Anti-Patent Bias in Applying Injunction Test Results in Another District Court’s Reversal – Aria Diagnostics v. Sequenom (Fed. Cir. Aug. 9, 2013)

Adam Mossoff —  19 August 2013

[Cross Posted to the Center for the Protection of Intellectual Property]

In its recent decision in Douglas Dynamics v. Buyers Products Co. (Fed. Cir., May 21, 2013), the Federal Circuit was forced to reverse a district court’s abuse of its discretion because the trial judge injected an anti-patent bias into the legal test for determining whether a patent-owner should receive a permanent injunction against an infringer. As highlighted in a blog posting, the Federal Circuit explained that district courts should not read the eBay four-factor test such that it eviscerates “the public’s general interest in the judicial protection of property rights in inventive technology” (to quote from the Douglas Dynamics opinion).

A scant two months later, the Federal Circuit again reversed another district court’s denial of an injunction and again had to explain why the equitable test for issuing injunctions should not be applied in a way that undermines the property rights secured in patented innovation.  In Aria Diagnostics, Inc. v. Sequenom, Inc. (Fed. Cir., Aug. 9, 2013), the Federal Circuit reversed a district court’s denial of the patent-owner’s request for a preliminary injunction, holding that the district court improperly balanced the multi-factor test governing issuance of preliminary injunctions. 

In Chief Judge Randall Rader’s opinion for a unanimous panel in Aria Diagnostics, the Federal Circuit criticized the district court’s denial of Sequenom’s request for a preliminary injunction against Aria Diagnostics.  In this case, Sequenom countersued Aria Diagnostics following Aria Diagnostics declaratory judgment lawsuit against it, alleging that Aria Diagnostics infringes its patented diagnostic test for identifying trisomy disorders (U.S. Patent No. 6,258,540).  Trisomy disorders are genetic disorders that can result in a range of complications during and after pregnancy—from death of a fetus to down syndrome in a newborn.  The evidence submitted to the district court established that Sequenom’s patented tests eliminated the need for risky amniocenteses and “presented fewer risks and a more dependable rate of abnormality detection.”

Following its countersuit for patent infringement, Sequenom requested a preliminary injunction and the district court denied its request.  In the proceedings below, as the Federal Circuit explained, the district court rejected Sequenom’s request for a preliminary injunction because it simple assumed that Sequenom would not suffer irreparable injury given that it would easily profit from its radically innovative test.  On the basis of this assumption, the district court concluded that “the erosion to Sequenom’s price and its loss of market share were not irreparable.”

The Federal Circuit pointedly identified the implicit anti-patent bias in the district court’s rarefied reasoning from such misguided and unproven assumptions:

While the facts may show that damages would be reparable, this assumption is not sufficient. In the face of that kind of universal assumption, patents would lose their character as an exclusive right as articulated by the Constitution and become at best a judicially imposed and monitored compulsory license. (original emphases)

In short, district courts should not read the multi-factor tests for injunctions so as to eviscerate the constitutional fact that a patent is a property right, and thus de facto convert a patent into merely a regulatory entitlement to a compulsory license. Property rights secure more than just a “reasonable” rate of profit as determined by either a court or a regulatory agency. As pointed out in Aria Diagnostics, the case law on injunctions have well established that “price erosion, loss of goodwill, damage to reputation, and loss of business opportunities are all valid grounds for finding irreparable harm,” which can and should justify an injunction (after these harms are appropriately balanced against the harms to the alleged infringer) to secure a property right in innovative technology.

The Federal Circuit further criticized the district court because, while finding that a preliminary injunction might put Aria Diagnostics out of business as a justification to deny Sequenom’s request for the injunction, the “district court made no findings on the harm that would accrue to Sequenom’s R&D and investment in the technology, undermining work and money spent developing, validating, and commercializing any covered product.”  The Federal Circuit emphasized that the balance of hardships in the legal test for issuing an injunction requires courts to not only assess harm to alleged infringers, but also to assess the harms to the patent-owner, such as “price erosion, loss of goodwill, damage to reputation, and loss of business opportunities.” 

In short, the district court failed to weigh the relevant harms to both the patent-owner and the alleged infringer, and instead the district court relied solely on the harm to the alleged infringer (Aria Diagnostics) as balanced against its pure conjecture of massive profits for Sequenom in some undetermined future. Thus, the district court denied Sequenom’s request for a preliminary injunction. But this was an entirely inappropriate application of the equitable inquiry required in issuing or denying a preliminary injunction.  In effect, the district court placed a large thumb on the judicial scale in favor of the alleged infringer in its equitable analysis—a violation of the fundamental principles of equity. For this reason, the Federal Circuit reversed and remanded the case back to the district court for it to make the appropriate fact findings under the appropriate application of the multi-factor test for issuing a preliminary injunction.

The significance of Aria Diagnostics is that the Federal Circuit continues to push back against the ongoing misinterpretation of the equitable tests for issuance of injunctions in patent infringement cases, whether by academics, federal officials or district courts.  In doing so, the court is providing some much-needed guidance to district courts in what facts they should consider in assessing the relevant harms to each party in issuing or denying an injunction.