A Medical Device Daily

OraSure Technologies (Bethlehem, Pennsylvania) said it has reached an agreement on the principal terms to settle its pending patent infringement lawsuit against Schering-Plough Healthcare Products (Kenilworth, New Jersey).

Schering-Plough will receive a license to OraSure’s patents in the U.S. over-the-counter market and OraSure will receive payments of past and future royalties.

OraSure filed the lawsuit in 2004 alleging that Schering-Plough’s manufacture and sale of its Dr. Scholls Freeze Away cryosurgical wart removal product in the U.S. OTC market infringed several OraSure patents (Medical Device Daily, July 27, 2004).

In January the companies reported collaboration for the development and promotion of a rapid oral test for the detection of antibodies to the hepatitis C virus using OraSure’s OraQuick technology platform (MDD, Jan. 5, 2007).

OraSure makes oral fluid specimen collection devices using oral fluid technologies, diagnostic products including immunoassays and other in vitro diagnostic tests, and other medical devices.

In other patent activity, Xenomics (New York), a developer of DNA diagnostic technologies, reported issuance of its U.S. patent “Methods for detection of nucleic acid sequences in urine,” that covers use of its transrenal nucleic acid technology in the area of infectious disease diagnostics and monitoring.

Transrenal nucleic acids (Tr-DNA and Tr-RNA) are fragments of DNA and RNA from cells dying throughout the body that cross the kidney barrier from blood to urine and can be used for genetic analysis, the company noted. Xenomics’ previous patents covered applications of the Tr-NA technology for prenatal genetic testing, tumor diagnostics and monitoring, and detection of rejection episodes after organ transplantation. The new patent covers diagnosis and monitoring of infectious diseases, the most rapidly growing area of molecular diagnostics, the company said.