context: Indeed, each generic Defendant specifically "carved-out" the pertinent indication (e.g., "adjunctive treatment for major depressive disorder") from their respective generic Ability(r) labels, affirmatively relinquishing the right to actively promote use of their aripiprazole products with any antidepressants, including citalo-pram and escitalopram. (See, e.g., Torrent's Opp'n at 1-2; Alembic's Opp'n at 2, 3, 6, 14,18; Zydus's Opp'n at 22-23; Sun's Opp'n at 12; Teva's Opp'n at 2, 13-14; Actavis's Opp'n at 13-14; Apotex's Opp'n at 11-12; Hetero's Opp'n at 17-18; San-doz's Opp'n at 4, 18.) Indeed, given these Defendants' "carve outs," Defendants cannot, as a matter of law, instruct patients and/or prescribers to use their aripiprazole products for purposes of "adjunctive treatment for major depressive disorder," a use or indication for. which only Otsuka holds approval.
citation_a.signal: see
citation_a.identifier: 132 S.Ct. 1677, 1677
citation_a.parenthetical: noting that, following the FDA's acceptance of the carve-out label, the generic company may "place its drug on the market, (assuming the [applicant] meets other requirements), but only for a subset of approved uses -- i.e., those not covered by the brand's patents "
citation_a.sentence: See Caraco Pharm. Labs., 132 S.Ct. at 1677 (noting that, following the FDA’s acceptance of the carve-out label, the generic company may “place its drug on the market, (assuming the [applicant] meets other requirements), but only for a subset of approved uses — i.e., those not covered by the brand’s patents ”) (emphasis added); see also Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1322-23 (Fed.Cir.2012) (generally noting that the applicable FDA regulations prohibit generic pharmaceutical companies from implying or suggesting that the generic product has indications .or uses other than those approved by the FDA).
citation_b.signal: see also
citation_b.identifier: 676 F.3d 1316, 1322-23
citation_b.parenthetical: generally noting that the applicable FDA regulations prohibit generic pharmaceutical companies from implying or suggesting that the generic product has indications .or uses other than those approved by the FDA
citation_b.sentence: See Caraco Pharm. Labs., 132 S.Ct. at 1677 (noting that, following the FDA’s acceptance of the carve-out label, the generic company may “place its drug on the market, (assuming the [applicant] meets other requirements), but only for a subset of approved uses — i.e., those not covered by the brand’s patents ”) (emphasis added); see also Bayer Schering Pharma AG v. Lupin, Ltd., 676 F.3d 1316, 1322-23 (Fed.Cir.2012) (generally noting that the applicable FDA regulations prohibit generic pharmaceutical companies from implying or suggesting that the generic product has indications .or uses other than those approved by the FDA).