A Diagnostics & Imaging Week

BioGenex (San Ramon, California) said it has emerged victorious after more than 2-1/2 years of litigation in federal court against Ventana Medical Systems (Tucson, Arizona). The U.S. District Court for the District of Arizona recently entered the ruling in favor of BioGenex in a patent infringement case between the two companies.

Judge Raner Collins ruled that BioGenex’s automated staining systems do not infringe Ventana’s U.S. 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.

Ventana sued BioGenex for patent infringement in February 2003, 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 Plus and i6000 Systems, used in histopathology labs worldwide, do not infringe because they dispense reagents differently from the dispensing method required by the ’861 patent.

Third Wave Technologies (Madison, Wisconsin) said it has filed two patent suits in U.S. District Court in Madison.

The company filed suit against Digene (Gaithersburg, Maryland), seeking a court ruling supporting Third Wave’s right to sell its human papilloma virus (HPV) products. It also filed suit against Chiron (Emeryville, California), Bayer Corp. (Pittsburgh) and Bayer HealthCare (Tarrytown, New York), asking for a similar ruling about its right to sell its hepatitis C virus products. Chiron is the owner of several patents relating to HCV; Bayer is its licensee for clinical diagnostics.

Third Wave’s Invader chemistry is used to analyze nucleic acids, the foundation of genetic material and infectious agents. The chemistry and methods of using it are protected by 45 patents, with more than 100 additional patents pending.

“Third Wave wants to clear any remaining ambiguities about the company’s freedom to operate in valuable markets like those for HCV and HPV,” said John Puisis, president and CEO of Third Wave. “[Our] Invader chemistry is both unique and well-protected by distinct intellectual property rights. We have been diligent, taking great care and making significant investments to achieve our freedom to market HCV and HPV products. We work hard to ensure that we respect the intellectual property rights of others. The value of the Invader chemistry and our pipeline is substantial and we see these actions as a logical progression to protect and expand our market presence.”

In other legalities, four elementary school students, along with the American Diabetes Association (ADA; Alexandria, Virginia), have filed a civil rights complaint in U.S. District Court for the Northern District of California seeking class-action relief against the California Superintendent of Public Schools, the California Department of Education, members of the California Board of Education, the San Ramon Valley Unified School District, the Fremont Unified School District and their superintendents and boards of trustees.

The suit asks the court to compel public school officials to comply with federal law by providing the assistance that California students with diabetes require to manage their diabetes during the school day.

The complaint alleges that the state and the local districts violate Section 504 of the Rehabilitation Act, the Individuals with Disabilities Education Act (IDEA), the Americans with Disabilities Act (ADA) and applicable federal regulations in their failure to ensure the health and safety of public school students in kindergarten through 12th grade with diabetes by providing insulin administration, blood glucose monitoring, proper care in emergency situations and other appropriate diabetes care.

The plaintiffs are represented pro bono by attorneys in the Oakland and San Francisco offices of the Reed Smith law firm, as well as by attorneys with the Disability Rights Education and Defense Fund (DREDF; Berkeley, California).

“Students with Type 1 diabetes, and some students with Type 2 diabetes, require insulin to survive,” said Reed Smith attorney James Wood. “Without access to regular and ongoing blood glucose testing and insulin administration during the school day, these youngsters are at risk of serious and possibly fatal health complications.”

Larisa Cummings of DREDF said, “The California Department of Education, the San Ramon Valley and Fre-mont districts and many other districts across the state refuse to assign any school personnel to assist students with the injection of insulin as prescribed by the students’ doctors, even though school personnel can be trained to do so and are regularly trained and assigned these tasks in some schools.”

The complaint asks the court to require the California Department of Education and the school districts to establish policy ensuring the provision of a sufficient number of trained school personnel to check students’ blood glucose levels, monitor their symptoms of high and low blood glucose, and assist with administering insulin or glucagon or other treatments they may require.

“Diabetes must be managed 24 hours a day, seven days a week. A student with diabetes cannot take a break from diabetes when he or she boards the school bus in the morning,” said L. Hunter Limbaugh, chair of the National Advocacy Committee at the ADA and parent of a daughter who has diabetes.