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AMP v. Myriad: SCOTUS Must Remember What Case Is Not About*


Written by Eric W. Guttag
Eric W. Guttag IP Law Office
Posted: December 9, 2012 @ 12:12 pm
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The Supreme Court of the United States.

Given the remand of the Federal Circuit’s original panel decision for reconsideration in view of Mayo Collaborative Services v. Prometheus Laboratories, Inc., I’m not surprised that the Supreme Court granted the ACLU’s/Pubpat’s petition for certiorari in AMP v. Myriad.  What is somewhat surprising is that the Supreme Court granted certiorari only as to the first question (“Are Human Genes Patentable”) posed by the ACLU/PubPat.  The patent-eligibility under 35 U.S.C. § 101 of Myriad’s claimed method of screening potential cancer therapeutics that was (again) unanimously upheld by the Federal Circuit panel, but will not be before the Supreme Court.  Nor will the issue of “lack of standing” with respect to but one of the plaintiffs be considered.

I’ve been following the various meanderings and wanderings of the Myriad case for almost three years now.  One unfortunate aspect of this case is that, from the beginning, the ACLU/PubPat has manipulated and fabricated what this case is about in terms of the applicable “science,” as well as the applicable “patent law.”  In fact, in distorting what this case is really about (i.e., the patent-eligibility of Myriad’s claimed “isolated” DNA sequences under 35 U.S.C. § 101), the ACLU/PubPat has also tried to hide the fact that the real plaintiffs in the Myriad case are none other than the ACLU/PubPat themselves; that has become readily apparent, given that all but one of the “alleged” plaintiffs have been knocked out of this case on “lack of standing” grounds.

Before the Myriad case becomes further obscured by the “pseudoscientific” nonsense foisted by the “real plaintiffs,” as well as the PR smokescreen of “politics, policy and philosophy” that the ACLU/PubPat has used to manipulate the applicable “patent law,” the Supreme Court needs to understand, to use Judge Lourie’s words, what this case “is not about.”

1. This case is not about “patenting human genes.” 

As Myriad has correctly pointed out in its brief in opposition to the grant of certiorari, the question posed by the ACLU/PubPat (“Are Human Genes Patentable”) is absolutely the wrong one to answer:  “The first question presented [by the ACLU/PubPat] bears no relation to the uncontroverted facts of this case.”  (Myriad’s brief in opposition has also pointed out at least 4 other significant factual and legal “misstatements” made in the petition for certiorari by ACLU/PubPat.)  As much as the ACLU/PubPat (and others) want to make the Myriad case into about “Who Owns You,” what Myriad has claimed does nothing of the sort.  In fact, a “yes” answer to the question posed by the ACLU/PubPat does not automatically lead to Myriad’s claimed “isolated” DNA sequences being patent-ineligible.  Those claimed “isolated” DNA sequences are not “genes” by any standard molecular biology definition of what that term actually means.  Instead, and as accurately characterized by Judge Lourie, these claimed “isolated” DNA sequences are “novel biological molecules.”  See The AMP v. USPTO Remand:  Déjà Vu as Federal Circuit Majority Reaffirms that Myriad’s Isolated DNA Sequences Are Patent-Eligible.

2. This case is not about patenting “products of nature.” 

Another distortion proffered by the ACLU/PubPat (and unfortunately relied upon by the district court) in the Myriad case is that the claimed “isolated” DNA sequences are “products of nature.”  But as I’ve noted before, these isolated DNA sequences are definitely not “products of nature.”  See What the CAFC Should Tell SCOTUS in the AMP Remand:  Chakrabarty Controls on Isolated DNA Sequences, not Mayo Collaborative Services.  Instead, the claimed isolated DNA sequences are man-made, don’t exist in “nature,” are usually produced by using man-originated synthetic techniques, and are “structurally distinct from native DNA, and have different properties and utilities.”  See Debunking the Gene Patent Mythology:  Professor Holman’s Supplemental Brief in the AMP Remand.  In other words, and unlike what the ACLU/PubPat have disingenuously said, we’re not simply “plucking a leaf” in making these claimed isolated DNA sequences, and far from it.  Mother Nature does not, (and more significantly cannot) “isolate” the claimed DNA sequences.

3. This case is not about preempting “laws of nature.” 

The ACLU/PubPat would like the Supreme Court to believe Myriad’s claimed “isolated” DNA sequences as preempting “laws of nature” and is thus controlled by Mayo Collaborative Services.  But consider Judge Lourie’s response in the Myriad remand to this so-called “preemption” argument posed by the ACLU/PubPat:  “Plaintiffs argue here that they are preempted from using the patented DNA molecules.  The answer to that concern is that permitting patents on isolated genes does not preempt a law of nature.  A composition of matter is not a law of nature.  Moreover, as indicated earlier, a limited preemption is inherent in every patent:  the right to exclude for a limited period of time.”  As I’ve also observed before, “preemption” really isn’t a patent-eligibility issue under 35 U.S.C. § 101.  Instead, “preemption” is really a question of “written description,” and especially “enablement,” under 35 U.S.C. § 112, first paragraph (and potentially “definiteness” under 35 U.S.C. § 112, second paragraph).

4. This case is not about “hindering research” on human genes.

Another “myth” presented in the ACLU’s/PubPat’s “preemption” argument is that Myriad’s isolated DNA sequence claims will “curtail the ability of scientists to examine human genes.”  But as Myriad pointed out in their opposing brief, “neither Myriad nor its patents hinder research of BRCA genes.”  (This is one of the other 4 factual and legal “misstatements” made by the ACLU/PubPat.)  In fact, one of the named plaintiffs conceded she “’could sequence the BRCA1 and BRCA2 genes for purely research purposes,’ and has been doing so without impediment.”  Myriad also pointed out in their opposing brief the thousands of studies conducted and relevant papers published on BRCA1/2 genes.  In addition, and before making any other “assumptions” about what “research of human genes” might be impeded by Myriad’s claimed “isolated” DNA sequences, the Supreme Court would do well to consider Professor Holman’s 2012 article entitled “Will Gene Patents Derail the Next-Generation of Genetic Technologies?:  A Reassessment of the Evidence Suggests Not” which factually analyzed the evidentiary basis for the statement made by a 2005 Jensen and Murray study that “20% of human genes are explicitly claimed as US IP.”  What Professor Holman concluded was 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).”

5. This case is not about the “informational content” of the claimed “isolated DNA sequences

Another disingenuous argument fabricated by the ACLU/PubPat to support their supposed “First Amendment is violated theory” is the so-called “informational content” of these isolated DNA sequences.  But as Judge Lourie has correctly noted, the claimed isolated DNA sequences are, instead, “novel biological molecules.”  That means the Supreme Court’s 1980 decision in Diamond v. Chakrabarty (man-made living organism is patent-eligible) is not only far more analogous in terms of the claimed subject matter (versus Mayo Collaborative Services which involved methods only), but should also be controlling on the patent-eligibility question under 35 U.S.C. § 101.  And Chakrabarty also made clear that “anything under the sun that is made by man” was patent-eligible under 35 U.S.C. § 101.  Because the Myriad’s “novel biological molecules” are “made by man,” they are therefore patent-eligible “compositions of matter” under 35 U.S.C. § 101.

6. This case is not about the judiciary making “policy” decisions that the legislature has already made, explicitly or implicitly.

The ACLU/PubPat has done everything it can to turn the question of patent-eligibility under 35 U.S.C. § 101 in the Myriad case into a “politics, policy and philosophy” circus.  But the Supreme Court would do well to consider that Congress is already aware of the “politics, policy and philosophy” of the patent-eligibility of Myriad’s claimed “isolated” DNA sequences and has already spoken explicitly (or at least implicitly) that these claimed “isolated” DNA sequences are not to be banned from being patented.  First, there have been at least two different sets of bills proposed by Congressman Becerra to specifically ban the patenting of such nucleotide subject matter which haven’t even gotten beyond the relevant Congressional committee.  Second, the consideration of what subject matter should be banned from patenting was duly considered by Congress in drafting the AIA (the Abominable Inane Act), and nucleotide subject matter was not part of that which was banned by the AIA.  Instead, the only subject matter that was explicitly banned by the AIA (i.e., deemed part of the “prior art”) was “any strategy for reducing, avoiding, or deferring tax liability.”  In fact, Congress was very careful to say that this ban on patenting “tax strategies” didn’t apply to other subject matter relating to preparing tax returns or to a “method, apparatus, technology, computer program product, or system used solely for financial management” that was severable from such “tax strategies.”  Patent law “policy” is for Congress to determine (not the Supreme Court), and Congress has definitely not “spoken” to ban the patenting of nucleotide subject matter like that claimed by Myriad.

Conclusion

With the technologically-challenged and patent law illiterate Supreme Court now reviewing the sole patent-eligibility question remaining Myriad case, apprehension is certainly justified that our Judicial Mount Olympus will apply the ACLU’s/PubPat’s disingenuous “pseudoscience” and “politics, policy, and philosophy” theories to this question, instead of the appropriate microbiological “science” and “patent law” that is actually involved.  Mayo Collaborative Services has already shown Justice Breyer’s penchant for spouting nonsensical (and conflicting) patent law doctrine, misapplying appropriate patent claim terminology, as well as arrogantly (and offensively) demeaning the “draftsman’s art” we patent attorneys and agents employ.  See Eviscerating the Patent-Eligibility of Drug Testing Methods:  The Nonsensical Reasoning in the Supreme Court’s Mayo Collaborative Services Decision.  One can only hope that the Supreme Court will “grow up” and get beyond the inapt “plucking leaf” and “magic microscope” analogies.  Indeed, much will depend on whether these nine Justices (especially Breyer) will consider what the Myriad case is (and especially isn’t) about.

*© 2012 Eric W. Guttag.  Posted December 9, 2012 on IPWatchdog.com.


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17 comments
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  1. The following comment posted earlier this month on Patently-O is, I believe, apt:

    What should be the criteria for the intervention of a non-specialist court of final appeal in a specialist legal area?

    Firstly that the non-specialist court has the skills to resolve the matter in dispute. Secondly that the existing state of the law amounts to a serious wrong. Thirdly that the non-specialist court has a reasonable chance of truly understanding the underlying technical facts and legal principles and of producing an opinion that is both correct in outcome and correctly reasoned (the Kalo case, for example, being a clear instance of a correct outcome based on reasoning that it is difficult to support). Fourthly that there is a reasonable chance of arriving at a new rule of law which is preferable to that which existed formerly. Fifthly that there is a reasonable chance that the new rule of law can be expressed in a way that meets the needs of those closely connected with the subject matter in dispute without major but unintended collateral damage in situations unforeseen when the opinion was written, especially by ill-advised and over-broad dicta.

    Although there have been outstanding decisions from the Supreme Court e.g. in Festo, its recent record in our field could most charitably be described as patchy. Did the opinion in Bilski leave the law in a clearer or a more uncertain state? Can anyone determine what the rule of law underlying Prometheus actually was?

    Is Myriad a case where intervention was justified? Two concurrent Federal Circuit decisions were well reasoned, have been generally welcomed in the profession and compelling reasons for disturbing them are difficult to discern. If it was a matter of legal certainty then refusing certiorari would have been the wiser course. An ill thought-out decision could be profoundly damaging to the chemical, pharmaceutical and biotechnology industries at least, could cut US law off from a century of legal thought concerning the patenting of new chemical entities and from international standard practice on this topic. In the present case, the decision to grant certiorari is not grounds for confidence but for the reverse.

    Coincidentally, the current edition of Scientific American carries a lengthy article by Shawn Otto warning of the dangers of science denial when carried into politics, warning that “When facts become opinions, the collective policymaking process of democracy begins to break down.” There appear to be real dangers of science denial being carried into law also, and the decision for certiorari in this case highlights the dangers of this happening. In appearing to support the wish of The Association for Molecular Pathology (which self-evidently has an axe to grind), Breast Cancer Action and Boston Women’s Health Book Collective, amongst others, that the public should have free access to the fruits of difficult and costly research, the Court has the appearance of embracing populism rather than rationality.

  2. Paul,

    I believe these comments were also directed at the Prometheus decision and in asking a certain poster to explain how that decision squares with the rest of SC precedent.

    I do not think I ever saw a response to your question on that matter. Did you receive an acceptable answer?

  3. Eric,

    Excellent points. While It is unlikely to be heard by the Supreme Court now, it is important that we publish the truth if there is to be a hope for the future.

  4. December 10, 2012

    Eugene R. Quinn, Jr.
    President & Founder of IPWatchdog, Inc.
    US Patent Attorney (Reg. No. 44,294)
    Zies, Widerman & Malek

    Dear Mr. Quinn:

    Mr. Guttag’s December 9 letter on Myriad Genetics that appeared in IP Watchdog seems misleading on a number of grounds set forth below.

    1. Patenting human genes

    Claim 1 of the ‘282 patent does in fact expressly claim the human BRCA gene: “1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.” Association for Molecular Pathology v. United States Patent and Trademark Office and Myriad Genetics, Inc. 689 F.3d 1303, 1309 (Fed.Cir. 2012). The Federal Circuit explained, a “gene’s nucleotide sequence … encodes for a linear sequence of amino acids that comprise the protein encoded by the gene, e.g., the BRCA1 gene encodes for the BRCA1 protein.” Id at 1311. The Federal Circuit said, “The composition claims at issue in Myriad Genetics “cover two ‘isolated’ human genes, BRCA1 and BRCA2… and certain alterations, or mutations, in these genes associated with a predisposition to breast and ovarian cancers.” Id. at 1309 (Emphasis added).

    The nucleotide sequence of claim 1 is identical to the nucleotide sequence of the same human gene in the body, and genes are defined by the nucleotide sequence, not covalent bonds or the proteins in chromosomes (none of which are part of claim 1). See, e.g. definitions of “gene” in Molecular Cell Biology (Sixth Edition) by Lodish, Berk, Kaiser, Kreiger, Scott, Bretscher, Ploegh and Matsudaira, and Principles of Biochemistry (Fourth Edition), Horton, Moran, Scrimgeour, Perry and Rawn. The issue is not whether human genes are involved, but whether the “isolation” of the human gene from the body, or the synthetic creation of the exact nucleotide sequence referenced in claim 1, makes claim 1 patentable subject matter, the issue in points 2 and 3 of Mr. Guttag’s post.

    2. Products of nature

    Prometheus does apply (see 3 below), and in fact two of the three judges in Myriad Genetics said that Prometheus was applicable. However, let’s assume for the sake of argument that only Chakrabarty and Funk Brothers were applicable.

    In Chakrabarty, the Supreme Court held that “the patentee has produced a new bacterium with markedly different characteristics from any found in nature and one having the potential for significant utility.” 447 U.S. 303, 310 (1980)(Emphasis added). The Court found, “This human-made, genetically engineered bacterium is capable of breaking down multiple components of crude oil. Because of this property, which is possessed by no naturally occurring bacteria, Chakrabarty’s invention is believed to have significant value for the treatment of oil spills.” Id. at 305. In other words, in Chakrabarty, the Court looked at both the chemical characteristics and functioning of the plasmid-enhanced bacteria.

    Judge Lourie’s decision in Myriad Genetics disregarded Chakrabarty when he rejected any consideration of the functioning of the DNA segments of claim 1, 689 F.3d at 1330. His position on this was inconsistent on Chakrabarty with both Judges Moore and Bryson.

    Judge Moore cited Chakrabarty for the proposition that “a composition of matter with ‘markedly different characteristics’ from that found in nature with the potential for significant utility is directed to patentable subject matter.” 689 F.3d at 1340 (Emphasis added). Judge Bryson also considered both the chemical characteristics and functioning of the DNA, saying “[M]erely isolating the products of nature by extracting them from their natural location and making those alterations that are attendant to their extraction does not give the extractor the right to patent the products themselves.” 689 F.3d at 1350. Judge Bryson concluded, “The structural differences between the claimed ‘isolated’ genes and the corresponding portion of the native genes are irrelevant to the claim limitations, to the functioning of the genes, and to their utility in their isolated form.” 689 F.3d at 1354.
    It appears that Judge Moore would have sided with Judge Bryson on claim 1 and held claim 1 constituted unpatentable subject matter, except for the deference she gave to the past practice of the USPTO in granting patents on isolated DNA segments. 689 F.3d at 1343. That deference is difficult to understand, since in Fort Properties, Inc. v. American Master Lease LLC, Fort Properties, the District Court had granted summary judgment that no claim constituted patentable subject matter and on appeal the three judge panel – including Judge Moore – affirmed the District Court and said, “Issues of patent-eligible subject matter are questions of law and are reviewed without deference.” 671 F.3d 1317, 1320 (Fed. Cir. 2012)(Emphasis added). There was no legal basis for Judge Moore to switch position and give deference to the USPTO in Myriad Genetics.

    3. Laws of nature and preemption

    Judges Moore and Bryson agreed that Prometheus’ discussion of laws of nature was relevant to Myriad Genetics. Judge Moore said, “the Prometheus discussion of laws of nature (process claims) clearly ought to apply equally to manifestations of nature (composition claims). Myriad’s argument that Prometheus is constrained to methods is an untenable position.” 689 F.3d at 1339-1340 (Emphasis added). She also said, “The scope of the law of nature/manifestation of nature exception was certainly enlarged in Prometheus.” Id. at 1343. Citing Prometheus, Judge Bryson said, “Just as a patent involving a law of nature must have an ‘inventive concept’ that does ‘significantly more than simply describe … natural relations,’ … a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product.” 689 F.3d at 1355.

    In citing Judge Lourie for the proposition that a “composition of matter is not a law of nature,” Mr. Guttag apparently forget that claim 1 is a functional claim covering all nucleotide sequences that “code for” the BRCA protein. As Judge Lourie himself said, “The relationship between the sixty-four possible codon sequences and their corresponding amino acids is known as the genetic code.” 689 F.3d at 1312.

    The genetic code – the relationship between nucleotides and amino acids set forth in claim 1 – is as much a law of nature as is the relationship between the human body and synthetic chemicals that the Supreme Court held was a law of nature in Prometheus. In Prometheus, the Court held, “Prometheus’ patents set forth laws of nature – namely, relationships between concentrations of certain metabolites in the blood and the likelihood that a dosage of a thiopurine drug will prove ineffective or cause harm.” 132 S.Ct. 1289, 1296 (2012).

    What Judge Lourie said about preemption in Myriad Genetics is irrelevant in light of what the unanimous Supreme Court said in Prometheus about preemption of “narrow” laws of nature. The Court rejected the suggestion of Prometheus that a claim to a narrow law of nature was permitted and stated the principle that “our cases have not distinguished among different laws of nature according to whether or not the principles they embody are sufficiently narrow.” 132 S.Ct. at 1303. The Court in Prometheus concluded, “[T]he cases have endorsed a bright-line prohibition against patenting laws of nature, mathematical formulas and the like, which serve as a somewhat more easily administered proxy for the underlying ‘building block’ concern.” Id.

    4. Hindering research on genes

    Although Mr. Guttag clainms it is clear that patents on isolated DNA segments do not hinder scientific research, there is much dispute on that issue. In Myriad Genetics, the District Court found, “there exists a sharp dispute concerning the impact of patents directed to isolated DNA on genetic research and consequently the health of society. As with the dispute concerning the effect of the patents-in-suit on BRCA1/2 genetic testing, the resolution of these disputes of fact and policy are not possible within the context of these motions.” 702 F.Supp.2d 181, 211 (S.D. N.Y. 2010). For instance, a group of distinguished scientists appointed by the U.S. Government concluded in 2010 – after thorough research and study – that patents on basic genetic discoveries had not increased basic genetic research and had probably harmed the availability of genetic testing. “Report of the Secretary’s Advisory Committee on Genetics, Health and Society, Gene Patents and Licensing Practices and Their Impact on Patient Access to Genetic Tests” (April 2010).

    If the effect of patents on DNA research is relevant to patentable subject matter, a factual dispute on this – such as found by the District Court – would raise a question of whether summary judgment for either side was appropriate. See, e.g., See In re Comiskey, 554 F.3d 967, 975 (Fed. Cir. 2009); and Arrhythmia Research Technology, Inc. v. Coraonix Corp., 958 F.2d 1053, 1055-1056 (Fed.Cir. 1992)(patentable subject matter is a question of law, but there can be underlying factual questions). Of course, in Prometheus, the Court said, “We need not determine here whether, from a policy perspective, increased protection for discoveries of diagnostic laws of nature is desirable.” 132 S.Ct. at 1305

    5. Informational content

    It is not clear why Mr. Guttag responds to a First Amendment claim, when that is not an issue on which the Supreme Court granted cert. Turning to a real issue, informational content, the informational content of the DNA is the genetic code that Judge Lourie admitted is present. 689 F.3d at 1312.

    Judge Bryson thought the informational content was crucial, since it directs the functioning of the DNA and since Chakrabarty considered functioning of the plasmid enhanced bacteria in determining patentable subject matter. He said, “The informational content of the nucleotide sequences is the critical aspect of these molecules; the terminal groups added to the molecules when the covalent bonds are broken—to which the majority and concurring opinions attribute such significance—are not even mentioned in the claims. The nucleotide sequences of the claimed molecules are the same as the nucleotide sequences found in naturally occurring human genes.” 689 F.3d at 1355.

    Judge Moore also recognized that the informational content of the DNA of claim 1 was the same as that of the native DNA: “the isolated full length gene … appears to simply serve the same ends devised by nature, namely to act as a gene encoding a protein sequence.” 689 F.3d at 1343. How can the isolated DNA of claim 1 be markedly different from, and have different utility than, native DNA when they serve the same function?

    The District Court similarly found the information content was important for determining patentable subject matter. It said, “This information quality is unique among the chemical compounds found in our bodies, and it would be erroneous to view DNA as ‘no different[]’ than other chemicals previously the subject of patents.” 702 F.Supp.2d at 228.

    To not consider informational content is to reject consideration of functioning of the claimed subject matter in determining patentable subject matter. That is contrary to the holding in Chakrabarty, and it is also contrary to the Supreme Court’s holding in Funk Brothers Seed Co. v. Kalo Innoculant, in which the Court held the aggregation of bacteria put together by man did not constitute patentable subject matter. The Court held, “The qualities of those bacteria, like the heat of the sun, electricity, or the qualities of metals, are part of the storehouse of knowledge of all men …. manifestations of laws of nature, free to all men and reserved exclusively to none.” 330 U.S. 127, 130 (1948).

    The Court in Chakrabarty did refer to the Congressional report mentioning “everything under the sun,” but the Court immediately followed that statement with the following principles of exclusion from patentable subject matter: “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.” 447 U.S. at 309. Myriad Genetics involves such physical phenomena (DNA) and the laws of nature (the genetic code).

    6. Policy decisions

    Mr. Guttag suggests that isolated DNA segments are patentable, because Congress did not pass some bills that would have prohibited patents on isolated DNA segments. If the Supreme Court started to interpret Congressional intent by what amendments Congress did not pass, the Court would truly be an activist court. That standard would also impose an impossible burden on the Court, because Congress fails to pass so many things. In fact, it is reasonable to conclude that if Congress exhibited any intent in not passing the amendments, it was because the amendments were unnecessary—isolated DNA segments have never been patentable.

    Conclusion

    Referring to the Supreme Court as “patent illiterate” – as Mr. Guttag does – is strange when a case he cares about is before that Court. Morover, his conclusion that “Mayo Collaborative Services has already shown Justice Breyer’s penchant for spouting nonsensical (and conflicting) patent law doctrine” is even stranger, because it disregards the fact that Prometheus was a unanimous decision of the Court, not an isolated opinion of Justice Breyer.

    In fact, Prometheus is a very important and good decision that – in emphasizing the need for an inventive concept when laws of nature are involved – confirms an important standard to help maintain a vibrant public domain in science.

    Sincerely,

    Douglas L. Rogers
    Adjunct Professor of Law
    The Ohio State University Moritz College of Law
    614-395-4686

  5. December 10, 2012
    Eugene R. Quinn, Jr.
    President & Founder of IPWatchdog, Inc.
    US Patent Attorney (Reg. No. 44,294)
    Zies, Widerman & Malek
    Dear Mr. Quinn

    I am writing to express my dissent from the views of Professor Rogers in his letter to you earlier today.
    1. As is common ground, the significant claim is to an isolated DNA sequence. That is a new substance, being an individual molecule or a collection of similar molecules, and is prima-facie patent-eligible under 35 USC 101. New molecules and new substances have been considered patent-eligible for more than a century in the US and worldwide. The issue is whether this particular molecule which would normally be considered patent-eligible as a matter of course is somehow rendered patent-ineligible by reason of the protein which it encodes.
    2. The isolated DNA sequence is not a product of nature but is a substance that does not exist in nature but has been created by human skill and by the application of restriction enzymes and other technology that are themselves the creation of human skill. The doctrine that products of nature should not be pressed too far – streptomycin was a natural product what was patented years ago, and who is to say that the grant of the patent was wrongful (the discovery of streptomycin also resulted in the award of a Nobel Prize). And Funk Brothers is a paradigm example of a decision that was correct in the outcome but flawed in its reasoning, along with A & P is one of the decisions intended to have been buried by the 1952 legislation and does not deserve resuscitation.
    3. There is no explanation in Prometheus as to why streptomycin would have been patentable under the doctrine of preemption. The antibiotic activity of the molecule was a law of nature and a patent for it would preempt that law.
    4. A patent for streptomycin would have hindered research on antibiotics in the same way that James Watt’s patent on the steam engine hindered research on steam engines. Richard Trevithick and other folk in Cornwall certainly thought so, and Oliver Evans was lucky enough to reside in the US and was not affected by the patent. As a policy issue this should be a non-starter.
    Prometheus had an oddly-drafted claim and was arguably an outlier. Contrary to the views expressed in the last paragraph, it is a thoroughly bad decision because it expresses a rule of great breadth without explaining the practical limitations necessary to make it workable. However, Myriad differs from Prometheus because it is a case following standard and long-accepted practice. That is why the decision of the Supremes to grant certiorari is a matter of such concern.
    Respectfully

    Paul G. Cole
    European Patent Attorney
    Professor of Law, Bournemouth University, UK
    Editor, CIPA Guide to the Patents Acts, 6th and 7th Editions
    (others have academic reputations, too!)

  6. Dear Professor Douglas,

    I’m not surprised that you disagree with what I’ve said, given the following article that you wrote: “Coding For Life — Should Any Entity Have The Exclusive Right To Use And Sell Isolated DNA?,” 12 U. Pitt. J. Tech. L. & Pol’y 1 (Fall 2011). You’re entitled to your opinion as I’m entitled to mine. But please refrain from calling what I say “misleading”:

    1. Contrary to you what you state, Myriad doesn’t claim the human gene BRCA, i.e., the native unisolated DNA. Myriad says as much in their patent. No matter what you or others may believe, Myriad doesn’t claim a human gene, only an “isolated” DNA sequence. The way the ACLU/PubPat framed the question (“Are Human Genes Patentable”?) is simply a PR stunt as far as I’m concerned.

    2. What Myriad claims isn’t a “product of nature.” I strongly suggest you read Professor Christopher Holman’s amicus brief filed in the Myriad case which shows that synthesizing the claimed isolated DNA sequence is hardly some “nature” can do. (By the way, Professor Holman is not only a patent attorney but also a Ph.D. biochemist). I’m also very familiar with the so-called “product of nature” doctrine, having written a law review article on it back in 1979, and Myriad’s claimed “isolated” DNA sequence is anything but a “product of nature.”

    3. Laws of nature and preemption. I stand by what I say. Also, Judge Lourie is the only judge on this panel who’s background is in chemistry (Moore is a EE major while Bryson’s background isn’t in science at all.) “Preemption” is a misused phrase in patent-eligibility doctrine, stemming from a misinterpretation of the O’Reilly v. Morse case.

    4 & 5. “It is not clear why Mr. Guttag responds to a First Amendment claim, when that is not an issue on which the Supreme Court granted cert.” I suggest you read the ACLU/PubPat petition for cert because it’s part and parcel of their “hindering research” argument: “Patents on isolated DNA also violate theFirst Amendment because they block scientificinquiry into the patented DNA.

    6. As far as “policy” goes, the Supreme Court has been engaged in it in the patent-eligibility area in Bilski, as well as Mayo. 35 USC 101 mentions no exclusions from eligibility based on “laws of nature,” “natural phenomena,” etc. That’s strictly a creation of the Supreme Court. Also, the issue of nucleotide subject matter eligibility has been before Congress before and after the Myriad case was in progress. That Congress chose not to ban it in the AIA when other subject matter was banned suggests that Congress intended to leave such subject matter patent eligible, especially as such nucleotide subject matter has been patented for over 30 years now.

    7. “Prometheus was a unanimous decision of the Court, not an isolated opinion of Justice Breyer.” You may believe that but Breyer was the only Justice who had any “skin” in that case (given Breyer’s dissent in LabCorp.)

    8. “Prometheus is a very important and good decision.” You may also believe that, but there are many in the patent law area (including at least one former IP law professor) who don’t share your view, including me. In particular, Mayo can’t be squared with the prior Diamond v. Diehr case.

  7. Professor Rogers-

    I write only to point out that you are horribly misstaken and misinformed.

    First, the Supreme Court took a very broad issue about the patentability of human genes. You seem to misunderstand what that means.

    Second, the Myriad claims most certainly do not claim a human BRCA gene. Apparently you are unfamiliar with the scientific reality that genes do not exist in isolated form in nature. You might not like that scientific truth, but it is still true nonetheless.

    Third, you say that what Judge Lourie says is completely irrelevant. That is an extraordinarily naive (and erroneous) view of the law. You can yell Prometheus from the highest mountains but the truth is that case is different.

    Fourth, the Supreme Court is indeed patent illiterate and anyone familiar with patent law and science knows that to be true. In the past they have said that magnesium and manganese are equivalents, which isn’t even the low point of patent jurisprudence at the Supreme Court. How you and others can ignore the reality that the Supreme Court is patent illiterate is really quite telling. Do you really think the Supreme Court knows everything about everything? They handle a few patent cases a year. If they were attorneys it would be malpractice for them to engage in representing on a patent matter. They are unfamiliar with science and unfamiliar with the body of patent law as a whole. There is no way to dabble in an area of law so complex, yet they do and sadly they have the final word. That means they can ignore the law, as they clearly did in Prometheus. So applaud them if you want, but don’t expect us to join you. We know that the Supreme Court doesn’t know enough about patent law to fill a thimble.

    I’ll let EG deal with the rest of your issues.

    -Gene

  8. 12/11/12 Reply to certain points by Gene Quinn, Eric Guttag and Professor Paul Cole

    I respect the points made by each of you, and we clearly disagree. I respond in this letter to certain points you either collectively or individually made, not to keep an argument going, but simply to avoid misunderstanding about what I was saying.

    1. genes

    The Federal Circuit said, “The composition claims at issue in Myriad Genetics “cover two ‘isolated’ human genes, BRCA1 and BRCA.” The Federal Circuit did not say the claims cover two sequences of nucleotides that used to be genes.

    Whether or not the Federal Circuit is correct or you are correct, I think the first issue in the Supreme Court will be – and in fact it is what the Court has certified – whether human genes are patentable subject matter. Under Chakrabarty, simply calling the subject matter an “isolated gene” does not make the subject matter patentable, just as calling the ccomposition claims in Chakrabarty “bacteria” did not make them unpatentable. A court has to consider the chemical structure of the subject matter (your view) or the chemical structure and functioning of the subject matter (my view and the view of Judges Moore and Bryson) under Chakrabarty to determine if a composition constitutes patentable subject matter, regardless of how the matter is titled.

    If human genes are patentable subject matter, then presumably the isolated genes would be patentable subject matter. If human genes are not patentable subject matter, then the issue becomes have there been enough human intervention and changes under Chakrabarty (your view) or Chakrabarty and Prometheus (my view) to become patentable subject matter. We do not need to argue whose view is correct on that, because the Supreme Court will resolve the issue of what the law is.

    The suggestion, however, in one or more of your comments that human intervention by itself is sufficient is not consistent with Supreme Court precedents. For instance, in I884, in Cochrane v. Badische Anlin & Soda Farik, the Supreme Court addressed a patent for a synthetically made product, alizarine, that was also found in nature in a naturally occurring “product,” the root of the madder plant. 111 U.S. 293, 296 (1884). The Court first analyzed the claim as a product by process claim and rejected the claim on that basis. The Court then addressed “another view of the case” and concluded the claim was also invalid on that basis, since the invented product had the same chemical formula as natural alizarine … and therefore “the article …. was an old article.” Id at 311. The Court continued, “Calling it artificial alizarine did not make it a new composition of matter.” Id. In other words, if a person synthetically makes a product that already exists in nature, the synthetically made product is not necessarily new and patentable. Human intervention was also not sufficient in American Fruit Growers, Inc. v. Brogdex Co., 283 U.S. 1, 6 (1931), or in Funk Brothers Seed Co. v. Kalo Inoculant Co., 333 U.S. 127 (1948), to turn the claims into patentable subject matter.

    It will be interesting to see if the Supreme Court takes the views that you three have expressed.

    2. Knowledge of Supreme Court

    Gene asks, “Do you really think the Supreme Court knows everything about everything? …. they can ignore the law, as they clearly did in Prometheus.”

    Regardless of what I think the Supreme Court knows, once the Supreme Court makes a ruling, it is the law. As you know, lawyers and others disregard the law at their and their clients’ peril. I assume Gene means he disagrees with the nine Justices on the decision in Prometheus and does not mean Prometheus is not the law.

    3. Misleading

    I did not say and was not suggesting that Mr. Guttag’s letter was intentionally misleading. I believe Mr. Guttag is an intelligent attorney who expressed his views in good faith. Obviously all three of you disagree with my views and think my views are misleading, which is fine. One of the many great things about this country is that we have free speech and encourage vigorous debate (I also think England is a wonderful country, but am not as familiar with its laws on free speech).

    4. 35 U.S.C. §101:

    Mr. Guttag says, 35 USC 101 mentions no exclusions from eligibility based on ’laws of nature,’ ‘natural phenomena,’ etc. That’s strictly a creation of the Supreme Court.”

    Although those express words are not in §101, since 1793 the applicable patent statute has required that in order to obtain a patent, the applicant must present a machine, manufacture, composition of matter or art (now process) that is “new” to the patent office (or initially Thomas Jefferson). A human gene is not new, so I do not think the exclusions by the Supreme Court were strictly a creation of the Court, since a human gene is not new. See, e.g., Linda J. Demaine & Aaron Xavier Fellmeth, “Reinventing the Double Helix: A Novel and Nonobvious Reconceptualization of the Biotechnology Patent, 55 Stan. L. Rev. 303, 386 (Nov. 2002).

    On the other hand, there are many people – like you – who do think the three exclusions from patentable subject matter are strictly the creation of the Supreme Court. Unless and until Congress passes a law overruling a Supreme Court decision (assuming the decision were not based on the Constitution), however, the Supreme Court decision is the law.

    5. Funk Brothers:

    Professor Cole says, “And Funk Brothers is a paradigm example of a decision that was correct in the outcome but flawed in its reasoning, along with A & P [sic]is one of the decisions intended to have been buried by the 1952 legislation and does not deserve resuscitation.”

    I do not think Funk Brothers was ever rejected by the Supreme Court, although many people disagree with the decision. In Chakrabarty the Court cited Funk Brothers at 309 without any suggestion Funk Brothers was no longer valid law. In Prometheus, the Court said, “Such discoveries [of laws of nature] are ‘manifestations of … nature, free to all men and reserved exclusively to none.’” Chakarabarty …(quoting Funk Brothers)…”. 132 S.Ct. at 1293. Both cases, of course were decided after the Patent Act of 1952.

    6. Amicus Briefs

    In response to Mr. Guttag’s comment, I have read Mr. Holman’s amicus brief in the Federal Circuit and found it very interesting. However, I also read the Amicus Brief of Professor Eileen Kane in the Federal Circuit. She is a law professor at Penn State Dickinson School of Law and has a Ph.D. in molecular biology. I found Professor Kane’s Brief more persuasive. Obviously we disagree on that. Discussing and learning the views of other people is one reason why the practice of law is so interesting.

    7. Conclusion

    I appreciate the opportunity to discuss these issues and respect all of your views and respect the IP Watchdog blog.

    Sincerely,

    Doug Rogers

  9. @ Professor Rogers

    Many thanks for drawing attention to Cochrane v BASF. However, the facts in that case differ fundamentally because at the time when the invention was made alizarine was a known substance that had been used since antiquity, had been prepared in isolated form, and was of known chemical formula. In those circumstances a claim to all methods of artificially making a known substance is invalid in the same way that a claim to all methods of automating a process perviously performed manually is invalid. In the present case, by contrast, the relevant sequence was newly isolated and hitherto unknown. The sequence is a new molecule whereas alizarine was an old molecule. That difference is self-evidently fundamental.

    The correct reasoning in Kalo was set out in the concurring opinion of MR. JUSTICE FRANKFURTER:

    “My understanding of Bond’s contribution is that, prior to his attempts, packages of mixed cultures of inoculants presumably applicable to two or more different kinds of legumes had from time to time been prepared, but had met with indifferent success. The reasons for failure were not understood, but the authorities had concluded that, in general, pure culture inoculants were alone reliable because mixtures were ineffective due to the mutual inhibition of the combined strains of bacteria. Bond concluded that there might be special strains which lacked this mutual inhibition, or were at all events mutually compatible. Using techniques that had previously been developed to test efficiency in promoting introgen fixation of various bacterial strains, Bond tested such efficiency of various mixtures of strains. He confirmed his notion that some strains were mutually compatible by finding that mixtures of these compatible strains gave good nitrogen fixation in two or more different kinds of legumes, while other mixtures of certain other strains proved mutually incompatible.

    If this is a correct analysis of Bond’s endeavors, two different claims of originality are involved: (1) the idea that there are compatible strains, and (2) the experimental demonstration that there were in fact some compatible strains. Insofar as the court below concluded that the packaging of a particular mixture of compatible strains is an invention, and, as such, patentable, I agree, provided not only that a new and useful property results from their combination, but also that the particular strains are identifiable and adequately identified. I do not find that Bond’s combination of strains satisfies these requirements. The strains by which Bond secured compatibility are not identified, and are identifiable only by their compatibility.”

    The opinion of MR JUSTICE DOUGLAS in Kalo is not deserving of the generality that it currently receives and is in danger of being misapplied.

  10. The sequence is a new molecule whereas alizarine was an old molecule. That difference is self-evidently fundamental.

    No, it is not.

  11. @ Anon

    Why not?

  12. Paul,

    You are conflating a time sense into the judicial exceptions of 101, making them sound as in 102 or 103.

    That particular time sense simply is not present in the judicial exceptions.

  13. You all should really read the amicus brief of James Watson:

    http://www.wileyrein.com/newsroom.cfm?sp=newsreleases&id=767

    That brief directly answers the Court’s question.

  14. anon-

    You do understand that Watson is incorrect and his positions legally indefensible, right?

    -Gene

  15. Incidentally, we now have two different people commenting with practically the same handle. “Anon” with the capital “A” is our regular here. “anon” with the lowercase “a” seems to be someone else (i.e., different e-mail and different IP address).

    -Gene

  16. Dear Professor Rogers,

    Thanks for your further comments. Also, please let me apologize for using your first name in my response to your earlier comments. I was writing with some haste as I was down in Florida, about to return home to Cincinnati, and was using a “not so perfect” wireless Internet network.

    1. As far as “Are Human Genes Patentable,” that question posed by the ACLU/PubPat, not only misses the patent-eligibility question under 35 U.S.C. § 101 involved in the Myriad case, but simply inflames (deliberately so in my opinion) the “rhetoric” over what the claimed isolated DNA sequence covers. Using the term “gene” implies to the public that Myriad is claiming the “native” DNA which their respective patents clearly say that’s not what is claimed. Also, the glossary’s of two molecular biology books (Lodish et al, Molecular Cell Biology and Alberts, Molecular Biology of the Cell) I’ve got define “gene” as the entire DNA sequence (including extrons and introns) which isn’t what is being claimed either.

    2. I of course accept that SCOTUS is the final “arbiter” on what the “law” is, be it patent law or otherwise. My problem (and concern) is that what they’ve done in the area of patent law doctrine amounts to subjective “patent law despotism” that greatly (and in my opinion, unwisely) diminishes the standing of the Federal Circuit as the jurisprudential authority on patent law doctrine that was Congress’ intention when the Federal Circuit was created back in 1982. I know others disagree with my view of what Congress intended in creating the Federal Circuit, but it’s pretty clear that Congress intended the Federal Circuit as the jurisprudential authority on patent law doctrine (not SCOTUS), and that SCOTUS, up until 2006-2007, pretty much treated the Federal Circuit as the jurisprudential authority on patent law doctrine. The Federal Circuit doesn’t always get patent law doctrine correct (as Judge Pauline Newman who I respect greatly can tell you), but SCOTUS is way out of its league in now taking control what patent law doctrine is, including ignoring (repeatedly) what the primary patent statutes say, and applying what I refer to as their version of “federal common patent law.” That sort of attitude (and misapplication) regarding patent law doctrine (as well as the patent statutes) by SCOTUS doesn’t gain the respect of the patent bar, many of whom like me are extremely upset with how SCOTUS demeans the area of law we work in (belittling patent claiming the “draftsman’s art” in the context it was used in Mayo Collaborative Services was extremely arrogant and offensive to what all of us patent attorney/agents). In fact, much of the difficulty in the Federal Circuit articulating sensible patent-eligibility doctrine under 35 U.S.C. § 101 is because SCOTUS does a terrible job in explaining in any rational or logical way what, exactly, is the standard for patent-eligibility, including providing an objective definition of what is a patent-ineligible “abstract idea” (the only comment by Justice Stevens in his concurring opinion in Bilski that I agree with).

    Please also let me clarify that I didn’t say Mayo Collaborative Services isn’t the “law,” but I stand by what I said in my article above: what Justice Breyer opined in that case is nonsensical logic that is his and his alone that makes a mockery of his assertion that it is, in any way, consistent or can be squared with the “claimed subject matter as whole” holding in the prior (and precedential-binding) Diamond v. Diehr. (As the dissenter in the LabCorps v. Metabolite, I also stand by my assertion that Breyer is the only one of the nine justices who had any judicial “skin” in Mayo Collaborative Services.) I would have been quite satisfied if Breyer had categorized what Prometheus’ claimed method as being too “abstract,” but he instead reached out to support his reasoning based on Prometheus’ claimed method as comprising essentially a “law of nature” like E=MC2 or gravity. It was nothing of the sort, especially given that the metabolites being measured are the result of man-made drugs, and the fact that the measurements that were also obtained by man (not “nature”). Even more astounding, is that Breyer expressly rejected the sensible view made by the government (and others such me and Professor Michael Risch) that patent-eligibility questions under 35 U.S.C. § 101 should not be considered until after the claimed subject matter has run the gauntlet of 35 U.S.C. §§ 112/102/103. In fact, until the claimed subject matter is evaluated under 35 U.S.C. § 112 for “written description”/”enablement”/”definiteness”, you have not objective idea what the claimed subject matter covers, be it patent-eligible process/method or “abstract idea.” But Breyer deliberately chose to “do it the hard way” because he wants subjective “veto power” under 35 U.S.C. § 101; there is no other explanation for choosing to continue to “squander” judicial resources on what is currently a subjective standard, rather than considering more objective standards for determining the validity of the claimed subject matter.

    Overall, the current SCOTUS is virulently anti-patent, reminding me much of the SCOTUS of the 70’s which articulated such patent law “nonsense” as Anderson’s-Blackrock and Sakraida v. Ag Pro (synergy required for patentability of combinations of old elements), as well as Gottschalk v. Benson (written by Justice Douglas, the most anti-patent justice even) and Parker v. Flook (written by Justice Stevens who wrote the disingenuous concurrence in Bilski that 35 USC 273 was a “red herring”). It simply doesn’t gain or engender my respect which such nonsensical reasoning as is expressed by Breyer in Mayo Collaborative Services.

    3. I accept that you didn’t intend to refer to what I said in my article as “intentionally misleading.” But please also understand that a significant reason why I reacted the way I did in my initial response to your initial comments was because of the reference to my alleged “misleading” grounds in my article.

    5. What Paul Cole says about Funk Brothers is correct. Justice Douglas (the most “anti-patent” of justices, other than perhaps Justice Stevens, before Justice Breyer came along) wrote the Opinion of the Court in Funk Brothers, and ihis reasoning can only be described as unintelligible (as I characterized it in footnote 76 of my 1979 article (Guttag, “The Patentability of Microorganisms: Statutory Subject Matter and Other Living Things,” 13(2) Richmond Law Review (1979), p. 247). In fact, as others have observed (Kevin Noonan of Patent Docs), the concurring opinion of Justice Frankfurter in Funk Brothers correctly “clarifies” the inarticulate reasoning of Douglas to explain that the claimed invention there was unpatentable for reasons of “obviousness,” not because it was a “product of nature” or otherwise not within one of the statutory classes of subject matter that is potentially patent-eligible.

    6. You’re correct that we’ll need to simply “agree to disagree.” The subject we’re talking about here stirs some signiicant “emotions” (mine included).

  17. Another comment from EG… who asked me to post on his behalf…

    Dear Paul, anon, and Dale
    Thanks for your comments and support.
    What might surprise some of you is who I view as the most “pro-patent”
    Justice: Clarence Thomas. Why do I say that? Well, he wrote the majority
    opinion in J.E.M AG Supply v. Pioneer Hi-Bred International (holding that
    sexually reproduced plants were patent-eligible under 35 USC 101) and Kappos
    v Hyatt (no limitation on introducing new evidence in 145 proceeding). I
    know Thomas authored the Opinion of the Court in eBay, but if you read his
    opinion carefully, he did his “legal homework” and even recognized the
    Supreme Court’s 1908 decision in Continental Paper Bag Company v. Eastern
    Paper Bag Company that rejected the “categorical” proposition that “a court
    of equity has no jurisdiction to grant injunctive relief to a patent holder
    who has unreasonably declined to use” the patented invention. Relative to
    Chief Justice Robert’s obtuseconcurrence and especially Justice Kennedy’s
    bizarre concurrence (“[I]njunctive relief may have different consequences
    for the burgeoning number of patents over business methods, which were not
    of much economic and legal significance in earlier times. The potential
    vagueness and suspect validity of some of these patents may affect the
    calculus under the four-factor test.”), Thomas’ opinion in eBay is
    significantly more “balanced.” Also, Thomas’s dissenting opinion in
    MedImmune seriously challenged the logic of Scalia’s majority opinion, which
    is saying something, given that Thomas and Scalia are usually on the same
    “ideological” page.

    On the other side, the worst of the current Justices when it comes to patent
    law are Breyer, Scalia, and Roberts in that order. Breyer is an anti-patent
    “ideologue,” as bad as Justice Douglas; as anon correctly points out,
    Breyer’s opinion in Mayo Collaborative Services is a travesty which can’t be
    squared with the prior Diehr case. Scalia has a “19th Century” mentality
    when it comes to what is patent-eligible under 35 USC 101 (as Bilski shows,
    he’s definitely against “business methods” being patent-eligible, but
    understands the implications of 35 USC 273 in that regard). For allegedly
    being fairly sharp, from the oral argument transcript in Bilski, the Chief
    Justice shows amazing befuddlement on understanding the difference between
    patent-eligibility under 35 USC 101 and patentability under 35 USC 102/103.

    As Paul suggests, SCOTUS is “out of its area competence” when it comes to
    patent law. And Congress could (but likely won’t) take away the ability of
    SCOTUS to hear patent cases. (I’ve suggested this before which brought forth
    “howls” from some, but the SCOTUS precedent is there for Congress to do it.)
    Frankly, when Congress gave the Federal Circuit 1982 appellate jurisdiction
    over all patent cases, that was also a not so subtle hint for SCOTUS to
    generally “stay out” of ruling on basic patent law doctrine. Unfortunately,
    the current SCOTUS can’t take that hint.