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
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
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.