Regents of the University of California v. Eli Lilly Co.
119 F.3d 1559 (Fed. Cir. 1997)
- Cal scientists figured out a way
to isolate a piece of DNA in rats and use it to create insulin. They
filed a patent.
- The patent was broad and
claimed the process for all animals, including humans, even though they
had only experimented in rats.
- When Lilly began making human
insulin from human DNA they isolated, Cal sued for infringement.
- Lilly argued that Cal's
patent was not valid under 35 U.S.C. §112 because the written description wasn't detailed to
support all of the claims.
- The written description did not detail the piece of DNA in humans
that could be used to make human insulin.
- The Trial Court found for
Lilly. Cal appealed.
- The Appellate Court affirmed.
- The Appellate Court found
that an adequate written description
of DNA requires a precise definition, such as by structure, formula,
chemical name, or physical properties.
- So basically, the Court
found that when talking about DNA, you have to specifically spell out
the genetic code.
- Since Cal's patent did not
disclose the sequence of human insulin-producing DNA in the written
description, Cal could not make a claim for it.