Indirect Patent Infringement in the US: Points to Consider for Generic and API Manufacturers

‘Except as otherwise provided in this title, whoever, without authority makes, uses, offers to sell or sells any patented invention within the United States or imports into the United States any patented invention during the term of the patent therefore, infringes the patent.’ 35 U.S.C. § 271(a).

This is generally done with a 'section viii’ or ‘little viii’ statement. F.D.C.A. § 505 (j)(2)(A)(viii).

‘[I]t is well settled that there can be no inducement or contributory infringement absent an underlying direct infringement.’ Novartis Pharms Corp. v Eon Labs Mfg., Inc., 363 F.3d 1306, 1308 (Fed. Cir. 2004).

‘Whoever actively induces infringement of a patent shall be liable as an infringer.’ 35 U.S.C. § 271(b).

See Carborundum Co. v Molten Metal Equipment Innovations, Inc., 72 F.3d 872, 876 n.4 (Fed. Cir. 1995).

See Manville Sales v Paramount Systems, 917 F.2d 544, 554 (Fed. Cir. 1990); Hewlett-Packard Co. v Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1529 (Fed. Cir. 1990) (‘proof of actual intent to cause the acts which constitute the infringement is a necessary prerequisite to finding active inducement’); Rodime PLC v Seagate Tech., Inc., 174 F.3d 1294, 1306 (Fed. Cir. 1999). Tegal Corp. v Tokyo Electron Co., Ltd., 248 F.3d 1376, 58 USPQ2d 1791 (Fed. Cir. 2001).

Rodime PLC v Seagate Tech., Inc., 50 USPQ2d 1429, 1437 (Fed. Cir. 1988).

Manville Sales Corp. v Paramount Sys., Inc., 16 USPQ2d 1587, 1594 (Fed. Cir. 1990) (emphasis added).

DSU Medical Corp. v JMS Co., LTD., 471 F.3d 1293, 1304 (Fed. Cir. 2006).

Id. at 1307.

Warner-Lambert Co. v Apotex Corp., 316 F.3d 1348, 1364 (Fed. Cir. 2003).

‘Whoever offers to sell or sells within the United States or imports into the United States a component of a patented machine, manufacture, combination, or composition, or a material or apparatus for use in practicing a patented process, constituting a material part of the invention, knowing the same to be especially made or especially adapted for use in an infringement of such patent, and not a staple article or commodity of commerce suitable for substantial noninfringing use, shall be liable as a contributory infringer.’ 35 U.S.C. § 271 (c).

‘In order to succeed on a claim of contributory infringement, in addition to proving an act of direct infringement, plaintiff must show that defendant knew the combination for which its components were specially made was both patented and infringing and that the defendant's components have no substantial non-infringing uses.’ Cross Medical Products Inc. v Medtronics Sofamor Danek Inc., 76 U.S.P.Q.2d 1622 (Fed. Cir. 2005) (internal quotes omitted).

Id..

See Demison v Ben Clements, 203 U.S.P.Q. 895 (S.D.N.Y. 1979).

Though not addressed in detail in this paper, the patent holder must also establish ‘that a component especially made or adapted for use in the patented combination is not a staple article suitable for substantial non-infringing use.’ See Preemption Devices v Minnesota Mining & Mfg. Co., 803 F.2d 1170, 1175 (Fed. Cir. 1986); Union Carbide v Shell, 2004 WL 1305849 (D. Del. 2005).

Note that this would not be a case of induced infringement because the patented use will have been carved out of the label.