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.