Court Injunction Bars Qiagen From Marketing Its NGS System in U.S.

A federal district court has granted Illumina’s request for a preliminary injunction to stop Qiagen from marketing its GeneReader NGS System in the U.S.

Illumina claims its ’537 patent, which covers labeled nucleotides used in DNA sequencing technology, was infringed by Qiagen and its subsidiaries when it developed the GeneReader NGS System, which it planned to distribute later this year.

Illumina accused Qiagen of infringing four different claims with its GeneReader product. The ’537 patent claims a method for labeling nucleotides using an “azido group” as the protecting group, rather than a phosphate group.

The U.S. District Court for the Northern District of California found that Illumina’s “likelihood of success on the merits is a probability of fifty-one percent or more.”

Qiagen began marketing its GeneReader NGS system in April 2016, and it referred to Illumina’s product in its marketing materials, stating that the GeneReader worked in the “same way as Illumina’s machines, flooding the sample DNA with fluorescently labeled nucleotides and imaging the results.”

“Although Illumina established a strong brand in the market for DNA sequencing products, Qiagen’s GeneReader began to compete with several of Illumina’s sequencing products, specifically in targeting clinical laboratories, where affordable desktop sequencing devices had just taken off,” court documents said.

Illumina argued that Qiagen’s GeneReader could interfere with Illumina’s brand reputation and usurp its business opportunities.

The market for DNA sequencing is expected to grow substantially in the near future, and Qiagen has a foothold in the market due to its other product lines. Now, as the doors to the market have swung open, Qiagen seeks to usurp Illumina’s position in the market with pirated technology, Illumina charged.

Qiagen said Illumina’s four-year delay in seeking the injunction undermines its argument that it would suffer irreparable harm without the injunction.

The judge disagreed, holding that Qiagen’s launch of the GeneReader was plagued by a series of false starts, delays, and reformulations, and the validity of the ’537 patent hung in limbo until the Federal Circuit upheld a Patent Trial and Appeal Board decision on Intelligent Bio-Systems’ IPR challenge just weeks before Illumina pressed for the injunction

“Illumina’s motion is well-timed, seeking to halt Qiagen’s assault on the market at its inception, before it can irreparably change the face of the market.”

Qiagen argued that the motion should be denied because Illumina has not yet suffered irreparable harm. The court said that the purpose of an injunction is to prevent harm from occurring in the first place, not to remedy irreparable harm that has already occurred.

The court also said that “Illumina has demonstrated a real risk that Qiagen could capture and redefine the market with its pirated technology.”

“Although Qiagen’s invalidity arguments are not frivolous, this order finds that Illumina is likely to defeat them, particularly in light of Qiagen’s burden to prove invalidity with clear and convincing evidence. Thus, this order finds Illumina is likely to succeed on the merits and now turns to the equitable considerations for a preliminary injunction.” — Tamra Sami