Federal Circuit Opinion On Myriad Remand

Today, the Federal Circuit issued its opinion following GVR from the Supreme Court in AMP v. USPTO and Myriad Genetics, Inc., App. No. 2010-1406 (August 16,2012). (A copy of the opinion is available at the end of this post.) Unfortunately, the opinion, authored by Judge Lourie and joined in part by Judges Bryson and Moore, contained nothing to give hope that diagnostic methods resting on natural correlations would be patentable in the future.

The panel began with 36 pages on the standing issue, holding that only Dr. Ostner, who had received a “licensing letter” from Myriad, had standing to pursue this action.

Pages 35-55 of the 62 page majority opinion focused on the claims to isolated DNA molecules, clarifying that “[i]solated DNA is not just purified DNA…but is different in name, character and use.” Judge Lourie wrote that isolating a sub-unit molecule by breaking covalent bonds is not a trivial alteration, since the covalent bond is the “defining boundary” between one molecule and another. Slip op. at 46-48.

Claim 20, directed to the use of transgenic BRCA gene-containing cells to screen for anti-cancer drugs, was likewise held to be patent-eligible, since the “underlying subject matter is man-made.”

The court required only about 4 pages to reaffirm that the method claims were patent-ineligible, repeatedly referring to them as simply “analyzing and comparing certain DNA sequences.” In other words, the claims directed to no more than determining whether or not there were mutations in a subjects BRCA DNA or in a tumor vs. “normal” DNA were in no way contrasted to, or analyzed differently than, claim 2 of the ‘857 patent, which recites that a diagnostic conclusion is made, following the comparison:

2. A method for diagnosing a predisposition for breast cancer in a human subject which comprises comparing the germline sequence of the BRCA2 gene…in a tissue sample from aid subject with the germline sequence of the wild-type BRCA2 gene…wherein an alteration in the germline sequence of the BRCA2 gene…of the subject indicates a predisposition to cancer.

In fact, claim 2 was not mentioned in the “Methods” section of the opinion, except to say that it too was invalid. Rather, in the face of Prometheus,  Judge Lourie just seemed to give up.: “Without expressly analyzing the instant method claims in the context of the Court’s reasoning, but in light of the Court’s holding, and in view of our own prior reasoning [ed. note – equally abbreviated], …those method claims cannot stand….We renew our conclusion that Myriad’s claims to “comparing” or “analyzing” two gene sequences fall outside the scope of s. 101 because they claim only abstract mental processes.” Slip op. at 56.

The next sentence could have been something like: “However, claim 2 of the ‘857 patent is directed to substantially more than simply comparing or analyzing a subject’s DNA sequence with a reference sequence, since the comparison is employed by the comparer/operator to arrive at a diagnosis of a predisposition to develop a cancer – a potentially life-saving result of the claimed method.” That sentence never was written. The court could have tried to explain why this claim “[does] not apply the step of comparing two nucleotide sequences in a process.” In other words,  the court missed a chance to state clearly why a diagnostic conclusion is not an application of natural law that renders the use of the natural law patent-eligible, and not just fold its legal hand with “Accordingly, Myriad’s challenged method claims are indistinguishable from the claims the Supreme Court found invalid under s. 101 in Mayo.”

Instead, back on page 38, there is a sort-of apology to the tech/IP community:

“We would further note, in the context of discussing what this case is not about, that patents on life-saving material and processes, involving large amounts of risky investment, would seem to be precisely the types of subject matter that should be subject to the incentives of exclusive rights. But disapproving of patents on medical methods and novel biological molecules are policy questions best left to Congress, and other general questions relating to patentability and use of patents are issues not before us.”

Judge Louie, I respectfully submit that  the “disapproving of patents on medical methods and novel biological molecules” (like stem cells?) is now going to be left to the Patent Office. Heaven help us all.

Opinion

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One Response to Federal Circuit Opinion On Myriad Remand

  1. Pingback: Personalized Medicine Takes Off | Biotech Paten Law | Patents4Life

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