Validity of Sequenom Patent Still to Be Decided

27 January 2015 PharmaPatents Blog

Although Sequenom has settled its dispute over U.S. Patent 6,258,540 with some parties (as I noted here), its case against Ariosa Diagnostics, Inc. remains active. Thus, we all should be waiting with bated breath to see whether the Federal Circuit determines that the claims of the Sequenom patent satisfy 35 USC § 101.

Dismissal Of Appeal No. 2014-1142

In late December, Verinata Health, Inc. and Sequenom (and the other the appellants) filed a joint motion for remand of Appeal No. 2014-1142, so that the district court can give effect to those parties’ settlement.  That motion was granted in an order dated December 31, 2014.

Pendency Of Appeal Nos. 2014-1139, -1144

The joint motion made clear that the settlement did not impact Appeal Nos. 2014-1139 and 2014-1144. Indeed, on December 22, 2014, Ariosa filed a letter to the Federal Circuit citing the court’s recent decision in Myriad II (which I summarized here and analyzed here) as “additional authority relevant to the issues presented.” In particular, Ariosa argued that “[t]he Ambry Court’s analysis—applying the framework set forth in [Myriad I] —compels the same conclusion [of ineligibility] here.”

In its response filed in early January, Sequenom argued that the claims at issue are directed to an “inventive concept” that supports eligibility:

The claimed method amplifies previously-discarded fractionated samples, isolates the paternally-inherited characteristics as surrogates for fetal DNA, and thereby detects potential fetal defects. Nothing like this had been done before with this “waste” material. This inventive concept satisfies Section 101.

Drilling down into specifics, Sequenom argued that its methods combine known techniques in an “unconventional manner,” that its methods do not “monopolize” the use cffDNA to detect fetal aneupoidies, and that its claims are “qualitatively identical” to claim 21 of Myriad I, which was not invalidated.

Will The Federal Circuit Uphold These Claims?

The remaining appeals are pending before Judges Reyna, Linn, and Wallach. who heard oral arguments on November 7, 2014.  As I summarized here, the judges seemed to be struggling with how to apply recent Supreme Court precedent to such an important medical invention. Needless to say, it will be very interesting to see what they decide. 

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