Festo Bars Preliminary Injunction

Article originally written on February 10, 2004

Cancellation of claims has taken on greater significance in view of the recent decision in Ranbaxy Pharmaceuticals, Inc. and Ranbaxy Laboratories Limited v. Apotex, Inc., Federal Circuit Appeal No. 02-1429, decided 11-26-2003. Ranbaxy involved an appeal of a New Jersey District Court's denial of a preliminary injunction against Ranbaxy Pharmaceuticals and Ranbaxy Laboratories Limited, and held that a narrowing amendment can occur when a broad claim is canceled and an original dependent claim is rewritten in independent form.

Ranbaxy et al brought suit for a declaration of non-infringement of Apotex's U.S. Patent No. 5,847,118. Apotex filed a counterclaim alleging that Ranbaxy infringed the '118 patent and Apotex requested the court to issue a preliminary injunction.

The application which issued as the '118 patent was filed with one independent claim and nine dependent claims. Claim 1 was directed to a process of preparing amorphous cefuroxime axetil by steps which included dissolving crystalline cefuroxime axetil in a "highly polar organic solvent." In the first Official Action, claims 1, 8 and 10 were rejected as indefinite, claims 1, 2, 9 and 10 were rejected as obvious over prior art and claims 3-7 were indicated as allowable. In response, Apotex canceled claims 1-10 and submitted new claims 11-16. Claim 11 was similar to canceled claim 1 but further defined the "highly polar organic solvent" as being selected from the group consisting of a sulfoxide, an amide and formic acid. These solvents are identical to the solvents recited in canceled claims 3, 5 and 7. Claim 11 was allowed and became claim 1 of the '118 patent.

In the District Court action, Apotex alleged that Ranbaxy's process (which used acetic acid) infringed the '118 patent under the doctrine of equivalents. The District Court denied Apotex's request for a preliminary injunction on the basis that Apotex did not show a reasonable likelihood of success on the merits. The Federal Circuit agreed that Apotex could not make the required showing of infringement due to prosecution history estoppel since the narrowing amendment resulted in a complete bar of equivalents under Festo Corporation v. Shoketsu Kinsoku Kogyo Kabushiki Co., 234 F.3d 558, 56 USPQ2d 1865 (Fed. Cir. 2000) (en banc), vacated by 535 U.S. 722, 122 S.Ct. 1831, 62 USPQ2d 1705 (2002).

In its appeal, relying on Bose Corporation v. JBL, Inc, 274 F.3d 1354, 61 USPQ2d 1216...