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Debunking the Gene Patent Mythology: Professor Holman’s Supplemental Brief in the AMP Remand*


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: June 22, 2012 @ 7:30 am
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The supplemental briefs for the parties and amicus are now finally in for the remand of the AMP v. USPTO case to the Federal Circuit.  As I’ve previously stated, the Supreme Court’s reasoning in Mayo Collaborative Services v. Prometheus Laboratories, Inc., which caused this remand should not change the fact that Myriad’s isolated DNA sequence claims are patent-eligible under 35 U.S.C. § 101.  That’s based on the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) being the controlling precedent, not Mayo Collaborative Services.  See Chakrabarty Controls on Isolated DNA Sequences, not Mayo*

Not surprisingly, the ACLU and PubPat’s supplemental brief assert that these Myriad’s isolated DNA sequence claims are patent-ineligible in view of Mayo Collaborative Services, arguing that these claims “patent laws of nature and products of nature.”  This further mischaracterization of Myriad’s isolated DNA sequence claims perpetuates the unfortunate “myth” by the ACLU and PubPat that this case “is about the validity of certain patent claims on human genes.”  See page 8 of Brief for Appellees that filed for the original Federal Circuit panel decision.  But what the Federal Circuit panel should especially take note of in the remand of the AMP case is the supplemental amicus brief filed by Professor Christopher Holman of the University of Missouri-Kansas City School of Law.

Professor Holman not only teaches patent law at UMKC, but has a Ph.D. in biochemistry and molecular biology, as well as well as some post-doctoral drug discovery research experience.  In other words, Professor Holman speaks as one who understands both the patent law and the technology involved in the AMP case.  And what Professor Holman’s supplemental brief does is debunk the “gene patent mythology” fabricated by ACLU, PubPat, (and others), as well as “ a number of assumptions regarding the nature of the claimed subject matter” made by the original Federal Circuit panel which he characterizes as “unsupported at best, and in some instances clearly mistaken.”

At the outset, Professor Holman states that he is filing his supplemental brief “in the hope that this Court will not decide the patent eligibility of the isolated DNA claims based on unfounded assumptions as to the nature of the claimed subject matter and the potential impact of the claims (and so-called ‘gene patents’ in general) on research and diagnostic testing.”  He also makes the very astute observation that the AMP case “has serious ramifications extending well beyond the context of genetic diagnostic testing, particularly with respect to biotherapeutics.”

But given these “serious ramifications,” Professor Holman also alarmingly observes that “[t]here has been no specific allegation that any particular[] technology infringes any of the challenged claims, and in fact my research indicates that no US court has ever addressed the question of whether an isolated DNA claim would be infringed by any form of DNA sequencing or diagnostic testing.”  Even more disconcerting is his observation that Myriad’s “claims have yet to be adequately construed, and their purported preemptive effect remains entirely speculative.”  Put differently, the patent-eligibility of Myriad’s isolated DNA sequence claims under 35 U.S.C. § 101 may unfortunately be judged by the Federal Circuit on remand without a sufficient “claim construction” record.

Professor Holman’s supplemental brief starts with the fundamental proposition that “isolated” DNA is not simply DNA which has been “cleaved” and “extracted” from native chromosomal DNA.  Or as Professor Holman further explains his proposition in more detail:

[S]ome members of this Court are under the impression that the claims encompass native genomic DNA that has been simply “cleaved” from the chromosome and “extracted” from the cell, in a process analogous to separating cotton fiber from cottonseed, or purifying human adrenaline from human tissue.  While the imagery of cleaving a piece of DNA out of the chromosome might serve as a useful metaphor for explaining difficult concepts to non-biologists, like the “magic microscope” it misrepresents the biology and obscures the very real distinction between the claimed DNA and native chromosomal DNA.  Properly construed, the challenged claims are limited to synthetic DNA molecules that are structurally and functionally distinguishable from their native counterparts.

So much also for the inapt analogy disingenuously propagated by the ACLU and PubPat that Myriad’s claimed isolated DNA sequences are equivalent to “plucking a leaf.”

Particularly important to Professor Holman’s proposition is that the “isolation of genomic DNA” according to Myriad’s patents “is fundamentally different from the isolation of other biomolecules, such as proteins, lipids, or the purified adrenalin claimed in” the 1928 case of Parke-Davis & Co. v. H. K. Wolford Co.  In fact, Professor Holman points out the highly synthetic (i.e., man-made) nature of the process for preparing such “isolated” genomic DNA:  (1) extracting chromosomal DNA from a cell sample; (2) cleaving the long chromosomal DNA into shorter fragments; (3) inserting these DNA fragments into DNA vectors capable of replicating in a host cell; (4) introducing these altered DNA vectors into, for example, bacterial or yeast host cells which are then cultured to multiply and create a collection of vector-containing cells known as the “genomic DNA library”; (5) screening this “genomic DNA library” to indentify cells containing the desired genomic DNA; and (6) isolating the cells containing the desired genomic DNA from the mixture of cells in the “genomic DNA library.”  Further copies of the desired “isolated” DNA sequence may then synthesized (replicated) by using, for example, conventional polymerase chain reaction (PCR) techniques.

Contrary to what the ACLU and PubPat suggest, nothing in “nature” (other than the host cells used essentially as “factories” for replicating DNA they don’t “natively” contain) makes these synthesized copies of the “isolated” DNA sequence a “product of nature.”  As Professor Holman further says in his supplemental brief, Myriad’s ‘282 patent “does not describe isolating DNA by extracting it directly from native human chromosome, and to do so would make little sense, since that is simply not how DNA was, or is isolated.”  Other than the initial isolation of the BRAC genes when extracting native chromosomal DNA from human cells and cleavage of that DNA into fragments which Professor Holman characterizes as “intermediate steps in the preparation of the genomic library,” that is close as Myriad’s claimed isolated DNA sequences get to “nature.”

In relying upon Mayo Collaborative Services, a key argument made by the ACLU and PubPat is that Myriad’s claimed isolated DNA sequences “are unduly preemptive of laws/products of nature.”  See page 6 of the Supplemental Brief for the Appellees.  Professor Holman’s supplemental brief does say that literal reading of Myriad’s claimed isolated DNA sequences might lead one to believe that the “claims would cover bulk extracted chromosomal DNA, or fragments of native DNA used in the preparation of a library, since they would inherently include a BRCA gene.”  But Professor Holman then says that giving Myriad’s isolated DNA sequence claims such a broad interpretation “would render them anticipated by the extraction and cleavage of chromosomal DNA, and the preparation of genomic DNA libraries, activities that were routine and widely described in printed publications long before the isolation of” the BRAC genes.  Instead, Professor Holman states that not only does Myriad’s claimed isolated DNA sequences “originate outside the body,” but that these claimed sequences also have “functional and structural characteristics that distinguish [them] from native genomic DNA.”  In particular, Professor Holm notes that the “methylation of genomic DNA, along with other epigenetic modifications, are not retained by the isolated DNA” such that Myriad’s claimed isolated DNA sequences do not “originate from a native source” and are “structurally different in a way that significantly affects function.”

One particular “myth” at the heart of the ACLU and PubPat argument that Myriad’s claimed isolated DNA sequences are “unduly preemptive” (and unfortunately bought into by Judge Bryson’s partial dissenting opinion in the original panel decision) is that these claimed sequences “effectively preempt any attempt to sequence the BRCA genes, including whole-genome sequencing.”  Professor Holman’s supplemental brief exposes that “myth” for what is:  uninformed belief having no factual support.  Professor Holman observes that there are “many alternate methodologies for sequencing DNA” that do not necessitate “any isolation of the specific DNA sequences.”  In fact, Professor Holman astutely observes that Judge Bryson’s partial dissenting opinion “provides no explanation as to how the challenged claims would necessarily be infringed by any, let alone all of these methodologies.”

Professor Holman also correctly reminds the Federal Circuit panel that “the name of the game is the claim,” despite all the “hand waving” by the ACLU, PubPat, and others, including Justice Breyer with his snide remark in Mayo Collaborative Services about the “draftman’s art.”  As Professor Holman astutely observes, without determining what is “within the scope” of Myriad’s isolated DNA sequence claims, “many critics of gene patents incorrectly assume that any patent claim that recites a gene sequence necessarily forecloses any research or diagnosis relating to that gene.”  Professor Holman then reemphasizes the point he made in his original amicus brief (co-authored with Professor Robert Cook-Deegan) that “there is no basis for assuming that all forms of DNA sequencing, especially next-generation single molecule methods, would necessarily entail the production of isolated DNA falling within the scope of the properly construed claims.”  Put differently, without understanding what Myriad’s isolated DNA sequence claims actually do (or do not) cover, any argument about “preemption” is completely divorced from reality.

Another “myth” present in the ACLU and PubPat’s “preemption” argument is that Myriad’s isolated DNA sequence claims will “curtail the ability of scientists to examine human genes.”  See page 11 of the Supplemental Brief for the Appellees.  Indeed, another “assumption” made by Judge Bryson in the original Federal Circuit panel decision is that, “unless this Court declares the broader isolated DNA claims patent ineligible whole genome sequencing will be impeded by thousands of gene patents.”  But as Professor Holman correctly observes, that “assumption” may be based on “the widespread perception that 20% of human genes are patented,” which he also correctly characterizes as “a myth based upon the misreading of” the Jensen and Murray study reported in a 2005 Science article entitled “Intellectual Property Landscape of the Human Genome.”

This Jensen and Murray study stated that “20% of human genes are explicitly claimed as US IP.”  In reference to this study, Professor Holman directs the Federal Circuit to consider two 2012 articles he wrote.  One of those 2012 articles entitled “Will Gene Patents Derail the Next-Generation of Genetic Technologies?:  A Reassessment of the Suggests Not” factually analyzed the evidentiary basis for this statement by the Jensen and Murray study, and concluded that “it should be quite apparent that the [Jensen and Murray study] provides absolutely no basis to infer that 20%, or for that matter any defined percent of human genes are covered by patents that would be infringed by sequencing the gene, or for that matter studying or using the gene (emphasis added).”  I would strongly suggest that the Federal Circuit panel (and especially Judge Bryson) read Professor Holman’s 2012 article before making any further “assumptions” about what “research of human genes” might be impeded by Myriad’s isolated DNA sequence claims.

In concluding his supplemental brief, Professor Holman states that a “determination by this court that any of the challenged isolated DNA claims is patent ineligible could cause serious unintended collateral damage to biotechnology, and should not be made cavalierly based on an overly simplistic and imprecise interpretation of the claims and speculation as to their potential preemptive effect.”  The Federal Circuit needs to heed this “warning” by Professor Holman very carefully in the context of what Myriad’s isolated DNA sequence claims actually cover, and without factually unsupported “speculation” or “assumptions” as to what “their potential preemptive effect” might be.  The ACLU, PubPat, and others have unfortunately fabricated the story that the AMP case is about “patents on human genes.”  But Professor Holman’s supplemental brief has carefully and factually exposed this fabricated story as being nothing more than “gene patent mythology.”

*© 2012 Eric W. Guttag.  Posted June 22, 2012 on IPWatchdog.com.


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66 comments
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  1. Eric,

    You need to stop talking science and instead start talking “magic”.
    The age of enlightenment is long gone.
    We now live in the age of sorcerers and speakers of the Gobbledygook language.

    Science is dead. Long live Gobbledygook.
    You people are laying claim to our precious bodily fluids. It’s as simple as that.

    (Link to Dr. Strangelove’s rant on bodily fluids is here: http://www.metroactive.com/papers/cruz/02.24.99/flouride-9908.html )

  2. SB,

    Like in “magic microscope”? Just kidding.

    Science isn’t “dead,: its that the discussion of the patent-eligibility of isolated genetic material has been taken over by hyperbole and disingenuous, inapt analogies like “plucking a leaf.” The ACLU and PubPat can’t win on the “science.” Instead, they resort to the bio equivalent of astrology.

    If I were a Federal Circuit judge on this panel I would directly ask the ACLU and PubPat to define what they mean by “gene”: that would likely expose that their definition of “gene” is not only unscientific but also false. While I’m not a molecular biologist, I’ve got two books on molecular biology with glossaries which define many biological terms, including “genes.” In molecular terms, a “gene” is defined as the “entire DNA sequence, including exons, introns, and non-coding transcription-control regions, necessary for production of a functional protein or RNA.” As Professor Holman’s supplemental brief carefully points out, Myriad’s isolated DNA sequence claims don’t cover “genes,” not even close.

    That the ACLU, PubPat (and others, including Harriet Washington’s book, Deadly Monopolies) refer to this case as an effort to “patent human genes” is simply a brazen PR campaign to generate in the public PR hysteria and emotional value for their agendas. In fact, the “real plaintiffs” in this case are not those that the ACLU and PubPat frankly fabricated to get this case launched (and to try to avoid the obvious “standing” issue), but the ACLU and PubPat themselves. That the Federal Circuit has knocked out all but one of the plaintiffs on the “standing” issue alone exposes how much the ACLU and PubPat have manipulated this case, including what Myriad’s isolated DNA sequence claims actually cover. As you might gather, I’ve got nothing but contempt for the ACLU and PubPat for manipulating our court system and patent law in this manner.

  3. This is in no way an opinion of my employer, Vanderbilt University. It is only my own view:

    I work for the Center for Stem Cell Biology at Vanderbilt University. For 10 plus years I have been studying and researching using molecular techniques described in Professor Holman’s brief. I cannot agree more that the “plucking of the leaf” is a poor analogy to describe what is done to make a genetic library and what is required to uncover the sequence of the genes that turn off and on in order to make us who we are. Dr. Holman’s description was right on the mark.

    However, in describing the process to find and clone the BRACA gene (or any other gene) is akin to describing the process of photocopying a book by describing what goes into making a photocopier work. It is complicated, most people don’t understand it even after it is explained, and it sounds good to make the point. It does not make the sequence of the BRACA gene any more patent eligible than my obtaining a copyright on a book because I photocopied it to pink paper rather than white. I also can’t get a copyright on a book just because I translate it into some other language or into a totally different format all together, digital. cDNA is indeed not present in the human body ever, however, and exact, reverse copy (“c” stands for copy) of it does come from a cell that is produced in nature. Sorry, but nature beat you to it and making a reverse copy of it does not constitute patent eligibility.

    The ACLU and PubPat may not understand the science behind their argument, but they do have it right on a deeper level.

    On your point of how the ACLU and PubPat are making all sorts of claims of a terrible future for research and how these patents will create blockades for future research and development that have no basis in actual, prior history… I must retort by asking: Are you not doing the same for business by saying there will be no incentive for private funding of projects and future human health will suffer if Myriad’s isolated DNA sequence claims are not upheld? Regardless, that is really, in my view, a moot point. Moot because the claims have no more standing than my claims for the paper book I just converted to my iPad.

    Jake

  4. Jake,

    IIRC, the patents at issue do not claim “the sequence”.
    They claims a composition of matter that has not been shown to naturally exist heretofore.

    One of the four enumerated areas of patentable subject matter in 35 USC 101 is “composition of matter”.

    Are you saying that isolated DNA is not a “composition of matter”?

    Are you saying that one of the four enumerated areas of patentable subject matter in 35 USC 101 is not “composition of matter”?

    Sorry, but nature beat you to it and making a reverse copy of it does not constitute patent eligibility.

    –Regretably by that passage you show that you do not understand what the whole argument is about. Not your fault though. Them who hate patents have created a new language that never existed before. It was called “statutory subject matter”, NOT the misleading “patent eligible” invention nonsense.

  5. Forgive me if the following seems naive, as I’m still learning the ins-and-outs of patent law and my subject is chemistry/materials not bio.

    However, given that preamble, from what I understand of DNA sequencing, it’s always confused me that the first person to isolate a DNA sequence would necessarily have claim to said isolated DNA sequence. I would tend to agree with step back on the isolated DNA sequence being a composition of matter, but not a composition of matter which necessarily did not exist before. I would argue that the fact that said composition of matter necessarily existed, albiet embedded within a chromosomal body, before sequencing, in order that it could in fact be sequenced results in it being preempeted as an article of nature and thus is rendered preempted by the very thing which Applicants seek to claim. Of course, if this is not how it should be viewed. I would not disagree, I don’t think, with the argument that the isolated DNA could be patented if it were entirely new (i.e. a grad student purposefully mutates a gene and resultant gene is not found to exist in nature). However, and to reenforce the prior point, just as “a new mineral discovered in the earth or a new plant found in the wild is not patentable subject matter” under Section 101, I would argue that the discovery of a pre-existing base pair sequence, which is discovered only by being isolated, does not allow said isolated base pair to escape falling under the Section 101 Judicial Exceptions.

    I welcome your thoughts on the matter. And I look forward to trying to become an active commentator here!

  6. Forgot to make sure I get followup comments via email. Now I’m done.

  7. said composition of matter necessarily existed, albiet embedded within a chromosomal body

    So as a person knowledgeable in the chemical arts, what you are basically saying/arguing –and forgive me if I misunderstand– is that even if CH4 had never been “isolated” before (in a hypothetical world and for argument’s sake), if most of that “isolated” compound (-CH3) had been “embedded” in a naturally occurring larger compound, CnH(2n+2) where n>>1, the first chemist to isolate CH4 has no right to patent this “discovery” of his because the smaller compound had been “embedded” in the naturally occurring larger compound? And that holds true for ALL chemical compounds?

  8. p.s. What I should have used as the better analogy for the “embedded” part is -CH2-, not -CH3 because in the case of the -BRAC- mini-compound, both terminal ends are inherently changed when the mini-compound is “isolated”. Also that isolated mini-compound folds differently in a 3D sense and therefore probably behaves differently as a physical substance. But you’re saying none of that matters? Is that correct?

  9. EG-

    I believe you are getting to the crux of the matter in your #2 comment. While I can sort of understand where the PubPat anti patent “no patent for you because it is inconvenient for us” attitude is coming from, just why the ACLU is getting all over this is somewhat of a mystery for me.

    In the somewhat distant past, the ACLU seemed to be all about “Truth, Justice, and the American Way” like Superman, in defending the civil rights of American citizens, but something seems to have changed pretty basically in their recent past. Now they seem to want to deny the property rights of American citizens seeking patents, and why that is so we may never know. The Shadow probably knows, but he isn’t about to tell us why in the foreseeable future I would imagine.

    Magic in the traditional sense is all about the art of misdirection, which is inherently dishonest, especially if done well and properly, but the motive behind the deception is the real determining factor. Pulling rabbits out of a silk hat or doves out of your pockets is benign and entertaining I suppose, as long as they aren’t also trying to steal the wallet out of your back pocket.

    Perhaps they misunderstand the greater public good that patents represent, and why folks invest so much time and energy in acquiring them. If they manage to break this section of patent law in the US, who will step up to spend hundreds of millions of dollars and many years just so they *might* be able to get a patent on the next Penicillin? And how is that better for the greater public good over the long haul? I think it is not, if they manage to get away with this dog and pony show.

    “Wanna see me pull a rabbit out of my hat?” (Bullwinkle the moose, of the Rocky and Bullwinkle Show) When he tried to do so though, he got a lions head instead of a rabbit out of his silk top hat. Oops!

  10. Thanks Eric,

    Can you provide the link to Professor Holman’s brief?

  11. By your argument, SB, all I have to do is add a coupple of bases before start codon and after the poly-a tail and get a patent for it? I am not a lawyer and don’t speak legalese yet. I converse based on my background and understanding of the arguments being made. I make arguments based on what i feel is common sense based on my knowledge of the subject. Once done with law school, perhaps I can understand more clearly why your tone was so condescending in refering to my use of the term “patent eligible.”
    at a

  12. My argument was based on my knowledge of how i thought the law was interpreted. If my understanding is right, then if discovering something that existed in nature cannot get a patent, then regardless of how you discover it, a gene cannot get a patent because you add a few base pairs, demethylate it and change the “U” to “T”. Unless you make the same argument for copyrights, I don’t see how you can make that argument with genes.

    My understanding of the law may exclude me from understanding your arguments and how the dialogue has changed, but it doesn’t exclude me from an argument that very much includes me. Because to my non-lawyer science type friends and me, it sounds a lot like ppl are trying to patent something that already existed in nature. It reminds me of when Vanilla Ice was trying to say he didn’t rip off Queen.

  13. Dale,

    Go to Patent Docs: they’ve got the link.

  14. J Stein-

    You say: “Because to my non-lawyer science type friends and me, it sounds a lot like ppl are trying to patent something that already existed in nature.”

    Well that isn’t the case. While you are entitled to an opinion, that doesn’t mean you and your non-lawyer friends are entitled to be incorrect on the law and science and then expect that your erroneous view be taken serious and inform the correct approach a Court should take.

    You say: “if discovering something that existed in nature cannot get a patent, then regardless of how you discover it, a gene cannot get a patent…”

    The problem is that you just don’t understand what is at issue. Do you even know what a “gene patent” is or are you just throwing around the term that you have heard elsewhere?

    The simple scientific truth is that isolated DNA does not exist in nature in its isolated form. The Myriad claims related to isolated DNA. The premise you are operating under is factually incorrect. You assume a gene patent gives exclusive rights to genes. You need to actually read the claims and determine what protection relates to. Since isolated DNA does not exist in nature the Myriad claims do not cover something that exists in nature.

    -Gene

  15. Jake-

    Perhaps an analogy of sorts will help you out a bit here. As Step Back alluded to briefly in his #8 comment, the fact that the DNA fragment or strand has been isolated from the native genetic information is crucial and would never have occurred naturally without an inventive step, if you will.

    A good friend of mine once showed me how to effectively cancel the twisting action inherently necessary to be able to make a single large coil out of a very heavy and stiff rope.

    If instead of trying to make it coil continuously in one direction, you might be able take a shorter genetic *rope* and stack it up in a back and forth figure eight manner, effectively “cancelling” all of the torque effects inherent in trying to coil it up the old dumb way. You can then just fold the figure eight in half, and there will still not be any built in stress to undo when you need to uncoil the rope again some day.

    Eminently impractical if the rope happens to be about 24,000 miles long, but extremely practical if the rope is very stiff but only about 150 or 200 feet long. Same sort of thing with electrical coils as a matter of Physics, and the right hand rule. A folded electrical coil like that would be effectively neutral in the sense of impedance, or reluctance or resistance, if you care to think of it in that way.

    The real issue here seems to be motives, and whether they happen to be benign, but perhaps they might not be, so due care and caution seems to be indicated to me in this situation. Beware of the Ides of March.

  16. Jake,

    Two chemistry majors walk into a restaurant.

    The waiter comes over and asks them if either wishes to start with an alcoholic beverage.

    After careful thought, the first one says ….

    (rest of joke/riddle is here …. http://loldamn.com/wp-content/uploads/2012/04/funny-cat-professor-chemistry-glasses-two-men-bar.jpg )

    The point is that some things are subtle and you have to pay close attention to understand.

    I’m trying to show you why your theory about “patent eligibility” (and I’m sorry; I’m not trying to be condescending to you –it’s not about you, it’s about the US Supreme Court switching to use of misleading language that clearly creates a likelihood of confusion, with you being an example of a lay consumer of law who clearly got confused and reached for the wrong look-alike box on the supermarket of ideas) … to show you why your theory about “patent eligibility” takes us down an unacceptable slippery slope.

    So here it goes again:

    Two chemistry majors walk into a restaurant.

    The waiter comes over and asks them if either wishes to start with an appetizer.
    The first one says, I’ll start off with some sucrose.
    The second one says, I think I’ll start off with a simpler snippet of that. Give me some H-CH2-OH
    The second one dies.

    The point is that many chemical substances (compositions of matter) are very different from one another and those difference can make the difference between life and death. BRAC1 and BRAC2 happen to be two unique “compositions of matter” that make that difference even though they are “merely” simpler snippets from a more complex and naturally occurring compound.

  17. Gene,

    I’m going to need a jailbreak please out of your spam catcher.
    Thanks. :-)

  18. Dale:

    Checkout this website for a list of Myriad briefs: http://holmansbiotechipblog.blogspot.com/

    Holman’s brief is here: https://docs.google.com/file/d/0B9_llJGo9WK0V1pqZGtSQnRXRGM/edit?pli=1

  19. Gene, on second thought I’ll need too jailbreaks please. ;-)

  20. Jake if you go through pages 5-9 of the AIPLA amicus brief (link below) perhaps you will understand why I, like many others, are accusing the US Supreme Ct of playing 3 card Monte with a phraseology like “patent eligible”.

    Here is the link to the AIPLA amicus brief :
    https://docs.google.com/file/d/0B9_llJGo9WK0MVAxX1pnZlYyaHc/edit?pli=1

  21. With all due respect to my fellow pro-patent posters, the “other blog” has an excellent thread on this subject, and is worth the read.

    Regardless of what “may be at stake” (and wishing to stay away from “Lochnerain Judicial Activism” as the term is used on the other blog), the CAFC has been asked to re-evaluate the Myriad decision in view of the Court’s reasoning of Prometheus.

    No matter how wrong (most) of us feel about Prometheus, it is law and it will be applied to the Myriad case.

    As is pointed out, again on the other thread, the issue is not whether the claims are actually found in nature; but rather, is the invention claimed effectively to the item found in nature. A cold splash of “realism” (or at least of “judicial realism” as oxymoronic as the term may be) is in order, or at least should be understood, if not considered.

    Prometheus severely weakened patents by outright dismissing steps that were clearly transformative and sought instead to sift out a “gist of the invention” and evaluated that gist against its own judge-made judicial exceptions. With that 9-0 major decision guiding the CAFC (and no doubt the Justices keenly eyeing what the CAFC will do), the thought that, regardless of consequences, the CAFC will likewise apply a judicial exception and say that even though the man-made item is not found in nature, even though it is structurally different, it is not different enough and the claimed invention is effectively a claim on a product of nature and thus not patent eligible. The court can very well say, Myriad is not enough.

    Please note that this is not (necessarily) what I believe (yet). But it is substantial enough to ponder the legal power of the argument.

  22. Post caught in filter, please release

  23. One of mine got imprisoned too. I usually use Create Mail to get everything just right, before copying to post. When I tried to post it again, I got a duplicate message notice.

  24. SB-

    Quite an extensive and impressive list of those who are amicably curious about the decision. Curiously enough, AIPLA seems to be mispelled on the first page in very large letters. I reads as APILA from what I can see. That might work in Spanish or French or Mexican, but probably not in English.

    Thanks for the link.

    Stan~

  25. SB,

    Thanks for the lnk to the AIPLA brief.

    No matter how logical I find the underlying thoughts (especially the attempted integration of Prometheus into 101 jurisprudence, the bottom line is that Prometheus cannot be so integrated.

    It is simply too large a jump from:

    In crafting a threshold patent-eligibility analysis that requires “significantly more” than “well-understood,” “routine,” “conventional,” or “obvious” steps, the Supreme Court was conscious of blurring the lines between patent-eligibility and other sections of the patent laws, such as novelty under 35 U.S.C. § 102 and obviousness under 35 U.S.C. § 103. 13 The Court said that “overlap” may “sometimes” be required to avoid making the “law of nature” exception to § 101 a “dead letter.”14

    to:

    the Court explained that it had resisted any “temptation to depart from case law precedent.” 15 As Diehr, for instance, makes clear, “[t]he ‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter.” 16 Likewise, this Court, following Supreme Court precedent, has consistently instructed that “it is inappropriate to determine the patent-eligibility of a claim as a whole based on whether selected limitations constitute patent-eligible subject matter.”17 Considering steps or elements of a claim in isolation from the claim as a whole remains improper.

    While we in the trenches would like to believe this true, the actions of Prometheus itself does otherwise.

    No amount of “soft-selling” this jarring incongruity can remove the plain truth: the Supreme Court is quite willing to mess around with the different sections of the law in order to preserve its version of the law. They are completely unaccountable to anybody.

    And it is in the glaring spotlight of that plain truth that the pleading of “While Prometheus endorses a threshold inquiry for the category of method claims that embody a law of nature or abstract idea, that inquiry about whether additional elements are “routine,” “conventional,” or even “obvious” should not be expanded to all patent claims.” is exposed as a naked and “legally” unsupported (unsupportable?) plea to treat the enumerated cateogries of patent eligible material differently one from another.

    In common vernacular, the AIPLA is saying “you F’d up methods, but please leave compositions alone.”

    The problem with this is that the Supreme Court’s sticky fingers of letter writing and its disdain of lawyers and the craft of writing claims to get around its view of patent law scream out that the court will not make such differentiation between compositions and methods.

    The brief give no justification for this deferential request.

    The plea of “However, an analysis that imports the requirements of novelty and non-obviousness into Section 101 would risk turning determinations of patent-eligibility into unmanageable exercises dislodged from
    long-established and well-understood principles.
    ” applies with equal force to method patents, and such simply did not stop the highest court from turning a 9-0 deaf ear to that exact risk.

    Why woudl the court treat composition claims any differently? The point of the matter from a legal purist point of view is that the court should NOT treat the enumerated categories any differently.

    That pessimism aside, I do hope that this court takes its cue from Judge Rich post Benson, but the historical context might be too much to overcome. In the Benson era, you had a lower court not suffering from repeated drubbings ffrom the Supreme Court, a lower court with a champion intimately familiar with the actual law who would not be bullied by Supreme philosophical dicta. I pray that Rader can fit into the Legend’s shoes and kick the High Court where it hurts the most.

  26. To all:

    I would also suggest reading “isolated DNA” in the CONTEXT of how Myriad’s patents define it. For example, U.S. Pat. No. 5747282 (the ’282 patent) says this:

    An “isolated” or “substantially pure” nucleic acid (e.g., an RNA, DNA or a mixed polymer) is one which is substantially separated from other cellular components which naturally accompany a native human sequence or protein, e.g., ribosomes, polymerases, many other human genome sequences and proteins. The term embraces a nucleic acid sequence or protein which has been removed from its naturally occurring environment, and includes recombinant or cloned DNA isolates and chemically synthesized analogs or analogs biologically synthesized by heterologous systems.

    By law, the patent applicant is entitled to be their own lexicographer. By Myriad’s own definition, “isolated DNA” is something outside “its naturally occuring environment” and therefore not the “gene” as it naturally occurs.

    Again, according to Myriad’s own defintion, their claimed isolated DNA sequences are not “plucking a leaf” or simply discovering a mineral lying on the ground. Instead, these claimed DNA sequences are different from what exists in “mother nature” which is the native, whole “gene” in “its naturally occurring environment.” In fact, as Professor Holman’s brief describe how Myriad’s isolated DNA sequences are replicated, it is reminiscent of how Chakrabarty’s microorganisms are created. In other words, these claimed DNA sequences are man-made, not “nature.” Therefore, and as I’ve also previously said, Diamond v. Chakrabarty controls on Myriad’s claimed isolated DNA sequences, not Mayo Collaborative Services.

  27. The “1928 case of Parke-Davis & Co. v. H. K. Wolford Co.” referenced briefly by Mr. Guttag is actually the 1911 case of Parke Davis & Co. v. H.K. Mulford. Perhaps some of you have already read my recent Guest Post on the history of this old case on Patently-O. If not here is a link: http://www.patentlyo.com/patent/2012/05/myriad-parke-davis.html

    That post also contains a link to my full article on the case in the most recent issue of the Journal of the Patent and Trademark Office Society. Very short version of the story: Learned Hand got the law wrong as it existed in 1911 when he said that extracted products of nature were patentable.

  28. EG,

    With all due respect, you are pointing out a fact that is superfluous to the issue being decided in view of what the court has been asked to do: review its decision by the fire of Court jurisprudence as lit by the as Prometheus fire of “is it enough”.

    One can grant that structure is changed.
    One can grant that the claim is something “outside its naturally occurring environment.”

    Those are not winning points.

    The analogous points would still fail a Prometheun examination.
    Separated is not enough.
    Isolated is not enough.
    Man-made is not enough.
    I would daresay purified is not enough.

    The question is not “is it different?” The question is “is it different enough?”

    Your view that Chakrabarty controls and not Prometheus ignores the very fact that the Court has asked the CAFC to look at the case in view of Prometheus. You cannot ignore that.

  29. All,

    Please don’t get me wrong. I am not a lawyer or a patent agent. All I know is there seems to be some legal controversy regarding DNA, mRNA, and cDNA. I have no doubt that everyone here understands the molecular biology involved in the process. As a lay person, in terms of law, I felt my arguments were relevant. Not based in legal analysis, but in my perspective as a researcher. I have no ulterior motives other than to present my side. To be honest, I am not totally convinced that my analysis is the right analysis, which is why I felt the need to chime in on this topic.

    You may wonder why I am even on this site… I will be starting law school in the fall after 20 years in bench science to study and become an IP/patent attorney. In my research, I found this site that I look at regularly for updates on the state of the biotech IP world. I am not an insider with the ACLU or PubPat, just a curious person who didn’t see things exactly as the author. I understand the ramifications of the cases at hand from both sides, but these cases are not cut-and-dry and one side or the other seems to present it that way.

    I totally understand that the ACLU and PubPat are presenting a story that is off base at best and fear mongering at worst. I don’t see how their doomsday scenarios are relevant to the argument. I also don’t see how the claims of the patent applicants are genuine. The techniques used to isolate the BRACA cDNA are not novel, not complicated to a molecular biologist, and are used every day in labs around the world. Compared to drug development, it is cheap. The incentive for innovation and human advancement should not, IMO, be the determinant factor in obtaining a patent, nor should an unfavorable outcome be a disincentive. I would like to limit free speech of a lot of hate groups because their words serve to increase human suffering, but, in this country, we value free speech more than silencing a few idiots.

    That being said, I am not convinced either way. A clear-cut example of something that should get a patent is the combination of a novel promoter sequence with a gene or the ligation of an isolated gene like BRACA into any plasmid. But a patent on the BRACA cDNA sequence itself and/or its use, I am not easy with.

  30. Jake,

    There you go again (as Ronald Reagan oft said), inventing an issue that no one else is considering.

    If indeed Myraid had filed a claim for nothing more that the “sequence” –in other words the abstract idea that a DNA based molecule should be T-U-G-A-….-T then that would be an entirely different story.

    In that latter case I suspect few here could reasonably debate that such a hypothetical case presents a claim to nothing more than an abstract idea (the “sequence” per se) and therefore falls outside the broad ambit of 101.

    But those are not the facts that present themselves to us and the courts.

    As EG points out above, Myriad provided a being-one’s-own-lexicographer definition of “isolated DNA”. Under traditional US patent law (as opposed to SCt fantasy law), that definition must be included in determining what the words of the claim (as a whole) mean in the first place (in other words, “claim construction” –as you will learn about in law school –good luck BTW :-) )

  31. “Your view that Chakrabarty controls and not Prometheus ignores the very fact that the Court has asked the CAFC to look at the case in view of Prometheus. You cannot ignore that.”

    Anon,

    I’m not ignoring that SCOTUS remanded for consideration in view of Mayo Collaborative Services. I’m simply saying that Myriad’s claimed isolated DNA sequences are “compositions of matter,” that Chakrabarty addresses “compositions of matter,” and that Mayo Collaborative Services only involved a “process,” not a composition of matter. That’s why Chakrabarty controls on the Myriad’s claimed isolated DNA sequences, not Mayo Collaborative Services.

    Please also recall that SCOTUS’s remand was very unclear as to whether that remand was with reference to Myriad’s claimed isolated DNA sequences, to the Claim 20 screening method or both, and is why this SCOTUS remand is so problematical. While Mayo Collaborative Services might be relevant to the Claim 20 screening method (I would argue that the Claim 20 screening method is distinguishable from the method claimed by Prometheus), it could also be deemed by the Federal Circuit on remand to be irrelevant to Myriad’s claimed isolated DNA sequences because of the different classes of statutory subject matter.

    Also, as others have pointed out, the fact that SCOTUS did a GVR with the Myriad case doesn’t mean the result in the remand should be different from the original panel opinion. That SCOTUS does a GVR just means reconsider in view of the case referred to, i.e., Mayo Collaborative Services. You simply cannot imply from the this nebulous SCOTUS GVR a rejection of the reasoning in the original panel decision.

    I also realize your Excedrin headache with regard to SCOTUS apparently treating “process” subject matter differently from say “composition of matter” subject matter. As you’ve also pointed out, SCOTUS has left us with two different precedents (Mayo Collaborative Services and Diehr) that are 180 degrees opposite. Similar to Diehr, Chakrabarty wasn’t overruled by Mayo Collaborative Services. So let’s not assume quite yet that Myriad’s claimed isolated DNA sequences won’t be controlled by Chakrabarty, even in view of Mayo Collaborative Services,

  32. “The techniques used to isolate the BRACA cDNA are not novel, not complicated to a molecular biologist, and are used every day in labs around the world. Compared to drug development, it is cheap.”

    JS,

    What you state speaks to novelty/unobviousness under 35 USC 102/103 (issues currently not in this Myriad appeal), not patent-eligiblity (or as SB states, statutory subject matter eligibiity) under 35 USC 101. As one who studied and wrote about the so-called “product of nature” (some have wondered, including me, whether this doctrine is simply dicta) ~35 years ago, the courts (including SCOTUS) have too often conflated novelty/unobviousness under 35 USC 102/103 with patent-eligibility under 35 USC 101. To satisfy 35 USC 101, all that Myriad’s claimed isolated DNA sequences need be is different, in some way, from “Mother Nature,” which they are if Myriad’s definition of “isolated” controls (which it does). That Myriad’s claimed isolated DNA sequences may be obvious under 35 USC 103 is an entirely different question, one that has yet to be addressed in the Myriad case.

  33. EG,

    Do you have any more of that Excedrin brand acetaminophen, aspirin, and caffeine composition of matter?

  34. EG,

    I would add that since the first court’s decision had the Chakrabarty decision before it, the GVR necessitates that the decision is being reviewed with specific emphais of Prometheus.

    You may well be correct that Chakrabarty still controls and that the first decision will remain unchanged. But you can also count on the fact that the court will provide rationale for why (or why not), or how (or how not) Prometheus bears on the issue.

    As for “overruling” anything, please see my comments concerning the impossibility of squaring Prometheus with the precedents it says it was reinforcing.

    Also make note of the other blog and a comment there that the Court is only too happy to conflate in order to maintain its version of law. There is a whole “must-prevent-dead-letter driver that must be accounted for. If nothing else, Prometheus was clear that the Court did not care if 102 or 103 or 112 could be used – the Court was going to use it’s judicial exceptions under 101. The fact that different enumerated categories are involved in the decisions cannot be depended on for anything!

  35. It was interesting to learn that an Amicus brief is limited to 15 pages. In this case, brevity is the soul of wit.

    If anyone can identify the real ratio decidendi of Prometheus, then it will be possible to gauge accurately its impact on this case. But as the Supremes said that they were not creating a new principle, just interpreting existing law, then as has been argued frequently the decision ought to be confined to its own facts. It is difficult to see how the broadest principles put forward in that case can be applied without leading to the conclusion that the patent for tetracycline (a naturally occurring substance) was wrongly granted.

    Viewed simplistically, what is created is a new molecule or family of molecules. Patents have always been granted for such. On any rational view, that would be the end of the matter, and the case would never go near the Supremes, since the point was black letter law a century ago. And on the whole, if you are structuring your case on facts or law, facts do 90% of the work. If, on the other hand, the court does not understand the facts, then it can bend its decision any way it likes.

  36. EG,

    Now, that makes sense. My main point was not from a legal framework, but an outsider looking in… I do appreciate everyone’s input and responses. I keep forgetting that resolving conflict in court is so much different that resolving conflict in the real world. :-) I hope I am good at making the transition.

    I will be watching you all closely… to learn, not spy.

    Jake

  37. Paul,

    The point of Prometheus is that even though the Supreme Court said “that they were not creating a new principle,just interpreting existing law” does not mean that that’s what they actually did.

    What they did was create a gordian knot.

    The fact that you recognise the difficulty in actually squaring Prometheus with your comment of “If anyone can identify the real ratio decidendi of Prometheus,” tells me at least you recognize the nose of wax the Supreme Court has created, maintained and invested in with its 101 jurisprudence and the judicially created exceptions.

  38. Jake-

    This is the best place I have ever found to learn about patent law and especially what the current events in patent law might happen to mean like this article. It will probably give you a real leg up for your formal law school training. Nothing like decades of real world experience from several of the respondents here to know what is really practical or wise in practice.

  39. Anon,

    I wish I did have some “magical” Excedrin that could take away the patent law headaches SCOTUS hurls at us “mere mortals” from their Judicial Mount Olympus!

    Given the nebulous GVR handed them by SCOTUS which simply says “reconsider in view of Mayo Colaborative Services,” I agree that this Federal Circuit panel needs to provide clearly why Mayo Colaborative Services does (or doesn’t) apply. With Lourie being on the Prometheus panel that was reversed, as well as the Myriad panel, you wonder whether he’s up for another showdown with SCOTUS (my bet is he is). What worries me more is what Moore will do; her orginal joining of the majority with Lourie was hardly unequivocal.

    If Moore does change her mind, I would expect the Federal Circuit to review the remand panel decision en banc review (and they might review it en banc anyway). There’s so much at stake in the Myriad case that goes beyond the patent-eligibility issue under 35 USC 101, especially whether the Federal Circuit will have any credibility on major patent jurisprudence issues without SCOTUS continuing to exert its current despotic control. Just thinking about what might be at stake in Myriad makes me want to reach for that bottle of Excedrin.

    As far as the “other blog,” are you referring to Patent Docs or Patently-O? I’ve been watching both on the Myriad case but only commenting on Patent Docs (the atmosphere on Patently-O remains too toxic for me to comment there).

  40. Jake,

    Good enough, I’m glad I made sense to you. Feel free to continue to “learn.” And this Myriad situation is definitely a “work in progress” in terms of “learning.”

  41. EG,

    The toxic one. A New Light seems to have a nice summary, pairing back some of the vocal fluff and moving logically through the issues.

  42. But wear your boots

  43. Anon,

    I read New Light’s post. What I think is the difference between a patent-ineligible “product of nature” and a patent-eligible “man-made” composition or article is whether or not the composition or article can be made by “nature” or can only be made by the “hand of man.’ In the Chakrabarty case, the microorganism involved inserting 4 vectors into a host organism which had none of those vectors; “nature” couldn’t make that microorgansim at all. Similarly, a therapeutically “pure” composition of taxol for treating cancer cannot be made by “nature” (or as someone has said, you can’t chew the bark of the Pacific Yew and expect to be free of the cancer).

    By contrast, “plucking a leaf” or “plucking fruit” from a fruit-bearing tree is something “nature” can do, e.g., wind or some other natural force. Man could pluck the leaf or fruit, but “nature” can also, therefore no patent-eligibility for the “plucked” item. Also, the “plucked item” essentially retains what it was before it was “plucked.” Similarly, simply picking up an element (e.g., gold) existing in nature doesn’t change what it was before being picked up. But if you have to separate that element from how it exists it “nature” (e.g., aluminum from bauxite ore), only the “hand of man” can do that, but then again, you can only patent that which doesn’t exist in nature, i.e., the extracted element from the ore in a purity that doesn’t exist in nature. (That’s how man-purified cultures of microorganisms like those made by Pasteur in the 19th Century can make it to the patent-eligibility zone.)

    Most, if not all of the “product of nature” cases are also really “lack of novelty” cases under 35 USC 102, not patent-eligibility. The only exception if see is the borax-treated fruit fo the American Fruit Growers v. Brogdex case which held such treated fruit to not be a manufacture. But the holding the borax-treated fruit not to be a “manufacture” was also inconsistent with the definition of the term “manufacture” employed by that case. That’s why I believe American Fruit Growers has essentially fallen into oblivion.

    The difference between Myriad’s claimed isolated DNA sequences and “nature” is even clearer, especially in view of how Myriad has defined “isolated.” Nature does not, and cannot make Myriad’s claimed isolated DNA sequences.

  44. One final Exedrin drive EG: The word effectively.

    Now take the purely different strucutred items and start over, asking yoru self if even thought there ar structureal differences, is there a difference ininventive gist? The DNA for example, replicates, It replactes effectively the same (or not) eventhough the structure ahs been changed (codons and such). The “evil” of Prometheus involves an insertion of subjective “was there enough change in the inventive concept.

    SB’s post way back at 16 is clearly one where the difference is enough and “different in kind” is passed. But when you look at the DNA snippets, the results may not be so clear.

  45. Or in other words, whether or not the actual sequences can or can not be made is not the right question.

    The right question is that whether of or not the mewly made sequence is different in kind. What nature cannot make is not the right question to ask.If nature cannot make what man can make, BUT what man makes is not different in kind (it effectively does what nature does) then you are in trouble per the Prometheun “need more” mentallity.

  46. And one more wrinkle: there is a proble with any leaning towards 102/103 because 101 does not care about time, while both 102 and 103 do.

    In other words, 101 is patent defeating no matter when the item of nature is found. Even if you find the item years into the patent term, the 101 patent eligibility exception would strip out the patent right.. 102/103 does not do this. This is driven from the Doctrinal Concerns that patents and exclusive rigth associated with patents cannot control nature, even later discovered nature. The toxic thread gets a little confusing on this as arguments are repeated without recognizing counterpoints., and without recognize the Supreme Court doctrines and their steadfast refusal to let their judicial exceptions end up as dead letters.

  47. EG-

    Your taxol example makes an great case for why it so important for the courts to get stuff like this right. Taxol saved my mother’s life for about 7 years, which would probably not have been possible if the folks that developed it didn’t think they might have been able to get a patent right for all of their efforts.

    Excellent discussion on this, and I agree completely about the other blog. I usually read the articles, but trying to wade through all the muck slinging in the comments to find anything of any real substance is not very pleasant. Fortunately Gene does not allow that to happen here.

  48. Also the way the posts are presented and often written makes it difficult to figure out who wrote what originally.

  49. To all:

    Jon Harkness is correct: the Parke-Davis case is from 1911 (189 F. 95 (CCSDY 1911), not 1928. I was looking at scanned copy of my 1979 law review article and looked the wrong footnote for the case cite.

  50. “The right question is that whether of or not the [n]ewly made sequence is different in kind.”

    Anon,

    You’re correct, the difference needs to be in “kind rather than degree.” That comes from Parke-Davis and other “product of nature” doctrine cases involving purfication of natural extracts such as the 1964 case of In re Doyle (6-amino penicillanic acid extracted from penicillin prouding molds held patentable). The criteria for determining whether the difference is in “kind” rather than “degree” usually involves whether the substance extracted was previously unknown and more typically exhibits “unexpected properties,” but that’s only a rule of thumb. As my 1979 article (The Patentability of Microoganisms: Statutory Subject Matter and Other Living Things, 13 Richmond Law Review 247, 252-256) points out , the “product of nature” doctrine has not been applied consistently or uniformly.

  51. EG,

    I’m a little confused by your comment #50 re difference in “kind” versus that in “degree” .

    Is that a criteria for section 101 determination in the case you cite or a criteria for determining section 103 obviousness?

    Thanks.

  52. SB,

    It’s the criteria for the section 101 determination. That’s pretty clear from the cases that refer to the “product of nature” doctrine.

  53. SB,

    Let me also say that the difference “kind rather than degree” has been cited for both 101 and 102/103 purposes. In Parke-Davis, it was probably cited for 102/103 purposes. But in later cases, such as Doyle, it is usually cited for 101 purposes.

  54. EG,

    Do you have a link to your article? I cannot get to it with either of my Lexis or Westlaw accounts.

    Thanks

  55. Anon,

    Just do a Google (or equivalent) search for parke-davis v. mulford

    Like this one:
    http://www.google.com/#hl=en&sclient=psy-ab&q=parke-davis+v.+mulford&oq=Parke-Davis&gs_l=hp.1.1.0l4.40.40.0.3018.1.1.0.0.0.0.846.846.6-1.1.0…0.0.MjPD9NQ-3Hc&pbx=1&bav=on.2,or.r_gc.r_pw.r_qf.,cf.osb&fp=dab550d5b65224bb&biw=1143&bih=708

    It should be noted however that the 1952 Patent Act superseded the 1911 Parke-Davis decision in that section 101 says “any” composition of matter that is “new and useful”. There is no degree and kind qualifier to the “any” adjective of section 101. Any means any.

  56. Step Back,

    Thanks, but I was looking specifically for Eric’s 1979 article. Even Google seems to fail me on that :-(

    However, before celebrating the 1952 patent act, recall that the designation of degree comes into play through the judicially created law of eligibility exceptions as opposed to the legislative law of the act itself.

    So while any means any to the legislature, it certainly does not mean that to the Justices of the Supreme Court, who are more than happy to tell you that patents have limits. (but I think your view is much better!)

  57. Anon,

    With due respect, I disagree.
    Section 101 of the 1952 Patent Act includes the dual requirements of “useful” and “new”.

    An abstract idea per se is not considered part of the “useful” arts (and besides, prohibition of dissemination of abstract ideas goes against the freedom of speech provision of the 1st Amendment). Therefore the judicial prohibition to use patents to preempt the use of abstract idea per se is in accord with the “useful” requirement of 101.

    A naturally occurring phenomenon per se is not newly invented or discovered by the hand of man. Therefore the judicial prohibition to use patents to preempt the use of things that were naturally occurring before the inventor came along and made claim to it is in accord with the “new” prong of 101.

    A “Law of Nature” is not an edict handed down by Mother herself but rather an abstract idea fabricated by man regarding how we currently believe Mother operates. The fact that the Supremes do not understand that a “Law of Nature” is merely a species of abstract ideas (of men) goes to their ignorance about science. The BRAC-1 and 2 molecules (in isolation) are not naturaly occurring and they are not abstract ideas. They are new and useful compositions of matter.

    This “degree and kind” stuff is a red herring that merely muds the waters.

  58. Anon,

    Unfortunately, there is no free “link” that I can provide to my 1979 article. (My article has been cited a few times in some recent law review articles.) I’ve created a pdf copy which, if you want, you can send an e-mail request to Eric@GuttagIPLaw.com, and I’ll gladly provide it to you.

  59. Anon and SB,

    I’ve gone back and reviewed my discussion of the “production of nature” doctrine in my 1979 article, especially with regard to the difference “in kind rather than degree.” Cases prior to the 1952 patent statutes, such as Parke-Davis tend to tie the “product of nature” doctrine to what we could now call novelty/obviousness issues under 35 USC 102/103. In fact, several of the very early SCOTUS cases like American Wood-Paper Co. v. Fibre Disintegrating Co. (The Wood Paper Patent) and Cochrane v. Badische Anilin & Soda Fabirk (involving aspirin) cited for the “product of nature” doctrine are really attempts to patent old compounds. Cases after the 1952 patent statutes, such as Merck & Col. v. Olin Mathieson Chemical Corp. and CCPA cases such as In re Bergstrom treat (or appear to treat) the “product of nature” doctrine as being an issue under 35 USC 101, usually referring to the purified compound as being a “new and useful” composition of matter or simply a “new” composition of matter (referring directly to 35 USC 101).

    The focus of my 1979 article was really directed to whether “living” subject matter (microoganisms) were statutory subject matter under 35 USC 101, primarily looking at the case of In re Bergy but also at In re Chakrabarty (before SCOTUS ruled in Diamond v. Chakrabarty). The situation in Bergy was further complicated by the claimed invention being directed to a microbiological process for preparing the antibiotic lincomycin using a newly discovered microogransim, so you had both the “product of nature” doctrine and the “living subject matter” issue in play. In fact, Board had switched the basis for rejection from “product of nature” to “living organism.” Even so, Judge Rich wrote in Bergy that the claimed “biologically pure culture” was man-made and not a “product of nature.”

  60. EG,

    Thank you for clearing that up.

  61. SB,

    You’re most welcome. As you’re aware, the courts (including SCOTUS) can be very sloppy sometimes about what patent statute the particular legal doctrine is related to. For example, Funk Bros. Seed v. Kalo Innoculant is often cited as relating to statutory subject matter under 35 USC 101 when it is really related to obviousness under 35 USC 103 (see my 1979 article and especially Justice Frankfurter’s concurring opinion). I also can’t tell you how many time O’Reilly v. Morse is characterized as an “abstract idea” case relating to 35 USC 101; it’s not, but instead an “enablement” case more related to 35 USC 112, 1st paragraph.

  62. EG,

    Not only “sloppy”, but also easily taken over by psycholinguistic re-framing of the issue they can be (last 3 words needed to make this a proper Yoda sentence).

    Take the phrase “patent eligible” as an example.

    I don’t recall exactly when it was injected into the lexicon. However, back in the day we always referred to this specific 101 issue as that of claiming “statutory subject matter” or not. The intentionally-ambiguous phrase of “patent eligible” appears to be custom tailored to throw the less experienced off track as to what the issue is supposed to be. If it is a “new and useful” composition of matter then it is “statutory subject matter” pursuant to 35 USC 101 pure and simple. Period.

  63. EG-

    Good stuff Eric. It becomes important in my case, when I am trying to decide whether to take an arm-waving napkin sketch concept to the next level. After doing a good search to make sure it might be actually novel, of course. Just making an experimental prototype to make sure it will really work can be very expensive of time and money, let alone filing an application that might not fly at all the way the law is developing these days. I almost wrote evolving, but evolution would seem to imply a positive direction of change.

  64. Stan,

    Most disturbing of all is how all this legal mumbo jumbo plays out to the ears of your average inventor or biochemistry research scientist or to the next generation of students thinking about entering the R&D field.

    Once the word gets out that the US Supreme Court is going to find all sorts of excuses for killing patents –and thus greatly reducing the market value of inventors and inventor wannabe’s– fewer and fewer people are going to invest their time, sweat and other equities to pursue a livelihood in science and the useful arts. And then where will we be?

    Welcome to the new burning down of Rome –same as the old burning down, except the fiddler’s music is slightly different. :-(

  65. SB-
    Interestingly enough, I found out that Nero was actually playing his Harpsicord that was then very new, if I recall it correctly. Maybe he had done everything he could have by then, but I suspect not. At least some folks here are trying to put the fire out.

    Part of what I have been seeing is that the newer generation of independents seem be getting few and far between these days. I think a lot of it might be due to access to the Internet, wherein they can just get lost in the clouds instead of actually thinking of or doing anything practical or new. You can get a sense of this, if they write horribly mis-spelled questions, and then you never hear from them again after you try to answer their question.

    The Universities are really hot lately though, especially as Tech Transfer programs get better and more efficient. Some of the Universities have been trying to aver that the student inventors owe them their patent rights because there was Federal funding involved, but that attitude seems to be slowly going away.

  66. http://en.wikipedia.org/wiki/Bayh-Dole_Act

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