The Concentration Range In An Independent Claim Must Include The Concentrations In The Dependent Claims

In Alcon Research, Ltd. v. Apotex Inc., No. 11-1455 (Fed. Cir. Aug. 8, 2012), the Federal Circuit reversed the district court's holding that claims 1-3 and 5-7 of U.S. Patent No. 5,641,805 ("the '805 patent") would not have been obvious over the prior art, and affirmed the district court's holding that claims 4 and 8 are not invalid.

The '805 patent is directed to a method for treating allergic eye disease in humans comprising stabilizing conjunctival mast cells, the primary cells involved in allergic reactions, by topically administering an olopatadine composition. Both the olopatadine compound itself and a method of treating allergies using the class of chemicals that encompasses olopatadine were already patented at the time of invention. Distinguishing itself from the prior art, the specification states that a compound's activity in a rodent's conjunctival mast cells or in mast cells located elsewhere in the body cannot predict its ability to stabilize mast cells in the human eye. The '805 patent is listed in the Orange Book for Patanol®, which is marketed by Alcon Research, Ltd. et al. (collectively "Alcon").

Apotex Inc. and Apotex Corp. (collectively "Apotex") submitted an ANDA to the FDA seeking approval to market a generic version of Patanol®. Alcon sued Apotex for patent infringement under 35 U.S.C. § 271(e)(2)(A), asserting claims 1-8 of the '805 patent. In a bench trial, the district court found that the '805 patent was enforceable and not invalid, and that Apotex's generic product infringed the asserted claims. The district court granted a permanent injunction against Apotex, and Apotex appealed.

On appeal, the Federal Circuit stated that it "must determine what olopatadine concentrations constitute a 'therapeutically effective amount,'" and that "[t]he dependent claims are a starting point for ascertaining the concentration of olopatadine covered by claim 1." Slip op. at 10. "Because [the dependent claims] set forth a concentration range, that range at a minimum must be included in claim 1, whatever its limitations." Id. at 12.

"This is not how patent law works. . . . [Y]ou can't simply disavow the invalid portion and keep the valid portion of the claim." Slip op. at 11.

The Federal Circuit rejected Alcon's argument that the inoperative portion of the range would not be covered by the claim by virtue of the limitation requiring mast cell stabilization to a clinically relevant extent. "This is not how patent law works...