In IBO’s first look this year at instrument and laboratory product firms’ patent infringement litigation, familiar names abound.

New Litigation

Last month, Illumina was named the defendant in a patent infringement suit brought in Delaware District Court. The initial complaint named only Columbia University as the plaintiff. An amended complaint filed in April listed Intelligent Bio-Systems (IBS) as co-plaintiff (see table). The complaint alleges infringement of five patents that involve sequencing-by-synthesis technology by Illumina’s instruments, consumables and services. According to the complaint, Illumina “became aware” of the patent in 2009 when it was considering acquiring IBS, and that Illumina “monitored” the patents and “provided prior art to IBS.”

Among the complaint’s charges are direct infringement, active inducement, and willful and deliberate infringement. The plaintiffs are seeking enjoinment of the manufacture and sale of Illumina products in the US, as well as damages. Illumina has not yet filed an answer to the complaint.

Illumina was also one of three companies sued by Enzo Life Sciences on April 6 in the US District Court in Delaware—each in a separate case—for infringement of US Patent No. 7,064,197, entitled “System, Array and Non-Porous Solid Support Comprising Fixed or Immobilized Nucleic Acids.” Enzo alleges infringement by Illumina’s products, including BeadArray technology, Omni microarrays and Infinimum BeadChips, as well as sequencer flow cells and Cluster Kits.

Enzo Life Sciences also filed suit against Agilent Technologies, citing several of the company’s microarrays and kits, including its ChIP (chromatin immunoprecipitation) and CGH (comparative genome hybridization) arrays, as infringing products. Affymetrix was the third company sued by Enzo, which contends that Affymetrix’s GeneChip technology, Axiom Genotyping Solution technology and GeneAtlas Array Strip products, among other products, infringe the patent.

Later in the month, Enzo also filed suit against Siemens Healthcare Diagnostics, charging infringement of the same patent by the company’s VERSANT branched DNA diagnostic assays. In each case, Enzo is seeking damages, preliminary injunctions, and permanent injunctions or licensing fees. Answers have not yet been filed by the defendants.

It has been a busy year for Enzo Life Sciences. In January, in the US District Court in Delaware, the company filed separate suits against three companies, alleging infringement of US Patent No. 6,992,180 (Oligo- or Polynucleotides Comprising Phosphate-Moiety Labeled Nucleotides). Among the defendants is Life Technologies for infringement by its TaqMan probe products. Alleging infringement of the patent by diagnostic products, Enzo has also brought separate actions against Gen-Probe, Roche Molecular, Abbott Laboratories, Hologic and Becton Dickinson.

Two sets of parties with cases pending are now involved in new suits. A new round of litigation involving Promega and Life Technologies was initiated in January in the US District Court in the Western District of Wisconsin. According to a partly redacted complaint naming Life Technologies and Applied Biosystems as defendants, Promega is seeking declaratory judgment of invalidity for a patent that was issued in January (see table), which is a reissue of US Patent No. 6,200,748.

Both the reissued patent and the original patent were assigned to the California Institute of Technology and licensed to Applied Biosystems. Promega is also seeking a declaratory judgment of unenforceability for prosecution laches (an unreasonable delay), stating that it invested in the products now claimed by the patent. US Patent No. 6,200,748 was issued in 2001, and an application to reissue and broaden it was submitted in 2003.

Life Technologies earlier this month filed two motions to dismiss the complaint, including a motion to dismiss Life Technologies as a defendant because were no claims made against the company and it is a separate corporate entity from Applied Biosystems. On April 19, Promega dismissed Life Technologies as a defendant but maintained the action against Applied Biosystems. Promega filed an amended complaint under seal the following week.

This latest suit follows Promega’s February announcement of a $52 million judgment in its favor as part of its 2010 infringement suit against Life Technologies involving STR (short tandem repeats) loci products (see IBO 2/29/12). In late February, District Court Judge Barbara B. Crabb approved the jury’s award. Life Technologies subsequently filed motions to overturn the judgment. Meanwhile, Promega filed motions seeking legal fees and a permanent injunction.

In a setback for Promega in the same suit, earlier this month, the US Court of Appeals for the Federal Circuit affirmed a District Court ruling allowing Life Technologies to compel arbitration related to Promega’s royalties obligations under a 1996 licensing agreement between Research Genetics (now Life Technologies) and Promega (see IBO 9/30/10). In addition to damages and injunctive relief for patent infringement, Promega’s 2010 action against Life Technologies also seeks declaratory judgments regarding the sublicense royalty obligation and the non-arbitrability of the licensing agreement, among other causes of actions related to the agreement. According to the Appeals Court, Life Technologies’ demand for arbitration with Promega regarding its noncompliance with the agreement prompted Promega’s suit.

Biotage and Merck & Co. find themselves the targets of a second suit brought by Scientific Plastic Products (see IBO 4/30/09). Last year, Biotage announced that the US Patent and Trademark Office (USPTO), upon re-examination, had rejected all of the claims of the three patents under dispute in the Scientific Plastic Products’ 2009 suit against Biotage and Merck & Co. (see IBO 4/30/09). Scientific Plastic Products is appealing the decisions. The case has been stayed pending the appeals.

Scientific Plastic Products (SPP) has now filed a second suit, alleging infringement of two recently issued patents. Filed in the US District Court in the Southern District of California in November 2011 and amended in January, the suit alleges infringement of patents issued in November 2011 and December 2011 (see table). According to Biotage, the patents are a continuation of US Patent No. 7,381,327, which is one of the patents under dispute in the previous suit. As in that suit, SPP alleges infringement by Biotage’s SNAP flash chromatography cartridges. In March, Biotage filed an answer, denying the allegations and filed counterclaims for declaratory judgments of invalidity and non-infringement.

Settled

In a case involving next-generation sequencing technology, in an April filing with the US District Court for the Northern District of California, Life Technologies and Pacific BioSciences have agreed to dismiss Life Technologies’ 2011 case (see IBO 4/30/11) against Pacific BioSciences with prejudice, subject to the terms of a settlement agreement. A discovery hearing had taken place in January.

A settlement also has been reached regarding one of the four patents under dispute in Cellectricon and Gyros’s 2009 infringement suit against Fluxion Biosciences involving microfluidic technologies. The action regarding US Patent No. 5,376,252 (Microfluidic Structure and Process for its Manufacture) had been severed and filed by Cellectricon as a separate suit in June 2011. The parties stipulated in January to dismiss the suit with prejudice. The original case has been stayed pending the outcome of USPTO re-examinations.

Selected New US Patent Infringement Cases Among Instrument and Lab Product Companies

Plaintiff: Scientific Plastics Products

Defendant: Biotage,Merck & Co.

US Patent No.: 8,066,875 B2, 8,070,957

Patent Title Case: Flash Chromatography Cartridge

Filed: 11/29/2011

Plaintiff: Promega

Defendant: Life Technologies and Applied Biosystems

US Patent No.: RE43,096

Patent Title Case: Tagged Extendable Primers and Extension Products

Filed: 2/27/2012

Plaintiff: The Trustees of Columbia University in the City of New York and Intelligent Bio-Systems

Defendant: Illumina

US Patent No.: 7,635,578, 7,713,698, 7,790,869, 8,088,575

Patent Title Case: Massive Parallel Method for Decoding DNA and RNA

US Patent No.: 7,883,869

Patent Title Case: Four-Color DNA Sequencing by Synthesis Using Cleavable Fluorescent Nucleotide Reversible Terminators

Filed: 4/11/2012