In IBO’s second part of its annual examination of new and existing litigation among analytical instrument and lab product companies (see IBO 4/30/10), we report on new suits involving third-generation sequencing technologies, as well as one case that may be headed for the Supreme Court.

Settlements

With the trial set to begin in November in Eppendorf AG’s case against Nanosphere for infringement of patents related to microarray technology (see IBO 10/31/09), the parties entered into a settlement agreement in August. Nanosphere announced that it had acquired certain patents and patent rights from Eppendorf for $4 million with a limited license back to Eppendorf.

In August, the District Court of Delaware dismissed Life Technologies’ patent infringement complaint against Bio-Rad Laboratories related to protein production (see IBO 8/31/09, 10/31/09). In a filing with the court, the parties disclosed that a licensing agreement was signed in June.

Following mediation, Scientific Specialties and Thermo Fisher Scientific entered into a settlement agreement in July, ending Scientific Specialities’ 2008 suit against Thermo for infringement of patents related to microcentrifuge strip tubes (see IBO 12/15/08). Also dismissed this July was Thermo’s suit against Innov-X, alleging unfair competition among other claims related to handheld X-ray fluorescence systems (see IBO 12/31/09).

In a suit involving hardness testers, MTS Systems reached a settlement agreement in August in Hysitron’s 2007 suit against MTS Systems for infringement of US Patent No. 6,026,677 (Apparatus for Microindentation Hardness Testing and Surface Imaging Incorporating a Multi-plate Capacitor System). The District Court of Minnesota suit alleged infringement of the Patent by MTS Systems’ NANOVision scanning probe microscope apparatus and other products. MTS announced that it paid Hysitron $7.5 million and that neither party admitted wrongdoing.

New Patent Suits

On the heels of Caliper Life Sciences’ suit against Carestream Health earlier this year (see IBO 4/30/10), Carestream Health has now brought a complaint against Caliper (see table). Filed in the District Court for the Western District of Wisconsin, the suit alleges that Caliper’s IVIS Lumina XR imaging system, among other products, infringes a Carestream Health patent issued in June. Caliper denied the claims and filed counterclaims.

Life Technologies and its subsidiaries Applied Biosystems and Invitrogen IP Holdings were named defendants in a patent infringement suit brought in May by Promega in the District Court for the Western District of Wisconsin (see table). According to a redacted complaint filed with the court after the original complaint was sealed, Promega is seeking declaratory relief, damages and other relief related to patent infringement and a contract dispute. Promega asserts that the infringement relates to products in Invitrogen’s AmpFISTR product line for amplification and typing of STR Loci for genetic identify and forensic applications. A claims construction hearing is scheduled for early next year.

The complaint also alleges violation of a 1996 licensing agreement under which Research Genetics, which was later acquired by Invitrogen (see IBO 12/31/99), licensed patent rights to Promega. Subsequently, Promega cross licensed the rights to Applied Biosystems, which was acquired by Life Technologies in 2008 (see IBO 6/15/08). Promega alleges breach of both license agreements, breach of the duty of good faith and fair dealing, economic duress and unjust enrichment. In August, the court dismissed three of the plaintiff’s claims related to declaratory judgment.

Life Technologies and Illumina are facing off yet again in a patent dispute. Cornell University and Life Technologies filed suit in May against Illumina in Delaware District Court (see table). The complaint charges that Illumina’s products and services for its GoldenGate Genotyping Assay and DASL (cDNA-mediated Annealing, Selection, Extension and Ligation) Assay infringe seven patents containing claims to PCR methods held by Cornell, and exclusively licensed to Life Technologies. The complaint also alleges a patent containing claims to instruments (US Patent No. 7,083,917) is infringed by Illumina’s Sentrix Array Matrix, BeadChip, VeraCode beads, BeadStation, BeadArray Reader, iScan, HiScanHQ, BeadLab and BeadXpress Reader. Cornell and Life Technologies are requesting preliminary and permanent injunctions, damages, and pre- and post-judgment interests and cost. Illumina denied the allegations in its answer to the complaint and filed counterclaims for declaratory judgment of invalidity and non-infringement.

Litigation related to patents on DNA sequencing technologies remains active. In a development related to Life Technologies’ ongoing 2009 case involving Illumina’s sequencing technology (see IBO 10/31/09), the US Patent and Trademark Office (USPTO) has granted Life Technologies’ request for a re-examination of the four patents that Illumina asserts in its counterclaims. Also, Life Technologies’ 2007 suit against Illumina that was decided last year (see IBO 1/31/09, 4/30/09), and which both companies appealed, appears to have come to an end. In May, the US Court of Appeals for the Federal Circuit affirmed the lower court’s decision.

Illumina is also the plaintiff in new sequencing suits. In August, Illumina filed a complaint against sequencing services firm Complete Genomics in the US District Court in Delaware (see table, page 6). Illumina alleges that the Combinatorial-Probe Anchor Ligation read technology used by the Complete Genomics Analysis Platform services infringes three patents held by Illumina. Illumina is requesting a permanent injunction, compensatory damages, attorney fees and the delivery of all infringing materials to Illumina for destruction.

In its answer to the complaint, Complete Genomics denied the charges and asserted that the patents are invalid and unenforceable. The company stated that the patents are unenforceable due to inequitable conduct, citing inadequate disclosure to the USPTO of material documents related to Lite Technologies’ 2009 suit against Illumina, specifically the stipulation that Claim 1 of the US Patent No. 6,306,597 was anticipated by a patent held by Edwin Southern. Complete Genomics’ counterclaims against Illumina include inequitable conduct and violation of the Sherman Antitrust Act, for which it is requesting treble damages and lost profits on sales. Complete Genomics has filed a motion to transfer the case to the Northern District of California.

Like their predecessors, new sequencing companies are also initiating patent battles. Helicos BioSciences filed suit against Pacific Biosciences last month in the US District Court for the District of Delaware, alleging infringement of its sequencing-by-synthesis technology by Pacific Biosciences’ Single Molecule Real Time DNA Sequencing technology (see table, page 6). Helicos is seeking a permanent injunction, punitive damages, costs and attorneys’ fees, and interest.

Updated

Finally, Enzo Biochem and Yale University’s six-year-old patent infringement suit against Applera (now Life Technologies) awaits may be heard by the US Supreme Court. A federal appeals court’s ruling earlier this year affirmed in part and reversed in part the lower court’s decision (see IBO 4/30/10). Life Technologies’ request for a rehearing was denied in May. As a result, Life Technologies has petitioned the Supreme Court to hear the case, citing a conflict between the Federal Circuit and USPTO as to the requirements of “definiteness” in patent claims. The two patents that were the focus of the appeal expired in 2004.