District Court Finds Forest Labs' Lexapro Patent Valid and Enforceable, Halting Teva's Plans for Generic
The U.S. District Court for the District of Delaware released its opinion last Thursday in the Lexapro patent infringement case, finding in favor of Forest Labs. Forest, the maker of Lexapro, sued IVAX, a division of Teva, for patent infringement based on IVAX's ANDA to market generic versions of Lexapro. Forest took in over $2 billion on Lexapro sales in the U.S. last year.
Post-trial briefing in the case was completed not even two months ago. The quick decision by Judge Farnan suggests the case was a slam-dunk for Forest.
Addressing defendants' lead argument, the court found the patent in suit, covering substantially pure (+)-citalopram, was not anticipated by a reference (Smith) that disclosed both the (+) and (-) enantiomers individually. According to the court:
Smith only discloses the chemical structure of (R)-citalopram and does not disclose the chemical structure of (S)-citalopram, which corresponds to (+)-citalopram. In addition, Smith does not disclose anything with regard to the purity of the (S)-enantiomer when it mentions that enantiomer, and the Court cannot presume that the disclosure of (R)-citalopram, individually and not in any mixture, necessarily discloses substantially pure (S)- or (+)-citalopram. In these circumstances, the Court cannot conclude that Smith discloses the entirety of the claimed invention.
Earlier last week, Forest Labs sued Caraco Pharmaceutical Laboratories, another generic drug company who filed an ANDA for generic Lexapro. That case was filed in the Eastern District of Michigan.
With last week's decision finding Forest's patent on Lexapro valid and enforceable, generic drug makers will likely have to wait until 2012 before they can market any generic versions of Lexapro. Forest's patent expires in 2011, but its pediatric exclusivity period runs until March 13, 2012.
Teva will probably appeal the case to the Court of Appeals for the Federal Circuit.
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