Tuesday, generic-drug maker Teva Pharmaceutical Industries Ltd. (TEVA) said the U.S. District Court for the District of Delaware has dismissed patent infringement allegations over its Abbreviated New Drug Application for marketing the generic version of Prevacid SoluTab, manufactured by Japanese drug maker Takeda Pharmaceuticals.
The court found that Israel-based Teva's generic lansoprazole orally-disintegrating tablets do not infringe U.S. Patent No. 5,464,632. Teva said it would complete an analysis of the decision before deciding upon its next course of action.
Lansoprazole is intended for the treatment of acid reflux, heartburn and stomach ulcers. Annual sales of the brand product were $500 million in the U.S. for the twelve months ended June 30, 2009.
In an earlier judgment in March, U.S. District Judge Sue Robinson had ruled that Teva's generic drug infringes one of the two patents held by Takeda. The court ruled that Teva infringed patent no. 4,628,098 covering the lansoprazole compound, while it dismissed allegations of infringement over patent no. 5,045,321 covering a composition of lansoprazole. The court had ruled that the lansoprazole and magnesium carbonate in Teva's product are not "in contact ... evenly" as required by the claims and therefore is not an infringement of the '321 patent.
While Teva had conceded during the trial that its generic drug infringes the '098 patent, it argued that the patent, along with patent no. 5,045,321 covering a composition of lansoprazole, were invalid for obviousness and unenforceable due to inequitable conduct. The court had rejected Teva's argument that the patents were obvious.
TEVA is losing $0.21 or 0.39%, and is trading at $52.99 on a volume of 1.58 million shares on the Nasdaq.
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