Subject Matter Patentability of Isolated DNA — Fed. Cir. Cleaves S. Ct. Prometheus Analysis Out of Its Subject Matter Patentability Determination; Relying on S. Ct. Chakrabarty Precedent in Upholding Validity of Isolated DNA Patent
Myriad 2 provides insight into how “cleaving of the covalent bond” in DNA supports subject matter patentability under Chakrabarty. The patent community now needs to know from the courts: how will this support subject matter patentability under a Prometheus-like analysis.
On August 16, 2012, the Federal Circuit decided Ass’n for Molecular Pathology v. Myriad Genetics, et al. (“Myriad 2”), upholding isolated DNA to be subject matter patentable. The case was before the Federal Circuit on remand from the Supreme Court for reconsideration in light of Mayo Collaborative Services v. Prometheus Laboratories, Inc., 566 U.S. ___ (2012). The District Court had invalidated the isolated DNA claims and in Myriad 1 decided July 29, 2011, the Federal Circuit upheld the isolated DNA claims on the basis that isolated DNA was “cleaved” (i.e., had covalent bonds in its backbone chemically severed) and so was not a naturally occurring composition and so is patentable under the Supreme Court’s Chakrabarty precedent. On remand in Myriad 2, the Federal Circuit, once again decided the subject matter patentability of the isolated DNA claims under Chakrabarty, effectively “cleaving” out the analytical backbone of the S.Ct.’s Prometheus case from its decision upholding the subject matter patentability of isolated DNA. This despite the S. Ct. decision in Prometheus being the reason for the S. Ct. remand.
“Mayo does not control the question of patent-eligibility of such [isolated DNA composition] claims,” Judge Lourie boldly proclaimed in the majority decision. Op. 38. “They are claims to compositions of matter, expressly authorized as suitable patent-eligible subject matter in § 101.” The majority went on to uphold the subject matter patentability of isolated DNA using an analytic framework that omitted Prometheus from the analysis.
“[T]he Prometheus discussion of laws of nature (process claims) clearly ought to apply equally to manifestations of nature (composition claims),” Judge Moore stated in her concurring opinion in refuting “Myriad’s argument that Prometheus is constrained to methods.” Concurring, at 7. Nonetheless, the concurring decision went on to uphold the subject matter patentability of isolated DNA without ever applying a Prometheus-like analysis of the “laws of nature/manifestations of nature” in that decision.
Only in Judge Bryson’s dissent does there appear to be any discussion of the subject matter patentability of isolated DNA claims under a Prometheus-like analysis. Relying on Prometheus, Judge Bryson found the isolated DNA claims to be not subject matter patentable since they are nothing more than “well-understood, routine, conventional” elements. Dissent, at 15. (“Just as a patent involving a law of nature must have an “inventive concept” that does “significantly more than simply describe…natural relations,” Mayo, 132 S. Ct. at 1294, 1297, a patent involving a product of nature should have an inventive concept that involves more than merely incidental changes to the naturally occurring product.”) Ibid.
In Prometheus, the S. Ct. held that the natural relationships between concentrations of certain metabolites in the blood and the likelihood that a thiopurine drug dosage will prove ineffective or cause harm are not themselves patentable. It is in the omission of any Prometheus-like analysis of the relationships that isolated DNA has with nature that may be one failing of the Fed. Court’s decision in Myriad 2. The majority appears to have dismissed these considerations by relying soley on Chakrabarty in deciding the subject matter patentability question. The concurring opinion seems to have recognized these considerations but never applied them. And the dissent seems to have applied these considerations without ever really explaining how compositions that do not occur in nature can exhibit naturally occurring relationships. Conversely, how the relationships of isolated DNA define naturally occurring relationships because isolated DNA effectively exists in nature but in a form in which it is covalently bonded in its backbone (i.e., in the natural DNA state as we know it to exist).
From the foregoing, it seems that what ought to have been decided by the Fed. Cir. on remand in Myriad 2 are two things. First, whether the relationships isolated DNA has with its surroundings (e.g., the relationship of the recited “polypeptide having the amino acid sequence set forth in SEQ ID NO:2” with nature and the relationship of the “isolated DNA coding for the recited BRCA1 polpytide” with nature) are naturally occurring relationships. Second, if these relationships include a law of nature/manifestation of nature, does the claim preempt that law of nature or a manifestation of nature (e.g., sequence) under a Prometheus-like analysis?
The answer to these questions may ultimately turn on the role played by the “cleaving of the covalent bond” in the natural DNA to form the isolated DNA, as the Fed. Cir. has surmised. More specifically, does the cleaving make isolated DNA an elemental form of natural DNA, that is to say that isolated DNA exists in nature but covalently bonded in its backbone in the form of natural DNA as we know it to exist (i.e., cleaving the backbone does no more than reduce the natural DNA into its isolated DNA element as the dissent suggests)? Or, does the cleaving really make a new compound from natural DNA called isolated DNA that does not exist in nature (even though the relationships that the isolated DNA has to its surroundings may mimic the naturally occurring relationships of normal DNA) as the majority suggests but in a decision that omits any Prometheus-like analysis?
The Myriad 2 decision has provided insight into how “cleaving of the covalent bond” in the backbone of the natural DNA to form the isolated DNA supports subject matter patentability under Chakrabarty. The patent community now needs to understand how “cleaving of the covalent bond” supports subject matter patentability under a Prometheus-like analysis. For example, is “cleaving of the covalent bond” to isolate DNA an insignificant extra-solution activity? Or is “cleaving of the covalent bond” something that makes the isolated DNA less naturally occurring (e.g., less a “law of nature/manifestation of nature”) so as to avoid preemption? It seems now that these questions have been left for the S. Ct. to decide.
The Juhasz Law Firm can help you to better understand the effect of Myriad 2 on your diagnostic method patents. For more information regarding these cases and advice on how these decisions may affect your patents, please contact The Juhasz Law Firm. Your patents may be your most important asset. To help you protect your patents, contact Juhasz Law, the firm committed to Guiding Your Patent Beyond The Horizon℠.
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[1] Representative isolated DNA claim before the Fed. Cir.: 1. An isolated DNA coding for a BRCA1 polypeptide, said polypeptide having the amino acid sequence set forth in SEQ ID NO:2.