Much ado about genes: untangling the evolving law of subject matter eligibility.

AuthorLeney, Sardiaa
PositionIV. Analysis B. Implications of Recent Decisions for Subject Matter Eligibility through V. Conclusion, with footnotes, p. 556-585
  1. Implications of Recent Decisions for Subject Matter Eligibility

    Having summarized why the USPTO, at least in the opinion of the commentators, failed to helpfully or satisfactorily interpret Mayo and Myriad, it is useful to turn back to the judicial arena to analyze what occurred in the interim, the specific impacts, and the general implications for subject matter eligibility. The narrowest consequence of the litigation culminating in Ambry is that Myriad was unable to prevent competitors from continuing to provide BRCA testing. (142) Looking more generally, it now appears settled that diagnostic tests, whether for genotype or phenotype, will not be protected by patents that can meaningfully exclude a competitor from providing functionally similar tests that detect and report the same underlying, naturally-occurring, genetic or physiological variation because Mayo, Myriad and Ambry have all but foreclosed patents on naturally-occurring genes and physiological states, healthy or diseased, that are found in nature. (143)

    A further general deduction is that, even outside the field of diagnostics, most genes or fragments of genes will no longer be accepted as patent eligible in the United States. A gene, a gene-variant (mutant, allele, polymorphism), or a piece of a gene (for example a hybridization probe or primer) that is "naturally occurring," is not patent eligible in its natural state, or if simply "isolated." (144) Method claims that seek to monopolize the information in the naturally-occurring generic sequences by framing a general instruction to examine or compare the genetic material to something else (a reference sequence) are also barred because they add nothing more than an abstract idea dressed up with concrete steps that are simply generic manipulations well understood by practitioners in the art field. (145)

    Some issues remain unresolved by the recent ruling. How is it that we are to reconcile the emergence of the so-called "Mayo Test" with the precedent cases that remain good law, in order to achieve a practical synthesis that makes it clear to the patent office, the patent bar, inventors, and investors how the [section]101 inquiry will be operated going forward?

    Many expert molecular biologists and commentators puzzled over the Supreme Court's decision to uphold patents based on cDNA which, to most scientists, seems facially at odds with the rest of the decision and some of the language in Myriad. (146) Whether or not the Supreme Court made a useful legal distinction here remains to be seen. This note argues that they probably did, although the weakness of their scientific argument and the plethora of casual errors in the scientific matter in the ruling have not helped either the legal or the scientific communities actually engage with what the court was really trying to say about cDNA, because it has proved so much more fun for the scientific and liberal elites to make fun of the Supreme Court Justices. (147)

    The short concurrence written by Justice Scalia attracted the most ridicule. (148) Given Scalia's position as the bete noire of the left, it is unsurprising that his opinion attracted some opprobrium by those who read into his words: "I am unable to affirm those details [of biology] on my own knowledge or even my own belief' a disavowal of basic scientific facts. (149) Perhaps when Scalia wrote that he didn't believe the details of the underlying biology, he was truly revealing himself as the sort of latter-day flat-Earther who denied the scientific consensus--a fitting counterpart to his provocative statements on race, homosexuality, and torture. (150) But, in the rush to jump on Scalia's belief (or lack of it), have we missed the reality that his brief concurrence said all that the court needed to say, but with brevity lacking in the other justices?

    Justice Thomas, with the rest of the court, takes us through a (perhaps slightly confused) explanation of how genes and DNA are put together. (151) The biology lesson however is merely a preamble to case, which in reality turns almost entirely on a straightforward application of Chakrabarty and its antecedents. (152) The majority opinion then continues for four pages articulating their decision. (153) It is instructive to compare this to what Justice Scalia accomplished in about a hundred words--including the two sentences he expended to explain that he didn't have enough knowledge or belief in biology to concur fully with Thomas's opinion. (154) Justice Scalia's opinion was this: "[i]t suffices for me to affirm having studied the opinions.. .and briefs presented, that the portion of DNA isolated from its natural state sought to be patented is identical to that portion of the DNA in its natural state; and that complementary DNA is a synthetic creation not normally present in nature." (155) This distinction, aligning cDNA with Chakrabarty's bacterium with supernumerary plasmids not found in nature, while recognizing that isolated genomic DNA was as unchanged as the naturally-occurring bacteria in Funk Bros., is the simple heart of the Myriad decision. (156) Whether or not one thinks that isolated DNA could have a function that it lacks in nature, or that cDNA is really no different from genomic DNA, (157) and Scalia's summary frames the Supreme Court's Myriad opinion, whether one agrees with it or not, with elegance and economy. (158)

    We can examine the proposition that Justice Scalia's concurrence is all that is needed to understand Myriad by comparing it to the Federal Circuit's rulings in Ambry and the consequent synthesis of Mayo., Alice and Myriad in that opinion. (159) The composition claims in Ambry concerned DNA primers--short lengths of DNA that match naturally-occurring genomic DNA--and serve to bind to single strands of DNA to initiate synthesis of the complementary strand. (160) Although isolated, primers are, as Justice Scalia would have it, "identical to that portion of the DNA in its natural state," and are thus patent ineligible under [section]101. (161)

    The remaining claims in Ambry, those that are framed as method claims rather than composition claims, are actually addressed rather differently. (162) Myriad, as illustrated by Justice Scalia, stands for the simple proposition that the broadest composition claims are eligible subject matter only if the composition is something not found in nature. (163) However, most claims are not as straightforward in claiming a judicial exception, containing limitations that frame (or claim) particular structural or functional features, or as in Ambry, a method or process for using the judicial exception. (164) The two method claims in Ambry instruct the user to compare the BRCA sequence of the subject to a reference sequence. (165) In both cases, the molecular embodiment of the patient and reference sequence is specified with generality to include genomic DNA, mRNA or cDNA. (166) Perhaps to avoid having to deal with the cDNA issue left open in Myriad, (167) the Federal Circuit opted to address this by tackling the abstract process recited at the heart of each claim--the simple instruction to compare A with B. (168) Declining to follow the urgings of the defendant to apply Mayo directly, the Court opted to focus on the analysis outlined in Alice Corp., although as they make abundantly clear, Alice Corp. itself is grounded in the Mayo ruling. (169)

    In Mayo, the Supreme Court dismissed limitations framed around the abstract comparison step because they "add[ed] nothing of significance to the natural law." (170) In Alice Corp., an information technology case, the Court rearticulated the reasoning they had applied to the diagnostic method in Mayo to recognize a generalized two-step inquiry--asking first if the claim is directed at a patent ineligible concept (natural phenomenon, or law, or abstract idea). (171) If it is, the inquiry then proceeds to a second step asking if, separately or as a whole, the elements of the claim amount to something significantly more by way of "inventive concept" to transform the claim in to a patent-eligible concept. (172) In applying this Alice articulation of the Mayo test to the facts of Ambry, the Federal Circuit found that the generally specified comparison was itself an abstract idea where the "comparisons [are] unlimited ... not restricted by purpose" (Mayo Step 1). (173) Further--using Mayo Step 2--the Ambry Court found that "the non-patent-ineligible elements of [the claims] do not add enough to make the claims as a whole eligible [as they] set forth well-understood, routine and conventional" instructions to apply the abstract idea. (174)

    Thus, Alice has set out, and Ambry has illustrated, a tool based in Mayo that manages the [section]101 inquiry, independent of any art field or specific technology, in a simple two-step process that leaves the lower courts with an adaptable tool to manage the fact-specific inquiry. (175) How the District Courts will manage this remains to be seen, and there clearly exists a large body of granted patents that may prove to be invalid if subject to the "Mayo Test." (176)

    The new subject matter eligibility law overall can be best applied by first using Scalia's Myriad criterion. (177) If it claims a "creation not normally found in nature," a patent is drawn to eligible subject matter. (178) If a patent is directed to, or claims something, found in nature (Mayo Step 1), it can only be transformed into eligible subject matter if the elements of the claim transform the invention into some thing more that the natural phenomenon itself (Mayo Step 2). (179) The economic value of patents comes with the measure of certainty that they provide, (180) and this certainty will hinge on the ability of the patent bar and the USPTO to conform patents granted to the precedent opinion, as the Supreme Court has made clear that it owes no deference to the USPTO's interpretation of the law, unless it is specifically confirmed by...

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