabilistic wave functions.

    Like Schrodinger’s cat, you are both here and not here; now and not now.

    ((And besides, you are merely a flickering shadow on the walls of my Plato’s cave.))
    ;-)

  120. or not.

  121. It would be nice if anyone can provide any evidence that patents are any good instead of merely asserting so.

    http://levine.sscnet.ucla.edu/general/intellectual/against.htm

    To say that progress won’t happen without patents deceptive lie. Much of the reason medicine is no longer innovative like it used to be is because patents, many of medicines fastest advancing periods occurred in places and during times where patents were either non existent or far scarcer. The founding fathers were very skeptical of patents, noting that places without them often innovated perfectly well and that places with them were often a laughing stock, and the founding fathers almost wanted to explicitly ban patents and copyrights from the monopolies that congress could grant.

    I suspect the author of this blog knows better but has a conflict of interest in the matter.

  122. Coward-

    I do provide evidence all the time. The fact you choose to ignore it and act as if I don’t provide it is a you issue, not a me issue.

    Over and over I point out that those countries without patent systems have no economy and no innovation. Where patent laws are adopted economies are developed and investment flows. Studies show VCs invest in companies only when there are patents, and investment and capital is required for innovation. Where patents laws weaken industry leaves, which is why the UK and Europe used to be dominant in biotech and lost out to the US.

    I give facts. Just read the entirety of my writings. Ignore it all if you like, but let’s keep it honest and not pretend I don’t provide uncontroverted evidence that is never addressed, but rather ignored.

    Sent from iPhone

  123. Anon Coward,

    The world is full of liars, cheats and scoundrels.
    That is “reality”.

    If inventors did not have patent protection, then most (the sane ones) would not bother to bring their innovations into the public lime light because just as soon as they show their stuff, every liar, cheat and scoundrel will show up to steal it.

    Maybe you should rent out a DVD of the movie, “Flash of Genius” which is based on a real story. If you believe that “business men” do not behave in that way then perhaps I have bridge property near the borough of Brooklyn that I might want to sell to you. ;-)

  124. What ever happened to David’s Bilski bet? Although the Bilski patent was denied, Supreme Court actually stated that ‘everything under the sun by the hand of man is patentable.’ They even cautioned the Fed Circuit against bright-line tests leaving the door fairly open for many different inventions as long as they are not ideas (for those of us that aren’t flickering on someone else’s walls =)

  125. Mr Quinn: An IP attorney friend turned me on to your blog. I am an academic biologist not a lawyer. I have an antibody that could possibly be one of the hottest biotherapeutic treatments for cancer but I cannot pursue it commercially. Why? A biotech company patented the DNA sequence for the gene that encodes the protein product to which my antibody binds. This biotech company received this ludicrously broad patent in 2004 and has done nothing with it in six years insofar as I can tell. I also cannot raise monoclonal rabbit antibodies because only one Chinese-owned company has the patent for making monoclonal rabbit antibodies and they charge 5X more than normal. I would pony up the money to have the monoclonals made but there’s a kicker. This company will not make the rabbit monoclonal antibody unless they are given 100% commercial rights to the antibody! Thus, the notion that patents stimulate invention, at least in biotechnology, is a pathetic farce (by your reasoning, we could further identify it as a pathetic right wing farce but this fantasy of yours that liberal progressives oppose patents is absurd too…but that’s a distraction). The point is that thousands of cancer victims are dying needlessly because of these absurdly broad patents.

    I also take umbrage at your implications that Judge Sweet is, because of his advanced age, senile and completely ignorant of modern developments in biotechnology. In fact, I think he has a more profound understanding of this matter than do you. Judge Sweet has the wisdom and insight to comprehend that DNA is no ordinary biological molecule. I was particularly struck by Sweet’s statement that, “DNA represents the physical embodiment of biological information, distinct in its essential characteristics from any other chemical found in nature.” I, too, had been thinking that the truly remarkable feature of DNA (in itself not a terribly complex chemical) is its ability to transmit information. DNA has been compared to a language, and I think that that comparison is more than poetic license. DNA sequences are more than just chemicals: like words and maps they are units of information. Isolating a gene is a bit like tearing a corner of a page from an atlas (let’s say the corner that contains Kalamazoo), and claiming that your isolated map fragment is a much more effective tool for finding Kalamazoo on the map than the entire atlas. Could I counter Rand McNally’s lawsuit by claiming that my isolated map of Kalamazoo is different because it exists separately from other components of the atlas?

    You should listen to your wiser elders instead of covering your ears and saying, “La la la la la la la… I’m not listening… la la la la la la… I’m a fat-cat lawyer and this judge is threatening my exalted livelihood … la la la la la la… Fox and Friends says that patents spur innovation … la la la la la la… old people are ugly and smell funny… la la la la la la… DNA is a chemical just like any other chemical… la la la la la… I’m not listening… la la la la la la la… the patent is valid… la la la la la la… I understand patent law… I’m not listening!

    Oh, and I wouldn’t buy stock in Myriad anytime soon.

  126. Ivorytowerboy-

    First, thanks for taking the time to comment. Now, where to start.

    Do you know for sure that the patent you complain is blocking you is still in force? If they haven’t done anything with it for 6 years, as you claim, maybe they didn’t pay the maintenance fees and it is in the public domain. Did you check that? I suspect the answer is no. If is far easier to complain than to educate yourself.

    Next, if that patent is so ridiculously broad, as you claim, what is stopping you from either (1) doing whatever you want; or (2) filing a request for reexamination. You see, you don’t actually have to stop doing something that is only prevented by an invalid claim. If you don’t want the risk and you have a good business plan there are certainly investors who would fund you and fund the filing of a reexamination request. Have you looked into reexamination? I suspect not because it is just so much easier to be lazy and not educate yourself and blame the patent system for your lack of motivation, knowledge and business savvy. But in case I am wrong about you and you are interested take a look at:

    http://www.ipwatchdog.com/2010/07/14/patent-trolls-conspiratorial-symbiosis/id=11646/

    About two-thirds through the article I give the latest available reexamination stats. Staggering how effective reexamination is to get rid of patent claims.

    Now I suspect you will complain about the cost associated with reexamination, but if that is a concern for you then no one would ever reasonably believe that you have what it takes to create “one of the hottest biotherapeutic treatments for cancer…” Being in that business would require many millions of dollars, a patent portfolio of your own and patient investors. It is certainly possible, but $25,000 to $50,000 for a reexamination to jump start the cure for cancer is inconsequential.

    So stop whining and put up or shut up. The patent system you seem to hate has tools you are ignoring.

    As for Judge Sweet, he is wrong and he will be reversed. No one other than the zealots thinks otherwise. And while I don’t own any Myriad stock and am instead investing in my own business, anyone with extra money to invest who overlooks Myriad is making an enormous mistake in my opinion. The Federal Circuit will reverse Judge Sweet and embarrass him with the decision explaining how he got everything wrong and ignored decades of patent law to pursue his own ideological agenda.

    -Gene

  127. Ivorytowerboy-

    Let me put this in a different light with a little less sarcasm, although there are never any 100% guarantees.

    I appreciate that you feel patents are restricting your research and development possibilties, but you need to understand what the ‘blocking patent’ actually claims before you develop your response. Claims in an issued patent are frequently amended from the time of application filing, if you are reading the claims anywhere other than http://www.USPTO.gov you are probably reading the application claims and not the issued patent claims. If the blocking company does have issued claims to 1) the isolated protein, 2) the isolated nucleic acid, and 3) the isolated antibody that binds (1) then there are limits on those claims. Rarely does anyone get claims to all variants without restrictions on identity, binding epitopes, and the like. We need the patent number to determine the true scope of the patent. I doubt it effectively blocks all possible research and development.

    Your statement that one Chinese company owns the patent to making all rabbit antibodies is completely 100% false. The Chinese company may own a patent to a certain immunoglobulin/label combination, or fluorescent label, or method of antibody generation, etc. BUT rabbit antibodies in general have been in the public domain for a long time. If you reference the ‘rabbit antibody’ patent, we may be able to provide more information.

    Patents are required to stimulate development on several levels, one level that many in this argument miss is disclosure. Large corporations would not disclose the ‘best mode’ without patent incentives. There is other evidence that patents stimulate innovation, but the argument becomes a tit-for-tat rather quickly. I likely won’t change your mind on that one.

    Regarding Judge Sweet’s ruling, although ‘nice’ it does not fit patent law. I agree with you that DNA does contain the genetic information encoding proteins and other functions. For a period of time, especially in the ’80’s and early ’90’s, it was much more difficult to properly identify a ‘gene’ and a lot of the information in those early patents is the isolation and use of a novel ‘gene’ (be it coding sequence, genomic DNA, or other DNA sequence). Early in the process one could show that the sequence was novel (no other sequence had 100% identity) and a patent could be obtained. Then as more sequences were isolated, patents narrowed and functional requiements were increased. Currently a lot more is required than just a sequence of nucleotides or amino acids. DNA/protein sequences are in essence though, still just a chemical entity, each unique sequence has a unique chemical structure as well as unique 1′, 2′ and 3′ structures. The unique structure will have unique properties and uses. As long as the structure, properties and/or use is new and novel, it qualifies as a patentable invention.

    Finally, if you would like protection for your Kalamazoo fragment you would have to talk with a copyright attorney. I don’t think ripping the page is transformative though (separate argument not applicable to patentability). Before you discuss the value of Myriad stocks, I would investigate your chances of commercial success if you have not to date received patent protection for “an antibody that could possibly be one of the hottest biotherapeutic treatments for cancer.”

    Best regards,

    Mike

  128. As Quoted by Mike “The unique structure [DNA] will have unique properties and uses. As long as the structure, properties and/or use is new and novel, it qualifies as a patentable invention.”

    Based on these metrics alone then by scientific logic gene “discovery” is not patentable. The gene’s (albeit) unique structure does not elucidate any particular unique property nor will the gene itself entail any unique “uses” on its own accord. A method needs to be used to manipulate the gene target and generate results (i.e.”uses”) to have any real informative data or definition. There are a variety of methods by which to do this “gene analysis” and all of them are indeed patentable.

    The issue at hand is understanding that a gene can be unique in structure, but at the same time render no property or use. The gene itself is useless and this is what the judge meant when he said genes need “markedly different characteristics in order to satisfy the requirements of § 101.”

  129. Liu,

    I appreciate what you are saying, “Gene discovery alone is not patentable.” That is true now that the genome has been published, but not true when the genome was unknown. Myriad’s patents do not antedate the BRCA sequence alone, but do antedate the mapping of specific mutations and association of those mutations with the development of various cancers. Facts about Myriad’s claims: 1) the claims are fairly broad, 2) the claims are directed to diagnosing a propensity for cancer, 3) the claims are well drafted. To paraphrase Judge Sweet’s opinion, based on emotion and not statute, “the patents are invalid because they claim genes.” This interpretation does not analyze the claim language, does not use legal standards and precedence to define patentable subject matter, and does not determine if the claims as drafted fall under patentable subject matter. The Supreme Court ruling In re Bilski clearly states that patentable subject matter is to be interpreted broadly as intended in the constitution and subsequent caselaw. The Federal Circuit, in discussions post Bilski indicates that diagnostic methods, as long as they are more than merely mental steps, fall under patentable subject matter. Therefore Judge Sweet’s purely emotional ruling is a waste of taxpayer money and time.

    This case was brought by the ACLU to grandstand against biotechnology patents, especially those encompassing genetic material and diagnostics. Patent protection for these inventions is required because it is costly to develop an FDA approved diagnostic test. Without exclusive protections (patents) companies would be unable to recoup those costs because generic providers would simply wait until new tests were approved then copy them. Currently the FDA provides much information to the public and biosimilars want to use that information, not develop their own, to achieve FDA approval. They may not even be required to prove that their product is ‘biosimilar.’ If you’ve ever produced proteins before, you would understand that subtle differences in cell strains and growth conditions can dramatically change the amount and quality of the product produced.

    I digress. If you want to challenge Myriad’s patents it should not be under 101, but under 102 and 103, anticipation and obviousness. There may be early art that hints at a connection between BRCA and cancer, because Myriad’s claims identify specific mutations, it may be difficult to invalidate these claims. If you want to abolish patents, argue before Congress to change the laws. The current route, get a sympathetic and emotional judge to rule in your favor instead of using precedent. That’s BULL-

  130. Now they ask Federal Circuit Judges to recuse themselves from the case : http://www.ipfrontline.com/depts/article.asp?id=24389&deptid=7
    http://ip.law360.com/articles/185289

    They are grandstanding against gene patents, not arguing invalidity of the Myriad patents.

  131. True, ACLU is a large body, deep pockets, media contacts out the wazoo, but if they can make things happen then that is cause and reason enough for AMP to ride their coattails. Gene patents is specifically an inequity of justice for those in the business of Molecular Pathology and it only falls generally under the ACLU umbrella. Lest we not be fooled that this force is coming from AMP and not ACLU. We (AMP) needed ACLU (despite their negative reputation) to help us move this mountain, then known as current law. The decision did not come easy and after 3 months of deliberating AMP gave the nod.

    The next morning AMP was amazed to see media’s attention on the topic starting with The Today Show. This example shows how hard it is to trust someone with power to manipulate and grandstand. But since we initiated the suit, we know that the purpose is authentic based upon our Professional knowledge of genetic materials, genes, isolated DNA, etc. Our Association represents largely BioIndustries and to say that such companies are threatened is an exaggeration.

    Isolated DNA and its sequence is not transformative. It does not express exogenous nucleotide sequence, nor augement or alter expression of a sequence, nor does is express a characteristic not naturally associated with an organism. Therefore, genes and isolated DNA do not fall under the definition of a “biotechnological process” and thereby should never have been patentable under 101 of the law.

    At the onset when in vitro PCR was invented, and if one had purchased and paid their royalties for instrumentation, anyone with lab experience could then race to isolate DNA. It would have been obvious subject matter then never a chance of early art thereby not patentable under 103 of the law.