Federal Circuit Finds Method-of-Treatment Claims Including In Vivo Dosing Limitations Are Not Enabled By In Vitro Data

Short summary

The Federal Circuit affirmed that Wyeth's method-of-treatment patent claims for EGFR inhibitors were invalid for lack of enablement, overturning a $107.5M jury verdict against AstraZeneca's Tagrisso. The court held that in vitro data cannot enable claims requiring in vivo dosing limitations. This contrasts with Teva v. Lilly, where functional 'effective amount' claims were upheld because the specification answered the question the claims posed.

• •Wyeth's $107.5M verdict wiped out—claims invalid for lack of enablement
• •In vitro data insufficient to enable claims requiring in vivo dosing
• •Contrasts with Teva v. Lilly where functional claims were upheld

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