TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY

TEVA PHARMACEUTICALS INTERNATIONAL GMBH v. ELI LILLY AND COMPANY [ORDER] The Federal Circuit denied both panel rehearing and rehearing en banc. Judge Dyk dissented, arguing the panel's enablement analysis for method claims conflicts with Amgen and permits overbroad functional claiming. The denial leaves in place a panel decision treating enablement of a medical-use method claim differently from enablement of the underlying antibody genus, an issue the dissent and amici viewed as important after Amgen. Petition for panel rehearing denied; petition for rehearing en banc denied. The asserted claims, as described in the dissent, cover methods of reducing or treating headache by administering an effective amount of a humanized monoclonal anti-CGRP antagonist antibody. The rehearing dispute centered on § 112(a) enablement for method claims that recite functionally defined antibody components. Judge Dyk argued that if identifying and humanizing the claimed antibody genus would require undue experimentation, the method claim should not avoid that enablement problem merely by claiming use of the antibodies to treat headache. The court did not issue a majority merits explanation in the order; it simply denied panel rehearing and en banc rehearing after a failed poll. The denial leaves the panel opinion intact, though the extracted order does not provide the full panel reasoning beyond the dissent's description. § 112(a) claim construction precedential § 112(a) claim construction precedential § 112(a) precedential