Chiron Corporation and Children's Hospital and Regional Medical Center of Seattle have settled a patent infringement suit against Roxane Laboratories, a subsidiary of Boehringer-Ingelheim Corporation, regarding Roxane's plans to market a generic equivalent of TOBI, tobramycin solution for inhalation. The suit was brought to enforce U.S. Patent No. 5,508,269 (the '269 patent), which is co-owned by Chiron and Children's Hospital. Under the terms of the agreement, Roxane, which had previously withdrawn its application for approval of a generic equivalent of TOBI, agreed it would not seek approval to market the product until the expiration of the '269 patent in 2014. Chiron and Children's Hospital agreed to dismiss their infringement relief claims against Roxane, and Roxane dropped its challenge to the '269 patent. No party received monetary compensation as part of the settlement.
TOBI, approved by the FDA for cystic fibrosis (CF) patients with chronic pseudomonal lung infection, is the cornerstone of Chiron's inhaled therapeutics franchise and is protected by the '269 patent. "This agreement underscores the strength of Chiron's intellectual property," said Craig Wheeler, president, Chiron BioPharmaceuticals. "TOBI has dramatically improved the health of cystic fibrosis patients worldwide, thereby achieving commercial success for Chiron. The company is committed to further investment in the cystic fibrosis market through the development of new products to help patients."
Chiron is currently conducting a Phase I study, in collaboration with Nektar Therapeutics, for the development of a dry-powder formulation of TOBI, which would significantly improve the ease of use and convenience for patients.
To better characterize TOBI's efficacy in less severe CF patient populations, Chiron has announced plans to start the ELITE study to confirm the potential benefit of early TOBI treatment at the onset of pseudomonal infections. The ELITE study is expected to begin enrollment later this year.