Going down With the Ship: Non-infringing Indications Are Barred When Listed in the Same ANDA as Infringing Indications

Written by: Zachary B. Messick & Jacob R. Rosenbaum

SALIX PHARMACEUTICALS, LTD. v. NORWICH PHARMACEUTICALS., INC.

Before Lourie, Chen, and Cunningham.  Appeal from the District of Delaware

Summary: The Federal Circuit ruled that an ANDA listing an infringing indication cannot be approved during the pendency of the infringed patent even if the ANDA also lists a non-infringing indication. 

Norwich filed an abbreviated new drug application (ANDA), seeking approval of a generic version of rifaximin to treat hepatic encephalopathy (HE) and irritable bowel syndrome with diarrhea.  Salix sued Norwich in the District of Delaware for infringement of various patents, including patents directed to methods of treating HE with rifaximin.  After a bench trial, the district court found the HE patents valid and infringed.  The district court therefore instructed the FDA that Norwich’s ANDA should not be approved before the expiration of the HE patents in accordance with 35 U.S.C. § 271(e)(4)(A). Norwich subsequently amended its ANDA application to remove the infringing indication for treatment of HE with rifaximin.  Norwich then moved to amend the final judgment to allow its ANDA application to be approved immediately for the noninfringing restrictions.  The district court denied the motion to modify the judgment.

On appeal, Norwich argued that the district court misinterpreted Section 271(e)(4)(A) in ordering the FDA to withhold approval of its ANDA until the HE patents expired.  Norwich argued that, in requiring the FDA to restrict “infringement,” the statute required the restriction of only the infringing indications in the ANDA. Norwich also argued that the district court abused its discretion in denying Norwich’s motion to amend the judgment in view of the amendments to the ANDA application.

The Federal Circuit affirmed.  The court held that, for purposes of Section 271(e)(4)(A)’s requirement that the FDA restrict infringement, the relevant infringement “is the submission of the ANDA that included an infringing use.”  “That the ANDA further recited a non-patent-protected indication does not negate the infringement resulting from the ANDA’s submission.”  Thus, the district court correctly barred approval of the entire ANDA application under Section 271(e)(4)(A).

The Federal Circuit also held that the district court did not abuse its discretion when it denied Norwich’s motion to amend the judgment based on the amended ANDA application. The Federal Circuit stressed that Norwich had presented no evidence that the amended ANDA would not infringe the HE patents, and that making that determination “would essentially be a second litigation.”

Editor: Sean Murray