Sanofi-Synthelabo v. Apotex, Inc.
470 F.3d 1368 (Fed. Cir. 2006)

  • Sanofi had a patent on a heart medication. Apotex wanted to make a generic version of the drug, so they filed an Abbreviated New Drug Application (ANDA) with the FDA. Sanofi sued for infringement.
    • Under the Hatch Waxman Act (35 U.S.C. 271(e)) just filing an ANDA on a patented drug is an infringement of the patent.
    • Apotex argued that Sanofi's patent was invalid.
  • While the litigation was going on, the FDA approved the ANDA. Apotex began distributing their generic drugs. Sanofi filed a motion for a preliminary injunction.
    • Preliminary injunctions are covered by 35 U.S.C. 283.
    • Apotex realized that they could get into trouble if they lost the patent case, but they figured they would win.
  • The Trial Court granted the injunction. Apotex appealed.
    • The Trial Court applied the four-factor test from Amazon.com, Inc. v. Barnesandnoble.com (239 F.3d 1343 (2001)) for determining if a preliminary injunction was warranted. The plaintiff must show:
      • A reasonable likelihood of its success on the merits,
      • Irreparable injury if an injunction is not granted,
      • That considering the balance of hardships between the plaintiff and defendant, a remedy in equity is warranted, and
      • The public interest would not be disserved by a permanent injunction.
    • Note that this is not the same as the four-factor test for determining if a permanent injunction should be granted. That test was described in eBay v. MercExchange (547 U.S. 388 (2006)).
    • The Court ordered Sanofi to posts a $400M bond to pay Apotex if they later won the patent case and could should they were harmed by the preliminary injunction.
  • The Appellate Court affirmed.
    • The Appellate Court found that the Trial Court had applied the four-factor test and had not abused its discretion. Therefore the decision would not be overturned.
      • The Court found that Apotex was unlikely to win.
      • The Court found that Sanofi was likely to suffer injury because of price erosion, loss of goodwill, lay-offs, and they would stop clinical trials.
      • The Court found that the balance of hardships favored Sanofi because Apotex voluntarily started marketing their drug before the case was concluded, so it's their own fault if they get hurt.
      • The Court found that the public interest was better served by enforcing Sanofi's patent because it would encourage research and development.
    • The Court found that $400M was a good amount for the bond.