For companies in the instrument industry, protecting patents is a crucial aspect of business. As was the case in last year’s article (see IBO 11/30/06), Bio-Rad, Applied Biosystems and Invitrogen continue to be among the most legally aggressive companies. First, to begin on a positive note, Bio-Rad’s suit against 4titude and Phenix Research Products was dismissed in August after the three parties reached an agreement. Bio-Rad filed the suit against the companies in March, alleging that 4titude’s FrameStar PCR microplates and certain Phenix 96- and 384-well skirted microplates for PCR infringed Bio-Rad’s US Patent No. 6,340,589, which the company obtained in its acquisition of MJ Research (see IBO 6/15/04). Terms of the agreement were not revealed and the three companies will pay their own legal costs. However, the ‘589 patent is the subject of another set of suits. In July, Bio-Rad sued Eppendorf North America and this month sued Eppendorf AG, claiming that Eppendorf’s twin.tec PCR plates, and possibly others, infringe the ‘589 patent (see table). Eppendorf North America filed a countersuit for declaratory judgment this month, claiming that the ‘589 patent is unenforceable and that its claims are invalid.

This year, Applied Biosystems prevailed in its suit against Enzo Biotech (see IBO 9/15/07) and settled with Agilent (see page 2) this year. However, two new suits have arisen. Applera filed its patent infringement suit in March, claiming that Michigan Diagnostic’s chemiluminescent substrates, including its alkaline phosphatase substrates and arylesterase substrates, infringed on Applera’s US Patents No. 6,514,717B2 and 6,322,727B1. After Michigan Diagnostic informed Applera that the two patents in question had expired in 2006, Applera added US Patent No. 6,107,024 to its suit (see table). As Michigan Diagnostic explained in the complaint with which it opened its countersuit, filed this May, the company is concerned that Applera will “continue to assert irrelevant and/or expired patents so as to impose extreme economic hardship” on Michigan Diagnostic. The countersuit calls for a judgment of noninfringement, and alleges that Applera has engaged in patent misuse, unfair competition and fraudulent activity in the filing of its patents. Applied Biosystems’ case against Solexa, which was filed in December 2006 (see IBO 12/31/06), is still in the pretrial phase. A jury trial for the case is currently scheduled for September 2008.

Invitrogen filed a suit against the President and Fellows of Harvard College in May. The patent in question is Harvard’s US Patent No. 5,614,365, which describes a modified DNA polymerase for DNA sequencing (see table). The civil suit appeals the US Patent and Trademark Organization’s (USPTO) decision on an interference—which occurs when two patents claim the same invention—between Harvard and Invitrogen, which was declared in April 2005 and decided in Harvard’s favor this March. Invitrogen’s case is similar to Agilent’s filing of a suit, in September of last year, against Affymetrix to appeal the USPTO’s decision on an interference (see IBO 11/30/06). Agilent’s case is still in pretrial and has a mediation deadline set for May 2008.

In addition, Invitrogen filed a trademark infringement suit against Novexin, a UK-based company, in July. Invitrogen has the trademark rights to the word NOVEX and sells electrophoresis gels and chromatography reagents under the trademark. Invitrogen argues that Novexin’s products, which include kits and reagents for protein analysis, are “likely to cause confusion, mistake and/or deception with respect to the origin, sponsorship or approval” for customers.

Two companies involved in litigation concerning patents related to their core technologies are Affymetrix and Caliper. The first phase of Affymetrix’s patent infringement suit against Illumina has already been decided, and a jury ruled that Illumina did infringe on three of Affymetrix’s patents for gene expression and genotyping (see IBO 3/15/07). The case’s second phase, which will consider whether or not Illumina’s infringement was willful and assess the merit of Illumina’s claims that Affymetrix’s patents are invalid, is scheduled to take place during the first quarter of 2008. However, this month, Illumina filed a motion to vacate the jury’s decision on US Patent No. 5,795,716 (“Computer-Aided Visualization and Analysis System for Sequence Evaluation”), claiming that Affymetrix made changes to the claims of the patent to gain a favorable judgment. A decision by the court in response to Illumina’s motion has yet to be delivered.

Although not the subject of a civil suit, in vivo fluorescence-based imaging is the subject of an inter partes reexamination of a patent issued to Caliper Life Sciences. VisEn Medical filed its inter partes reexamination request, a process by which a company can request that the claims of a patent be reassessed, with the USPTO on August 15, one day after the patent was granted. According to VisEn, Caliper’s US Patent No. 7,255,851 (“Noninvasive Localization of a Light-Emitting Conjugate in a Mammal for Methods in Fluorescence-Based Imaging”), which establishes a July 1994 priority date, is antedated by the work of “numerous investigators worldwide.” The USPTO has not yet announced a decision on the reexamination request.

Caliper is also the subject of a suit brought by AntiCancer. A San Diego, California, company that manufactures small animal imaging technology and cancer therapeutics, AntiCancer has filed a suit against Xenogen, which Caliper acquired in 2006 (see IBO 2/15/06). AntiCancer claims that Xenogen’s IVIS Imaging System 200 Series infringes five of AntiCancer’s patents—US Patent Nos. 6,232,523; 6,235,968; 6,251,384; 6,759,038 (all titled “Metastasis Models Using Green Fluorescent Protein (GFP) as a Marker”); and 6,649,159 (“Whole-Body Optical Imaging of Gene Expression and Uses thereof”). The suit was filed in March 2005. This year, AntiCancer sued two other companies, Kodak and Cambridge Research, for the infringement of US Patent No. 6,649,159 and US Patent No. 6,759,038, in addition to other patents excluded from the suit against Xenogen.

Also filed this year, febit biotech GmbH’s case against Codon Devices (see IBO 8/31/07) is being vigorously defended. Codon’s motion to dismiss disputes the ownership of the patent in question, US Patent No. 6,586,211, which febit considers to be “the cornerstone of its portfolio” of patents covering the use of microarrays for synthetic gene production. Febit claims that Codon’s BioFAB gene synthesis platform violates the ‘211 patent.

Finally, in August, Health Card Technologies filed a suit against Thermo Fisher Scientific claiming the infringement of two patents, US Patent Nos. 5,683,786 and 5,919,553, related to labeling microscope slides with a laser marking system. Health Card argues that Thermo Fisher’s Shandon Laser MicroWriter is the infringing product (see table).

To follow up on the other cases covered in last year’s examination of the patent infringement suits in the instrument industry, Apogee Scientific’s suit against Thermo Electron regarding patent infringement of mercury analysis technology was brought to an end this May, when Apogee voluntarily dismissed the case. Genetic Applications’ suit against Invitrogen for reagents used for gene transfer, which was filed last October, is scheduled for a Markman hearing. The hearing, during which certain claims of Genetic Applications’ patent will be defined in plain language, will be held within the next two months. Finally, Invitrogen’s suit against Bio-Rad involving technologies used for controlling the contamination of nucleic acid amplification reactions was dismissed in April. The dismissal was agreed on by both companies and each company will pay its own legal fees.