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Myriad vs. Mayo - Detection vs. Processing at the Fed. Cir.

iStock_000005967663_SmallRapid Litigation Mgmt v. CellzDirect: Splitting Detection of a Natural Phenomenon from its Application to Yield a Product.

Courtenay G. Brinkerhoff at summarized the oral arguments at the Fed. Cir. (App. No. 15-1570) conducted on April 5, 2016 in Rapid Litigation Mgmt Ltd. v. CellzDirect, Inc. (You can download an MP3 of the oral arguments here.) The district court invalidated claims directed to a method for isolating hepatocytes that can survive more than one freeze-thaw cycle as a patent-ineligible law of nature (US Pat. No. 7,604,929):

1.    A method of producing a desired preparation of multi-cryopreserved hepatocytes….comprising:

(A)  Subjecting hepatocytes that have been frozen and thawed to density gradient fractionation to separate viable hepatocytes from non-viable hepatocytes,

(B)  Recovering the separated viable hepatocytes, and

(C)  Cryopreserving the recovered viable hepatocytes to thereby form said desired preparation of hepatocytes without requiring a density gradient step after thawing the hepatocytes for the second time, wherein the hepatocytes are not plated between the first and the second cryopreservations, and wherein greater than 50% of the hepatocytes of said preparation are viable after the final thaw.

Briefly, the method separates the hardy hepatocytes from their weaker brethren, and permits the formation of pooled hepatocyte products.

The defendant’s attorney argued that this method was simply the discovery of a natural phenomenon coupled with routine freeze-thawing, density gradient fractionation and cryopreservation of hepatocytes, and that the hardy hepatocytes were isolated unchanged from their natural state. He took the position that this was a detection claim, like those invalidated in GCG and Ariosa.

Judges Dyk and Reyna may well agree, and Judge Prost was on this panel and well as the Ariosa panel (and was noticeably silent during oral argument). But the plaintiff for CellzDirect encountered lots of skepticism from both Judges Moore and Stoll (both EE’s), who began by referencing Myriad:

      “[T]here are no method claims before us….[Myriad] does not involve patents on new applications of knowledge about the BRCA1 and BRCA2 genes. Judge Bryson aptly noted that, ‘[as] the first party with knowledge of the [BRCA1-2] sequences, Myriad was in an excellent position to claim applications of that knowledge. Many of its  unchallenged claims are limited to such applications.’”

Judge Moore asked if this wasn’t simply a preparation method, as opposed to a method of detection of the existence of the natural phenomenon. Of course, Judge Dyk would argue that the discovery of the natural phenomenon cannot supply the “inventive concept” required in any sort of claim, be it detection or isolation and, in this case, the steps required to yield the final cryopreserved hardy hepatocytes were all conventional.

Judges Moore and Stoll struggled a bit with Mayo which, after all, also considered a method claim that involved conventional steps such as dosing, sampling and measuring metabolite levels. However, the end-product in Mayo was not a novel composition, but rather, precise information about the limits of the natural correlation (between metabolite levels and side-effects or efficacy of the drug).

Here, Judges Moore and Stoll simply called Mayo “detecting a trait,” and took the common sense approach—to a scientist or engineer—that the cryopreserved, hardy hepatocytes were a product not occurring in nature. (Remember, the hardy hepatocytes end up cryopreserved in some medium, not simply isolated from the non-viable hepatocytes or detected in the starting mixture.) Perhaps they were influenced by the two negative limitations in step (C).

Moore and Stoll seemed to want to derive the further inventive step required by Mayo, from the use of the conventional separation and preservation steps to obtain a novel composition—the cryopreserved hardy hepatocytes. This is in direct contradiction with Judge Dyk’s rationale in GTG that recognition of the significance of the correlation—cannot provide the inventive step required by the Mayo test. We do live in interesting times.



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