Wednesday, November 13, 2013

Sanofi-Synthelabo v. Apotex, Inc. case brief

Sanofi-Synthelabo v. Apotex, Inc. case brief summary
470 F.3d 1368 (2006)

Plaintiff owners of a patent for a pharmaceutical compound sued defendant competitor, alleging that the competitor's generic compound infringed the owners' patent, and the competitor admitted infringement but asserted that the patent was invalid and unenforceable. The competitor appealed the order of the United States District Court for the Southern District of New York which granted the owners' motion for a preliminary injunction.

The competitor contended that the active ingredient in the patented formula was anticipated and made obvious by prior art, and that the patent was unenforceable based on the owners' inequitable conduct in concealing research and making false statements, and based on unclean hands related to misconduct during settlement negotiations.


  • The court held, however, that the competitor failed to show a likelihood of patent invalidity or unenforceability. 
  • The prior art did not disclose the specific salt in the patented formula's active ingredient as required to establish anticipation, and a finding of obviousness was precluded since the specific salt could only be determined by testing numerous possible salts for suitability. 
  • Further, the competitor's generalized allegations of inequitable conduct failed to establish the requisite deceptive intent, and any misconduct of the owners in settlement negotiations was unrelated to the validity of the patent. 
  • Also, the owners showed irreparable harm from the competitor's infringement, any harm to the competitor was self-inflicted, and the public interest in pharmaceutical research outweighed the interest in low-cost generic drugs.

The order granting the preliminary injunction was affirmed.

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