Judgment against generic pharmaceutical company IVAX after bench trial

Forest Laboratories, Inc., et al., v. IVAX Pharmaceuticals, Inc. et al., No. 03-891-JJF; July 13, 2006.

Farnan, J.   After 5-day bench trial, court finds defendants have not established that the patents-in-suit are invalid as anticipated, obvious, or impermissibly broadened upon reissue, nor that a patent is unenforceable for inequitable conduct.


The technology relates to citalopram, the active ingredient in LEXAPRO, which is an antidepressant drug.  Infringement was undisputed.  The court found that the prior art reference relied on by defendants did not anticipate the patent-in-suit, nor was it enabled such that it anticipates.

Furthermore, the court found the disputed claims were not obvious, based on the reasoning in Pfizer that prior art disclosure of a racemate does not anticipate the individual isomers of the racemate or render the individual isomers of the racemate obvious.  Secondary considerations weigh in favor of court’s conclusion that the patent is valid.

Claim II was not invalid for broadening a reissued claim.  The claim was changed two years after the patent first issued from a method for converting (+)-diol intermediate to (+)-citalopram to a means for converting (-)-diol intermediate to (+)-citalopram.  Defendant’s claim that the change from (+) to (-) designation of the diol intermediate improperly broadened the claim was rejected.

No inequitable conduct was found where a withheld reference was either immaterial, cumulative or less material than the art disclosed.  With respect to one reference, there was no evidence that it was known to anyone with a duty of candor to the PTO. No evidence of intent or materiality existed with respect to misstatement to the PTO.

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