1. Applicable Law
In order to prove infringement, a plaintiff must show that the accused product or method includes every limitation of an asserted claim of a patent. Baxter Healthcare Corp. V. Spectramed, Inc., 49 F.3d 1575, 1582 (Fed. Cir. 1995). A party need not commit the full act of infringement itself. As 35 U.S.C. § 271(b) provides, "whoever actively induces infringement of a patent shall be liable as an infringer." Warner-Lambert Co. v. Apotex Corp., 316 F.3d 1348, 1365 (Fed. Cir. 2003).
To succeed on a claim of inducement, a patentee must show, that there has been (i) direct infringement, and that (ii) the alleged infringer knowingly induced infringement and possessed specific intent to encourage another's infringement. See Symantec Corp. v. Computer Assocs. Int'l, Inc., 522 F.3d 1279, 1292 (Fed. Cir. 2008) (quoting MEMC Elec. Materials, Inc. v. Mitsubishi Materials Silicon Corp., 420 F.3d 1369, 1378 (Fed. Cir. 2005)). In the context of ANDA filings the direct infringing acts are hypothetical-since the generic manufacturers have not yet distributed the product-so a court need only consider the second element. Id. The proper inquiry here, then, is whether specific intent exists.
Defendants urge that they cannot be liable for inducement to infringe because the acts of infringement cannot be attributed to one person. Essentially, they argue, that both doctors and patients are needed to perform the "treating" and "administering" steps covered by the patent. They argue, then, that because no single party directly infringes upon the patent, there will be no direct infringement, and therefore Defendants cannot be liable for inducement to infringe. This Court disagrees. A number of courts have conflated the actions of patients and doctors in determining whether the combined actions (i.e., treating/administering) infringe upon a patent. AstraZeneca LP v. Apotex, Inc., 623 F. Supp. 2d 579, 598-600 (D.N.J. 2009); Alza Corp. v. Andrx Pharms., LLC, 607 F. Supp. 2d 614, 623 (D. Del. 2009). The actions of the doctors and patients will be treated together, and will be considered a directly infringing act.
The specific intent necessary to induce infringement "requires more than just intent to cause the acts that produce direct infringement. . . . [T]he inducer must have an affirmative intent to cause direct infringement." Symantec Corp. v. Computer Assocs. Int'l, Inc., 522 F.3d 1279, 1292 (Fed. Cir. 2008) (quoting DSU Med. Corp. v. JMS Co., 471 F.3d 1293, 1306 (Fed. Cir. 2006)). The Federal Circuit has held that, "a method of use patent holder may sue an ANDA applicant for induced infringement of its patent, if the applicant is seeking FDA approval for the use claimed in the patent." Warner-Lambert, 316 F.3d at 1354-55. Intent may be inferred based on marketing literature or product instructions.See, e.g., Chiuminatta Concrete Concepts, Inc. v. Cardinal Industries, Inc., 145 F. 3d 1303, 1312 (Fed. Cir. 1998) (advertisements encouraging use during the time of the claimed process); AstraZeneca LP v. Apotex, Inc., 623 F. Supp. 2d 579, 603 (D.N.J. 2009) (finding that "the language of [a manufacturer's] label is relevant to the issue of intent" to induce infringement under § 271); VLT Corp. v. Unitrode Corp., 130 F. Supp. 2d 178, 200 (D. Mass. 2001) ("[I]t is a textbook violation of § 271(b) where . . . a defendant selling products capable of either innocent or infringing use provides through labels, advertising or other sales methods instructions and directions as to the infringing use") (internal citations omitted). 2. Analysis
Whether Defendants will induce infringement of Plaintiff's patent depends on whether they have the requisite intent to cause direct infringement.
As noted above, the Court has determined that direct infringement will occur based upon the acts of doctors and patients who prescribe and administer the drug. See note 21,supra.
Defendants' primary argument in support of their contention that they cannot be liable for inducing infringement is that they lack the necessary intent. They argue that they market the product as a commodity, and do not encourage any particular use of the drug. As such, they assert that they have no intent to infringe the patent (i.e., to induce others to violate the patent by using atomextine in the patented manner). In support of this argument, they note that doctors prescribe the drug for a number of non-infringing uses as well. Defendants, essentially, conclude that there is no evidence of their intent to induce infringement of the patent.
Plaintiff asserts that Defendants are aware of Plaintiff's patent, and they supply a product to customers with instructions on how to use the product in a manner that encourages acts of infringement. Plaintiff suggests that this evidences Defendants' intent to induce. See Minn. Mining and Mfg. Co. v. Chemque, Inc., 303 F.3d 1294, 1305 (Fed. Cir. 2002); Abraxis Bioscience, Inc. v. Navinta, LLC, 2009 U.S. Dist. LEXIS 66958 (D.N.J. Aug. 3, 2009).
Defendants respond that the labels, which instruct consumers to use the drug in an infringing manner, cannot be evidence of their intent because they are required by the FDA to include the label. Indeed, the only use of atomoxetine approved by the FDA is the infringing one. Therefore, Defendants must include the label encouraging infringement if they are to sell the drug. The question for this Court, then, is whether Defendants intent to induce infringement of the patent can be established notwithstanding the fact that the label instructing the infringing use of the product is required by the FDA.
The only other Court to address this precise issue was Alcon Labs., Inc. v. Bausch Lomb, Inc., 52 U.S.P.Q.2d 1927, 1933-34 (N.D. Tex. 1999). There, an alleged infringer argued that it did not have intent to induce infringement because its package inserts, which instructed the infringing use, were required by the FDA. The alleged infringer, there, as here, asserted that doctors will prescribe the drug for non-infringing uses. The Court nonetheless determined that there was no "authority, however, indicating that the FDA's requirements regarding the package insert absolve [the alleged infringer] of liability for inducing infringement when the suggested uses in its package insert come within the method claimed in the . . . patent." Id. The Court went on to explain that it "finds unpersuasive the fact that doctors may not always use the product in the manner specified on the package insert's indications[; t]he sole question is whether B L actively encourages the use of its generic in a manner that infringes the patent." Id. Accordingly, the Court found that the labeling could be sufficient to establish intent.
In Aventis Pharms., Inc. v. Barr Labs., Inc., 411 F. Supp. 2d 490, 518 (D.N.J. 2006), aff'd, 208 Fed. Appx. 843 (Fed. Cir. 2006), the Court explained that intent is determined "from an objective viewpoint, not by undertaking an analysis of whether the accused inducer subjectively experienced a purpose or an intent that the steps affirm." Here, the accused infringers will be labeling the product in a manner which encourages direct infringement by others. See id.; AstraZeneca LP, 623 F. Supp. 2d at 598-607 (determining that a generic manufacturer intended to induce infringement of plaintiff's patent by including a label instructing an infringing use, notwithstanding the fact that defendant took several affirmative steps to work around the potential infringement; noting that defendant's demonstrated intentions were overcome by its decision to move ahead with an infringing label). This objective evidence is critical in determining whether intent to cause infringement exists, and such evidence is sufficient to establish Defendants' intent.
Plaintiff's motion for summary judgment as to Defendants' infringement is granted.
