Illumina Sues Qiagen for Infringement of Gene Sequencing Patent

Life Sciences Law & Industry Report connects the dots among the many disciplines that make up the burgeoning life sciences industry, with biweekly updates on current regulatory, legislative,...

By John Aquino

May 26 — Qiagen's GeneReader DNA sequencer infringes Illumina's patent, Illumina alleged in a May 24 federal district court complaint ( Illumina, Inc. v. QIAGEN, N.V., N.D. Cal., No. 3:16-cv-02788, filed 5/24/16 ).

The complaint filed in the U.S. District Court for the Northern District of California is the latest volley in the battle between these two competitors in the global gene sequencing market, which Illumina's then-chief executive officer said in January is at least a $20 billion market opportunity (10 LSLR 02, 1/22/16).

Judgment in Its Pocket

Intelligent Bio-Systems, a Qiagen subsidiary, challenged the validity of the same patent at issue in the present litigation before the Patent and Trademark Office's Patent Trial and Appeal Board, but the board ruled Feb. 11 that Qiagen hadn't established invalidity. On May 9, on Intelligent Bio-Systems' appeal, the U.S. Court of Appeals for the Federal Circuit upheld the PTAB's judgment (10 LSLR 10, 5/13/16).

With the Federal Circuit's judgment in its pocket, Illumina alleged in the Northern District of California that Qiagen, Intelligent Bio-Systems and other Qiagen subsidiaries infringed Illumina's U.S. Patent No. 7,566,537 (“Labelled Nucleotides,” issued July 28, 2009).

Illumina is based in San Diego. Qiagen is based in Hilden, Germany, and has U.S. offices in Germantown, Md.

Direct, Induced Infringement

The '537 patent covers methods of labeling a nucleic acid molecule with a non-natural, labeled nucleotide.

It demonstrates sequencing by synthesis (SBS), a process used to identify the sequence of nucleotides in DNA by synthesizing a single strand using nucleotides that complement the nucleotides in a sample single strand of DNA.

In the complaint, Illumina referenced the brochure for the GeneReader and its product description on Qiagen's Web page. Both describe the GeneReader's reliance on an SBS technology that “involves a 3 step process: extend, measure, and cleave.”

Illumina alleged that Qiagen's GeneReader infringes the '537 patent directly and that Qiagen and its subsidiaries have induced infringement and contributed to the infringement by others.

Illumina asked the court for an order stopping Qiagen and its subsidiaries from infringing the patent, damages, a declaration that the infringement was willful and a consequent trebling of the damages, a declaration that the case is exceptional and a subsequent award of its attorneys' fees and costs.

The complaint was filed by Weil, Gotshal & Manges LLP, Redwood Shores, Calif.

A Qiagen spokeswoman didn't immediately respond to Bloomberg BNA's request for comment.

To contact the reporter on this story: John T. Aquino in Washington at jaquino@bna.com

To contact the editor responsible for this story: Randy Kubetin at rkubetin@bna.com