Abbott Labs. v. Sandoz, Inc., No. 07 C 1721, Slip op. (N.D. Ill. May 3, 2007) (Anderson, J.).
Judge Anderson denied plaintiffs’ motion for a preliminary injunction to prevent defendants Sandoz, Inc. ("Sandoz") and Teva Pharmaceutical Industries, Ltd. ("Teva") from selling a generic version of plaintiff Abbott Laboratories’ ("Abbott") antibiotic cefdinir, which it markets using the name Omnicef. Plaintiffs’ original patent, U.S. Patent No. 4,559,334 (the "’334 patent"), covering a form of cefdinir expired on Sunday, May 6, 2007 at 10:59 p.m. CDT. Plaintiffs’ second patent, U.S. Patent No. 4,935,507 (the "’507 patent"), covering a crystalline cefdinir, does not expire until December 4, 2011. Plaintiffs argued that Sandoz’s and Teva’s respective formulations of cefdinir (the "accused products"), which the parties agree can be classified as cefdinir monohydrate, infringed the ‘507 patent and, therefore, sales of the accused products should be enjoined. The Court, with agreement of the parties, adopted a prior claim construction from Judge Payne of the E.D. Virginia for purposes of the PI determination. Using Judge Payne’s construction, the Court held that the accused products did not likely infringe the ‘507 patent. First, cefdinir monohydrate only displayed four of the seven peaks in an x-ray diffraction pattern that the ‘507 patent identified as indicative of crystalline cefdinir within the +/-.1 degree margin of error that the Court determined was the proper construction of the ‘507 patent’s "about" qualifier. Second, the Court held that "trace" amounts of crystalline cefdinir that were allegedly in the accused products in addition to the cefdinir monohydrate did not likely amount to literal infringement.
The Court also held that plaintiffs had not shown a likelihood of proving infringement pursuant to the doctrine of equivalents. First, the Court discounted plaintiffs’ expert’s allegation of equivalents because he did not support his opinions with "empirical or substantive evidence." Second, the Court denied plaintiffs’ argument that Sandoz’s and Teva’s statements that the accused products were bioequivalent to crystalline cefdinir in their ANDAs was proof of infringement. The court noted that if bioequivalency were infringement, there could never be generics during a patent’s life.
Because Sandoz’s ANDA was previously approved by the U.S. Food & Drug Administration (the "FDA"), the Court’s ruling meant that Sandoz was free to sell its generic beginning Sunday, May 6 at 11:00 p.m. CDT. Teva’s ANDA had not been approved, however, so it must wait until the FDA acts upon its ANDA. You can find the Chicago Tribune’s brief coverage of the decision in last weekend’s Midwest Briefs.