Cephalon, Inc. v. Mylan Pharms. Inc.

Indirect infringement can be shown by demonstrating that an accused infringer knew or should have known that its actions would induce infringement of a patent.

Opinion (ROBINSON): Mylan Pharmaceuticals, Inc. ("Mylan") filed an Abbreviated New Drug Application seeking permission to market a generic version of Fentora, which is sold by Cephalon, Inc. ("Cephalon") for the treatment of pain in cancer patients. Cephalon filed a lawsuit claiming the generic drug infringed several of its patents. Two of the patents (the Khankari patents) claim the use of an effervescent agent to enhance oral mucosa absorption. The other patent (the '158 patent) relates to the oral administration of fentanyl to effectively treat pain while using a lower dosage of that substance. Chephalon alleged that Mylan's generic indirectly infringed the Khankari patents and that that infringement was literal. To establish indirect infringement, the patent holder can show the alleged infringer either actively induced infringement of the patent or contributed to the infringement of the patents. To demonstrate active inducement of infringement the plaintiff must show the accused infringer knew or should have known its actions would induce actual infringement. Liability for indirect infringement requires showing direct infringement. Where that infringement is literal, the accused invention must perform every claim of the infringed patent. During a bench trial, Chephalon showed that Mylan's generic practiced each of the disputed claims in the Khankari patents. Because the only approved use of its generic was as a medicine, Mylan knew that by marketing the drug it would be inducing infringement. Because each claim in the infringed patents was implemented by the generic and because Mylan knew its actions would induce infringement of the patents, the court held that Mylan's generic infringed the Khankari patents. Chephalon alleged both direct and indirect infringement of the '158 patent. Following claim construction, Mylan could not offer a non-infringement defense for '158 patent and the court held it directly and indirectly INFRINGED that patent.