Mastering the Written Description Requirement

Biotech Patenting Conference

10/22/04

London, England

Speaking Engagement

C5 Biotech Patenting Conference

  • What constitutes an adequate written description under U.S. law?
     
  • Should U.S. courts recognize a written description requirement independent of the enablement requirement? Judge Rader's concurrence in Moba, B.V. v. Diamond Automation, Inc. (Fed. Cir. 2003) argues they should not.
     
  • Written description's original role as "priority policeman" — showing possession of a later-claimed invention as of the application's filing date. e.g., Vas-Cath, Inc. v. Mahurkar (Fed. Cir. 1991).
     
  • Written description as "super enablement":
    • Regents of the Univ. of Cal. v. Eli Lilly & Co. (Fed. Cir. 1997) and its progeny.
    • Harsh application of the written description requirement in biotechnology cases without priority issues — no functional claiming for DNA.
  • The qualified return of functional claiming for DNA:
    • Enzo Biochem, Inc. v. Gen-Probe, Inc. (Enzo II) (Fed. Cir. 2002).
    • Amgen Inc v. Hoechst Marion Roussel, Inc. (Fed. Cir. 2003).
  • The Lilly rule expands to non-DNA inventions, but USPTO-sanctioned functional claiming of monoclonal antibodies permitted Noelle v. Lederman (Fed. Cir. 2004).
     
  • Univ. of Rochester v. G.D. Searle (Fed. Cir. 2004)
    • what does it mean for biotechnology inventions?
    • is functional claiming dead again?
    • is actual reduction to practice required now?
    • are valid biotechnology claims now limited to exemplified embodiments?
    • does the presumption of validity apply to written description anymore?

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