Attorney at Law - Texas
Intellectual Property Law Author, Consultant & Expert Witness
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.”
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Cephalon, Inc. v. Watson Pharms., Inc., 707 F.3d 1330, 1336, 105 U.S.P.Q.2D (BNA) 1817 (Fed. Cir. 2013) (district court’s non-enablement determination reversed where evidence on the record did not sufficiently show that the experimentation necessary to co-administer a soluble acid source with a single compound effervescent agent would be unduly extensive).
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“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.”
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Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1386, 107 U.S.P.Q.2D (BNA) 1273 (Fed. Cir. 2013) (affirming district court that there was no genuine dispute that practicing the full scope of the claims related to use of rapamycin for the treatment and prevention of restenosis, or renarrowing of an artery, measured at the time of filing, would require excessive experimentation).
“[R]outine experimentation is ‘not without bounds.’ ”
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Wyeth & Cordis Corp. v. Abbott Labs., 720 F.3d 1380, 1386, 107 U.S.P.Q.2D (BNA) 1273 (Fed. Cir. 2013) (affirming district court that there was no genuine dispute that practicing the full scope of the claims related to use of rapamycin for the treatment and prevention of restenosis, or renarrowing of an artery, measured at the time of filing, would require excessive experimentation).