Federal Court Victory for BioGenex on Patent Infringement Suit Against Ventana Medical Systems

20 October 2005

BioGenex has emerged victorious
after more than two-and-a-half years of litigation in federal court against
Ventana Medical Systems (Nasdaq: VMSI). The United States District Court for
the District of Arizona recently entered the ruling in favor of BioGenex in a
patent infringement litigation between the two companies. Judge Raner C.
Collins of the District Court in Tucson ruled that the BioGenex automated
staining systems do not infringe Ventana's US Patent No. 6,352,861 (the '861
Patent) issued in March 2002.
The '861 Patent contains claims for a method of automated dispensing of
reagents onto a slide. In February 2003, Ventana sued BioGenex for patent
infringement, claiming that BioGenex's automated staining systems infringe the
reagent 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(R) Plus and i6000(TM) 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 reagent dispensing 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, as practiced by Ventana, requires positioning the reagent
container over the sample, and applying the reagent directly from the
container onto the sample below it. After correct positioning over the sample
slide, the reagent bottle is pumped downward to dispense one or more drops of
reagent onto the slide below. By contrast, BioGenex systems aspirate or "sip"
reagent out of its container with an intervening reagent transfer device such
as a pipette, then move this intervening device over the slide and use air
pressure to dispense or "spit" reagents onto the slide.
In court, BioGenex presented evidence showing that Ventana, in order to
obtain its patents, told the U.S. Patent Office that its automated staining
instruments are distinct from "sip and spit" systems, and by contrast dispense
reagent directly from the reagent container onto the slide. These exchanges
with the Patent Office took place over several years.
Consequently, BioGenex argued in court that Ventana had disclaimed, or
given up, all rights to patent coverage of "sip and spit" dispensing. Ventana
disagreed. Notwithstanding its arguments to the Patent Office, Ventana told
the Trial Court that its reagent dispensing claims should not be limited to
direct dispensing of reagents.
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. Ventana plans to appeal
the ruling. BioGenex is confident that it will prevail on appeal.
Krishan L. Kalra, Ph.D., Chairman and C.E.O. of BioGenex stated the
following: "We are glad that this arduous court proceeding is over so that we
can focus on our business, especially on promoting our next generation
stainer, the Xmatrx(TM) System. Given Ventana's disclaimer of "sip and spit"
dispensing at the U.S. Patent Office, we have asked the Court to award us our
attorneys' fees for having to defend ourselves in a litigation that we believe
was unnecessary. We will vigorously pursue recovery of our attorneys' fees
and oppose Ventana on appeal. We are confident that Judge Collins' ruling
will be upheld on appeal."

About BioGenex Laboratories, Inc.
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, 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. For more
information on BioGenex Laboratories, visit http://www.biogenex.com or call
1-800-421- 4149. BioGenex, Accelerating the Pace of Predictive Medicine.

About Ventana Medical Systems, Inc.
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.