CAFC Finds Eagle Doesn’t Drift Into Par’s Infringement Trap

In Par Pharmaceutical Inc v Eagle Pharmaceuticals Inc 21-2342 the Court of Appeals for the Federal Circuit (CAFC) affirmed a District Court’s finding that fluctuations in pH levels in a generic composition would not inevitably result in infringement.

Par obtained two patents 9,744,209 and 9,750,785 relating to its vasopressin injection product used to treat patients with critically low blood pressure. The ‘785 patent concerns vasopressin compositions, while the ’209 patent concerns methods of increasing blood pressure with those compositions. The claims of both patents require the vasopressin composition to have a rounded pH between 3.7–3.9, i.e., a pH between 3.65–3.94 before rounding. Following FDA approval in April 2017 of that product it was added to the Orange Book and marketed under the brand Vasostrict®.

In 2018 Eagle filed an abbreviated new drug application (ANDA) with the aim of manufacturing and selling a generic version of Vasostrict®. It sought to avoid infringing Par’s patents by specifying a different pH range. In particular, Eagle’s ANDA specified that the pH range of its product both when released for distribution and during its shelf life would be between 3.4-3.6 (after rounding) or 3.35-3.64 (before rounding).

Par claimed infringement would inevitably be more likely than not based on the combination of evidence showing that the pH of Eagle’s product drifts up over time and Eagle seeking to manufacture with a pH around the 3.64 level. The District Court rejected Par’s infringement allegation, finding that the evidence only established minor fluctuations in pH, not a discernible upward drift. The District Court also rejected Par’s request for a declaratory judgment to the effect that Eagle will infringe in the future, again finding Eagle’s post-release pH data did not establish basis for that.

On appeal the CAFC also declined to find infringement. It noted that under § 271(e)(2) it is an act of infringement to submit an ANDA seeking FDA approval to make and sell a patented drug. Where the terms of the ANDA clearly show that the generic drug will fall outside the scope of the patent’s claims there will be no infringement. It is only if the ANDA does not speak clearly and directly to the question of infringement that courts may look to other relevant evidence, such as data or samples the ANDA filer has submitted to the FDA. Given that the release and stability undertakings in Eagle’s ANDA directly and unambiguously address the pH range the CAFC found no basis for infringement. In the absence of evidence that Eagle would not comply with its undertakings the CAFC considered Par’s allegations to be unsupported conjecture.

Par also challenged the District Court’s denial of declaratory judgment, arguing that the District Court was wrong to find no discernible upward drift or to reject the relevance of the fluctuations and to find that Eagle was not engaged in, or making meaningful preparation for, infringing activity. However, the CAFC found no clear error in the District Court’s findings in any of those respects.

Author: Quinn Miller

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