Wednesday, September 19, 2007

Scope of ANDA Injunction Cannot Go Beyond Compounds Listed In ANDA

Case: Forest Laboratories, Inc., et al. v. Ivax Pharmaceuticals, Inc., et al. (Fed. Cir. No. 07-1059, 9/5/07)

The One Sentence Summary: The district court was affirmed in rejecting anticipation, obviousness and broadening reissue challenges to a patent, but the patent infringement injunction arising from an Abbreviated New Drug Application ("ANDA") was too broad in covering compounds not listed in the ANDA.


Federal Circuit Holdings:
  • The district court did not err in finding that the patent was not anticipated by a prior reference where the reference discussed the patented compound but did not disclose how to isolate it.
  • The district court did not err in rejecting an obviousness challenge to the patented enantiomer in light of evidence showing the failure of others to isolate the enantiomer.
  • The correction on reissue of a typographical error in the optical sign of the patented compound was not an improper broadening reissue where the mistake would have been apparent to one of skill in the art.
  • The injunction issued by the district court was too broad in that it covered other products under the patent even though those products were not listed in the ANDA application.

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