Comprehensive economic analysis performed by Secretariat expert Dr. Anup Malani and the Secretariat team demonstrates that a permanent injunction is warranted.

Natera, Inc., which specializes in cell-free DNA testing technology, sought a permanent injunction against competitor Invitae Corp. At a trial held in Delaware district court earlier this year, Invitae was found to infringe Natera’s patents. Revolutionary cell-free DNA detection methods have the potential to detect cancer prior to conventional diagnostic methods, and thereby have the potential to significantly improve patient outcomes. Secretariat* and attorneys at McDermott Will & Emery presented a comprehensive analysis in support of a permanent injunction on Invitae’s PCM product.

After considering Secretariat’s analysis and the legal arguments of Natera’s attorneys, U.S. District Court Judge Gregory B. Williams granted Natera a permanent injunction.

For a permanent injunction to be granted, the patent holder must demonstrate that (1) it faces irreparable injury, (2) there is no adequate remedy under the law to cure the irreparable injury, (3) the balance of hardships favors the patent holder, and (4) the public interest would not be harmed if an injunction is granted. Secretariat evaluated each of these factors.

For irreparable injury and lack of adequate remedies under the law (factors 1 and 2), Secretariat evaluated harms that Natera would face in the absence of an injunction and whether those harms were quantifiable and compensable via an award of damages. Secretariat’s analysis involved evaluation of the complex and unique dynamics of the marketplace in which PCM competes, first-mover advantages, the competitive relationship between the parties, and the nexus between the alleged infringement and the harms faced. Based on the analysis performed, Secretariat determined that Natera would face irreparable injury in the absence of an injunction and that remedies under the law were insufficient to compensate Natera for the irreparable injury. Judge Williams agreed, noting that “Natera would suffer irreparable injury if the legacy PCM is not enjoined. The PCM market is nascent, and there are significant first-mover advantages. … That Natera and Invitae are competitors and Natera has lost market share strongly suggests irreparable harm.” Judge Williams also determined that “the remedies available at law are unable to adequately compensate Natera.”

For the balance of harms (factor 3), Secretariat evaluated the harm Natera would face in the absence of an injunction relative to the harm Invitae would face if an injunction was granted. Secretariat determined that the balance of harms favored Natera. Judge Williams agreed, noting that “[w]hen the harms an infringer faces are ‘almost entirely preventable’ and triggered by a ‘calculated risk to launch its product pre-judgment,’ the balance of hardships strongly tilts in favor of the patentee.”

For the public interest (factor 4), Secretariat evaluated if an injunction would harm patients and if there were alternative treatment options available to patients should the injunction be granted. Secretariat determined that the public interest would not be harmed by an injunction on PCM, in large part, because Natera’s competing product, Signatera, could be substituted in place of PCM. Judge Williams agreed, noting that Natera’s competitive product, Signatera, appears to be equally accurate, covers all the same diseases, and has sufficient capacity to meet the market’s needs.”

Invitae was allowed to continue using PCM in ongoing clinical trials, for updating old studies, for quality control purposes, and for patients already using PCM.

The permanent injunction follows a $19 million infringement verdict against Invitae where Secretariat expert Dr. Ryan Sullivan provided expert testimony at deposition and at trial relating to damages. Dr. Malani and Dr. Sullivan were supported by Managing Director Aminta Raffalovich, Vice President Dr. Anushree Subramaniam, Vice President Dr. Matt Farber, Director Dr. Stephanie Khoury, Director Robert Flanagan, Economist Dr. Kyle Kost, Manager Maxwell Urman, and Senior Associate Nathaniel Tolles.

Law360 coverage and a link to the Order granting the permanent injunction (subscription may be required) is available here.

*Work was performed by team members at Intensity LLC. Intensity is part of Secretariat.