$ 0.415 6.62%
Vtorrent (VTR) Rank 2973
Vtorrent is aiming to be limewire, emule or bittorrent with the block chain as its core system.
| Mkt.Cap | $ 0.00000000 | Volume 24H | 0.00000000VTR |
| Market share | 0% | Total Supply | 20 MVTR |
| Proof type | PoW/PoS | Open | $ 0.39 |
| Low | $ 0.39 | High | $ 0.42 |
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Co., Ltd. v. Ajanta Pharm. Ltd., Civil Action No. 14–5876 (JBS/KMW) (filed September 19, 2014); Otsuka Pharm. USA, Inc., Civil Action No. 14–5878 (JBS/KMW) (filed September 19, 2014); Otsuka Pharm. Ltd., Civil Action No. 14–6158 (JBS/KMW) (filed October 2, 2014); Otsuka Pharm.
Similar motions were brought against Mylan, Inc., Zhejiang Huahai Pharmaceutical Co., Ltd., and Ajanta Pharma Limited, which were unopposed by those parties, and Otsuka has, as a result, filed the amended pleading in those respective cases. These motions, filed on March 19, 2015, were a surprise because Otsuka had made no mention of its intent to amend to assert the '350 patent against these parties just three days before at the conference of March 16, 2015, which the Court called specifically to plan for this injunctive motion practice. [See id. at ¶ 2.] In accordance with the Court's Scheduling Order, briefing followed in these cases. As relevant here, “ ‘[p]rice erosion, loss of goodwill, damage to reputation, and loss of business opportunities' ” all constitute potential and “ ‘valid grounds for finding irreparable harm.’ ” Aria Diagnostics, Inc. v. Sequenom, Inc., 726 F.3d 1296, 1304 (Fed.Cir.2013) (quoting Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922, 930 (Fed.Cir.2012) ).
Rather, these generic Defendants must demonstrate a substantial question of invalidity, that is, they must show the potential vulnerability of the '350 patent, a showing far less rigorous than the clear and convincing showing necessary to establish invalidity itself. See, e.g., Celsis In Vitro, Inc. v. CellzDirect, Inc., 664 F.3d 922, 935 (Fed.Cir.2012) (Gajarsa, J., dissenting); Kimberly–Clark Worldwide, Inc. v. First Quality Baby Prods., LLC, 431 Fed.Appx. 884, 886–87 (Fed.Cir.2011) (noting that, “[v]ulnerability is the issue at the preliminary injunction stage, while validity is the issue at trial”) (citations omitted); Erico Int'l Corp. v. Vutec Corp., 516 F.3d 1350, 1356 (Fed.Cir.2008) (“a defendant must put forth a substantial question of invalidity to show that the claims at issue are vulnerable”); Abbott Labs.
No. 14–1078 (filed March 18, 2014); Otsuka Pharma Co., Ltd. v. Alembic Pharm. No. 14–2982 (filed May 9, 2014), and despite long knowing the April 20, 2015 date certain of the '528 patent's expiration, Otsuka first referenced its proposal in these related cases to file motions for temporary restraining orders and preliminary injunctions on March 9, 2015. products approved under the Food, Drug, and Cosmetic Act (hereinafter, the “Orange Book”), 21 U.S.C. § 355(j), Otsuka identifies the '528 patent, the '092 patent, the '615 patent, the '796 patent, the '600 patent, the '760 patent, and the '350 patent, all of which Otsuka owns by virtue of assignment. Otsuka, a pharmaceutical company organized and existing under the laws of Japan, holds New Drug Application (hereinafter, “NDA”) No. 21–436, approved by the FDA, for aripiprazole tablets, which Otsuka markets under the trademark Abilify ®. James E. Cecchi, Esq., Michael Cross, Esq., Carella, Byrne, Cecchi, Olstein, Brody & Agnello, PC, Roseland, NJ, Claire J. Evans, Esq. (argued), James.
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Inc. v. Exela PharmSci Inc., 780 F.3d 1364 (Fed.Cir.2015). For purposes of a preliminary injunction, however, these generic Defendants need not prove actual invalidity.
Warner–Jenkinson Co. v. Hilton Davis Chem. Co., 520 U.S. 17, 29, 117 S.Ct. 1040, 137 L.Ed.2d 146 (1997). Otsuka cannot legitimately contend that any of these Defendants' products contain escitalopram and/or citalopram, nor that Defendants' products are specifically indicated for the adjunctive treatment of major depressive disorder.
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10 to Tang Dec.) See also Medrad, Inc. v. MRI Devices Corp., 401 F.3d 1313, 1322 (Fed.Cir.2005) (noting that, “a court is not bound by the PTO's actions and must make its own independent determination of patent validity”) (citation omitted). Curiously, with respect to infringement, Otsuka argued, as stated above, that any reference to “antidepressants” would necessarily and immediately lead any reader to envision citalopram and/or escitalopram, given their preeminence in the category of antidepressants. With respect to invalidity, however, Otsuka appears to distance itself from this argument, claiming instead that a general reference to the category of antidepressants proves insufficient to lead a reader to immediately envision these antidepressants, despite the fact that Claim 40 of the Migaly '043 patent specifically identifies escitalopram and citalopram. Additionally, and in the alternative, these Defendants argue that International Application Publication No.
vTorrent APK 6
- v. Lupin, Ltd., 676 F.3d 1316, 1318 (Fed.Cir.2012).
- Delays, strategic or otherwise, have plagued these actions from their inceptions.
- (See Otsuka's Br. at 22–28; Otsuka's Reply at 9–10.) Despite these arguments, however, the Court finds that Otsuka has, upon this record, failed to demonstrate that these Defendants' market entry will result in irreparable harm.
- Torrent, Zydus, and Teva, challenge Otsuka's motions to amend on futility, prejudice, and delay grounds.
Moreover, the Court's commonsense, plain language construction finds further support in dependent Claim 18, which discloses “[t]he composition of Claim 1, wherein the amount of (a) aripiprazole in combination with (b) at least one serotonin reuptake inhibitor selected from citalopram, escitalopram and salts thereof is 1 to 70 parts by weight of the total composition. ” ('350 patent at col. 30, ln. 44–48 (emphasis added).) Claim 18 therefore describes the single “pharmaceutical composition ” of Claim 1 in terms of the combined weight of its active ingredients formulated together in a “total composition. ” (Id. (emphases added).) By claiming a specific weight ratio (i.e., “1 to 70 parts”), dependent Claim 18 recites subject matter admittedly narrower than Claim 1. Nevertheless, the Claims' consistent language makes clear that both disclose aripiprazole and citalopram or escitalopram formulated together in a single dosage form, even if at slightly varied weights.
Nor does Otsuka's citation to limited portions of the specification support any contrary construction. Moreover, when viewed in context, the relied-upon passages lend additional support to the position that Claim 1 refers to a single composition or tablet comprised of two active ingredients. Otsuka originally sought injunctive relief in these and ten other related cases. However, because certain defendants filed notices, in lieu of oppositions to Otsuka's motions for temporary restraining order, stating that each defendant did not intend to launch a generic aripiprazole product prior to June 20, 2015, the Court dismissed Otsuka's motions as against those opt-out defendants as moot on March 30, 2015. The FDA approved Otsuka's NDA 21–436 in 2002, and the pediatric exclusivity period associated with the '528 patent expires on April 20, 2015.
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On the oral argument record on April 10, 2015, counsel for [redacted] represented that recent amendments to Otsuka's Abilify® label would require [redacted] to conform their warning language to that of the other generic Defendants in these actions. The carve-out provisions, 21 U.S.C. § 355(j)(2)(A)(viii) and 21 C.F.R. § 314.94(a)(12)(iii)(A), specifically permit an ANDA applicant to submit a “section viii statement” certifying that the applicant does not seek approval for any indications or uses asserted to be covered by a patent from the proposed label in the ANDA.
In these respects, Otsuka's position principally relies upon contraindications and language tending to warn about aripiprazole's potential effects and/or adverse reactions/interactions. But, a warning is just that—a warning. It is not an instruction to coadminister aripiprazole with any particular drug, much less escitalopram or citalopram, the only antidepressants covered by Claim 1. Nor does Otsuka's reliance upon AstraZeneca LP v. Apotex, Inc., 633 F.3d 1042 (Fed.Cir.2010), require any different result. (See Otsuka's Br. at 14, 15, 17.) Critically, in affirming the district court's grant of a preliminary injunction, the AstraZeneca court relied upon the fact that the generic's label contained explicit instructions in the “Dosage and Administration” section to administer the product in an infringing manner.
This Court is not precluded from reviewing the issue of patent validity anew, despite the fact that the Patent Examiner ultimately appears to have rejected Migaly as a prior art reference. (See Otsuka's Reply at 7–8 (generally arguing that the Patent Examiner considered and rejected Migaly as a prior art reference); see Ex.
to potentially requiring potential corporate restructuring and/or employee layoffs. (See Otsuka's Br. at 22–28; Otsuka's Reply at 9–10.) Despite these arguments, however, the Court finds that Otsuka has, upon this record, failed to demonstrate that these Defendants' market entry will result in irreparable harm.
The Court must, however, note that, unlike the majority of these generic Defendants, [redacted], thereby limiting Otsuka's ability to shoulder significant losses in revenue. (See Jarosz Dec. at ¶¶ 80–85.) As a result, counsel for Otsuka argued on the oral argument record on April 10, 2015, that the balance of hardships favors Otsuka, because the Defendants have the ability to absorb any harm caused by an injunction by [redacted]. Nevertheless, given that Otsuka's claimed harms derive from the natural expiration of the '528 patent, and not from the patent at issue in these temporary restraining order proceedings, the Court does not find any absorption, accepted as true, a burden that these Defendants should be required to face. It appears that these Defendants have all taken affirmative steps to enter the aripiprazole market, by developing and testing aripiprazole products, preparing ANDAs, seeking regulatory approval from the FDA, ordering raw materials, and preparing manufacturing and supply pipelines.
In that regard, induced infringement premises liability upon “purposeful, culpable expressions and conduct” and “active steps” taken to encourage direct infringement, including advertising and/or instructions. Corp. v. JMS Co., 471 F.3d 1293, 1305–1306 (Fed.Cir.2006) (en banc in relevant part). Therefore, the Court turns to the merits of Otsuka's motions for temporary restraining orders to prohibit at-risk launches by these generic product defendants.
