US court rules against Teva in Protonix case

Upholding an April ruling means Teva may have to pay over $1 billion in damages.

A US court has denied a motion by Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) to invalidate a patent for Wyeth's GERD treatment Protonix.

On April 23rd, a jury found that the patent was "not invalid". Teva made an at-risk launch of generic Protonix in December 2007, so the April ruling may lead to hundreds of millions, or even billions, of dollars in damages, that Teva has to pay.

Teva said that the US District Court for the District of New Jersey denied Teva’s motion to overturn the April 23, 2010 verdict. The court also denied Wyeth and Nycomed's request for the US Food and Drug Administration (FDA) to reset the date of Teva's final approval to January 2011. The court based the decision on the fact that Teva has patent defenses remaining at the district court, including patent misuse. If a judge sides with Teva on these issues, it would also invalidate the patent.

Teva is still not prohibited from making further sales prior to January 2011, the date when the pediatric exclusivity expires.

Teva’s Pantoprazole Sodium DR Tablets are the AB-rated generic equivalent of Wyeth's erosive Gastro Esophageal Reflex Disease (GERD) treatment Protonix DR Tablets. Analysts estimate that Teva's version reached a 40-50% market share since its release.

Nycomed licensed Protonix to Wyeth. Wyeth was bought by Pfizer at the end of 2009. Nycomed and Wyeth filed the patent infringement case against Teva in May 2004.

Shares in Teva fell 2.5% on Friday to $54.33, giving a market cap of $48.52 billion.

Published by Globes [online], Israel business news - - on July 18, 2010

© Copyright of Globes Publisher Itonut (1983) Ltd. 2010

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