Opinion ID: 3153478
Heading Depth: 2
Heading Rank: 2

Heading: Momenta’s Motion to Amend

Text: Momenta served amended infringement contentions that accused two additional Amphastar testing procedures and sought to provide additional documentary support for the new infringement contentions. Thereafter, Momenta moved for leave from the district court to file the amendments. J.A. (-1276, -1278) 11. The district court denied leave, noting Momenta had “failed to seek leave prior to serving [the amendments] as required by the [district court’s] scheduling order,” and that the amendments would in any event be “futile.” J.A. (-1276, -1278) 11–12. The district court’s decision to deny leave was based in part on its conclusion that its “summary judgment holding that the [§] 271(e)(1) safe harbor provision applies to the 15–25% procedures also applies to” one of the two additional accused testing procedures. J.A. (-1276, -1278) 12. Decisions whether to allow an amendment to plead- ings after the scheduling order deadline are reviewed under the law of the regional circuit. Aventis Pharma S.A. v. Hospira, Inc., 675 F.3d 1324, 1333 (Fed. Cir. 2012). In the First Circuit, a district court’s decision whether to allow an amendment to pleadings after the scheduling order deadline is reviewed for abuse of discretion. O’Connell v. Hyatt Hotels of P.R., 357 F.3d 152, 154–55 trex Int’l PLC v. M.D. Pers. Prods. Corp., 5 F.3d 1505, 1993 WL 306169, at  (Fed. Cir. 1993) (unpublished table decision) (Devices “made for FDA approval” do not forfeit their § 271(e)(1) exemption “when used in other noninfringing manners.”); Intermedics, Inc. v. Ventritex Co., 991 F.2d 808, 1993 WL 87405, at  (Fed. Cir. 1993) (unpublished table decision) (“All of [the defendant’s] activities providing clinical units of the [accused device] to its researcher in Germany were solely reasonably related to generating data for FDA approval.”). 20 MOMENTA PHARM., INC. v. TEVA PHARM., INC. (1st Cir. 2004). Given our vacation of summary judgment on the reach of § 271(e)(1), the district court may choose to reconsider on remand its denial of leave in light of our holding.