Drug Labels Can Provide The "Specific Intent" Required For Inducement Of Infringement


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). —Read more on Fish’s Litigation Blog