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.”
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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.
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.