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Hologic's Gen-Probe Wins Judgment in IP Suit Against BD, but Dispute Remains Unresolved

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Hologic said today that it has received a favorable judgment in a patent infringement lawsuit filed by subsidiary Gen-Probe against Becton Dickinson related to the companies' nucleic acid testing and molecular diagnostic platforms.

According to BD, however, only some of Gen-Probe's infringement claims have been substantiated by the court, and "significant issues" still need to be resolved as the dispute moves to a jury trial later this year.

In addition, a second patent-infringement suit filed by Gen-Probe after the initial suit and also related to molecular diagnostic technologies is ongoing.

Gen-Probe filed its initial suit against BD in October 2009, alleging that sales of BD's Viper molecular diagnostics platform with XTR Technology infringed US Patent Nos. 7,560,256; 7,560,255; 7,524,652; 7,482,143; 7,118,892; and 5,612,200, held by Gen-Probe.

In addition, Gen-Probe asserted that BD infringed two other 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 a decision handed down last week by the US District Court for the Southern District of California, Gen-Probe was granted summary judgment motions that BD's ProbeTec Qx CT/GC assays for chlamydia and gonorrhea on the BD Viper system with XTR technology and its group B Streptococcus assays on the BD Max system infringe three of Gen-Probe's patents covering automated nucleic acid testing, Hologic said in a statement.

Hologic said that the court also granted summary judgment that BD's ProbeTec specimen collection products infringe another Gen-Probe patent covering penetrable caps.

Further, the court denied BD's summary judgment motion to dismiss Gen-Probe's infringement claims based on an alleged lack of standing to sue, as well as BD's summary judgment motions seeking to invalidate the asserted patents, Hologic said.

However, the court also ruled that BD did not infringe a fourth automation patent and a second penetrable cap patent. In addition, a jury trial on remaining issues is scheduled to begin on Dec. 4.

In response to Hologic's statement today regarding the court's judgment, BD noted in a US Securities and Exchange Commission filing that the court ruled that "some of Gen-Probe's asserted patent claims are infringed, but other claims are not infringed, thus reducing from six to four the number of patents to be contested at the trial … and significant defense issues relating to patent invalidity, inequitable conduct and standing, remain to be adjudicated."

BD added that the decision "does not change [BD's] views and it continues to believe that it has meritorious defenses to this litigation."

Hologic said in a statement that remaining issues to be decided at the Dec. 4 trial include whether BD is liable for inducing its customers to infringe Gen-Probe's patents; whether BD's infringement was willful; the monetary damages owed Gen-Probe; and challenges by BD to Gen-Probe's standing to sue and the validity of the patents.

Hologic said that Gen-Probe is requesting the court triple the monetary damages and enter a permanent injunction to prevent further infringement.

BD is continuing to move forward with its molecular diagnostics test pipeline on both its higher throughput Viper system and medium-throughput benchtop BD Max platform (PCR Insider, 8/9/2012). In August company executives noted that it is on track to launch a Clostridium difficile assay for the BD Max in the US by the end of this calendar year. The test would join commercial BD Max assays for detecting GBS DNA in Lim broth cultures and for detecting methicillin-resistant Staphylococcus aureus.

In addition, BD Diagnostics plans to launch a Trichomonas vaginalis assay for the Viper testing system in Europe by the end of the current quarter and in the US mid-2013; and plans to introduce a new benchtop version of Viper with tests for chlamydia, gonorrhea, and human papillomavirus genotyping throughout its fiscal year 2013 in both Europe and the US.

A second patent-infringement lawsuit between BD and Hologic's Gen-Probe is ongoing. In March 2010 Gen-Probe filed suit in the same district court alleging that the BD Max system infringes the '892, '143, '652, and '255 patents owned by Gen-Probe and cited in the first lawsuit (PCR Insider, 3/25/2012).

Hologic agreed in April to acquire Gen-Probe for $3.7 billion, a transaction that closed on Aug. 1.

Gen-Probe sells the automated Tigris and Panther molecular diagnostic platforms. Tigris is available in the US and Europe and is intended for use in high-volume clinical testing labs. Panther is CE-marked and available in Europe, but is still pending approval by the US Food and Drug Administration, and is intended for use in low- to mid-volume labs.

Gen-Probe is also developing a next-generation version of Panther that will incorporate real-time PCR capabilities along with the TMA technology

The current STD test menu for Tigris includes the Aptima Combo 2 assay, which qualitatively detects and differentiates ribosomal RNA from C. trachomatis and N. gonorrhoeae to aid in the diagnosis of chlamydial and gonococcal genital disease; Aptima HPV for detecting the HPV types likely to progress to cancer; and the Aptima T. vaginalis assay.

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