Aria Diagnostics, Inc. v. Sequenom, Inc.

Docket No. 2012-1531

August 9, 2013

Brief summary: DC found to have improperly limited claims (e.g., “specification states that the examples ‘do not in any way limit the scope of the invention'”) and failed to properly address the preliminary injunction equitable factors (irreparable harm, balance of equities, public interest).

Summary: Aria (now Ariosa) sought a declaration that its fetal diagnostic genetic test did not infringe Sequenom’s US 6,258,540 (exclusively licensed from Isis). Sequenom sought a preliminary injunction against Ariosa, which the DC denied. The FC panel concluded that the claims were not properly interpreted and that the preliminary injunction factors were improperly balanced. The ‘540 patent relates to identifying fetal genetic defects from “fluid that had commonly been discarded as medical waste-the maternal plasma or serum” (“non-nucleated free-floating fetal DNA” (“cffDNA”); typical tests used isolated fetal cells in maternal blood). The disputed claim term was “paternally inherited nucleic acid” which the DC held to mean “DNA sequence known [in advance] to be received only from the father which is not possessed by the mother” (“[in advance]” not used by DC but agreed to by the parties). This means that “infringement can only occur after a user knows the father’s gene sequence”, which the FC panel determined was incorrect because “[h]ad the applicant wanted to limit the claim to those nucleic acids known in advance to have come from the father, it could easily have done so” but did not. The panel wrote that “to incorporate that requirement into the claim, this limitation must find its source and support elswehere” and that “one sentence from the specification, the examples, and isolated events in the ‘540 patent’s prosecution history” was not enough (“certainly is not clear lexicography or disavowal”) (it is “not enough that the only embodiments, or all the embodiments, contain a particular limitation to limit a claim beyond its ordinary meaning” (Aventis, FC 2012)). It was pointed, for instance, that the “specification states that the examples ‘do not in any way limit the scope of the invention'”. The term “amplifying” was also interpreted by the DC as requiring “increasing the concentration of a paternally inherited nucleic acid relative to the other DNA in the sample” but the FC panel disagreed as the claim does not mention any “effect on the quantity of other nucleic acid”. For these reasons, the FC panel reversed the DC decision that Ariosa had raised a substantial question of noninfringement. Patent eligibility under Myriad (US 2013) was also raised but no opinion was offered; the panel did state, however, that it “would benefit from the district court’s initial and further consideration”. The FC panel also found that the DC did not properly “address the traditional equitable factors for a preliminary injunction” (irreparable harm, balance of equities, public interest). Thus, the DC decision was vacated and remanded.

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