Patent Statements of Law

Eric E. Bensen

Quotations (Sample excerpt):

Chapter 18 Adequate Disclosure—Enablement

[4] Disclosure Must Alleviate the Need for “Undue Experimentation”

[c] Routine Experimentation Permitted

“[A]lthough experimentation must not be undue, a reasonable amount of routine experimentation required to practice a claimed invention does not violate the enablement requirement.”

  • “Enablement is not precluded where a ‘reasonable’ amount of routin experimentation is required to practice a claimed invention … .” ALZA Corp. v. Andrx Pharms., LLC, 603 F.3d 935, 940, 94 U.S.P.Q.2D (BNA) 1823 (Fed. Cir. 2010) (affirming district court conclusion that asserted claims were invalid for lack of enablement because the specification did not enable the full scope of claim 1, which covered both osmotic and non-osmotic dosage forms of Attention Deficit and Hyperactivity Disorder drug).

“Even a considerable amount of experimentation is permissible, as long as it is merely routine or the specification provides a reasonable amount of guidance regarding the direction of experimentation.”

“[R]outine experimentation is ‘not without bounds.’ ”