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The Federal Circuit Court of Appeals ruled this week that Streck Inc. beat Research & Diagnostic Systems, Inc. (R&D) to the punch in developing hematology control products, and upheld Streck’s patents on the products.
Hematology instruments, such as those used to analyze samples of blood, measure the different types of blood cells in the sample. Government regulations and best practices require that these instruments be regularly checked for accuracy. Instrument accuracy is checked through the use of “controls” of known blood composition, which verify whether an instrument is accurately reading the blood sample.
The controls are made from chemically stabilized blood cells, or analogs thereof, that simulate or mimic the relevant characteristics of blood cells. Laboratories, hospitals, clinics, and doctor's offices use such controls to test whether a hematology instrument is working accurately, by running the control through the instrument and comparing the instrument's analysis of the control with the assay sheet provided by the control's manufacturer.
Both Streck and R&D are in the business of providing such controls.
The invention at issue in this case was an "integrated reticulocyte control," which contains at least a reticulocyte component combined with a white blood cell component capable of identifying the five types of white blood cells: lymphocytes, monocytes, neutrophils, eosinophils, and basophils. An "interference count" is critical the success of such a control.
Both companies claimed to have been the first to develop the count.
The district court found, and R&D agrees, that the Streck researcher's count was reduced to practice beginning in 1997 and continuing into 1998 and 1999. R&D argued that its researcher, although second to conceive, had reduced the invention to practice before the Streck filing date and before Streck's actual reduction to practice. R&D also argued that Streck's researcher had not shown diligence from his date of conception to his actual or constructive reduction to practice.
The Federal Circuit Court of Appeals disagreed.
The Federal Circuit found that the district court properly awarded priority of invention to Streck and its researcher because R&D did not establish that its interference count had been reduced to practice before 1997.