In Metacel Pharmaceuticals LLC v. Rubicon Research Private Ltd., the Court of Appeals for the Federal Circuit (CAFC) held that the optional product storage temperatures stated in Rubicon’s proposed generic product label did not induce infringement of US Patent No. 10,610,502 because Rubicon’s proposed label only optionally permits the refrigeration storage claimed by Metacel’s patent, and clearly instructs room temperature storage.1 In so holding, the CAFC affirmed a district court grant of summary judgment of noninfringement.2

Background

Induced patent infringement occurs when one person actively causes another to directly infringe a patent.3 Patentees frequently assert inducement in Hatch-Waxman cases, which involve pharmaceutical products. The instructive nature of pharmaceutical pres

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