Opinion ID: 615508
Heading Depth: 1
Heading Rank: 4

Heading: Apotex Inc.'s Liability

Text: After Apotex engaged in the commercial sale of its generic product, Sanofi never amended its complaint to allege either direct infringement under 35 U.S.C. § 271(a) or induced infringement under 35 U.S.C. § 271(b). Instead, Sanofi only alleged that Apotex infringed pursuant to 35 U.S.C. § 271(e)(2)the infringement provision of the Hatch-Waxman Act. Infringement under § 271(e)(2) is a hypothetical case that asks the factfinder to determine whether the drug that will be sold upon approval of the ANDA will infringe the asserted patent. In re Brimonidine Patent Litig., 643 F.3d 1366, 1377 (Fed.Cir. 2011). Section 271(e)(4) sets out the only remedies which may be granted by a court for an act of infringement [under § 271(e)(2).] Relevant here, the statute sets forth that damages are only available in specific instances, namely: [D]amages or other monetary relief may be awarded against an infringer only if there has been commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug. . . . § 271(e)(4)(C). Apotex does not argue that Apotex Inc. is not an infringer under § 271(e)(2). However, during the damages phase of the lawsuit, Apotex argued for the first time that Apotex Inc. is not liable for damages, because it never engaged in the commercial manufacture, use, offer to sell, or sale within the United States or importation into the United States of an approved drug, as required by § 271(e)(4)(C). Instead, Apotex argued that Apotex Corp. alone imported the drug and made all commercial sales in the United States. Although Apotex Inc. conceded that it manufactured the drug in Canada, Apotex nevertheless argues that Sanofi failed to present any evidence showing that Apotex Inc.'s actions took place in the United States. As a result, Apotex Inc. claims that it cannot be held liable for infringement under § 271(e)(4)(C). The district court determined that the May 2006 agreement governed the damages at issue, and that both Apotex Inc. and Apotex Corp. were parties to the agreement. Sanofi-Aventis, 748 F.Supp.2d at 295. The district court also noted that Apotex waited until the damages phase of the trial, after the trial on liability already concluded, to draw a distinction for these purposes between Apotex Inc. and Apotex Corp., and to assert for the first time a defense to Apotex Inc.'s liability for damages. Id. at n. 2. We agree with the district court that the May 2006 agreement governs liability in this case and need not address Apotex's statutory arguments. As discussed above, the clear purpose of paragraph 14(ii) of the May 2006 agreement was to define Sanofi's compensatory damages from Apotex's infringement. The May 2006 agreement broadly defines Apotex to include Apotex Inc. and Apotex Corp., collectively and individually, and including any entity now or hereafter owned or controlled by any of them. J.A. 690. Dr. Barry Sherman, the Chairman and CEO of Apotex Inc., signed the agreement on behalf of both Apotex Inc. and Apotex Corp. J.A. 694. Additionally, in the parties' Stipulated Statement of Facts in the Joint Pre-Trial Order, Apotex admitted that the acts of Apotex Corp. with respect to the subject matter of this action were done at the direction of, with the authorization of and with the cooperation, participation and assistance of Apotex Inc. J.A. 2498. Thus, the only logical reading of the May 2006 agreement is that both Apotex Inc. and Apotex Corp. agreed to be jointly and severally liable for Sanofi's actual damages. Therefore, we affirm the district court's determination that Apotex Inc. is jointly and severally liable for Sanofi's damages.