Roche Products, Inc. v. Bolar Pharmaceutical Col., Inc.
733 F.2d 858 (Fed. Cir. 1984)

  • Roche had a patent for a drug called flurazepam. About a year before the patent was to expire, a generic drug company, Bolar, began working on a process for producing the drug. Bolar experimented a bit, and then submitted their work to the FDA for approval.
    • The FDA approval process took a long time, and Bolar wanted bring an approved generic drug to market the day after Roche's patent expired.
    • Note that the first sale doctrine was not applicable in this case because Bolar bought the flurazepam they were experimenting with from an overseas manufacturer.
  • Roche sued Bolar for infringement.
    • Roche argued that Bolar violated their patent by experimenting with their patented drug.
    • Bolar argued that they had no intention of marketing the drug before the patent expired (and couldn't even if they wanted to because they needed FDA approval). Bolar argued such experimental use should not be considered infringement.
  • The Trial Court found for Bolar. Roche appealed.
  • The Appellate Court reversed
    • The Appellate Court found that Bolar's experimental use was strictly for commercial purposes. They were not experimenting for "amusement, to satisfy idle curiosity, or for philosophical inquiry."
      • Therefore it didn't fall under the common law experimental use exception, which was intended to cover amateur hobbyists.
      • Experimental use goes all the way back to Whittemore v. Cutter (29 Fed. Cas. 1120 (C.C.D. Mass. 1813)).
    • Bolar argued that there was a public policy reason to allow for their experimental use exception, because if it legitimately took several years to get FDA approval, that unjustly extended Roche's patent. However, the Court found that there was nothing in the FDA Statutes that implied that Congress meant to rewrite the patent laws.
      • The Court suggested that if Bolar didn't like how long FDA took to approve a generic drug, they lobby Congress to change the law.
      • Note that Roche also had to get FDA approval, so is it really fair to say that their patent would be unjustly extended by having Bolar go through the same process?
  • Congress listened, and passed the Drug Price Competition and Patent Term Restoration Act (aka the Hatch-Waxman Act), which addressed some of Bolar's concerns.