A patent dispute over the heartburn drug Protonix escalated Monday when Wyeth said it will sue to recover lost profits from sales of Teva Pharmaceutical Industries Ltd.'s generic version.
The US4758579 which covers Fluoroalkoxy substituted benzimidazoles useful as gastric acid secretion inhibitors including petoprazole as product. The patent is set to expire in July 2010, though Wyeth could extend the date to 2011 if it seeks a pediatric use for the drug. Protonix had sales of $1.4 billion during the first nine months of 2007.
Meanwhile, the companies are still discussing a possible settlement and Teva said it is voluntarily halting additional shipments of the generic drug for 30 days.
Teva has already been awarded a 180-day period of market exclusivity for being the first company to file for a generic version of the drug, which the U.S. Food and Drug Administration approved in August.
Wyeth estimated that Teva likely began shipping the generic drug Friday and, in a conference call, several analysts expressed concern that Teva's launch may have been substantial.
In its own conference call, Teva categorized the Protonix launch as "relatively full" but limited to the United States. Most shipments won't be received until after the new year and will be included in the 2008 financial results. Teva did not provide additional details on the launch.
The companies are already embroiled in a patent infringement lawsuit over the drug. In September, a federal judge in New Jersey denied a motion by Wyeth and its partner Altana Pharma AG to halt sales of Teva's generic version. While Teva is not disputing it infringed the patent, it is arguing the patent itself is not valid.
Both Wyeth and Altana have already filed an appeal over the denied injunction. The drug was licensed to Wyeth by Altana, which was recently bought by Nycomed Holding AS.
Wyeth president Bernard Poussot said the company will stand by its position that the patent is valid and enforceable while heading into further Teva negotiations.
"We are going to use the days ahead to assess our best options," he said in a conference call
Wyeth expects the patent trial to start in the second half of 2008 and said the lawsuit raises significant revenue challenges in the New Year. The company will revise its 2008 business plan and guidance in January.
Sun pharma and Schwarz Pharma are the other two para IV filers.
The US4758579 which covers Fluoroalkoxy substituted benzimidazoles useful as gastric acid secretion inhibitors including petoprazole as product. The patent is set to expire in July 2010, though Wyeth could extend the date to 2011 if it seeks a pediatric use for the drug. Protonix had sales of $1.4 billion during the first nine months of 2007.
Meanwhile, the companies are still discussing a possible settlement and Teva said it is voluntarily halting additional shipments of the generic drug for 30 days.
Teva has already been awarded a 180-day period of market exclusivity for being the first company to file for a generic version of the drug, which the U.S. Food and Drug Administration approved in August.
Wyeth estimated that Teva likely began shipping the generic drug Friday and, in a conference call, several analysts expressed concern that Teva's launch may have been substantial.
In its own conference call, Teva categorized the Protonix launch as "relatively full" but limited to the United States. Most shipments won't be received until after the new year and will be included in the 2008 financial results. Teva did not provide additional details on the launch.
The companies are already embroiled in a patent infringement lawsuit over the drug. In September, a federal judge in New Jersey denied a motion by Wyeth and its partner Altana Pharma AG to halt sales of Teva's generic version. While Teva is not disputing it infringed the patent, it is arguing the patent itself is not valid.
Both Wyeth and Altana have already filed an appeal over the denied injunction. The drug was licensed to Wyeth by Altana, which was recently bought by Nycomed Holding AS.
Wyeth president Bernard Poussot said the company will stand by its position that the patent is valid and enforceable while heading into further Teva negotiations.
"We are going to use the days ahead to assess our best options," he said in a conference call
Wyeth expects the patent trial to start in the second half of 2008 and said the lawsuit raises significant revenue challenges in the New Year. The company will revise its 2008 business plan and guidance in January.
Sun pharma and Schwarz Pharma are the other two para IV filers.
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