AMGEN INC. v. SANDOZ INC., decided May 8, 2019, Claim Interpretation

U.S. Patent Nos. 6,162,427 and 8,940,878 are directed to protein purification by absorbent chromatography and treatment of diseases using peripheral stem cell transplantation (pages 4-6). The ‘878 claims require “applying a solution to remove . . . while preserving binding” and “applying a solution that reverses the binding” (page 7). The district court interpreted these limitations to require distinct solutions added at different times (page 8). The claim language indicates sequential performance (page 9) and the specification treats these limitations as two different steps in sequence, not functions to be performed (pages 9-10). A one-step, one-solution process is not equivalent (pages 10-11). Equivalents cannot override clear claim language (page 11). The ‘427 claims require a “disease treating-effective amount” (page 14). The agent must be administered to treat a disease, not just for stem cell mobilization, as the preamble is directed to treatment of disease (page 15), different claim terms are used for treatment and mobilization (page 15), and the specification teaches to treatment (page 16).

Hindsight: A claim may be restricted to an ordered sequence expressly or based on necessary pre-cursers linking limitations. Alternatives may be used to distinguish function from actual steps in claiming, such as indicating one solution to perform the different functions in any order. The specification may directly or expressly deal with possible difference in order of acts of any method. Some claims may not be being directed to an end result or purpose, such as treating disease, in order to more broadly claim how that purpose is achieved. This may allow for the claims to cover “how” without requiring the purpose. Alternatives in the specification to indicate other purposes may be helpful.