Opinion ID: 2993897
Heading Depth: 2
Heading Rank: 4

Heading: The Claim Against Johnson Matthey

Text: Under § 271(e)(2), Congress made it “an act of in- fringement to submit an [ANDA] application . . . for a drug claimed in a patent or the use of which is claimed in a patent.” 35 U.S.C. § 271(e)(2)(A). But Congress also provided a safe harbor in § 271(e)(1) for those engaged in certain activities in support of the filing of an ANDA. Specifically, § 271(e)(1) states that “[i]t shall not be an act of infringement to make, use, offer to sell, or sell within the United States or import into the United States a patented invention . . . solely for uses reasonably related to the development and submission of information under a Federal law which regulates the manufacture, use, or sale of drugs or veterinary biological products.” 35 U.S.C. § 271(e)(1). Johnson Matthey does not seek FDA approval to sell a generic form of Vyvanse® and has therefore made no ANDA filing. Its only involvement in this dispute arises from its actions in supplying the ANDA defendants with the active pharmaceutical ingredient LDX dimesylate. The district court found it undisputed that each of the ANDAs at issue lists Johnson Matthey as the manufacturer of the LDX dimesalyate used in their generic products. It was also undisputed that Johnson Matthey filed a drug master file for that ingredient with the FDA in support of the ANDA defendants’ applications and in anticipation of the eventual commercial exploitation of both its API and the generic products made from it. From this, the district court entered judgment that Johnson Matthey “has induced infringement of the compound claims at issue.” Op. at . SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC 15 Johnson Matthey argues that providing the ANDA defendants with an active ingredient so they could submit their ANDAs was reasonably related to the submission of information under a federal law and was therefore within the safe harbor of § 271(e)(1). Since it did not itself submit an ANDA, Johnson Matthey contends that it cannot be liable under § 271(e)(2) for its past actions and therefore the district court was wrong to enter judgment against it. Further, it asserts that because no direct infringement has yet to occur, it cannot be liable for induced infringement under § 271(b). It thus contends that it should never have been named in the litigation and should be dismissed from the case. Shire counters by asserting that Johnson Matthey is properly in the suit and can be liable for induced infringement. According to Shire, this court’s decision in Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc., 501 F.3d 1263 (Fed. Cir. 2007), held that a party can be liable “under section 271(e)(2) for its future infringement under section 271(b) as the ANDA-filers’ API supplier.” Resp. Br. at 52. Shire contends that on the facts before us “Forest cannot be distinguished.” Id. at 55 (capitalization altered). Finally, Shire argues that under the reasoning of Forest Labs., Johnson Matthey can be enjoined. Johnson Matthey is correct that it cannot be liable for the API it sold the ANDA defendants up to this point. Johnson Matthey, as an API supplier, has thus far done nothing more than provide material for use by the ANDA defendants in obtaining FDA approval. As the district court found, these sales, and the ANDA defendants’ use of the API for filing the ANDA, were “reasonably related to the submission of an ANDA.” Op. at . As such, Johnson Matthey’s activities are protected by the safe harbor of § 271(e)(1), and the district court erred by entering judgment that Johnson Matthey has induced infringement of the compound claims at issue. 16 SHIRE LLC v. AMNEAL PHARMACEUTICALS, LLC Moreover, as Johnson Matthew did not submit an ANDA, it cannot be liable for infringement under § 271(e)(2). We do not agree with Shire that this Court’s decision in Forest requires a different result. To the contrary, Forest involved the scope of an injunction under § 271(e)(4). No such injunction has been issued against Johnson Matthew here and thus Forest is inapposite. Johnson Matthey is therefore not currently liable for infringement. Accordingly, we reverse the district court’s judgment that Johnson Matthey has induced infringement of the compound claims at issue and remand for further proceedings consistent with this opinion.