REDACTED OPINION
I.INTRODUCTION. .!.468
II. BACKGROUND.470
A. Factual and Procedural Background.470
III. PRELIMINARY ISSUES .472
A. Otsuka’s Motions to Amend .472
B. Informal Applications to Strike.474
IV. STANDARD OF REVIEW APPLICABLE TO MOTIONS FOR
TEMPORARY RESTRAINING ORDER.475
V. DISCUSSION. *Ñ1 cn
A. Likelihood of Success “.....475
476 Induced Infringement Claims.
477 a.Standard for Induced Infringement.
i. Claim Construction: Claim 1 of the '350 Patent
478 Discloses a Composition, Namely a Tablet, Comprised of a Single Dosage that Contains At Least Two Active Ingredients.
ii. Otsuka Has Not Demonstrated That Defendants’
483 Proposed ANDA Products Directly Infringe Construed Claim 1 of the '350 Patent.
in. Otsuka Has Not Shown that Defendants Actively and
484 Purposefully Encouraged Infringement.
a. Defendants’ “Carve Out” of the Relevant Indication
485 Significantly Diminishes Any Suggestion of Intentional Action.
b. Defendants’ Proposed Labels Do Not Reflect Actual
486 Instruction in Furtherance of Inducing Infringement.
c. The Substantial Non-Infringing Uses Further
Diminish Any Inference of the Requisite Specific Intent to Induce Infringement. LO s
2. Defendants Have Raised a Substantial Question of Invalidity. §
B. Otsuka Has Not Demonstrated that it Will Suffer Immediate and
Irreparable Harm in the Absence of an Injunction as a result of the Market Entry of these Defendants’ Aripiprazole Products. ^ o <X>
1. Otsuka’s Alleged Harms Are Quantifiable. cn o O
Otsuka Has Not Met the “Causal Nexus” or © to
3. Otsuka’s Delay in Requesting Injunctive Relief Suggests Lack of Urgency . or o 00
C. The Balance of Hardships Favors these Defendants. cjx o CR
D. The Public Interest Counsels against the Issuance an Injunction
VI. CONCLUSION. .507
I. INTRODUCTION
These related patent infringement actions under the Hatch-Waxman Act, 35 U.S.C. §§ 271, 281, generally concern Plaintiff Otsuka Pharmaceutical Co., Ltd.’s (hereinafter, “Otsuka”) position that various defendants’ submissions of abbreviated new drug applications (hereinafter, “AN-DAs”) infringe one or more claims of the various patents covering Otsuka’s Ability® aripiprazole product, U.S. Patent Nos. 5,006,528 (“the '528 patent”), 7,053,092 (“the '092 patent”), 8,017,615 (“the '615 patent”), 8,580,796 (“the '796 patent”), 8,642,600 (“the '600 patent”), 8,642,760 (“the '760 patent”), and 8,759,350 (“the '350 patent”).
As the lengthy exclusivity period for the original compound patent covering Ability®, the '528 patent, comes to close on April 20, 2015, Otsuka moves to enjoin these Defendants
1. Torrent Pharmaceuticals Limited, Inc., Torrent Pharma Inc., and Hetero Labs Limited (collectively, “Torrent”), Civil Action Nos. 14-1078 ' (JBS/KMW), 144671 (JBS/KMW), seek FDA approval to sell generic aripiprazole [redacted];
2. Alembic Pharmaceuticals Limited, Alembic Limited, Alembic Global Holding Sa, and Alembic Pharmaceuticals Inc. (collectively, “Alembic”), Civil Action Nos. 142982 (JBS/KMW), 14-7405 (JBS/KMW), seek FDA approval to sell generic aripiprazole [redacted];
3. Zydus Pharmaceuticals USA, Inc., and Cadila Healthcare Limited (collectively, “Zydus”), Civil Action No. 143168 (JBS/KMW), seek FDA approval to sell generic aripiprazole [redacted];
4. Sun Pharmaceutical Industries Ltd., Sun Pharma Global Inc., Sun Phar-ma Global Fze, Sun Pharma USA, Sun Pharmaceuticals Industries, Inc., and Caraco Pharmaceutical Laboratories (collectively, “Sun”), Civil Action Nos. 14-4307 (JBS/KMW), 14-6397 (JBS/KMW), seek FDA approval to sell generic aripiprazole [redacted];
5. Teva Pharmaceuticals USA, Inc. (hereinafter, “Teva”), Civil Action Nos. 14-5878 (JBS/KMW), 14-6398 (JBS/KMW), seeks FDA approval to sell generic aripiprazole [redacted];
6. Actavis Elizabeth LLC, Actavis, Inc., Actavis PLC, Jubilant Life Sciences Limited, Jubilant Generics Limited, and Jubilant Life Sciences (USA) Inc. (collectively, “Acta-vis”), Civil Action No. 14-7106 (JBS/KMW), seek FDA approval to sell generic aripiprazole [redacted];
7. Apotex Corp., Apotex Inc., Apotex Pharmachem Inc., and Hetero Labs Limited (collectively, “Apotex”), Civil Action No. 14-8074 (JBS/KMW), seek FDA approval to sell generic aripiprazole [redacted];
8. Hetero Drugs Limited, Hetero Labs Limited, and Hetero USA, Inc. (collectively, “Hetero”) Civil Action No. 15-161 (JBS/KMW), seek FDA approval to sell generic aripiprazole [redacted]; and
9. Sandoz Inc., Sandoz Private Ltd., and Sandoz International Gmbh. (collectively, “Sandoz”), Civil Action No. 15-1716 (JBS/KMW), seek FDA approval to sell generic aripi-prazole [redacted].
In support of its request for temporary restraining orders, Otsuka claims that Defendants’ generic aripiprazole tablets and/or orally disintegrating tablets infringe Claim 1 of the '350 Patent, a follow-on composition patent indicated for the treatment of major depressive disorder. (See generally Otsuka’s Br. at 4-5; see also Ex. 4 to Fues Dec.) Claim 1, however, discloses only a combination aripiprazole and escitalopram/citalopram product, and each of these Defendants seek approval for a generic product containing only aripipra-zole. (See generally Ex. 4 to Fues Dec.)
Nevertheless, in relying upon Claim 1 in connection with its request for a temporary restraining order, Otsuka argues that Defendants’ proposed generics will induce infringement of Claim 1 of the '350 patent, because Defendants’ proposed package inserts or labels
These generic Defendants have mounted substantively identical oppositions to Otsu-ka’s motions, and indeed argued their opposition collectively through designated counsel at the April 10, 2015 hearing.
In addition, and in the alternative, Defendants argue that their respective package inserts deliberately “carved out” the basis for Otsuka’s claim of induced infringement by omitting the treatment indication claimed by the '350 patent, and omitting instruction on the use of aripipra-zole in conjunction with either citalopram or escitalopram, thereby negating the intent prerequisite for inducing infringement, and otherwise eliminating any active or implied instruction or encouragement of any infringing aripiprazole composition and/or use.
The primary issues before the Court concern whether Otsuka has demonstrated a likelihood of success on its claims of induced infringement, and whether Otsuka has demonstrated that it will, in the absence of an injunction, suffer irreparable harm as a result of these generic Defendants’ entry into the aripiprazole market.
For the reasons that follow, Otsuka’s motion for a temporary restraining order will be denied.
II. BACKGROUND
A. Factual and Procedural Background
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 Otsu-ka markets under the trademark Ability®.
In connection with Ability’s® listing in the Orange Book, the FDA’s book of drug
Prior litigation involving these and related generic defendants, and concerning the '528 patent covering the aripiprazole compound, compositions, and methods of treatment, resulted in a decision that, in effect, precludes any generic competition in aripi-prazole market prior to the expiration of the '528 patent (inclusive of its pediatric exclusivity period) on April 20, 2015. See generally Otsuka Pharm. Co. v. Sandoz, Inc., No. 07-1000(MLC),
Moreover, in the aftermath of that decision (and indeed during the litigation), Ot-suka sought and obtained FDA approval for an array of “follow on” patents, all of which generally concern the aripiprazole drug substance, and seek to elongate Otsu-ka’s long-held monopoly over the aripipra-zole market. As relevant here, the '350 patent, a product patent which the FDA issued on June 24, 2014, generally discloses a combination aripiprazole product comprised of aripiprazole together with serotonin reuptake inhibitors in a pharma-ceutically acceptable carrier, for the “Ad-junctive Treatment of Major Depressive Disorder.”
As Otsuka’s patent plateau approached, a flurry of generic Defendants, many if not all of which are implicated in these related patent infringement actions, filed ANDAs seeking approval to market an array of aripiprazole products. As a result of the ANDA filings, Otsuka filed Complaints in this District, alleging that these Defendants proposed generic aripiprazole products will, if approved and marketed, infringe some combination of the follow on patents, e.g., at least one specific claim of the '615, '796, '760, '092, '600, and/or the '350 patents.
After nearly one year of litigation in certain cases, see, e.g., Otsuka Pharm. Co., Ltd. v. Torrent Pharm. Ltd., Civil Act. No. 14-1078 (filed March 18, 2014); Otsuka Pharma Co., Ltd. v. Alembic Pharm. Ltd., Civil Act. 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.
Faced with the prospect of such motions with regard to potential at-risk launches by as many as two-dozen Defendants on or after April 20, 2015, the Court promptly convened an in-person conference with all counsel in the related actions on March 16, 2015, in order to enter a global schedule for Otsuka’s seemingly long-anticipated motions for preliminary injunctions.
During the conference, the nature of Otsuka’s proposed motions came into focus. Critically, despite these related Defendants’ ANDA filings, Otsuka did not know which, if any, of the generic defendants intended to launch generic aripipra-zole products “at risk” at the expiration of the '528 patent’s pediatric exclusivity on April 20, 2015, and therefore did not know against whoim to seek injunctive relief. The Court, in turn, faced the prospect (for generic defendants not intending to launch at this time) of addressing motions without live controversies, but recognized the confidential and sensitive nature of these defendants’ launch intentions. Therefore; following arguments of counsel, the Court
The Scheduling Order, in particular, permitted any defendant to file, in lieu of opposition to Otsuka’s motion, a statement that such defendant did not intend to launch its aripiprazole product prior to June 20, 2015, in which case Otsuka’s motion would be dismissed without prejudice to renewal, and that opt out defendant would be deemed precluded from launching prior to June 20, 2015, unless otherwise ordered by the Court. [See id. at ¶ 2.] In accordance with the Court’s Scheduling Order, briefing followed in these cases.
The Court heard arguments and proffers of evidence on behalf of all parties at the hearing upon these motions for temporary restraining order on April 10, 2015, in which the parties have amassed a record of thousands of pages spanning the 13 above-captioned dockets.
III. PRELIMINARY ISSUES
Prior to addressing Otsuka’s motions for a temporary restraining order, the Court must address two threshold issues.
A. Otsuka’s Motions to Amend
First, Otsuka has very recently
Under Federal Rule of Civil Procedure 15, leave to amend should be “freely give[n] when justice so requires.” Fed. R.Crv.P. 15(a)(2). Therefore, in the absence of undue prejudice, unfair prejudice, or futility, motions to amend must be granted. See Arthur v. Maersk, Inc., 434.
Torrent, Zydus, and Teva, challenge Otsuka’s motions to amend on futility, prejudice, and delay grounds. (See Torrent’s Opp’n to Mot. to Amend at 2-5; Zydus’s Opp’n to Mot. to Amend at 6-13; Teva’s Opp’n to Mot. to Amend at 6-19.) The Court, however, finds that Otsuka’s proposed amendments provide sufficient factual matter, if accepted as true, to state plausible, non-futile claims for relief. See Ashcroft v. Iqbal,
In addition, the Court does not find that Otsuka unduly delayed in seeking to amend, nor that its motions have caused unfair prejudice to these Defendants in connection with Otsuka’s motions for temporary restraining orders. Delay was not undue in these cases because Otsuka had asserted the '350 patent, among others, against all ANDA-filers in the many companion cases which had filed Paragraph IV certifications under 21 U.S.C. § 355(j)(2)(A)(vii), asserting their positions that their ANDAs would not infringe the patents at issue, and/or their position on the invalidity of the patents at issue.
With respect to prejudice, the Court notes that, despite the short notice, these Defendants have shown the ability to address these claims through their filing of oppositions and sur-replies equivalent and substantively identical to those of the generic defendants against whom Otsuka asserted the '350 patent far earlier. Given
Consequently, for the reasons stated above and on the oral argument record on April 10, 2015, Otsuka’s motions to amend will be granted.
B. Informal Applications to Strike
Second, the Court addresses Defendants’ application to strike the supplemental declarations of Otsuka’s experts, Dr. Roth and Mr. Jarosz [see, e.g., Docket Item 103 in 14-1078],
In that respect, both applications concern, at their cores, the purportedly improper expansion of the factual record on substantive issues implicated in Otsuka’s pending motions. Nevertheless, the Court finds that all issues relevant to Otsuka’s pending motions for temporary restraining orders, including, all issues with respect to claim construction, invalidity, and irreparable harm, have been amply dealt with in the parties’ voluminous submissions, and through counsels’ lengthy presentations at the April 10, 2015 hearing. Indeed, counsels’ comprehensive oral arguments mitigated any arguable prejudice associated with the new assertions in supplemental declarations and/or sur-replies.
For these reasons, and those set forth during the April 10, 2015 hearing, Defendants’ application to strike will be granted in part only with respect to certain legal arguments of Otsuka’s experts and denied with respect to Defendants’ remaining challenges, and Otsuka’s application to strike will be denied in its entirety.
IV. STANDARD OF REVIEW APPLICABLE TO MOTIONS FOR TEMPORARY RESTRAINING ORDER
“The decision to grant or deny ... injunctive relief is an act of equitable discretion by the district court.” eBay, Inc. v. MercExchange, LLC,
A party seeking a temporary or preliminary injunction must therefore demonstrate: (1) a reasonable likelihood of success on the merits; (2) the prospect of irreparable harm in the absence of an injunction; (3) that this harm would exceed harm to the opposing party; and (4) that the public interest favors such relief. See, e.g., Sciele Pharma Inc. v. Lupin Ltd.,
In determining whether to issue injunctive relief, no one factor, taken individually, proves dispositive. See Hybritech v. Abbott Labs.,
The Court will address each of the four, factors in turn.
V. DISCUSSION
A. Likelihood of Success
Otsuka claims that nine groups of generic Defendants in these 13 cases should be enjoined from launching their aripiprazole products on or after April 20, 2015 because their aripiprazole products will infringe Claim 1 of the '350 patent, the only patent asserted in these preliminary injunction motions.
In order to establish a likelihood of success on the merits, the “patentee seeking a preliminary injunction in a patent infringement suit must show that it will likely prove infringement, and that it will likely withstand challenges, if any, to the validity of the patent.” Titan Tire v. Case New Holland,
Here, the Court will first address the issue of infringement, prior to turning to invalidity.
1. Otsuka Has Not Demonstrated a Likelihood of Success on its Induced Infringement Claims
For purposes of these requests for injunction relief, Otsuka argues that it will likely prevail at trial on its position that all of Defendants’ labels induce infringement of Claim 1 of the '350 patent.
Nevertheless, based upon certain warning and safety information concerning the coadministration of aripiprazole with antidepressants, particularly in the Defendants’ various “ ‘black box’ warning[s],” Otsuka submits that each label implicitly teaches and encourages the beneficial nature of co-administering aripiprazole in the manner protected by the '350 patent. (Otsuka’s Br. at 11, 15-17; Otsuka’s Reply at 4-6; see.also Roth Dec.) As a result, Otsuka asserts that Defendants’ package inserts induce infringement of Claim 1 of the '350 patent, because Claim 1 purportedly “discloses and claims novel pharmaceutical compositions comprising aripiprazole in combination with serotonin reuptake inhibitors ” (as opposed to only escitalopram and/or citalopram), and “encompasses any use of that composition,” particularly the use of the composition “as an adjunctive therapy for major depressive disorder.” (Otsuka’s Br. at 4-5 (emphasis added).)
These Defendants, however, uniformly counter that Otsuka’s inducement claim fails, even at this preliminary stage, and
First, Defendants claim that Otsuka’s infringement claim lacks merit, because Defendants’ ANDA products seek only to' market aripiprazole, without any accompanying ingredient. Therefore, because no Defendant seeks to market and/or distribute a “pharmaceutical composition” comprised of aripiprazole and citalopram and/or escitalopram, Defendants argue that they will not make, use, offer for sale or sell a product within the scope of Claim 1 (See, e.g., Actavis’s Opp’n at 6; Sun’s Opp’n at 9-10; Sandoz’s Opp’n at 1, 15; Hetero’s Opp’n at 8 n.10; Apotex’s. Opp’n at 8-9), and, as a result, could never directly infringe the '350 patent, a threshold requirement for a finding of inducement. {See, e.g., Alembic’s Opp’n at 1013; Torrent’s Opp’n at 8-10; Zydus’s Opp’n at 19-21; Sandoz’s Sur-reply at 1-3.) Second, Defendants argue that Otsuka has failed to demonstrate that their package inserts or prescribing information reflect the requisite specific intent to induce infringement. {See, e.g., Actavis’s Opp’n at 13-18; Hetero’s Sur-reply at 2-4.)
In order to properly frame the issues implicated by the pending motions — namely, the parties’ disputes concerning whether Otsuka sufficiently demonstrated the threshold elements of an induced infringement claim — the Court must briefly discuss the relevant framework,
a. Standard for Induced Infringement
“Whoever actively induces infringement of a patent shall be liable as an infringer.” 35 U.S.C. § 271(b) (emphasis added). In order to establish inducement, the patentee must show “direct infringement, and that the alleged infringer ‘knowingly induced infringement and possessed specific intent to encourage another’s infringement.’ ” i4i Ltd. P’ship v. Microsoft Corp.,
As relevant here, in order to obtain a preliminary injunction, Otsuka must prove that it will “ ‘more likely than not’ ” succeed in establishing the elements of induced infringement. Trebro Mfg., Inc.,
In its submissions, Otsuka makes little mention of the need to construe Claim 1 of the '350 patent.
These generic Defendants, however, uniformly characterize Otsuka’s proposed construction as untenably broad, and argue, based upon the plain claim language, that Claim 1 should be construed to require a single pharmaceutical composition or dosage form, i.e., a single tablet, comprised of at least two different active ingredients: (a) aripiprazole and (b) either citalopram or escitalopram. (See, e.g., Apotex’s Opp’n at 6; Sandoz’s Opp’n at 7-15; Teva’s Br. at 10-12; Hetero’s Br. at 9-17; Actavis’s Opp’n at 7-9.)
In construing claim terms, courts “look to, and primarily rely on, the intrinsic evidence, including the claims themselves, the specification, and the prosecution history of the patent.”
The disputed composition claim in this instance, Claim 1 of the '350 patent, requires no complex construction. Indeed, the limited claim language leaves little to the imagination, and requires no more than “the application of the widely accepted meaning of commonly understood words.”
Claim 1 of the '350 patent specifically discloses, in its entirety, as follows: “A pharmaceutical composition comprising (a) aripiprazole in combination with (b) at least one serotonin reuptake inhibitor selected from citalopram, escitalopram and salts thereof.” ('350 patent, reprinted at Ex. 4 to Fues Dec. at col. 28, In. 64-67 (emphases added).) In that regard, Claim 1 discloses, on its face, only a composition product comprised of the identi-lied active pharmaceutical ingredients, but not any method of administration, particular molecular structure, nor ’any method of use.
Moreover, despite the brevity of the claim language, several features critically relevant to construction immediately emerge from even an cursory review of Claim l’s brief language, namely, the inclusion of “a pharmaceutical composition ” in the singular, followed by grammatically uninterrupted identification of the composition’s at least two component parts. (Id. (emphasis added).) See Credle v. Bond,
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 cítalo-pram, escitalopram and salts thereof is 1 to 70 parts by weight of the total composition.” (’350 patent at col. 30, In. 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. Indeed, Claim 18’s disclosure of a specific ingredient ratio explicitly teaches that Claim l’s “pharmaceutical composition” necessarily occurs in a single dosage format. See, e.g., Research Plastics, Inc. v. Fed. Packaging Corp.,
The overall structure of the patent, throughout its various sequential components, then consistently .and repeatedly teaches that the claimed invention concerns a single dosage form, comprised of two active ingredients.
Indeed, the '350 patent describes the invention at the outset in its abstract as a “pharmaceutical composition” comprised of “(1) a carbostyril derivative,” either “aripi-prazole or a metabolite,” together with “(2) a serotonin reuptake inhibitor,” e.g., citalo-pram and/or escitalopram, “in a [single] pharmaceutically acceptable carrier.” (See Ex. 4 to Fues Dec. at Abstract (emphasis added).) In the disclosure of the invention, the '350 patent then reiterates that the claimed invention consists of at least two ingredients “in a pharmaceutically acceptable carrier.” (Id. at col. 2, In. 66 to col. 6, In. 17.)
Identical disclosures appear in the Detailed Description, which describes in detail the “first” and “second” ingredients, “contained,” “combined,” or “mixed” in the single “pharmaceutical composition.” (See, e.g., id. at col. 6, In. 4755; col. 10, In. 52-57; col. 11, In. 47-48 (“Combination of the First Ingredient with the Second Ingredient”); col. 13, In. 5662 (“the amounts of the first ingredient and the second ingredient to be contained in the pharmaceu
The eighteen “non-limiting formulation examples of aripiprazole” then uniformly disclose formulations for “the [claimed] tablet” that contain multiple active pharmaceutical ingredients, namely aripipra-zole combined with at least one SRI, together in a single “tablet.” (Id. at Col. 20, In. 46-Col. 25, In. 17 (emphases added); see also Col. 11, In. 54-58 (setting forth a non-exhaustive list of the relevant SRIs).)
Given the volume and pervasiveness of these consistent references to a composition in a single dosage form, the Court finds no support for Otsuka’s position that the “pharmaceutical composition” of Claim 1 should be construed, for purposes of the pending motions, to teach that aripiprazole and the at least one SRI (namely, escitalo-pram and/or citalopraip) may be presented in separate and/or multiple dosage forms. (See Otsuka’s Br. at 4; Otsuka’s Reply at 3.)
Nor does Otsuka’s citation to limited portions of the specification support any contrary construction. At the outset, the Court notes that Otsuka cannot cherry pick portions of the specification to support its argument that the '350 patent teaches a broadened definition of Claim l’s “pharmaceutical composition,” all while ignoring the actual wording of Claim 1 and the other and numerous portions of the specification that provide a clear contrary indication that better comports with the plain claim language. 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, in particular, relies upon the following portions of the specification:
The novel compositions of [the] present invention comprising at least one carbos-tyril derivative ... and at least one serotonin reuptake inhibitor in a pharma-ceutically acceptable carrier may be combined in one dosage form, for example a pill. Alternatively the at least one carbostyril derivative ... and the atleast one serotonin • reuptake inhibitor may be in separate dosage forms, each in a pharmaceutically acceptable carrier.
(Id. at col. 3, In. 52-60 (emphases added).)
Administration forms of the pharmaceutical composition of the present invention may be any type by which the effective levels of both carbostyril derivatives and serotonin reuptake inhibitors can be provided in vivo at the same time. In one embodiment, a carbostyril derivative together with a serotonin reuptake inhibitor are contained in one pharmaceutical composition and this composition may be administered. On the other hand, each one of carbostyril derivative and a serotonin reuptake inhibitor are contained individually in a pharmaceutical preparation respectively, and each one of these preparations may be administered at the same time or in suitable intervals.
(Id. at col. 14, In. 17-21 (emphases added).)
The aripiprazole can be administered in one dosage form, for example a tablet, and the serotonin reuptake inhibitor may be administered in a separate one dosage form, for example a tablet. The administration may occur at about the same time or at different times during the day.
Alternatively, a dosage form containing aripiprazole in combination with at least one serotonin reuptake inhibitor may be administered. Such combinations include without limitation the following: aripiprazole/fluoxetine, aripipra-zole/duloxetine, aripiprazole/venlafaxine, aripiprazole/milnacipran, aripiprazole/ci-talopram, aripiprazole/fluvoxamine, ari-piprazole/paroxetine, and aripipra-zole/sertraline. A preferred embodiment comprises a combination of aripi-prazole and citalopram.
(Id. at col. 26, In. 15-20 (emphases added).)
These passages, particularly the emphasized portions, make plain a distinction between the preferred “combined” composition, e.g.,, the composition otherwise disclosed in the remainder of the specification, and an alternative composition in which the aripiprazole and the at least one SRI exists “in separate dosage forms, each in a pharmaceutically acceptable carrier.” (Id.) Beyond recognizing this critical distinction, these passages further reflect the patent drafter’s appreciation of the language necessary to disclose the potential for separate or multiple administrations. Nevertheless, the patent drafter included no sufficiently flexible or broad language in Claim 1 or in the “Detailed Description,” choosing instead to refer to the singular claim term “pharmaceutical composition.” In that respect, these passages appear to disclose, at most, “alternative” or “on the other hand” embodiments. The Court, however, need not credit alternatively disclosed embodiments that, as here, “contradict” the relevant claim language. TIP Sys., LLC v. Phillips & Brooks/Gladwin, Inc.,
As stated above, the amount of intrinsic evidence that consistently dis
ii. Otsuka Has Not Demonstrated That Defendants’ Proposed ANDA Products Directly Infringe Construed Claim 1 of the '350 Patent
A claim of induced infringement requires Otsuka, as stated above, to make a threshold showing of direct infringement — through either evidence “of specific instances of direct infringement” or through evidence “that the accused products necessarily infringe.” Ricoh Co., Ltd. v. Quanta Computer Inc.,
Here, while the Court has preliminarily determined that Claim 1 requires a single composition, or tablet, containing aripiprazole in combination with either citalopram and/or escitalopram, Defendants’ proposed generic products indisputably contain, as stated above, only one active ingredient-aripiprazole. (See, e.g., Torrent’s Opp’n at 8; Alembic’s Opp’n at 2; Zydus’s Opp’n at
Nevertheless, even if Otsuka could meet this threshold requirement, Otsuka has not established that any of these Defendants specifically and actively intend to induce infringement of asserted Claim 1, the second requirement of an induced infringement claim, for reasons next discussed,
iii. Otsuka Has Not Shown that Defendants Actively and Purposefully Encouraged Infringement
Otsuka argues that Defendants’ proposed package inserts or labels teach that aripiprazole should be co-administered with an antidepressant like citalopram
The Court, however, need not belabor Otsuka’s position, because the Defendants’ labels fail to contain, even under the reading most generous to Otsuka, any sufficiently significant specific and active instruction to, and/or encouragement of, an infringing use.
Inducement requires, as stated above, that the alleged infringer “ ‘knowingly induced infringement and possessed [the] specific intent to encourage another’s infringement.’ ” Ericsson, Inc. v. D-Link Sys., Inc.,
As generics of Ability®, these Defendants’ ANDA products have the same active ingredient (aripiprazole), dosage strengths, and route of administration (oral or oral disintegrating tablets) as Ability®. Nevertheless, these generic Defendants’ proposed package inserts differ, in material respects, from the approved Ability® label for at least two reasons, both of which prove fatal to Otsuka’s assertions of intentional action.
a. Defendants’ “Carve Out” of the Relevant Indication Significantly Diminishes Any Suggestion of Sufficiently Intentional Action
Critically absent from each proposed label is any indication that the generic aripi-prazole products should be used for ad-junctive treatment of major depressive disorder, the primary indication for the '350 patent. Indeed, each generic Defendant specifically “carved-out” the pertinent indication (e.g., “adjunctive treatment for major depressive disorder”) from their respective generic Ability® labels, affirmatively relinquishing the right to actively promote use of their aripiprazole products with any antidepressants, including citalo-pram and escitalopram.
The fact that all of these Defendants actively and voluntarily removed any reference to the allegedly infringing indication, in turn, belies any suggestion that these Defendants acted with the specific intention to encourage infringement. Indeed, this affirmative action would seem to negate any reasonable inference of an active intent to induce infringement. See Acorda Therapeutics Inc. v. Apotex Inc., No. 07-4937,
b. Defendants’ Proposed Labels Do Not Reflect Actual Instruction in Furtherance of Inducing Infringement
In addition, the Court also finds significant deficiencies in Otsuka’s positions concerning the substance of Defendants’ actual labels. Critically, Otsuka does not claim that any individual Defendant instructs and/or encourages the infringing use of its aripiprazole product in either of the key sections of the package inserts: “INDICATIONS AND USAGE” or “DOSAGE AND ADMINISTRATION.” See Bayer Sobering Pharma AG,
Rather, Otsuka’s position on induced infringement hinges upon the fact that the black box warnings and related sections of Defendants’ labels purportedly imply that the adjunctive use of aripiprazole with any antidepressant results in reduced rates of suieidality in patients aged 65 and older; identify escitalopram and/or “substrates of CYP2C19” as drugs without any clinically important interactions with aripiprazole; and otherwise discuss and/or reference the use of antidepressants, generally, in conjunction with aripiprazole.
Otsuka specifically points to the following emphasized portions of Defendants’ proposed package inserts which the Court has grouped for convenience into representative examples of the relevant sections of Defendants’ labels:
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS and SUICIDAL THOUGHTS AND BEHAVIORS WITH ANTIDEPRESSANT DRUGS
_[redacted],
Anyone considering the use of adjunctive aripiprazole or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suieidality with antidepressants com
WARNINGS AND PRECAUTIONS
Clinical Worsening of Depression and Suicide Risk/Suicidal Thoughts and Behaviors in _Children, Adolescents, and Young Adults_
_._[redacted!_
All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases._
[redacted![redacted!
Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
It should be noted that aripiprazole is not approved for use in treating depression in the pediatric population.
Screening Patients for Bipolar Disorder: A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled trials) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder, such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.
_Metabolic Changes Weight Gain_
_[redacted]
In the trials adding aripiprazole to antidepressants, patients first received 8 weeks of antidepressant treatment followed by 6 weeks of adjunctive aripiprazole or placebo in addition to their ongoing antidepressant treatment. The mean change in body weight in patients
_ADVERSE REACTIONS 6.1 Overall Adverse Reactions Profile_
_íredactedl_
The conditions and duration of treatment with aripiprazole (monotherapy and adjunctive therapy with antidepressants or mood stabilizers) included (in overlapping categories) double-blind, comparative and noncomparative open-label studies, inpatient and outpatient studies, fixed- and flexible-dose studies, and short- and longer-term exposure.
7.2 Drugs Having No Clinically Important Interactions with Aripiprazole
[redacted]
Escitalopram
Coadministration of 10mg/day oral does of aripiprazole for If days to healthy subjects had no effect on the steady-state phar-macokinetics of 10mg!day esci-talopram, a substrate of CYP2C19 and CYPSAf. No dosage adjustment of escitalopram is required when aripiprazole is added to escitalopram.
Based on pharmacokinetic studies, no dosage adjustment of ari-piprazole is required when administered concomitantly with famotidine, valproate, lithium, lo-razepam.
In addition, no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethor-phan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., war-farin), CYP2C19 (e.g., omepra-zole, warfarin, escitalopram), or CYP3A4 (e.g., dextromethor-phan) when co-administered with aripiprazole. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotri-gine, lorazepam, or sertraline when co-administered with ari-piprazole [see CLINICAL PHARMACOLOGY (12.3) ].
Based on pharmacokinetic studies, no dosage adjustment of ari-piprazole is required when administered concomitantly with famotidine, valproate, lithium, lo-razepam.
In addition, no dosage adjustment is necessary for substrates o/CYP2D6 (e.g., dextromethor-phan, fluoxetine, paroxetine, or venlafaxine), CYP2C9 (e.g., war-farin), CYP2C19 (e.g., omepra-zole, warfarin), or CYP3A4 (e.g., dextromethorphan) when co-administered with aripiprazole. Additionally, no dosage adjustment is necessary for valproate, lithium, lamotrigine, lorazepam, or sertraline when co-administered with aripiprazole. [see CLINICAL PHARMACOLOGY (12.3)].
MEDICATION GUIDE
Aripiprazole Tablets
[redacted]
Read this Medication Guide before you start taking aripiprazole and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your health care provider about your medical condition or treatment.
What is the most important information I should know about aripiprazole tablets?
(For other side effects, also see “What are the possible side effects of aripiprazole tablets?”).
Serious side effects may happen when you take aripiprazole, including:
• Increased risk of death in elderly patients with dementia-related psychosis: Medicines like aripiprazole can raise the risk of death in elderly people who have lost touch with reality (psychosis) due toconfusion and memory loss (dementia). Aripiprazole is not approved for the treatment of patients with dementia-related psychosis.
• Risk of suicidal thoughts or actions: Antidepressant medicines, depression and other serious mental illness, and suicidal thoughts or actions:
1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment.
2. Depression and other serious mental illness are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic depressive illness) or suicidal thoughts or actions.
3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member?
• Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed.
• Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings.
• Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms.
Call a health care provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you:
• thoughts about suicide or dying
• attempts to commit suicide
• new or worse depression
• new or worse anxiety
• feeling very agitated or restless
• panic attacks
• trouble sleeping (insomnia)
• new or worse irritability
• acting aggressive, being angry, or violent
• acting on dangerous impulses
• an extreme increase in activity and talking (mania)
• other unusual changes in behavior or mood
What else do I need to know about antidepressant medicines?
• Never stop an antidepressant medicine without first talking to a healthcare provider. Stopping an antidepressant medicine suddenly can cause other symptoms.
• Antidepressants are medicines used to treat depression and other illnesses. It
is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants.
• Antidepressant medicines have other side effects. Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member.
• Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member takes. Keep a list of all medicines to show the healthcare provider. Do not start new medicines without first checking with your healthcare provider.
As illustrated above, Otsuka’s theory of induced infringement turns, in its entirety, upon fleeting references to antidepressants, certain generic Defendants’ single reference to the coadministration of their respective aripiprazole products with esci-talopram, and Defendants’ general reference to antidepressants. 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 coad-minister aripiprazole with any particular drug, much less escitalopram or citalo-pram, the only antidepressants covered by Claim 1.
Indeed, courts have repeatedly found incidental references to even infringing uses in these sections insufficient to constitute instruction or encouragement, as opposed to mere permission, and have consistently rejected safety discussions as a basis for inducement liability. See, e.g., United Therapeutics Corp.,
Nevertheless, the Court finds the deficiency in Otsuka’s argument best illustrated by the following side-by-side comparison of relevant sections of Otsuka’s Ability® insert to that of each of these generic Defendants:
Otsuka’s ABILIFY® (aripiprazole) Tablets label (Ex. B to Roth Dec.) BLACK BOX WARNINGS
1 INDICATIONS AND USAGE ABILIFY is an atypical antipsychotic. The oral formulations are indicated for. . .
Adjunctive Treatment of Major Depressive Disorder
Adjunctive Treatment of Major Depressive Disorder [see CLINICAL STUDIES (14.3) ] 2 DOSAGE AND ADMINISTRATION
2.3 AJjunctive Treatment oí Major Depressive
Disorder
Adults
The recommended starting dose for ABILIFY as adjunctive treatment for patients already taking an
1. No reference to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder, other than in black box warning.
2. No reference to coadministration of aripipra-zole with eitalopram
3.Only one reference to escitalopram in section 7.3, entitled “Drugs Having No Clinically Important Interactions with Aripiprazole”]
Alembic’s Aripiprazole Label (Alembic’s Br. at 15-16.)
1. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
2. No reference to coadministration of aripipra-zole with eitalopram
3. Escitalopram appears twice, once in section 7, “DRUG INTERACTIONS,” and again in section 12, “CLINICAL PHARMACOLOGY”_
Zydus’s Aripiprazole [redacted] Label (Exs. 1 & 2 to Srinivas Dec.)
6.1 Clinical Trials Experience
Adult Patients Receiving ABILIFY as Adjunc-tive Treatment of Major Depressive Disorder
The following findings are based on a pool of two placebo-controlled trials of patients with major depressive disorder in which ABILIFY was administered at doses of 2 mg to 20 mg as adjunctive treatment to continued antidepressant therapy.
Adverse Reactions Associated with Discontinuar tion of Treatment
The incidence of discontinuation due to adverse reactions was 6% for adjunctive ABILIFY-treated patients and 2% for adjunctive placebo-treated patients.
Commonly Observed Adverse Reactions
The commonly observed adverse reactions associated with the use of adjunctive ABILIFY in patients with major depressive disorder (incidence of 5% or greater and ABILIFY incidence at least twice that for placebo) were: akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision.
Less Common Adverse Reactions in Adult Patients with Major Depressive Disorder
7 DRUG INTERACTIONS
7.2 Drugs Having No Clinically Important Interactions with ABILIFY
no dosage adjustment is necessary for substrates of CYP2D6 (e.g., dextromethorphan, fluoxetine, pa-roxetine, or venlafaxine), CYP2C9 (e.g., warfarin), CYP2C19 (e.g., omeprazole, warfarin, escitalo-pram), or CYP3A4 (e.g., dextromethorphan) when co-administered with ABILIFY. . .
1. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
2. No reference to the eoadministration of aripipra-zole with any antidepressant
3. Escitalopram appears once in section 7.2,
“Drugs Having No Clinically Important Interactions with Aripiprazole”
Sun’s Aripiprazole Label (Ex. 2 to Gangasani Dec.)
1. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
2. No reference to eoadministration of aripiprazole with citalopram or escitalopram
Teva’s Aripiprazole Label (Ex. 2 to Birbach Dec.)
1. No reference to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder, other than in black box warning.
2. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
3. No reference to eoadministration of aripipra-zole with citalopram or escitalopram, only more generally to antidepressants.
Actavis’s Aripiprazole Label (Ex. D to Gannon Dec.)
1. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
2. No reference, to eoadministration of aripiprazole with citalopram or escitalopram
Apotex’s Aripiprazole Label (Ex. 1 to Halper Dec.)
1. No reference to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder, other than in black box warning.
2. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
Adults
The efficacy of ABILIFY in the adjunctive treatment of major depressive disorder. . .
MEDICATION GUIDE
WHAT IS ABILIF.Y?
• ABILIFY Oral Tables, Orally-Distintegrating Tablets, and Oral Solution are prescription medicines used to treat:
• major depressive disorder (MDD) when ABI-LIFY is used with antidepressant medicines
3. No reference to coadministration of aripiprazole with citalopram
4. Escitalopram appears once in section 7.2,
“Drugs Having No Clinically Important Interactions with Aripiprazole”
Hetero’s Aripiprazole Label (Ex. 6 to Ives Dec.)
1. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
2. No reference to coadministration of aripipra-zole with citalopram or escitalopram
Sandoz’s Aripiprazole Label (Ex. 5 to Fues Dec.)
1. No references to the use of the generic for the Adjunctive Treatment of Major Depressive Disorder
2. No reference to coadministration of aripiprazole with citalopram or escitalopram
Critically, in arguing that Defendants’ labels contain “compelling encouragement” to prescribe aripiprazole in a manner that infringes Claim 1, i.e., in conjunction with escitalopram and/or citalopram, Otsuka entirely ignores the context in which the warning language appears and relies upon language too general to constitute active encouragement to prescribe an infringing combination aripiprazole product.
Indeed, in insisting that these Defendants’ labels induce infringement, Otsuka relies, almost exclusively, upon language that warns of the potential risks associated with the interaction between aripiprazole and antidepressants, generally. The term “antidepressants,” however, identifies a general class of “different drugs,” comprised of “about two dozen” varieties. (Calabrese Dec. at ¶ 33.) Claim 1, however, only concerns one limited and narrow subset of antidepressants, namely, citalo-pram and escitalopram. In that respect, Otsuka argues that a reference to the broad and far larger class of antidepressants necessarily amounts to substantial encouragement of an infringing combination product. The Court, however, can hardly imagine that a general reference to antidepressants will inevitably encourage the combination of aripiprazole and escital-opram and/or citalopram, the only relevant combination for purposes of Otsuka’s theory of induced infringement. As a result, any discussion of antidepressants generally cannot be taken as active instruction to encourage users to perform a patented method that, on its face, concerns only citalopram and escitalopram. AstraZene-ca,
Moreover, even if the Court accepted Otsuka’s position that a reference to “antidepressants” would necessarily evoke esci-talopram and/or citalopram in the mind of any reader, the Court cannot find that the information admittedly contained only in the warning provisions of Defendants’ labels demonstrates the active instruction
Indeed, the weight of authority has deemed warning and safety information insufficient to constitute inducement, requiring instead that the information be set forth in the “Uses and Indication” or “Dosing and Administration” sections of the allegedly offending labels. See, e.g., Shire,
One court in this District has in fact persuasively noted the “rather significant difference between a warning and an instruction.” United Therapeutics Corp.,
The disputed warnings in this instance do far less, and do not, by their very natures, encourage underlying, infringing behavior.
Indeed; in their black box warnings, Defendants uniformly disclose that “short-term studies” indicate that the use of aripiprazole in conjunction with antidepressants increases the risk of suicidality in children, adolescents, and young adults; has no impact on the risk of suicidality in patients over age 24; and results in a decreased risk of suicidality in patients aged 65 and older. Nevertheless, Otsuka argues that these provisions constitute active encouragement to prescribe an infringing product, to the extent the language discloses that the adjunctive use of aripiprazole results in a decreased risk of suicidality in a certain population. As a result, Otsuka asserts that these Defendants’labels actively instruct the beneficial combination of aripiprazole with escitalo-pram and/or citalopram at least with respect to those older than 64.
In so arguing, however, Otsuka mischar-acterizes the fundamental nature and placement of this information. Indeed, placed in context, the language does not
Rather, these warnings, as a whole, serve to discourage adjunctive use in certain populations, by specifically placing physicians on notice of the potential harmful side effects and contraindications. Against this backdrop, the remaining statements convey, at most, indifference to the administration of the ANDA products in conjunction with an antidepressant, and imply that aripiprazole could be administered with an antidepressant, without any increased risk of suicide in adults aged 65 and older. They do not, however, actively encourage or direct such administration. Takeda,
Nor can the Court conclude .that the isolated references to escitalopram in the Clinical Pharmacology and Drug Interactions sections of certain Defendants’ labels compel any different conclusion. Indeed, escitalopram appears amongst references to a laundry list of disparate drugs used to treat conditions far removed from that indicated by the '350 patent like, for example, high blood pressure (warfarin) or excess stomach acid (omeprazole), and Ot-suka has provided no sufficient explanation as to how this information might induce anyone to do anything. As a result, these limited references in labels that each exceed 50 pages can hardly be described as an indication of these Defendants’ active encouragement of infringement.
For all of these reasons, the Court concludes that these Defendants’ labels provide no sufficient indication that the information cited by Otsuka will inevitably and necessarily lead to infringing acts, an essential showing for Otsuka’s inducement
c. The Substantial Non-Infringing Uses Further Diminish Any Inference of the Requisite Specific Intent to Induce Infringement
The “existence of a substantial non-infringing use does not,” as a matter of law, “preclude a finding of inducement.” Toshiba Corp. v. Imation Gorp.,
The overwhelmingly predominant use of Ability® is as a tablet containing only aripiprazole as the active ingredient, which is not the combination drug claimed by the '350 patent. Likewise, the Defendants’ proposed generic aripiprazole contains only aripiprazole as repeatedly noted above. The undeniably non-infringing use of aripiprazole’s generic dosage will thus constitute the substantial and dominant usage having nothing to do with co-administration of aripiprazole and citalopram or escitalopram antidepressants.
Moreover, although the parties dispute the exact percentage of non-infringing use, the record contains no dispute that the non-infringing uses remain, under any parties’ estimation, substantial. (Compare Hetero’s Opp’n at 3-4 (arguing that the “peripheral” material covered by the '350 patent concerns [redacted] of Otsuka’s overall market), with Otsuka’s Reply at 10 (arguing that product covered by the '350 patent results in [redacted] of Otsuka’s overall market).) Moreover, because none
Therefore, for this additional reason, the Court finds that Defendants’ labels provide no basis from which to infer a specific intent to encourage infringement. See Vita-Mix Corp.,
In conclusion, Otsuka has failed to prove likelihood of success on its claim for direct infringement or induced infringement in the event these generic products are launched after April 20, 2015.
2. Defendants Have Raised a Substantial Question of Invalidity
In addition to concluding that Otsuka has not demonstrated a likelihood of success on its theory of induced infringement, the Court additionally, and in the alternative, concludes that these Defendants have raised a substantial question of invalidity.
As relevant here, these Defendants,
A patent is invalid if “the invention was patented or described in a
In light of the presumption of patent validity, 35 U.S.C. § 282, and the related presumption that the USPTO “ ‘properly’ ” performed its function in reviewing patent applications, generic defendants must ordinarily prove invalidity by clear and convincing evidence. See Cadence Pharm. Inc. v. Exela PharmSci Inc.,
At the outset, the Court notes that Claim 1 of the '350 patent and Claim 40 of the Migaly '043 patent disclose, on their faces, the same general combination:
_Claim 1 of the '350 Patent_
A pharmaceutical composition comprising (a) aripiprazole in combination with (b) at least one serotonin reuptake inhibitor selected from citalopram, escitalopram and salts thereof
Claim 40 of the Migalv '043 Patent
The method of claim 11, wherein said antidepressant is selected from the group consisting of fluoxetine, norfluoxetine, paroxetine, sertraline, fluvoxamine, citalopram, escitalo-pram, zimelidine, indalpine, femoxetine, ala-proclate and pharmaceutically acceptable salts thereof, and wherein said atypical anti-psychotic drug is selected from the group consisting of risperidone, quetiapene, olanza-pine, ziprasidone and aripiprazole.
The Migaly '043 patent, in particular, discloses a “method for treatment of a patient suffering from major depressive disorder” (Ex. 13 to Ives Dec. at col. 32, In. 2-3), through the administration of a combination product comprised of an antidepressant and an antipsychotic. (Id. at col. 33, In. 17-25.) Claim 40 of the Migaly '043 patent then delineates 11 specific antidepressants, including citalopram and escital-opram, and 5 antipsychotics, including ari-piprazole. (Id.) In that regard, it appears that the Migaly '043 patent discloses each and every claimed element of Claim 1 of the '350 patent. Moreover, despite Otsu-ka’s expert’s contention that the “long list[ ] of antipsychotics and antidepressants” clouds any clear “recitation in the Migaly Patent that discloses the specific combination of aripiprazole and escitalo-pram/citalopram” (Roth Validity Dec. at ¶ 16),
Moreover, based upon the submissions, the Court cannot conclude that Otsuka’s priority-based challenge demonstrates that these Defendants’ invalidity position lacks substantial merit. Indeed, Otsuka provides little support for its position that the Migaly '043 patent cannot claim priority based upon its Provisional Application. (See generally Otsuka’s Reply at 7-8; Roth Validity Dec.) Rather, Otsuka points to the unique nature of the Migaly Provisional Application, and to the fact that it discusses “a number of disparate and abstract concepts,” including several pages concerning “motivational talks intended to help people quit smoking.” (Roth Validity Dec. at ¶ 8.) Despite the Application’s certain unusual features, the Court cannot ignore that the Provisional Application squarely states that it concerns a combination antidepressant and antipsychotic product for the treatment of depression. Moreover, though the Migaly
Given the substantial relation and overlap between the claimed compounds, and the fact that the Migaly patent claims priority to its provisional application on its face and in its specification, the Court concludes that these Defendants (all other than Zydus) have established a substantial question of invalidity based upon the Migaly '043 patent, and that Otsuka has not shown that this question of invalidity lacks substantial merit. Thus, temporary in-junctive relief premised upon the vulnerable '350 patent should not be granted.
B. Otsuka Has Not Demonstrated that it Will Suffer Immediate and Irreparable Harm in the Absence of an Injunction as a result of the Market Entry of these Defendants’ Aripiprazole Products
In order to demonstrate irreparable harm, Otsuka “must make ‘a clear showing’ ” that, in the absence of an injunction, (1) “it will suffer [immediate and] irreparable harm,” and (2) “that a sufficiently strong causal nexus relates the alleged harm to the alleged infringement.”
1. Otsuka’s Alleged Harms Are Quantifiable
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.,
Indeed, Otsuka’s expert, John C. Jarosz, states that the “general consequences of generic entry tend to be somewhat predictable,” and has resulted, under parallel facts, in “virtually the same [outcome]: rapid declines almost immediately after the entry of the generic, followed by steady and continuing declines thereafter.” (Jarosz Dec. at ¶¶ 33, 39.) Moreover, although Mr. Jarosz ultimately concludes that the purported injuries to Otsuka prove unquantifiable to “a reasonable degree of accuracy and certainty” (id. at ¶¶ 61-67), in the preceding portions of his declaration, he specifically estimated and quantified these alleged harms in terms of percentage losses, and he provided specific projections of Otsuka’s losses in the face of generic competition. (Id. at ¶¶ 55 41, 48-51.) Mr. Jarosz further acknowledges that these harms may prove reparable, even if “costly to reverse” or difficult to “reverse[ ] instantly.” (Id. at ¶¶ 36, 62.)
Finally, the Court must note that Mr. Jarosz bases his initial estimations upon Otsuka’s overbroad and unsupported construction of Claim 1, by discussing the impact of generic competition on Abilify®’s overall performance.
The Court of Appeals for the Federal Circuit has, however, expressly concluded that “neither the difficulty of calculating losses in market share, nor speculation that such losses might occur, amount to proof of special circumstances justifying the extraordinary relief of an injunction prior to trial.” Nutrition 21 v. United States,
Otsuka’s submissions reflect, as stated above, a detailed and nuanced ability to assess and calculate Otsuka’s sales and market share, and an ability to project the potential impact of Defendants’ entry. (See Jarosz Dec. at ¶¶ 29-77; Jarosz Supplemental Dec. at ¶¶ 36-74.) Indeed, Ot-
2. Otsuka Has Not Met the “Causal Nexus” Requirement
The Court also finds that Otsu-ka has failed to demonstrate the second and “ ‘inextricably related’ ” irreparable harm consideration, namely, a sufficient causal nexus between the alleged infringement and Otsuka’s claimed harm. See Apple Inc. v. Samsung Elecs. Co. Ltd.,
not whether there is some causal relationship between the asserted injury and the infringing conduct, but to what extent the harm resulting from selling the accused product can be ascribed to the infringement. It is not enough for the patentee to establish some insubstantial connection between the alleged harm and the infringement and check the causal nexus requirement off the list.
Apple II,
As stated above, none of these generic Defendants’ aripiprazole products include either escitalopram and/or citalopram and, as a result, none of these products will be infringing. Given this, none of Otsuka’s claimed harm can be ascribed to, or be said to have a causal nexus with, infringement of the '350 patent. See, e.g., Briggs
However, even if the Court accepted Otsuka’s infringement theory—which it does not—the record in this instance contains no dispute that at least of the time,
For all of these reasons, the Court also finds that Otsuka has failed to meet the causal nexus requirement. See Merck & Co. v. Teva Pharm. USA Inc.,
3. Otsuka’s Delay in Requesting Injunctive Relief Suggests Lack of Urgency
Finally, the Court turns to Otsuka’s delay—an important factor bearing on the need for a preliminary injunction, particularly irreparable harm. See Pfizer,
The delay most relevant for purposes of the Court’s consideration of irreparable harm is Otsuka’s delay in requesting in-junctive relief when the inevitable April 20, 2015 expiration dáte of the '528 patent approached. In that respect, the Court notes that Otsuka filed the first of these related patent infringement actions more than 13 months ago on February 18, 2014, see Otsuka Pharm. Co., Ltd. v. Torrent Pharm., Inc., Civil Action No. 14-1078 (JBS/KMW)? followed shortly thereafter by a cascade of twenty-four related actions.
For this secondary reason, the Court finds that Otsuka has not demonstrated the urgency in avoiding irreparable harm, and turns to the balance of hardships.
C. The Balance of Hardships Favors these Defendants
“The balance of hardships factor ‘assesses the relative effect of granting or denying an injunction on the parties.’ ” Apple III,
The hardship on a preliminarily enjoined generic which has taken affirmative steps to enter the market can be devastating. On the- other hand, the hardship on a patentee denied an injunction after showing a strong likelihood of success on validity and infringement consists of an equally serious impingement on its right to exclude. See Ill. Tool Works, Inc. v. Grip-Pak, Inc.,
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. (See, e.g., Torrent’s Br. at 14; Alembic’s Br. at 27; Zydus’s Br. at 36-37; Sun’s Br. at 14; Teva’s Br. at 38; Actavis’s Br. at 26-27; Apotex’s Br. at 27-28; Hetero’s Br. at 27; Sandoz’s Br. at 29.) The issuance of an injunction would seriously erode these and related efforts. Indeed, these generic Defendants would face the loss of all of the “costly enterprises” made to prepare their products “in readiness of ultimate FDA approval and commercial launch” on April 20, 2015. Graceway Pharm.,
In addition, the issuance of a TRO would deprive these Defendants of the advantage of being an early market entrant, and may force these Defendants to ultimately launch with competitors that would otherwise have only been able to launch after these early entrants. See, e.g., Bracco Diagnostics, Inc. v. Shalala,
The Court must, however, note that, unlike the majority of these generic Defendants, [redacted], thereby limiting Otsu-ka’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.
For. all of these reasons, the Court finds that the balance of hardships tips in favor of these generic Defendants.
D. The Public Interest Counsels against the Issuance of an Injunction
The public interest factor requires Otsuka to demonstrate that the entry of an
In enacting the H atch-Waxman Act, Congress “ ‘struck a balance between two competing policy interests: (1) inducing pioneering research and development of new drugs and (2) enabling competitors to bring low-cost, generic copies of those drugs to market.’ ” Dey Pharma, LP v. Sunovion Pharm. Inc.,
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. Therefore, Ot-suka has long enjoyed the exclusive rights to the aripiprazole market in the United States and has, in turn, been duly rewarded for bringing its innovation to market. In fact, Otsuka’s aripiprazole exclusivity has generated, in the last eight years alone,.over $100 billion in revenue. (See generally Jarosz Dec.) The public’s interest in encouraging and rewarding innovation has been well served already. Given this, Otsuka has had ample opportunity to fully and completely realize a return on its investment, many times over, and to adjust its business as it deemed necessary in order to address the loss of exclusivity it knew, for years, rested upon the horizon.
Given Otsuka’s monopoly in aripiprazole, the public interest that at one point favored them has now tipped in favor of Defendants, because although Hatch-Wax-man seeks to foster innovation, it also encourages finality upon the expiration of a long protected pharmaceutical patent exclusivity. Therefore, there can be little question that extending Otsuka’s protection from competition in the absence of Otsuka’s likelihood of success on the merits would result in a disservice to the public interest. Indeed, under these circumstances, the public interest would benefit from increased competition from these generic Defendants that have waited patiently for the expiration of the '528 exclusivity period.
Finally, the Court must note that, “neither the public interest nor equity favors the grant of an injunction against one who does not infringe.” Novo Nordisk of N. Am. v. Genentech, Inc.,
The Court, accordingly, concludes that the public interest counsels against the issuance of temporary restraints.
VI. CONCLUSION
Ah injunction constitutes a drastic remedy and Otsuka bears the burden of establishing an entitlement to such extraordinary relief. See, e.g., Nitro Leisure Prods., LLC v. Acushnet Co.,
Notes
. 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 Court will refer to Defendants' "package inserts” and/or "labels” interchangeably.
. Otsuka filed individual briefs in each of these thirteen actions with pending motions. Though the submissions contain, in part, some argument tailored to a specific defendant, Otsuka’s submissions remain substantively identical, and seek injunctive relief based upon the identical arguments in each case.
. Therefore, the Court will consider these Defendants’ positions in unison, unless otherwise indicated. Any argument with relevance to only one particular Defendant will, of course, be specifically indicated and addressed separately.
. As stated above, generic defendants in ten related actions opted out of this motion practice.
. Indeed, the record developed in these Hatch-Waxman Act cases includes lengthy opening briefs, opposition briefs, reply briefs, and sur-replies, together with the fact and expert declarations and supplemental declarations of Aaron Deves, John C. Jarosz, Bryan L. Roth, M.D., Ph.D, Ira S. Halper, M.D., Anthony Palmieri III, Ph.D., R.Ph., Philip B. Nelson, Ph.D., S. Shane Konrad, M.D., Jeffrey Hampton, Robert J. Orr, Ph.D., Christopher A. Ross, M.D., Ph.D., Christopher H. Spadea, Gilbert Block, M.D., Ph.D., David Blackburn, Ph.D., Harinath Gangasani, Joseph R. Cala-brese, M.D., and Sumanth Addanki, M.D.
. 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.
. Similar motions were brought against My-lan, 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.
. See Otsuka Pharma. Co., Ltd. v. Sun Pharma. Indus., Ltd., Civil Action No. 14-6397 (JBS/KMW) (filed October 6, 2014); Otsuka Pharma. Co., Ltd. v. Aurobindo Pharma Ltd., Civil Action No. 146890 (JBS/KMW) (filed October 31, 2014); Otsuka Pharma. Co., Ltd. v. Lupin Ltd., Civil Action No. 14-7105 (JBS/KMW) (filed November 3, 2014); Otsuka Pharma. Co., Ltd. v. Actavis Elizabeth LLC, Civil Action No. 14-7106 (JBS/KMW) (filed November 10, 2014); Otsuka Pharma. Co., Ltd. v. Alembic Pharma., Ltd., Civil Action No. 14-7405 (JBS/KMW) (filed November 26, 2014); Otsuka Pharma. Co., Ltd. v. Apotex Corp., Civil Action No. 14-8074 (JBS/KMW) (filed December 24, 2015); Otsuka Pharma. Co., Ltd. v. Hetero Drugs, Ltd., Civil Action No. 15-161 (JBS/KMW) (filed January 8, 2015); Otsuka Pharma. Co., Ltd. v. Amneal Pharma. Co, Ltd., Civil Action No. 15-1585 (JBS/KMW) (filed March 2, 2015); Otsuka Pharma. Co., Ltd. v. Sandoz Inc., Civil Action No. 151716 (JBS/KMW) (filed March 9, 2015); Otsuka Pharma. Co., Ltd. v. Indoco Remedies Ltd., Civil Action No. 15-1967 (JBS/KMW) (filed March 17, 2015).
. Counsel for Alembic moved to strike Otsu-ka's supplemental declarations on behalf of all Defendants by letter dated April 8, 2015.
. On the oral argument record, counsel for Apotex argued that Otsuka’s supplemental declarations prejudiced the record (here and potentially on appeal), by enabling Otsuka to cure an initial deficiency in Otsuka's opening submission, namely, the alleged lack of argument on claim construction. As stated below, Otsuka’s opening submission gave little attention to claim construction. Nevertheless, the Court does not find any prejudice to the record. Indeed, given the substantive nature of the issues presented in Otsuka’s motions for temporary restraining orders, there could be little mystery about the need for claim construction and, in that respect, the only new aspect of Otsuka's supplemental declarations •concerned the fact that Otsuka did indeed have an expert on claim construction. Given the volume of expert opinions, these Defendants cannot be heard to claim any surprise in the late introduction of certain, limited expert opinion.
. In these actions, Otsuka claims that Defendants’ generic aripiprazole tablets infringe one or more claims of the '615, '796, '760, '600, and/or the '350 patents. Nevertheless, according to Otsuka, because the infringement issues related to the '615, '796, '760, and/or the '600 patents “raise complex technical issues that may require expert analysis” and implicate "ongoing” discovery, Otsuka solely relies upon “infringement issues” associated with the '350 patent in support of its request for preliminary injunctive relief. (Ot-suka's Br. at 2.) This Opinion will therefore make no further reference to the '615, '796, '760, and the '600 patents, because only the '350 patent is in play.
. Indeed, in its opening briefs, Otsuka sets forth no discussion of the standard applicable to claim construction (see generally Otsuka’s Br. at 4-5), and only cursorily introduces one selfserving portion of the claim construction standard in its reply briefings. (See Otsuka’s Reply at 4 (asserting that "a court should give a claim term the full range of its ordinary meaning as understood by a person of ordinary skill in the art”) (citing Rexnord Corp. v. Laitram Corp.,
. The construction of claim terms constitutes a question of law, Markman v. Westview Instruments, Inc.,
.The parties all proffer expert opinion concerning the proper construction of Claim 1. (See, e.g., Roth Dec. at ¶¶ 13-17 (Otsuka's psychopharmacology expert); Palmieri Dec. at ¶1¶ 24-55 (Alembic's, Zydus’s, Sun’s, Teva’s, Apotex’s, and Hetero’s pharmaceutical formulator expert).) Nevertheless, because the intrinsic evidence, namely, the plain claim language, discloses the meaning of the disputed claim, the Court need not examine any extrinsic evidence, including expert testimony. Phillips,
. Indeed, Otsuka conceded in at least four of these related actions that phrases "a/the pharmaceutical composition” and "in combination with” should be construed in accordance with the phrases' “plain and ordinary meaning as understood by a person of ordinary skill in the art.” (Ex. 11 to Tang Dec.) For that reason, the Court rejects Otsuka's suggestion on the April 10, 2015 oral argument record that Claim 1 arguably possesses any special definition.
. In arguing for a construction with greater breadth, Otsuka implicitly acknowledges that its proposed construction finds little support in the plain claim language (see Otsuka’s Br. at 4 (arguing that Claim 1 of the '350 patent “is directed generally to a pharmaceutical composition,” and then quickly turning to the specification)), and entirely ignores the "in combination with” language. (See Otsuka’s Reply at 3; see also Roth Supplemental Dec. at ¶¶ 12-15 (suggesting, based upon the specification, that the composition disclosed by Claim 1 could, in certain "circumstances,” appear in two or more dosage forms).)
. Otsuka's new argument concerning Claim 9, which Otsuka raised for the first time in its reply briefings and supplemental declarations, requires no different conclusion. (See Roth Supplemental Dec. at ¶ 17.) Otsuka, in particular, argues that Claim 9 supports its position that Claim 1 "can be in one or more dosage forms,” to the extent Claim 9 discloses "a 'method of treating a mood disorder ... comprising administration of an effective amount of a pharmaceutical composition which comprise(s) aripiprazole in combination [with] (b) at least one serotonin reuptake inhibitor.' ” (Roth Supplemental Dec. at ¶ 17 (citation omitted).) Nevertheless, the Court finds this new position unconvincing for two reasons. Critically, Claim 9 constitutes an independent claim, thereby diminishing its relevance to the interpretation of Claim 1. (See Ex. 4 to Fues Dec. at Col. 9, In. 26-40.) Second, and relatedly, Claim 9 discloses a "method of treatment,” while Claim 1 concerns, on its face, only a pharmaceutical composition. (Compare id. at col. 28, In. 64-67, with id. at col. 29, In. 26-40.)
. The Court's construction also finds support in the weight of authority that has construed the term "pharmaceutical composition,” and consistently concluded that this term of art refers to a single, aggregated product. See, e.g., Ortho-McNeil Pharm. v. Kali Labs., No. 06-3533,
. Indeed, citalopram does not appear, at all, on Otsuka’s Abilify® label.
. 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. See Caraco Pharm. Labs. v. Novo Nordisk A/S, — U.S. —,
. The section heading of [redacted] label omits the phrase "with antidepressant drugs.”
. By letter dated April 14, 2015, counsel for [redacted] advised the court that [redacted] recently amended its label, but asserts that the “labeling amendment does not change the TRO infringement inquiry because [redacted] modified labels remain similar (and with respect to some passages that Otsuka has relied on to support its infringement allegations, identical) to the labels of the other defendants.” [See, e.g., Docket Item 97 in 14-6398.]
.On the oral argument record on April 10, 2015, counsel for [redacted] represented that recent amendments to Otsuka’s Ability® label would require [redacted] to conform their warning language to that of the other generic Defendants in these actions.
. On the oral argument record on April 10, 2015, counsel for Otsuka argued that [redacted] label contains this, or a substantially similar, provision. The Court, however, located no such language in [redacted] label in the present record.
. This language appears in section 7.3 on [redacted] package insert.
. On the oral argument record on April 10, 2015, counsel for [redacted] represented that recent amendments to Otsuka's Ability® label would also require [redacted], to conform their section 7.2 language to a very similar variant of that used by the other generic Defendants in these actions.
. Though the Medicine Guide of each Defendant may contain slight variations, all remain substantially similar in relevant part.
. Nor does Otsuka’s reliance upon AstraZeneca LP v. Apotex, Inc.,
. Though only Alembic, Apotex, Hetero, Torrent, and Sandoz (by sur-reply) substantively briefed the issue of invalidity, Sun, Teva, and Actavis specifically incorporated those discussions by reference into their oppositions, and restated their intentions to rely upon Alembic's, Apotex's, and Hetero's invalidity positions on the oral argument record on April 10, 2015. At the hearing, counsel for Otsuka objected to these Defendants’ incorporation. Nevertheless, because the question of invalidity presents a common question of law with equal application to all joining Defendants, the Court will, in its discretion, consider the invalidity arguments as if fully set forth in each Defendant’s briefing. The Court will, however, exclude Zydus, the only Defendant which expressed “no position” concerning invalidity, and instead "reserve[d] the right to assert any and all” invalidity defenses in the event the Court granted Otsuka's motion to amend. (Zydus’s Opp'n at 3 n. 1)
. Additionally, and in the alternative, these Defendants argue that International Application Publication No. WO 99/62522 (hereinafter, “Tollefson”), and U.S. Patent Publication No. 2002/0156067 (hereinafter, "Wong”), taken together, render Claim 1 invalid on obviousness grounds, and/or demonstrate that the product claimed by the '350 patent was otherwise within the public knowledge during the relevant period. (See, e.g., Alembic’s Br. at 23-24; Apotex’s Br. at 16-17; Hetero’s Br. at 22-23.) Nevertheless, because the Court concludes that these Defendants have demonstrated a substantial question of invalidity based upon the Migaly '043 patent, the Court need not reach Defendants' alternative arguments concerning invalidity based upon Tol-lefson in view of Wong, or the public knowledge.
. The Leahy-Smith America Invents Act (hereinafter, the "AIA''), Pub.L,. No. 112-29, § 3(c), 125 Stat. 284, 287 (2011), subsequently amended this provision. However, because the pending claims have an effective filing date prior to March 16, 2013, the pre-AIA § 102(b) applies. See Kennametal, Inc.,
. 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.
. In eBay Inc. v. MercExchange, LLC,
. The Court rejects Otsuka's claim of lost opportunity to conduct research and development at the outset, because the Court of Appeals for the Federal Circuit has expressly found such a claim insufficient "to compel a finding of irreparable harm.” Eli Lilly & Co. v. Am. Cyanamid Co.,
. At the outset, the Court notes that Apotex argues that Otsuka “lacks standing to claim irreparable harm,” because its "indirect subsidiary” and another entity directly market Ability®. (Apotex's Opp'n at 17 n. 10 (citing a number of cases that disclose the revenues of Otsuka's subsidiary).) Otsuka’s Complaint identifies Otsuka as the holder of the '350 patent by assignment. (See Compl. at ¶ 47.) Because this action concerns the harms caused by the alleged infringement of the '350 patent, the Court finds that Otsuka has standing to allege irreparable harm.
. Otsuka does not dispute that it discontinued production of its orally disintegrating Ability® tablets. Therefore, the Court cannot, at the outset, find that any irreparable harm will result from [redacted] efforts to market orally disintegrating aripiprazole tablets.
. The Court acknowledges that, under Otsuka’s construction of Claim 1, the harm derived from these generic Defendants' products would have affected the entirety of its market. Nevertheless, Claim 1 would be infringed only if Otsuka showed that Defendants’ products contained each and every claim limitation,
. Otsuka appears to suggest that this requirement somehow changes, or applies less forcefully, in connection with " 'simple' ” products, comprised of few distinguishable features. (Otsuka’s Reply at 15.) "Contrary to [Otsuka’s] suggestion, however, the causal nexus requirement applies regardless of the complexity of the products,” Apple III,
. Otsuka initially represented sales associated with the '350 patent indication accounted for “approximately [redacted]%” of Abilify®’s overall sales. (Otsuka’s Br. at 3, 26.) After these Defendants uniformly challenged this assertion—and alleged that '350 sales instead account for only [redacted]% of Abilify®’s overall sales—Otsuka retreated from its initial position, and clarified its position on the relevant position in reply.
. See L. Civ. R. 2.2.
. Otsuka, for its part, has prepared and submitted an incredibly detailed spreadsheet describing the delays in these actions, all of which Otsuka attributes, in relevant part, to these Defendants. (See Ex. 7 to Fues Dec.)
. See Otsuka Pharm. Co., Ltd. v. Alembic Global Holding SA, Civil Action No. 14-2982 (JBS/KMW) (filed May 9, 2014); Otsuka Pharm. Co., Ltd. v. Zydus Pham. USA Inc., Civil Action No. 143168 (JBS/KMW) (filed May 16, 2014); Otsuka Pharm. Co., Ltd. v. Aurobindo Pharma Ltd., Civil Action No. 14-3306 (JBS/KMW) (filed May 23, 2014); Otsuka Pharm. Co., Ltd. v. Intas Pharm. Ltd., Civil Action No. 14-3996 (JBS/KMW) (filed June 20, 2014); Otsuka Pharm. Co., Ltd. v. Zydus Pham. USA Inc., Civil Action No. 143168 (JBS/KMW) (filed May 16, 2.014); Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus., Ltd., Civil Action No. 14-4307 (JBS/KMW) (filed July 7, 2014); Otsuka Pharm. Co., Ltd. v. Mylan Inc., Civil Action No. 14-4508 (JBS/KMW) (filed July 11, 2014); Otsuka Pharm. Co., Ltd. v. Torrent Pharm., Inc., Civil Action No. 144671 (JBS/KMW) (filed July 25, 2014); Otsuka Pharm. Co., Ltd. v. Zhejiang Huahai Pharm. Co., Civil Action No. 14-5537 (JBS/KMW) (filed September 4, 2014); Otsuka Pharm. Co., Ltd. v. Ajanta Pharm. Ltd., Civil Action No. 14-5876 (JBS/KMW) (filed September 19, 2014); Otsuka Pharm. Co., Ltd. v. Teva Pharm. USA, Inc., Civil Action No. 14-5878 (JBS/KMW) (filed September 19, 2014); Otsuka Pharm. Co., Ltd. v. Intas Pharm. Ltd., Civil Action No. 14-6158 (JBS/KMW) (filed October 2, 2014); Otsuka Pharm. Co., Ltd. v. Sun Pharm. Indus., Ltd., Civil Action No. 14-6397 (JBS/KMW) (filed October 6, 2014); Otsuka Pharm. Co., Ltd. v. Teva Pharm. USA, Inc., Civil Action No. 14-6398 (JBS/KMW) (filed September 19, 2014) (filed October 10, 2014); Otsuka Pharm. Co., Ltd. v. Aurobindo Pharma Ltd., Civil Action No. 14-6890 (JBS/KMW) (filed October 31, 2014); Otsuka Pharm. Co., Ltd. v. Lupin Ltd., Civil Action No. 14-7105 (JBS/KMW) (filed November 3, 2014); Otsuka Pharm. Co., Ltd. v. Actavis Elizabeth LLC, Civil Action No. 14-7106 (JBS/KMW) (filed November 10, 2014); Otsuka Pharm. Co., Ltd. v. Zydus Pham. USA Inc., Civil Action No. 14-7252 (JBS/KMW) (filed November 20, 2014); Otsuka Pharm. Co., Ltd. v. Alembic Pharm., Ltd., Civil Action No. 14-7405 (JBS/KMW) (filed November 26, 2014); Otsuka Pharm. Co., Ltd. v. Apotex Corp., Civil Action No. 14-8074 (JBS/KMW) (filed Decem
. The Court nonetheless endeavored with all parties to set a last-minute briefing and argument schedule on March 16, 2015, accelerating Otsuka's filing of motions with initial briefing, Defendants’ oppositions, and Otsu-ka’s replies and Defendants' sur-replies, all completed by April 6th, so that at least the motions for TRO could be hearing on April 10th and decided before April 20th. Otsuka was perhaps disadvantaged by its delay, since it was required to complete its initial outlines of positions on injunctive relief in the 25 related cases within just 3 days after the March 16th conference. In the end, Otsuka and each generic Defendant intending to launch its product have had a full and fair opportunity to be heard. Commendably, all parties met these demanding deadlines, and the day-long TRO hearing explored all issues.
. Having concluded that Otsuka has failed to demonstrate a likelihood of success and irreparable harm, the Court need not discuss the remaining equitable factors. See, e.g., McDavid Knee Guard, Inc. v. Nike USA, Inc.,
. As a result, the Court need not reach the issue of an appropriate bond.
. This Opinion is being filed on the public docket in slightly redacted form to protect certain confidential information, as discussed in the TRO hearing on April 10, 2015 and in the Sealing Order of today’s date. An unre-dacted version of the Opinion is being filed under seal and will be available to those attorneys who have signed the requisite stipulated confidentiality agreements. The Order,, on the other hand, has not been redacted.