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This article was originally published in The Gray Sheet

Executive Summary

ROCHE GRANTS KODAK LICENSE TO PCR IVDs UNDER SETTLEMENT of a legal dispute regarding rights to polymerase chain reaction-based in vitro diagnostics. The settlement provides that "Kodak and its affiliates receive a nonexclusive royalty-bearing license without sublicensing rights" to two principal PCR patents for use in IVD products, according to a June 3 release jointly issued by Roche, Kodak and Chiron. Kodak "acknowledges Roche as the sole owner of the key patents covering the PCR process and other defined patent properties pertaining to PCR," the release says. The settlement eliminates the need for an arbitration ruling on Kodak's claim that it had gained rights to the PCR DNA amplification process under the terms of a 1986-1989 research and development pact with Cetus. Over the course of the R&D agreement, Kodak and Cetus worked on the development of IVDs, including PCR products. In April 1991, Kodak, invoking a provision of the pact, asked the American Arbitration Association to evaluate its claim to the PCR technology. Two months later, Cetus agreed to be acquired by Chiron; a precondition of the deal was the sale of PCR technology to Roche, which had obtained a license to the technology following the termination of the Kodak/Cetus pact. Kodak sought to enjoin to the sale; however, a Delaware court allowed the deal to go ahead in December 1991 after Roche agreed to be bound by the decision of the arbitrators. Although the settlement allows both Roche and Kodak to sell PCR diagnostic tests, Roche is likely to be the first to the U.S. market with a product. The firm currently is awaiting FDA clearance of a 510(k) for a PCR-based chlamydia test. The firm launched the chlamydia assay and an HIV-1 detection test in Europe last year ("The Gray Sheet" Nov. 2, 1992, p. 11). Roche also is working on a test to quantify HIV-1 and an assay that will identify species of mycobacterium, including mycobacterium tuberculosis. Additional products under development include a combination chlamydia/gonorrhea test, a combination HTLV-I 1/HTLV-II test, an enterovirus assay to distinguish between viral and bacterial meningitis, a typing assay for tissue/organ transplant, and tests for cystic fibrosis and hepatitis C. Roche's diagnostic kits, which will be marketed under the Amplicor name, will incorporate Amperase, a quality control enzyme designed to eliminate the chance of false positive results. Amperase destroys "any contaminating DNA samples or 'amplicons' carried over from previous PCR tests." Kodak says that it has done "extensive work" on developing PCR tests and instrumentation. The firm says that it has developed a prototype system that will be suitable for use in all hospital settings. The technology, for which the firm has applied for patents, addresses the "carry-over" problem through mechanical means, Kodak says.

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