Teva scores again. The Israeli generics maker won a favorable ruling in the U.S. District Court for the District of Delaware yesterday after a judge determined that a Merck patent on the cancer treatment Temodar is unenforceable. If the ruling holds up on appeal, it would clear the way for Teva to launch its version of the brain-cancer remedy. Teva is looking for FDA approval for six doses of the drug to treat two types of brain cancer.
District Judge Sue Robinson ruled Merck's patent is unenforceable because of "prosecution latches and/or inequitable conduct." She cited Merck's delayed pursuit of a key patent as well. "Something was awry, insofar as not a single piece of data was provided to the patent office in over 11 years, despite over a decade's worth of research on the technology," Robinson says in her decision (as quoted by the Philadelphia Inquirer).
Merck says it plans to appeal. "We are very disappointed with the court's ruling, and we continue to believe the patent for Temodar in the U.S. is valid and enforceable," Merck EVP and General Counsel Bruce Kuhlik tells BusinessWeek. No word on whether Teva might go ahead with a launch upon FDA approval--with or without an appeals court ruling.
- see the Merck release
- read the BusinessWeek story
- get more from the Inquirer