Patent ruled not enabled on remand

Impax Laboratories, Inc. v. Aventis Pharmaceuticals Inc., C.A. No. 02-581-JJF, July 19, 2007.

Farnan, J.  On remand from the Federal Circuit to determine whether this patent-in-suit was enabled by prior art, the Court found that the patent was not enabled and therefore does not invalidate the patent on the grounds of anticipation.


This is an ANDA case.  The patent relates to the use of riluzole for the treatment of ALS.  The trial court previously ruled that the ‘940 patent did not anticipate the patent-in-suit, since there was no evidence that the ‘940 patent was effective.  The Federal Circuit noted that the prior art need not be effective in order to be enabling and anticipating and remanded with instructions to determine whether the prior art was enabling.  The trial court found the art was not enabling because it references hundreds to thousands of compounds and does not direct one skilled in the art to conclude that ALS can be treated with riluzole without undue experimentation.

A copy of the full opinion is available here.

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