Comprehensive economic analysis finds no need to halt sales of device at center of patent dispute
Edwards Lifesciences thwarted a competitor’s bid for a significant temporary restraining order and preliminary injunction against its innovative PASCAL heart device after Intensity and attorneys at Paul, Weiss, Rifkind, Wharton & Garrison LLP presented a comprehensive analysis refuting arguments for halting sales of the product.
Abbott sought a TRO and preliminary injunction in federal court in Delaware amid a global patent dispute over devices used to treat mitral regurgitation, where the leaflets of the mitral valve do not close tightly and allow blood to backfill into the heart. Abbott claimed PASCAL violated several of its patents and was harming sales of its competing MitraClip. Abbott sought injunctive relief and economic damages.
To evaluate the threatened TRO and preliminary injunction, Intensity economist Dr. Ryan Sullivan prepared multiple expert reports for courts in the United States and Ireland, and provided live court testimony to examine the economic analysis underlying Abbott’s claim it would suffer irreparable harm and that the public interest and the balance of equities between weigh in favor of Abbott.
To assess the claim of irreparable harm, Dr. Sullivan determined not only the types of damage Abbott might suffer but whether it could be quantified and compensable. He also evaluated whether an injunction would address Abbott’s claimed harms and the extent of the economic relationship between the alleged patent infringement and the claimed harms. “The multifaceted economics issues combined with the importance of the case to both parties and patients made this an engaging project to apply our rigorous approach, “ Dr. Sullivan said. “I am very gratified that our work was a substantial basis for the court’s ruling.”
The public interest was an important consideration, since the dispute involved devices used to treat a common and dangerous heart condition. Intensity conducted market research to determine if PASCAL benefitted patients and whether removing it from the market would cause unnecessary harm. Intensity also weighed the relative hardships Abbott and Edwards would face if the court granted the injunction.
Intensity’s economic analysis included an in-depth examination of products in the structural heart device marketplace, market definition, competition, pricing dynamics and existing licensing agreements. Intensity also mapped out product substitution patterns at the customer level to accurately quantify Abbott’s claim of lost profits.
After considering Intensity’s analysis and the legal arguments of Edwards’ attorneys, U.S. District Judge Maryellen Noreika denied Abbott’s motions for a TRO and a nationwide preliminary injunction. On July 13, Abbott and Edwards announced they had reached a settlement of all disputes involving the mitral regurgitation device patents. That agreement ended parallel litigation in Ireland, where Intensity and Dr. Sullivan were prepared to present their analysis again.