Home About RSS

Law and Biosciences Blog
Law and Biosciences Blog

Federal Circuit Decides AMP v. Myriad (Again)

The Federal Circuit yesterday issued its opinion in AMP v. Myriad.  The Supreme Court had remanded the Myriad case (GVR) in light of its decision in Prometheus v. Mayo.  The Prometheus case held that a personalized medicine dosing process was an insufficient application of a law of nature to be patent eligible.

After affirming that it does have jurisdiction, Federal Circuit essentially repeats the reasoning it offered in the first go-round:

1.  As before, the court rejected claims directed toward methods of comparing or analyzing gene sequences as too abstract.  Prometheus applies, and doesn’t change that outcome.  No surprises here.

2.  The court also upheld method claims to screening therapeutics as eligible.  In light of Prometheus, they are still transformative.

3.  The interesting issue is how Prometheus might apply to Myriad’s composition claims to isolated DNA.  The court side-steps this issue, stating that because the claims relate to “isolated DNA molecules,” the Prometheus case “does not control the question of patent-eligibility of such claims.”

Essentially, the majority repeats the analysis it offered previously, finding that the cleaving and isolation of the DNA is inventive because it results in the creation of a different chemical entity.  The court declined to discuss how Prometheus might apply to composition of matter claims, instead cabining Prometheus’ reach.

In her well-reasoned concurrence, Judge Moore recognizes that the discussion in Prometheus about laws of nature ought to apply to compositions of matter as well.  However, she notes that Funk Brothers and Chakrabarty are “clearly more analogous” to the Myriad case.  Judge Moore synthesizes the precedent, concluding that although laws of nature are not patentable, 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.”

Applying these principles, Judge Moore concludes that isolated DNA is patent eligible, but she does not rely on the structural difference between the gene as it naturally occurs and the isolated gene. Instead, Judge Moore reasons that the structural changes in the isolated DNA, coupled with its different and beneficial utility, makes the isolated DNA patent eligible.  Judge Moore’s concurrence provides a thoughtful analysis of the effects of Prometheus in light of more applicable case law.

Given the majority’s narrow reading of Prometheus, the Myriad case seems a likely candidate for en banc rehearing or a certiorari grant by the Supreme Court.

2 Responses to “Federal Circuit Decides AMP v. Myriad (Again)”

  1. Jacob S Sherkow says:

    I agree with the assessment that Judge Moore’s opinion is, at a minimum, well-reasoned. What’s interesting about Judge Moore’s opinion is that it, like Judge Lourie’s and Judge Bryson’s opinions, does not significantly address the patent-eligibility vs. patentability distinctions. That is, whether Myriad’s patents’ claims fail, or would likely fail, under a section of the patent statute besides § 101. For an opinion that does wrestle with the § 101 issue and try to synthesize an incongruous slate of Supreme Court cases, it still appears to side-step, or at least not substantively involve itself, with the concern that Myriad’s claims may also fail for lack of novelty or obviousness, subject matter eligibility notwithstanding.

    It’s true that the question presented to the court was firmly fastened to § 101, but that has not previously prevented the Federal Circuit–or the Supreme Court–from making parallel observations about the “dispute behind the dispute”; whether those claims may also fail under §§ 102 or 103.

  2. Brenda Simon says:

    Interesting point. Given the subject matter issues raised on appeal, however, Judge Moore correctly focused her concurrence on those questions. As the majority pointed out, the appeal and resulting decision are focused on the issues raised by section 101, even if the claims suffer from problems under the other sections of the statute.

Leave a Reply