Settlement agreements highlight the second of IBO’s yearly articles on patent infringement litigation involving lab instrument and product companies (see IBO 4/30/11). In addition, new suits involving Agilent, PerkinElmer and Waters were filed.

New Litigation

Among the patent infringement suits initiated since April is Waters’s complaint against Aurora SFC Systems for infringement of two patents related to pumps used in supercritical fluid chromatography (SFC) systems (see table, page 3). The complaint alleges infringement by Aurora’s SFC Fusion A5 product, which is used to transform an HPLC system into an SFC system. Filed in the US District Court for the District of Delaware, the suit seeks injunctions, royalties and damages. According to the complaint, Aurora SFC founder and Chief Technology Officer Dr. Terry A. Berger is the first-named inventor on both patents. His former company, Berger Instruments, and its technology were sold and subsequently purchased by Waters (see IBO 2/15/09).

In August, publicly listed Korean firm NanoEnTek filed suit in the Alexandria Division of the US District Court in the Eastern District of Virginia against Bio-Rad Laboratories, alleging infringement of a patent exclusively licensed to NanoEnTek and assigned to its subsidiary Digital-Bio Technology (see table). The suit alleges infringement by Bio-Rad’s TC10 Automated Cell Counter and TC10 Counting Slides. In Bio-Rad’s answer to the complaint filed earlier this month, the company denies the allegations and asserts the patent is invalid due to prior art.

Life Technologies is the target of a patent infringement suit brought in July by Catalyst Assets in the US District Court for the Northern District of California. The suit alleges Life Technologies’ SOLiD sequencing system infringes US Patent No. 5,858,731 (Oligonucleotide Libraries Useful for Producing Primers). Life Technologies denies the allegations and counterclaims for declaratory judgment of patent invalidity and noninfringement. According to court documents, the patent expired in May. Life Technologies has requested a stay in the case, citing its September request to the US Patent and Trademark Office (USPTO) for patent reexamination. The request concerns the invalidity of two of the patent’s claims, including claim 18, which is the subject of the suit, due to prior art.

Resonant Biotechnologies, which is owned by Acacia Research, a firm that acquires patent licenses in order to collect licensing fees, has filed two patent infringement suits this year involving US Patent No. 6,218,194 (see table). Corning and PerkinElmer are among the defendants in an action brought by the firm in the Delaware District Court in April. The plaintiff alleges infringement by Corning’s Epic label-free screening system and PerkinElmer’s EnSpire Multimode Plate Reader, which is based on Epic technology. The suit also names several major drug companies that use the Epic system as defendants.

In August, Resonant Biotechnologies filed suit in District Court in New Jersey against SRU Biosystems for infringement by its BIND system. Other defendants named in the suit due to their use of the system included Caliper Life Sciences and HighRes Biosolutions.

Publicly listed Australian firm Genetic Technologies (GTG) filed suit in May against 10 plaintiffs, including Agilent and 454 Life Sciences, in Colorado District Court. The suit claims infringement of a patent related to methods for analyzing non-coding DNA sequences (see table). This is the latest in a series of suits brought by GTG against research tool providers, genomic-testing service firms, diagnostics companies and drug developers for infringement of the patent. These suits have resulted in licensing agreements. A 2003 suit against Applera resulted in a settlement agreement two years later, under which Applera licensed the technology and, according to GTG, paid GTG AUD $15 million ($12.5 million) in cash, equipment, reagents and intellectual property. In 2006, GE Healthcare Bio-sciences filed suit against the firm for declaration of noninfringement of the patent, as well as another patent. The companies entered into a settlement and licensing agreement in 2008.

The complaint states that Agilent products, including its Stratagene business, utilize methods that infringe the patent. As examples, the complaint cites the use of the company’s 2100 Bioanalyzer, GeneSpring Analysis Platforms and comparative genomic hybridization microarrays for analyzing mutations in non-coding regions. The complaint also alleges infringement of the patent by 454 Life Sciences’ sequencing reagent kits. Other companies named as plaintiffs are pharmaceutical companies Bristol-Myers, GSK and Pfizer for analysis of non-coding DNA in the development of pharmacogenomics tests, including genotyping studies; genomic service companies ESTA, Eurofins STA Laboratories, Navigenics and Neogen for analysis services; and genomic test developers Hologic and Merial. In June, GTG announced a settlement and license agreement with Navigenics.

Dismissed and Settled

In August, the Federal Circuit Court of Appeals affirmed the dismissal of Illumina’s suit against Affymetrix (see IBO 12/31/10).

Fluidigm and Life Technologies settled litigation in July, less than a month after it began. In early June, Life Technologies filed an action alleging infringement of US Patent Nos. 7,858,365 (Sample Block Apparatus and Method for Maintaining a Microcard on a Sample Block) and 6,143,496 (Method of Sampling, Amplifying and Quantifying Segment of Nucleic Acid, Polymerase Chain Reaction Assembly Having Nanoliter-sized Sample Chambers, and Method of Filling Assembly) by Fluidigm’s BioMark HD System. In late June, Fluidigm filed a suit against Life Technologies involving US Patent Nos. 7,452,712 and 7,858,365, which have the same title, and 7,531,328 (Methods and Devices for Multiplexing Amplification Reactions). Under the settlement, Fluidigm cross-licensed and sublicensed Life Technologies’ patent families for PCR-related technology, and Life Technologies gained access to Fluidigm patent families related to imaging readers and other technologies. Fluidigm disclosed that the agreement included a net $3.0 million payment in the second quarter, as well as a $2.0 million payment in the third quarter to prevent litigation on existing patents for four years.

In August, Carestream Health and Caliper Life Sciences settled their patent infringement litigation (see IBO 4/30/10, 9/30/10). Under the settlement, Carestream agreed not to sell in vivo optical–imaging systems for certain applications that it licensed from Caliper. In turn, Carestream agreed not to assert that Caliper’s Lumina XR system infringes Carestream patents.

Voluntarily dismissed this month was NuSep’s action against Thermo Fisher Scientific and Expedeon (see IBO 4/30/11). In June, NuSep announced a settlement with Thermo in the case. Later that same month, NuSep announced a new three-year distribution agreement with Thermo for its nUView electrophoresis gels in the Bio-Rad- and Invitrogen-format cassettes. The contract guaranteed a minimum commitment of $850,000 for the first 15 months.

Upon the parties’ requests, in July, a Delaware District court dismissed GE Healthcare’s 2010 suit against Beckman Coulter related to patents for isolating and purifying nucleic acids (IBO 4/30/10).

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

 Plaintiff                    Defendant             US Patent No.      Patent Title                                Case Filed

 Genetic Technologies Ltd.    Agilent Technologies,    5,612,179       Intron Sequence Analysis Method for          5/25/2011

                              454 Life Sciences,                       Detection of Adjacent Locus Alleles

                              Neogen et al.                            as Haplotypes

 NanoEnTek, Digital-Bio       Bio-Rad Laboratories     7,842,157       Method for Bonding Plastic Micro Chip         8/2/2011

 Technology

 Resonant Biotechnologies     SRU Biosystems et al.    6,218,194       Analytical Methods and Apparatus Employing

                                                                       an Optical Sensor with Refractive Index 

                                                                       Modulation

 Waters Technologies          Aurora SFC Systems       6,561,767       Converting a Pump for Use in Supercritical   8/11/2011

                                                                       Fluid Chromatography

                                                       6,648,609       Pump as a Pressure Source for Supercritical

                                                                       Fluid Chromatography Involving Pressure 

                                                                       Regulators and a Precision Orifice