US Courts Annual Review - Edition 3
Third Circuit: Pharmaceutical Cases
J Mark Gidley, Kevin C Adam, Daniel Grossbaum, Gina Chiappetta, Tim Keegan and Andrew Costello
White & Case LLP
The Third Circuit is a prominent venue for antitrust litigation involving pharmaceuticals. The proximity of the industry and the large body of pharmaceutical antitrust case law ensure that there will be noteworthy developments each year. Indeed, plaintiffs continue to find creative antitrust claims to assert that raise novel questions of substantive and procedural law. This chapter outlines a number of notable decisions from the past year regarding, for example, the application of the ascertainability requirement under Rule 23 of the Federal Rules of Civil Procedure (FRCP), the expansive scope of the Noerr-Pennington safe harbor, allegations that a series of patent settlement agreements collectively amounted to a conspiracy, and an analysis of the evidence needed to prove class-wide antitrust injury.
In re Niaspan Antitrust Litigation
This district court's second denial of the plaintiffs' attempt to certify a class of indirect purchasers turned on findings for defendants on ascertainability.
In 2020, the court considered whether a putative class of indirect-purchaser plaintiffs (IPPs) – including both third-party payers and consumers – should also be certified.[1] The court ultimately found that class certification was not appropriate because the IPPs failed to satisfy the Third Circuit's ascertainability, predominance, and superiority requirements of FRCP Rule 23(b)(3).[2] Subsequently, the IPPs moved again, this time seeking certification of a class of third-party payors – omitting consumers and narrowing the state laws at issue.[3] Together with their renewed motion for class certification, both the IPPs and the defendants filed additional expert reports.
District court decision
The parties agreed that the IPPs met the requirements under FRCP Rule 23(a) relating to numerosity, commonality, typicality, and adequacy.[4] The defendants instead argued that the IPPs failed to satisfy the ascertainability requirement under Rule 23(b)(3). The court focused on the defendants' argument that the IPPs failed to provide a sufficient methodology to apply their class exclusions.[5]
The court began by examining whether the IPPs had proposed 'objective criteria' for identifying class members.[6] The court found – and the defendants did not challenge – that the IPPs had satisfied this requirement because the class was 'defined with reference to objective criteria'.[7]
Next, the court turned to whether the IPPs had presented a 'reliable and administratively feasible mechanism' for 'determining whether putative class members fall within the class definition'.[8] The court focused on whether the IPPs proposed a methodology to reliably and feasibly 'distinguish between class members and (1) government plans or (2) mere intermediaries, such as fully insured plans, in drug transactions, both of which [were] excluded from the class'.[9]
As regards the government plans, the IPPs argued – based on opinions proffered by one of their experts – that pharmaceutical benefit managers (PBMs), from whom the IPPs planned to obtain the relevant data, could 'exclude state and government payors prior to producing the data'.[10] The court credited the plaintiffs' expert's representations and held that the IPPs had 'made a sufficient showing' that government plans could be excluded from the class in an administratively feasible manner.[11]
As regards the fully insured plans and other intermediaries, the court was not so convinced. In their renewed class certification motion, the IPPs argued that they could identify fully insured plans using certain data fields maintained by PBMs or through information maintained on the 'nature of the plan'.[12] However, the court found that the PBM data merely contained '"code numbers" – not "names or descriptions"' and thus found this proposal insufficient.[13] For the 'nature of the plan' descriptions, the court found that those descriptions could not reliably be used to identify fully insured plans.[14] In particular, the court was concerned by the IPPs' expert's inability to properly identify examples of class members from the already collected PBM data in the case.[15] As a result, the court held that the IPPs had 'not presented an administratively feasible mechanism to distinguish between class members and mere intermediaries such as fully insured plans' and denied class certification.[16]
Louisiana Health Service & Indemnity Company v Janssen Biotech, Inc
The district court's dismissal of sham litigation claims sheds light on the breadth of the Noerr-Pennington safe harbor, particularly for abbreviated new drug application (ANDA) cases.
In Louisiana Health Service & Indemnity Company v Janssen Biotech, Inc, the court dismissed an antitrust complaint accusing Janssen Biotech (Janssen) and BTG International Limited (BTG) of initiating sham patent litigation in an effort to delay generic competition for its blockbuster prostate cancer drug, Zytiga. The opinion highlights the expansiveness of the 'right to petition the government for redress [which] is shielded from antitrust liability' by the Noerr-Pennington safe harbor from antirust liability.[17] Indeed, the claims were dismissed even though the asserted patent was invalidated for obviousness.[18]
In 1997, BTG obtained a patent on a therapeutic compound called abiraterone acetate, the key ingredient in Zytiga, which was widely prescribed for prostate cancer and earned Janssen billions in revenue.[19] The plaintiffs alleged that to extend its exclusivity as the sole seller of the profitable prostate cancer drug (for which the compound patent was due to expire in 2016), Janssen[20] obtained a follow-on combination therapy patent, stressing that obviousness was rebutted by Zytiga's prior commercial success.[21] However, Janssen 'allegedly never disclosed . . . that Zytiga's commercial success was attributable to the [prior] "blocking patent," dating back to 1997, which had blocked any other company from manufacturing and selling any drug that contained abiraterone acetate'.[22]
In 2015, a number of generic companies filed ANDAs with the Food and Drug Administration (FDA), claiming that Janssen's new patent was invalid and that they should be permitted to sell generic versions of Zytiga when the compound patent expired in 2016.[23] In response, Janssen filed a patent infringement suit under the Hatch-Waxman Act against the generic manufacturers, which – with its appeals – lasted for more than four years.[24] After an eight-day bench trial, the second patent was invalidated for obviousness.[25]
Following resolution of the lengthy patent infringement lawsuit, the plaintiffs – 'indirect purchasers of Zytiga who allegedly overpaid for the drug' – alleged that the prior lawsuit amounted to anticompetitive sham litigation to delay the entrance of generics onto the market.[26] The antitrust case was eventually transferred to the district court judge who presided over the underlying patent litigation.[27] The defendants moved to dismiss the complaint on standing, Illinois Brick, and Noerr-Pennington grounds.[28] The court granted the defendants' motion to dismiss and dismissed all of the plaintiffs' claims.
The plaintiffs asserted antitrust, consumer protection, and unjust enrichment claims under laws of various jurisdictions but the named plaintiffs only alleged that they purchased or were reimbursed for Zytiga in 22 states.[29] 'Janssen argue[d] . . . that plaintiffs lack[ed] standing to assert state-law claims under the laws of states where the named plaintiffs did not purchase Zytiga'.[30] The court denied this aspect of Janssen's motion to dismiss. In doing so, the court highlighted the differences between personal standing and class standing. Although a named class representative must suffer injuries to have standing, the court held that a representative need not suffer an injury in every state whose laws are asserted:
Because she was allegedly injured by product A, the question is no longer one of standing. Rather the question is whether it is appropriate for the named plaintiff to represent a nationwide class, despite the differences in state law. . . . Once plaintiffs are found to have standing, the issue becomes a Rule 23 issue.[31]
Because the named plaintiffs alleged they overpaid for Zytiga, satisfying standing requirements, the court 'den[ied] the motion to dismiss plaintiffs' claims on standing grounds, without prejudice to consideration of how these and related issues may be altered in light of the class certification process'.[32]
Illinois Brick standing
Janssen also moved to dismiss under the Illinois Brick doctrine, which 'limit[s] antitrust actions to suits brought by parties that are the direct purchasers of the product'.[33] The plaintiffs, while acknowledging that they were a class of indirect purchasers, argued that the 'case f[ell] within the control exception' to the Illinois Brick doctrine – 'which applies where the direct purchaser is owned or controlled by its customer' – 'by virtue of Janssen's close relationship with the pharmacies that purchased Zytiga from Janssen and then resold it', including CVS and Walgreens.[34] The court disagreed and found the exception did not apply, explaining that the control exception 'applies only when the original seller had a degree of control over a buyer analogous to that of a parent corporation over a subsidiary', which the plaintiffs did not allege.[35] The court also rejected the plaintiffs' argument that Janssen and the pharmacies had a principle-agent relationship:
the complaint does not allege the key requisites of an agency relationship: that the agent shall act on the principal's behalf and subject to the principal's control. . . . A mutually profitable business relationship is a far cry from the fundamental economic unity required for plaintiffs to fall into this narrow exception to Illinois Brick's direct purchaser rule.[36]
Finally, the court rejected the plaintiffs' argument that Janssen's ability to control the price of Zytiga made the control exception applicable, explaining that '[b]oth the Supreme Court and the Third Circuit have rejected price-setting as the relevant criterion for determining whether the Illinois Brick direct purchaser rule applies'.[37]
Noerr-Pennington doctrine
Finally, the court evaluated whether the plaintiffs' claims survived antitrust immunity afforded to litigants under the First Amendment and the Noerr-Pennington doctrine.[38] The court explained that to attach antitrust liability to litigation conduct, a plaintiff must prove the patentee engaged in sham litigation, which requires a showing that the claims were both subjectively and objectively baseless.[39] The court explained that such a burden is higher still in ANDA cases, because the Hatch-Waxman Act deems it an act of infringement to submit an ANDA for a drug covered by a duly issued patent.[40] Thus, 'an infringement suit filed in response to an ANDA with a paragraph IV certification could only be objectively baseless if no reasonable person could disagree with the assertions of noninfringement or invalidity in the certification'.[41] This requirement is rooted in important policy goals: 'we must not penalize a brand-name manufacturer whose litigiousness was a product of Hatch-Waxman because doing so would punish behavior that Congress sought to encourage'.[42]
The plaintiffs argued that 'Janssen knew that its patent was invalid and had been granted only because the . . . blocking patent had not been revealed to the PTO [Patent and Trademark Office] . . . [and thus] any reasonable litigant in Janssen's position would have known that it had absolutely no chance to prevail in its infringement action'.[43] The court disagreed. Relying on its experience presiding over the underlying patent suit, the court explained that the infringement suit was not objectively baseless and, in the court's own judgement, required a trial to determine the merits of Janssen's claims, including the fact-intensive inquiry of whether the combination patent was obvious: 'Overall, Janssen presented a plausible case, if not a winning one. I did not doubt then and do not doubt now that it had probable cause to bring the case and a real, if not strong, chance of prevailing.'[44]
The opinion highlights the expansive boundaries of the Noerr-Pennington doctrine on safe harbor – particularly as applied to ANDA cases. The decision aligns with that of Chief Judge Freda Wolfson in Takeda Pharmaceutical Company Limited v Zydus Pharmaceuticals (USA) Inc.[45] In that case, the court dismissed sham litigation counterclaims brought by Zydus against Takeda, who initiated Hatch-Waxman litigation against Zydus but voluntarily dismissed its patent-infringement claims.[46] The ruling came despite the fact that the parties had litigated the patents and that Zydus certified in its ANDA that its product did not infringe.[47] The court was also not swayed by allegations that Takeda brought suit but failed to review Zydus's ANDA during the 45-day notice period from the filing of Zydus's ANDA, or conduct a sufficient pre-suit investigation, even though '[t]he entire purpose of the . . . notice period is to give the brand-name manufacturer time to evaluate the noninfringement claims and decide whether to sue'.[48]
In its rationale, the court first explained that the very act of filing an ANDA and making a Paragraph IV certification is a legal act of infringement, making it unlikely that an infringement suit is objectively baseless.[49] The court then explained that Takeda did not have to take Zydus's word on non-infringement as 'suing is a common way for a brand-name to obtain further information about a generic's product, notwithstanding an ANDA's representations', particularly given the pressures associated with the short period to act, and thus Zydus's 'boilerplate noninfringement assertion in [its] ANDA [wa]s insufficient to demonstrate' that Takeda's lawsuit was objectively baseless.[50] Finally, even though the parties had litigated the patents and particles at issue, Takeda asserted a new doctrine-of-equivalents infringement theory not previously asserted.[51] Because Takeda reasonably believed it had some chance of prevailing on this theory, it had probable cause to sue and, thus, the suit was not objectively baseless so as to constitute sham litigation.[52]
Value Drug Co v Takeda Pharm, USA, Inc
The district court dismissed allegations that separate settlement agreements, between Takeda and the generic drug companies, restrained trade in the Colcrys market.
This dispute between Value Drug Co and Takeda Pharmaceuticals (Takeda) and Par Pharmaceuticals (Par), Amneal Pharmaceuticals, LLC (Amneal), and Watson Laboratories, Inc (Watson) concerns when separate alleged reverse payment settlements together can constitute a unified conspiracy under section 1 of the Sherman Act. At issue was whether Value Drug Co pleaded sufficient facts to show a plausible conspiracy through either (1) direct or (2) circumstantial evidence to overcome Takeda's motion to dismiss for failure to state a claim.
The FDA approved Takeda's new drug application (NDA) for Colcrys, which contains the active ingredient colchicine, in 2009 for the treatment of Mediterranean fever and gout.[53] In December 2011, Par filed an ANDA, followed by several other generic manufacturers, of relevance here Amneal and Watson.[54] Takeda responded promptly with a lawsuit against all filing generic drug companies for patent infringement.[55]
Takeda settled with all the generic drug companies individually in 2015 and 2016. The settlement agreements occurred in quick succession, close in time, and with similar terms and structures.[56] Par's settlement also included that it would replace Takeda's authorized distributor of generic Colcrys.[57] Also included in each of the contracts was an 'escape clause' that allowed the generic drug companies to sell their version of generic Colcrys under certain conditions, including if another generic manufacturer entered the market.[58]
In October 2016, Takeda sued Mylan, another generic pharmaceutical manufacturer that sought to produce a generic Colcrys.[59] Takeda and Mylan settled in November 2017.[60] Within Mylan's and Takeda's settlement agreement, the parties included a clause so that Mylan could launch its generic Colcrys if a court decision invalidated the patents covering Colcrys.[61] In December 2018, a judge in Delaware ruled for Hikma Pharmaceuticals in a patent lawsuit that Takeda's patents covering Colcrys were invalid.[62] After the Delaware decision, Mylan launched its generic Colcrys in November 2019, triggering the escape clause within Par's, Watson's, and Amneal's settlements.[63]
Because it believed that Takeda, Par, Amneal, and Watson engaged in a horizontal conspiracy to restrain trade and monopolize the market for colchicine, Value Drug Co sued the defendants in 2021.[64] Value Drug argued that the settlement agreements between Takeda and Par, Amneal, and Watson only made economic sense if there was an agreement among them to restrain their respective generic output to prevent a collapse of Colcrys's price.[65] By agreeing to have only two entrants in the market at any one time, the parties would, in concert, maintain Colcrys's price at supracompetitive levels.[66] Key to the conspiracy, argued Value Drug, were the escape clauses in each settlement.[67] The co-conspirators were willing to restrict their own output, but only if the other non-conspirators would also.[68]
Motion to dismiss for failure to plead an antitrust conspiracy
On 28 December 2021, the District Court for the Eastern District of Pennsylvania granted the defendants' motions to dismiss for failure to plead an antitrust conspiracy but granted Value Drug's request for leave to amend.[69] The court identified the issue at stake as 'whether the pleading delineates to some sufficiently specific degree that a defendant purposefully joined and participated in the conspiracy'.[70] Value Drug, the court stated, could prove the existence of plausible conspiracy through either direct or circumstantial evidence.[71]
First the court evaluated whether the separate settlements Takeda made with Par, Amneal, and Watson, respectively, could constitute direct evidence of a restraint of trade. The court found that the mere fact that the agreements occurred at a similar time using similar terms and structures does not transform the agreement into direct evidence of a conspiracy.[72] At most, the court stated, the similarity and timing could constitute circumstantial evidence.[73]
But the court was also not satisfied with Value Drug's arguments on circumstantial evidence. The court applied the plus factors commonly used in the Third Circuit for circumstantial evidence analysis in antitrust claims.[74] Value Drug's argument for circumstantial evidence distilled down to one point: the purpose of the conspiracy, as evinced by the settlement agreements, is to prevent Colcrys's price from collapsing by keeping out all entrants but the two allowed by the settlements.[75] The court quickly rejected this argument based on the inclusion of the escape clauses in the settlement agreements. The proposed theory, the court stated, 'makes no economic sense', and 'it forecloses an inference of concerted action among the four competitors'.[76] In other words, the presence of the escape clauses did not forestall a price collapse, it guaranteed it. Because Value Drug could not prove a plausible overarching horizontal conspiracy, based on the separate settlement agreements, among Takeda and the generic drug companies to restrain trade in the Colcrys market using either direct or circumstantial evidence, it granted Takeda's motion to dismiss Value Drug's complaint.
In the midst of its argument, Value Drug also advanced an unpleaded 'second wave' theory: the real purpose of the conspiracy, Value Drug asserted, was to 'order their market entry to compete against three generics rather than the potential nine, and thus avoid the looming Second Wave of generics which would cause an even larger price collapse'.[77] The court rejected this new argument because it was an unpleaded theory offered only at oral argument.[78]
Motion to dismiss for lack of personal jurisdiction
Next, the court dealt with the motion to dismiss for lack of personal jurisdiction brought by Teva Pharmaceuticals Industries, Ltd (Teva).[79] Value Drug argued that the court enjoyed personal jurisdiction over Teva, an Israeli corporation with its principal place of business in Israel,[80] through either general or specific jurisdiction.[81] The court rejected Value Drug's two arguments for general jurisdiction. Value Drug first argued that the court enjoyed general jurisdiction over Teva through an alter ego theory but, because Value Drug did not plead such a theory, the court refused to address it.[82] The court also dismissed Value Drug's argument that Teva's contacts with the forum were sufficiently pervasive to establish general jurisdiction.[83] Value Drug advanced three theories to establish specific jurisdiction over Teva: (1) that Teva's contacts with the forum are sufficient; (2) that Watson's contacts can be imputed to Teva as its successor-in-interest; and (3) that Watson's contacts can be imputed to Teva because Teva ratified Watson's conduct.[84] The court granted limited jurisdictional discovery on the first theory because Value Drug 'proffered evidence of Teva Ltd.'s contacts with the United States' but still needed to demonstrate that the claims at issue arose from the contacts it evinced.[85] The court rejected Value Drug's second theory because, under Pennsylvania law, when the predecessor entity exists, liability cannot impute to a successor.[86] Because Watson still exists, and Value Drug pleads to its existence, the court cannot impute Watson's contacts for jurisdictional purposes to Teva.[87] Last, the court rejected Value Drug's third theory on the basis that the plaintiff did not 'plead or proffer facts supporting its legal conclusion'.[88]
Motion for sanctions
Finally, the court addressed Watson and Amneal's motion for sanction under 28 USC section 1927 against Value Drug. Watson and Amneal specifically moved for Value Drug to pay their attorneys' fees associated with their motions to dismiss Value Drug's complaint.[89] 28 USC section 1927, as interpreted by the Third Circuit, allows for sanctions where counsel intentionally brings an unreasonable and vexatious proceeding in bad faith.[90] The court declined to sanction Value Drug because its pleading, although 'inaccurate and possibly inartful', did not bear any indication of 'bad faith or intentional misconduct'.[91]
In re Lamictal Direct Purchaser Antitrust Litigation
On remand from the Third Circuit, the district court denied the direct-purchaser plaintiffs' (DPPs) motion for class certification as to generic-only purchasers.
On 9 March 2020, the Third Circuit in In re Lamictal vacated a lower court's decision certifying a class of DPPs who alleged that a patent litigation settlement, which required brand defendant GlaxoSmithKline (GSK) to forego the launch of an authorized generic version of an anti-epilepsy drug, Lamictal, constituted an anticompetitive reverse payment under FTC v Actavis.[92] In its order, the Third Circuit held that the district court abused its discretion when 'it assumed, absent a rigorous analysis', that it was appropriate for DPPs to rely on average evidence to show class-wide antitrust injury.[93] In particular, the Third Circuit stressed that GSK implemented a unique contracting strategy to compete with defendant Teva Pharmaceuticals USA, Inc's (Teva) generic lamotrigine, whereby it offered discounts of up to 40 per cent on brand Lamictal to certain customers who would agree to dispense the brand 'as a generic'.[94] Furthermore, on learning of GSK's contracting strategy, Teva preemptively lowered the price of lamotrigine.[95] In light of these facts, the Third Circuit found that:
the acceptability of averages depends largely on the answer to several factual predicates, most importantly: 1) whether the market is characterized by individual negotiations; 2) whether Teva preemptively lowered its pricing in response to the Contracting Strategy; and 3) whether and to what extent GSK, absent the settlement agreement, would or could have pursued both the Contracting Strategy and an [authorized generic].[96]
On remand, the district court resolved the three questions posed by the Third Circuit, analyzed the parties' supplemental class certification submissions and oral arguments, and reconsidered whether the DPPs proved by a preponderance of the evidence that they can show antitrust injury to all generic-only purchasers via common evidence.[97]
District court's analysis on remand
After weighing the evidence and expert analysis put forth by the parties, the district court first determined that neither side proved that the lamotrigine market is characterized by individual price negotiations between lamotrigine manufacturers and the DPPs. Rather, the evidence showed that Teva offered different lamotrigine prices to different categories of customers, but did not individually negotiate a price with each customer.[98] Second, the court noted that, although it wished the evidence provided by the parties was more specific, 'based on the current record' Teva proved that it lowered its lamotrigine prices for most (but not all) of its customers in response to GSK's contracting strategy.[99] Third, the court found that the DPPs demonstrated their ability to prove through common evidence that GSK 'would and could have pursued both the Contracting Strategy and an [authorized generic]'.[100]
In light of the answers to these predicate questions, the court addressed whether the DPPs proved by a preponderance of the evidence that they can prove class-wide antitrust injury through the use of common evidence.[101] As the court explained, the key question was whether common evidence can show that Teva would have lowered its prices 'across the board' if GSK pursued its contracting strategy and launched an authorized generic version of Lamictal.[102] To answer this question, the DPPs presented real-world data demonstrating that the 'prices for lamotrigine generally moved in unison, downward, upon the entrance of additional generics to the market'.[103] However, the court pointed out that, in the real world, there was never a period in which two generics competed in the lamotrigine market.[104] Rather, Teva exclusively sold lamotrigine for 180 days and eight generics 'flooded the market' when Teva's exclusivity ended. Thus, the data did not speak to the lamotrigine price that Teva would have charged its customers in the face of authorized generic competition during its exclusivity period.[105]
The DPPs also relied on their expert's analysis of Teva forecasting documents, and argued that Teva's lamotrigine prices would have been 34.3 per cent less if GSK had launched an authorized generic version of Lamictal.[106] The court recognized that the DPPs presented a 'sound theory' that GSK did not lower brand Lamictal's price to an authorized-generic level under its contracting strategy.[107] The court pointed out that only some of GSK's customers received a 40 per cent discount on Lamitcal's price, GSK expected that many physicians would be reluctant to switch stable patients to generic lamotrigine (and thus, discounting brand Lamictal to authorized-generic price levels was unnecessary), and that GSK internally acknowledged that new patients and unstable patients would likely use generic lamotrigine instead of the discounted brand – presumably because GSK anticipated the generics would be cheaper.[108]
The defendants criticized the DPPs' expert analysis as merely 'compar[ing] a dizzying assembly of averages' and not demonstrating that all the defendants' 'customers would have received an additional discount if GSK had launched an authorized generic'.[109] The court agreed, noting that 'however rational [the DPPs' theory] may be, [it] is missing critical supporting evidence'.[110]
For example, Plaintiffs did not produce evidence showing that if Teva faced an authorized generic and the Contracting Strategy at the same time, it would have further lowered the prices of lamotrigine across the board. Nor did Plaintiffs, for instance, cite to evidence demonstrating that the Teva customers who received discounts in response to the Contracting Strategy, would have received additional, commensurate discounts in response to authorized generic competition. The Court assumes that Teva provided discounts for rationale business reasons rather than charitable, idiosyncratic, or arbitrary motivations. This assumption would mean that Teva would do the same in response to authorized generic competition. But this is an assumption, not evidence, and Plaintiffs have the burden of producing such evidence and proving the issue by a preponderance of the evidence.[111]
Furthermore, the court found that the DPPs failed to present additional evidence to rebut the analysis of the defendants' expert, who posited that the use of averaged data masked that '25 of the 33 generic-only purchasers likely paid the same or lower prices in the actual world under the Contracting Strategy than they would have paid had GSK launched an AG' – an analysis that was emphasized by the Third Circuit.[112]
As a result, the court denied the DPPs' motion for class certification as to generic-only purchasers.[113]
[1] In re Niaspan Antitrust Litig., 464 F. Supp. 3d 678 (E.D. Pa. 2020).
[3] In re Niaspan Antitrust Litig., No. 13-md-2460, 2021 U.S. Dist. LEXIS 154992, at *5–6 (E.D. Pa. Aug. 17, 2021). This decision is currently on appeal before the Third Circuit. See, generally, In re Niaspan Antitrust Litig., No. 21-2895 (9th Cir.).
[4] Id. at *8–9.
[5] See id. at *26 n.10. The defendants also made several arguments relating to ascertainability that the court did not reach.
[6] Id. at *10–11.
[9] Id. (citation omitted).
[10] Id. at *17.
[12] Id. at *20–21.
[17] See La. Health Serv. & Indem. Co. v. Janssen Biotech, Inc., No. 19-cv-14146-KM-ESK, 2021 U.S. Dist. LEXIS 207239, at *20 (D.N.J. Oct. 27, 2021).
[18] See id. at *27–28.
[19] See id. at *4–5.
[20] The court defined BTG and Janssen as 'Janssen'. For convenience, the authors adopt that definition here.
[21] See id. at *5.
[25] See id.
[27] See id. at *8, *25.
[28] See id. at *10, *15, *20.
[30] See id. at *9–10.
[33] See id. at *16 (internal quotation omitted).
[36] See id. at *19 (internal quotations and alteration omitted).
[42] Id. at *24 (internal quotations and alterations omitted).
[45] No. 18-cv-1994-FLW, 2021 U.S. Dist. LEXIS 138933 (D.N.J. July 26, 2021).
[46] See Takeda Pharm. Co. Ltd. v. Zydus Pharms. (USA) Inc., No. 18-cv-1994-FLW, 2021 U.S. Dist. LEXIS 138933 (D.N.J. July 26, 2021), at *24–25, *46–47.
[48] See id. at *33–34 (quotation omitted).
[49] See id. at *32 n.15.
[53] Value Drug Co. v. Takeda Pharm., U.S.A., Inc., No. 21-3500, 2021 U.S. Dist. LEXIS 246364, at *5–6 (E.D. Pa. Dec. 28, 2021).
[54] Id. at *7–8 (Watson and Amneal filed soon thereafter).
[55] Id. at *8.
[56] Par settled in November 2015, Watson in January 2016, and Amneal in March 2016; all agreements included an exclusive distribution agreement in exchange for each staying out of the market for a certain period. Id. at 10–14.
[68] Value Drug argued that this condition went against each firm's unilateral economic interests. Id. at *25.
[69] Id. at *4–5; Value Drug filed its amended complaint on 18 January 2022. Pl.'s Am. Compl. ECF No. 163. On 30 March 2022, the plaintiff's amended complaint survived the defendants' motion to dismiss based on sufficient circumstantial evidence of an overarching conspiracy and antitrust injury. Value Drug Co. v. Takeda Pharm., U.S.A., Inc., No. 21-3500, 2022 U.S. Dist. LEXIS 58574 (E.D. Pa. Mar. 30, 2022), at *5–19.
[70] Id. at *22 (citing In re Processed Egg Prod., 821 F. Supp. 2d 709, 718–20 (E.D. Pa. 2011)).
[71] Id. at *27, *34.
[74] The plus factors are (1) the motive to enter the conspiracy, (2) evidence that the defendants acted contrary to their interests and (3) evidence implying a traditional conspiracy. Id. at *35.
[79] Teva purchased Watson on 26 July 2015. Id. at *43.
[82] Id. at *45 ('Value Drug does not plead we have personal jurisdiction over Teva Ltd. under an alter ego theory. It cannot now attempt to reply on an unpled theory through briefing.').
[92] In re Lamictal Direct Purchaser Antitrust Litig., No. 12-995, 2021 U.S. Dist. LEXIS 107361, at *4–8 (D.N.J. Apr. 9, 2021).
[97] Id. at *3–4, 12.
[100] Id. at *38–52. In deciding the third question, the court stressed that this issue did not seem susceptible to individualized proof at all: 'either GSK would have done so or it would not have'. Id. at *51.
[101] Id. at *52–54.
[104] Id.
[106] Id. at *57–61. The district court stressed that the Third Circuit had already considered this same evidence, and nevertheless remanded the case. Id. at *57, *62–63.
[109] Id. at *61, *63.
[110] Id. at *62.
J Mark Gidley
Kevin C Adam
Author | Associate
Daniel Grossbaum
Gina Chiappetta
Tim Keegan
Andrew Costello
Author | Law Clerk
Rosanna McCalips and Peter Julian
Docket Navigator Data
Part 1: Topics and Trends
Status of Reverse Payment Cases against Pharmaceutical Companies
Zarema Jaramillo and Jonathan Lewis
Lowenstein Sandler
The 'No-Poach' Approach: Antitrust Enforcement of Employment Agreements
Dee Bansal, Jacqueline Grise, Beatriz Mejia and Julia Brinton
Trends in Class Certification
William F Cavanaugh, Jonathan Hermann and David Kleban
Patterson Belknap Webb & Tyler LLP
Part 2: Court Decisions
Bevin M B Newman and Thomas Dillickrath
Sheppard Mullin
DC Circuit
Kiersen Commons, Brandon Haase and Irma Kroneman
First Circuit
Christopher T Holding and Brian T Burgess
Goodwin Procter LLP
Second Circuit
Adam S Hakki, John F Cove and Jerome S Fortinsky
Shearman & Sterling LLP
Second Circuit: Southern District of New York
Lisl Dunlop and Evan Johnson
Axinn, Veltrop & Harkrider
Third Circuit: Non-Pharmaceutical Cases
Barbara T Sicalides, Daniel N Anziska and Daniel J Boland
Sixth Circuit
Lisa Jose Fales, Danielle R Foley, Paul Feinstein and Isaiah Smith
Seventh Circuit
Michael T Brody, Jay K Simmons, Daniel S McCord, Michael B Kang and Annie Wilt
Jenner & Block
Ninth Circuit
Michael E Martinez, Lauren Norris Donahue, John E Susoreny, Brian J Smith, Victoria S Pereira and Michelle R Conklin