In DSU Medical Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006) (en banc in relevant part), the Federal Circuit held that inducement of infringement under section 271(b) requires a “specific intent” to infringe. A general intent to encourage direct infringement will not establish a successful inducement claim. But the court failed to provide any guidance on establishing the requisite intent. In pharmaceutical cases, however, specific intent may be established by the wording of a drug label, particularly in Hatch-Waxman cases.
Inducement is particularly relevant in pharmaceutical litigation as method-of-use claims are infringed under section 271(b). Conventional principles of induced infringement apply in determining infringement under the Hatch-Waxman Act. See Warner- Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003). First, the inducer must have knowledge of the asserted patent. See Global-Tech Appliances, Inc. v. SEB S.A., 131 S. Ct. 2060, 2070 (2011). In Hatch-Waxman actions, this knowledge is easily proven by reference to the Orange Book. Moreover, the filing of a paragraph IV certification undoubtedly shows that a generic manufacturer had actual knowledge of any patents that claim the proposed method-of-use. See, e.g., Bone Care Int’l, L.L.C. v. Roxane Labs., Inc., 2012 WL 2126896 (D. Del. June 11, 2012). Therefore, once direct infringement is established, a plaintiff must only prove that the generic manufacturer had the specific intent to induce infringement. Such intent may be inferred from evidence of a sales force, advertisements in medical journals, direct marketing to doctors, or funded research or meetings on the claimed method. See Warner-Lambert Co. v. Apotex Corp., 2001 WL 1104618, at *3 (N.D. Ill. Sept. 14, 2001), aff’d, 316 F.3d 1348 (Fed. Cir. 2003). Continue Reading »