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BioGenex obtains favorable patent ruling against Ventana

BioGenex Laboratories, Inc. (San Ramon, CA) received a favorable ruling in its patent infringement litigation against Ventana Medical Systems . The ruling, known as a Markman Ruling, limits the scope of Ventana's patent for automated staining.

Judge Raner C. Collins of the United States District Court for the District of Arizona issued the Markman Ruling. The ruling interprets the reagent dispensing claims of Ventana's United States Patent 6,352,861 (the '861 Patent). Ventana had alleged that BioGenex's automated staining instruments infringe the dispensing claims of the '861 Patent . Ventana asserted that any automated staining device that uses bar codes to coordinate reagent dispensing onto samples infringes the '861 claims. BioGenex disagreed, maintaining that its automated staining systems, the OptiMax Plus and i6000 Systems, used in major histopathology labs worldwide, do not infringe because they dispense reagents differently from the dispensing method required by the '861 Patent .

Specifically, BioGenex contended that Ventana's patent claims apply only to competitors using bar coding in conjunction with instruments that dispense reagent directly from the reagent container onto a slide. Direct dispensing requires positioning the reagent dispenser over the sample, and applying the reagent directly from the dispenser onto the sample below it. By contrast, the BioGenex automated staining systems dispense reagent indirectly. BioGenex's automated staining systems dispense reagent by means of an intervening reagent transfer device, a robotic XYZ arm holding a micropipette. The micropipette aspirates or "sips" reagent from the reagent bottle, then moves over to and above the tissue sample, and applies the reagent to the sample. This indirect dispensing procedure is known as "sip and spit" dispensing. The Trial Court agreed with BioGenex, limiting the meaning of the term "dispensing," as used in Ventana's '861 Patent, to "direct dispensing" and to exclude BioGenex's "sip and spit dispensing" method.

BioGenex and Ventana have agreed that due to this ruling, the Court should now enter Summary Judgment of Non-Infringement in favor of BioGenex.

The ruling in favor of BioGenex enhances the already robust environment for BioGenex's bar coded automated staining systems, not only the OptiMax Plus and i6000 Systems, but also the recently launched Xmatrx Automated Staining System, which is capable of performing almost all slide- based cell and tissue tests.

Krishan L. Kalra, Ph.D., BioGenex C.E.O., said: "We are very excited to bring to closure the '861 Patent dispute with Ventana Medical Systems. The Judge's ruling clearly strengthens BioGenex's position in the in vitro diagnostics market. This victory now allows BioGenex to focus on launching our exciting new platform, the Xmatrx System." The Xmatrx is BioGenex's latest instrument product offer that automates the entire slide processing for IHC, SS, ISH and FISH from microtome to microscope. The Xmatrx System automates more steps and more technologies than any other system currently on the market.

BioGenex, a technology leader in molecular pathology, provides systems for complete automation of cell and tissue testing. BioGenex offers a broad range of reagents, detection kits, antibodies, probes, special stains, tissue microarrays, automated staining and imaging systems to streamline and standardize cellular and molecular diagnostics. The automated systems are designed for high throughput at a low cost of ownership, providing ease of use and maximum flexibility for clinical diagnostics, life science research, and drug discovery.

Ventana develops, manufactures, and markets instrument/reagent systems that automate slide preparation and staining in clinical histology and drug discovery laboratories worldwide. Ventana's clinical systems are important tools used in the diagnosis and treatment of cancer and infectious diseases. Ventana's drug discovery systems are used to accelerate the discovery of new drug targets and evaluate the safety of new drug compounds.

BioGenex Laboratories, Inc.
+1-925-866-2579
www.biogenex.com