Pfizer Inc. (PFE:US), the world’s largest drugmaker, and its business partners OSI Pharmaceuticals Inc. and Genentech Inc. sued Roxane Laboratories Inc. over its plans to market generic copies of the lung-cancer drug Tarceva.
Pfizer, based in New York; OSI, a unit of Tokyo-based Astellas Pharma Inc. (4503); and Genentech, a unit of Roche Holding AG (ROG) of Basel, Switzerland, contend Ingelheim, Germany-based Boehringer AG (0205298D)’s Roxane has applied to the U.S. Food and Drug Administration for permission to sell its version of Tarceva before the patents expire.
The patent owners, Pfizer and OSI, and licensee Genentech “will be substantially and irreparably harmed” if a judge doesn’t stop the infringement, their lawyers said in a complaint filed today in federal court in Wilmington, Delaware.
Roxane, based in Columbus, Ohio, is facing another patent suit filed April 10 in the same court. In that case, drugmaker Abbott Laboratories contends Roxane is infringing patents for the HIV drug Norvir.
Angela Chirico, a spokeswoman for Roxane, said in an e- mailed statement that the lawsuit is “an expected response” to its abbreviated new drug application for a generic copy.
“Roxane Laboratories Inc. complies with all FDA regulations and will not comment further on pending litigation,” she added.
The case is OSI v. Roxane, 12-cv-465, U.S. District Court, District of Delaware (Wilmington).
To contact the reporter on this story: Phil Milford in Wilmington, Delaware, at email@example.com; Michael Bathon in Wilmington, Delaware, at firstname.lastname@example.org.
To contact the editor responsible for this story: Michael Hytha at email@example.com.