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Gen-Probe Slaps BD with Second Infringement Suit Related to Molecular Dx Instruments

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Gen-Probe this week filed a patent-infringement lawsuit against Becton Dickinson alleging that the company's BD Max system infringes upon several patents owned by Gen-Probe and related to its Tigris molecular diagnostics blood-screening system.

It is the second patent-infringement lawsuit filed by Gen-Probe against BD in the past six months. The first lawsuit, filed in October, alleges that certain other BD instrument platforms infringe upon the same and additional Gen-Probe patents.

The new suit, filed Tuesday in the US District Court for the Southern District of California, alleges that the sale of the BD Max nucleic acid testing system — formerly known as the HandyLab Jaguar system — infringes US Patent Nos. 7,118,892; 7,482,143; 7,524,652; and 7,560,255.

In its complaint Gen-Probe alleges that BD "has actual knowledge" of the aforementioned patents; has "manufactured, distributed, and sold those nucleic acid testing systems and companion assays specifically for uses that practice" the patents; and has "provided written instructions to the users of such systems and assays with the specific intent to encourage those users" to practice the patents.

BD acquired HandyLab for $275 million in cash in November 2008, primarily for the Jaguar system, which incorporates sample preparation, nucleic acid extraction, microfluidic real-time PCR amplification, and detection into a single automated platform.

BD said at that time that it would move its BD GeneOhm assays for methicillin-resistant Staphylococcus aureus, Clostridium difficile, and vancomycin-resistant Enterococcus to the HandyLab platform and rename it the BD Max.

As reported in January by PCR Insider, at the JP Morgan Healthcare Conference in San Francisco, BD CEO Ed Ludwig said that the company planned to launch a revamped BD Max system at the end of 2011 (see PCR Insider, 1/21/2010).

It is unclear whether BD is currently marketing or selling the BD Max, although it does have a page dedicated to the new platform on its website. A company spokesperson could not be reached for comment.

The suit follows on the heels of a similar ongoing lawsuit filed in October by Gen-Probe against BD in the same district court. That lawsuit alleges that BD's Viper with XTR Technology molecular diagnostics system infringes several patents — the four aforementioned patents, as well as US Patent Nos. 7,560,256 and 5,612,200, also held by Gen-Probe.

That lawsuit also alleges that BD is infringing two other Gen-Probe patents — US Nos. 7,294,308 and 6,893,612 — through the sale of its BD ProbeTec Female Endocervical and Male Urethral Specimen Collection Kits for Amplified Chlamydia trachomatis/Neisseria gonorrhoeae DNA Assays.

In both suits, Gen-Probe has asked the court to find that BD has infringed and continues to infringe all of the patents listed in the complaints; to enjoin BD from further alleged infringement; and to award Gen-Probe unspecified damages. Gen-Probe also asserts in its suits that BD has willfully infringed its patents, and as a result it should be awarded treble damages.

Gen-Probe's Tigris system is used to screen a portion of the nation's blood supply and is also used in clinical labs to diagnose infectious diseases, including sexually transmitted diseases such as chlamydia and gonorrhea.

According to Gen-Probe's website, the Tigris system with direct tube sampling, or Tigris DTS, automates all phases of molecular diagnostics testing from sample preparation, amplification, and detection to reporting results; and is used with the company's Aptima assay kits for nucleic acid testing.

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