Nycomed and Pfizer Sue Generic Firms

Teva's and Sun Pharmaceuticals’ motion to overturn a verdict issued against them in April 2010 for patent infringement has been denied by a US court, leaving the companies at the mercy of pharmaceutical giants Pfizer and Nycomed, who have said they will “vigorously” pursue damage claims.

Both Teva and Sun launched generic versions of Protonix (pantoprazole), a proton pump inhibitor, in late 2007 and early 2008, respectively-approximately 3 years before the original patent (including pediatric exclusivity) had expired. These so-called ‘at-risk’ launches can boost a generic-drug company’s earnings, particularly as many other generic-drug firms will not take the risk of launching a generic version of a drug so early. However, the penalties for losing any subsequent litigation can be huge.

And losing is what has just happened to Teva and Sun. The detailed opinion of the court was not available at the time of going to press; however, various third-party sources have estimated that Teva and Sun could end up paying anywhere between $250 million–$2 billion. According to a statement from Nycomed, Protonix sales reached $1.9 billion in 2007, but have suffered “considerably” since the launch of Teva's and Sun’s generic versions.

In press statements, Teva and Sun have said they both believe the patent is “invalid and unenforceable” and will “pursue all available legal remedies including appeals.”

The court’s verdict is also not an entire victory for Pfizer and Nycomed. The companies had requested that Teva and Sun be stopped from their selling generic versions of Protonix until January 20, 2011 (the day after the end of pediatric exclusivity), but this was denied by the court as both generic-drug firms have patent defenses in place. As such, both generic-drug firms can continue to sell their products prior to January 20, 2011.

Nycomed said it will “seek a rapid adjudication of Teva’s and Sun’s remaining miscellaneous unenforceability defenses which were, together with Nycomed’s damage claims, bifurcated from the first trial.”