Second Circuit: Southern District of New York

Overview

This chapter highlights the key 2021 antitrust decisions of the United States Court of Appeals for the Second Circuit (Second Circuit) in appeals from decisions of the United States District Court for the Southern District of New York (SDNY). It also addresses some of the most significant SDNY antitrust decisions.

In 2021, 52 new antitrust cases were filed with the SDNY, tying with the Northern District of Illinois for the second most active jurisdiction, and only slightly behind the Northern District of California. Unsurprisingly, many of the SDNY and the Second Circuit decisions involved motions to dismiss, with a few summary judgment opinions. Antitrust litigation was concentrated on the financial and pharmaceutical industries, including various benchmark litigations, such as the London Inter-Bank Offered Rate (LIBOR) multidistrict litigation, and several pay-for-delay patent-settlement litigations.

Notable opinions included Second Circuit decisions on ‘umbrella standing’^[1] and personal jurisdiction over a foreign person based on a conspiracy theory; various decisions in ongoing litigation in the pharmaceutical industry, including a Second Circuit opinion concerning generic delay as a consequence of a brand allegedly mischaracterizing its patents; and two SDNY opinions concerning pay-for-delay settlements. Finally, the high-profile monopolization case brought by the Federal Trade Commission (FTC) and several states against Vyera Pharmaceuticals and company executives was concluded (see further, below).

Second Circuit declines to apply umbrella standing

Last year’s chapter^[2] highlighted the ongoing debate about whether ‘umbrella plaintiffs’ have antitrust standing to sue cartelists. The ‘umbrella theory’ underlying these claims is that the cartelists’ actions create a ceiling, or ‘umbrella’, of higher prices under which other firms that are not part of the cartel raise their prices, damaging purchasers from those other firms. Other circuits – including the Fifth and Seventh – have upheld claims based on umbrella standing in certain cases. In 2021, however, the Second Circuit issued two opinions within weeks of each other affirming dismissals of claims based on umbrella standing.

Schwab Short-Term Bond Mkt Fund v Lloyds Banking Grp PLC^[3] was an appeal from several orders of the SDNY granting motions to dismiss claims brought by purchasers of bonds that included LIBOR as a price component, part of long-running multidistrict litigation concerning LIBOR-based financial instruments.^[4]

To establish antitrust standing, plaintiffs must show both antitrust injury and that they are ‘efficient enforcers’ of the antitrust laws.^[5] In prior appeals in the same litigation, the court had held that the plaintiffs had met the pleading standards for antitrust injury and other elements of their Sherman Act Section 1 claims.^[6] In the decisions under appeal in Schwab, the SDNY had concluded that the umbrella plaintiffs in the case were not efficient enforcers and dismissed their complaints for lack of antitrust standing. The Second Circuit agreed.

The court analyzed whether the SDNY had properly applied the four-factor test for efficient enforcers outlined by the Supreme Court in Associated General Contractors,^[7] finding that the ‘directness of the injury’ test was not met. This test requires proximate cause between the harmful behavior and the injury sustained. The court found that the SDNY acted correctly in drawing a line between plaintiffs whose injuries resulted from their deals with third parties and those who were parties to direct transactions with the banks that participated in LIBOR setting. The court held that the independent decision of a third party to incorporate LIBOR as a term in the financial instrument ‘snap[s] the chain of causation linking Plaintiffs’ injury to the Banks’ misconduct’.^[8] Further, the alleged harm – lower interest payments on the plaintiffs’ bonds – did not benefit the defendant banks, only the third parties who transacted with the plaintiffs.

Shortly before its ruling in Schwab, the court made a similar decision declining to apply umbrella standing in an appeal from the Eastern District of New York in American Express Anti-Steering Litigation.^[9] In that case – addressing claims by merchants who did not accept American Express (Amex) cards that Amex’s anti-steering rules resulted in increased merchant fees across the market – the Second Circuit again focused on the first efficient-enforcer factor and the question of proximate causation. The court held that the merchants’ injuries did not occur at the ‘first step’ following Amex’s conduct. The injuries, therefore, were not proximately caused by Amex; the alleged antitrust violation was instead a ‘remote’ cause of the injuries.^[10]

In Schwab, the court noted that the Second Circuit had never adopted the umbrella theory of antitrust standing.^[11] The court further noted that the unique nature of the LIBOR conspiracy makes umbrella standing particularly inappropriate, where the conduct was around fixing an index number that was available to unlimited third parties to reference and incorporate into their own products, and the liability was therefore far too sweeping and raised the concern of damages disproportionate to the wrongdoing.^[12] Even though the Schwab decision appears to have been influenced by the disproportionate impact of granting umbrella standing in the LIBOR context, the focus on the first step in the chain of causation in both Schwab and American Express means that umbrella standing will be difficult to establish in the Second Circuit, potentially setting up a circuit split on the issue.

Second Circuit validates conspiracy theory of personal jurisdiction

Under a conspiracy theory of personal jurisdiction, even if never physically present in the relevant forum, a defendant may be subject to the court’s jurisdiction through participation in a conspiracy. This theory would permit antitrust conspiracy claims to be brought against foreign defendants who may not be present in any US jurisdiction. The Supreme Court, which has issued several opinions limiting the reach of personal jurisdiction,^[13] has yet to weigh in on the conspiracy theory, but the theory has been considered and in some cases adopted by other circuit courts.^[14] The theory was first considered by the Second Circuit in 2018, where the court adopted a three-factor test to determine whether to subject a defendant to personal jurisdiction based on a conspiracy theory.^[15]

In the 2021 Schwab case (discussed above), the SDNY had dismissed several plaintiffs’ claims against foreign bank defendants on the basis of lack of personal jurisdiction, and those plaintiffs appealed. At issue was whether the foreign banks would be subject to personal jurisdiction in New York based on their alleged participation in the conspiracy to manipulate LIBOR.

The three-part test previously adopted by the Second Circuit requires the plaintiff to allege that ‘(1) a conspiracy existed; (2) the defendant participated in the conspiracy; and (3) a co-conspirator’s overt acts in furtherance of the conspiracy had sufficient contacts with a state to subject that co-conspirator to jurisdiction in that state’.^[16] Because the Second Circuit previously held that the plaintiffs had adequately pleaded the other two elements, the foreign bank defendants only contested whether the third prong was met.^[17] The foreign defendants asserted that the plaintiffs’ allegations that executives at US banks directed subordinates at foreign banks to make low LIBOR submissions were inadequate to establish jurisdiction.^[18] The banks also argued that conspiracy-based jurisdiction requires a relationship of direction, control, and supervision before a co-conspirator’s forum contacts may be imputed to absent defendants for jurisdictional purposes.^[19]

The Second Circuit rejected these arguments, holding that various allegations about communications between the US and foreign banks are overt acts sufficient to meet the third prong of the test.^[20] In doing so, the Second Circuit disregarded the SDNY’s reliance on the defendants’ declarations, stating that the foreign defendants did not send their LIBOR submissions from the United States because that was a factual assertion not suitable for determination on a motion to dismiss.^[21] The Second Circuit also rejected the argument that conspiracy-based jurisdiction requires a relationship of direction, control or supervision.^[22] Although ‘purposeful availment’, a due process requirement to establish personal jurisdiction, may be established if a foreign defendant delegates in-forum actions to a co-conspirator, no such control is required to establish personal jurisdiction based on conspiracy.^[23]

Though the Second Circuit’s 2018 decision opened the door for lower courts by adopting a test for conspiracy-based jurisdiction, Schwab is the first Second Circuit decision that applied those factors to assert personal jurisdiction over a foreign defendant based on a conspiracy theory. This may lead to plaintiffs and lower courts applying this theory with more frequency.

Scrutiny of pharmaceutical industry actions delaying generic entry

The Second Circuit and the SDNY were busy in 2021 with pharmaceutical-industry litigation arising out of the Hatch-Waxman Act regulatory process. There is currently heightened attention at all levels of government on prescription drug prices and the ability of generic manufacturers to compete and offer lower prices. For example, several bills have been introduced in the US Senate that would limit pay-for-delay settlements,^[24] curb brand companies’ product-hopping tactics,^[25] and give the FTC increased ability to litigate against pharmaceutical companies that file sham petitions with the Food and Drug Administration (FDA).^[26] This section analyzes four opinions (one from the Second Circuit and three from the SDNY), concerning efforts to delay generic manufacturer entry through either the regulatory process, contracting practices or litigation settlements.

Mischaracterizing patents

In United Food v Takeda,^[27] the Second Circuit addressed a novel and complex question concerning the competitive impact of a branded drug manufacturer’s patent-reporting requirements under the Hatch-Waxman Act. The plaintiffs (pharmaceutical distributors and health insurers who purchased Takeda’s diabetes drug ACTOS) alleged that Takeda had misrepresented its patents to the FDA, in effect extending the duration of its patent protection and delaying generic entry. Takeda sought to dismiss the complaint on the basis that it had properly listed its combination patents as covering the active ingredient in ACTOS (‘claiming’ the drug itself) as well as the methods of using ACTOS, and that the Hatch-Waxman Act should shield it from antitrust liability.

The Hatch-Waxman Act requires a generic drug manufacturer seeking to enter a branded market to file with its abbreviated new drug application (ANDA) a certification under either Paragraph IV or Section viii of the Act. A ‘Paragraph IV certification’ requires the generic manufacturer to certify that the brand’s patents are invalid or would not be infringed by the manufacture, use or sale of the generic drug.^[28] This permits the branded drug manufacturer to sue the generic manufacturer for patent infringement; if the branded manufacturer sues, the FDA cannot approve the generic ANDA for 30 months or until the resolution of any patent infringement litigation.^[29] In contrast, a ‘Section viii certification’ allows the generic manufacturer to launch immediately if the brand’s patents only cover a method of using the drug – as distinct from the drug itself – and the generic manufacturer ‘carve[s] out patented methods from its drug’s production and labeled uses’.^[30]

Takeda’s patent for the active ingredient in ACTOS was due to expire in 2011, which would permit generic entry at that time.^[31] In 1999 and 2002, however, Takeda supplemented its new drug application (NDA) with two ‘combination patents’ for compounds combining the original ACTOS active ingredient with a new active ingredient.^[32] The combination patents were due to expire in 2016.^[33] In its NDA supplements, Takeda characterized the combination patents as claiming the drug ACTOS as well as the methods of using ACTOS.^[34] However, the FDA’s ‘Orange Book’, which is widely used in the industry for brand-patent information, only listed the combination patents as covering the methods of using ACTOS.^[35]

This caused confusion among generic manufacturers, some of whom filed Paragraph IV certifications and others Section viii certifications. One generic manufacturer filed a citizen’s petition with the FDA concerning the listing, to which Takeda responded, asserting that the combination patents claimed both the drug and method of use.^[36] Because of this representation, the FDA stated that it would not approve a generic manufacturer’s ANDA that did not include a Paragraph IV certification.^[37] The FDA’s decision required the generics that originally filed Section viii certifications to file Paragraph IV certifications. This subjected them to patent litigation, which the plaintiffs alleged kept generics off the market for nearly two years after the expiration of the active-ingredient patent in 2011.^[38]

In 2013, the plaintiffs sued Takeda under Section 2 of the Sherman Act, claiming that Takeda monopolized the market by improperly representing its combination patents to the FDA and delaying generic entry. In the course of several rounds of motions to dismiss, the SDNY held that Takeda’s combination patents did not properly claim the drug ACTOS and, therefore, it had mischaracterized its patents to the FDA, delaying generic entry. Takeda appealed this ruling.

On appeal, Takeda argued that the combination patents correctly covered the ACTOS active ingredients.^[39] The Second Circuit disagreed, citing Supreme Court case law that combination patents do not cover the individual parts of such a combination.^[40] Accordingly, but for Takeda’s representation to the FDA that its combination patents covered both the drug ACTOS and its methods of use, generic manufacturers would have been able to launch in 2011 via a Section viii certification. Instead, generic competition was delayed for nearly two years by the FDA’s requirement that generic manufacturers file Paragraph IV certifications.

‘Pay-for-delay’ cases

The SDNY confronted two class actions concerning ‘pay-for-delay’ settlements, one in 2021 and the other in early 2022. Both addressed whether reverse payments in combination with ancillary or side agreements triggered scrutiny as ‘large and unjustified’ payments under Actavis.^[41]

In In re Namenda Indirect Purchaser Antitrust Litigation,^[42] the SDNY considered whether the contemporaneous amendment of an existing agreement between a brand and a generic manufacturer concerning a different drug not at issue could constitute a ‘large and unjustified payment’. The court held in the affirmative, denying the defendants’ motion for summary judgment.

Forest Laboratories launched Namenda, a branded drug used to treat dementia related to Alzheimer’s disease, in 2003. In 2007, 14 generic manufacturers filed ANDAs to enter the market, and in 2008 Forest commenced patent litigation against them.^[43] All the generic manufacturers settled with Forest except for Mylan NV.^[44] Forest and Mylan had a pre-existing agreement regarding another drug, Lexapro, under which Forest manufactured and Mylan marketed an authorized generic version of the drug.^[45] At the same time, Forest and Mylan entered into a settlement agreement concerning the Namenda patent litigation under which Forest paid Mylan $2 million and they negotiated and executed an amendment to the Lexapro agreement. The Lexapro Amendment provided that:

• Mylan’s obligation to share profits from sales of the Lexapro authorized generic were reduced;
• Mylan would pay Forest a $20 million up-front fee;
• the manufacture of the Lexapro authorized generic was shifted to Mylan; and
• the end date of the agreement was extended.^[46]

The plaintiffs contended that the Lexapro Amendment was worth $30 million to Mylan and, in combination with the reverse payment settlement, amounted to a ‘large and unjustified’ reverse payment by Forest to Mylan to settle the Namenda litigation.^[47] Forest argued that, overall, the Lexapro Amendment gave a net benefit to Forest rather than benefiting Mylan – including that shifting the manufacture of the authorized generic version of Lexapro to Mylan would benefit Forest by reducing its Medicaid liability – so it was not in effect a reverse payment.^[48]

In deciding summary judgment motions brought by all the parties, the court focused on whether there were genuine issues of material fact concerning the key aspect of the case: whether the reverse-payment settlement – and specifically the Lexapro Amendment – was anticompetitive. The SDNY found that there were several disputed facts and denied summary judgment. First, Forest did not concede that the two agreements were linked. However, although nearly all of Forest’s settlement agreements with the other generic challengers contained a clause stating that payments under the settlement agreements were the ‘sole consideration’ in exchange for the generic manufacturers’ decision to end their patent challenge, Mylan’s settlement agreement with Forest did not contain such a clause.^[49] The SDNY found that this raised an issue of material fact that was sufficient to preclude summary judgment. The SDNY also held that there was a disputed fact as to how to value the Lexapro Amendment.^[50]

In In re Bystolic Antitrust Litigation,^[51] the SDNY considered a series of settlements between Forest and its various potential generic competitors for Bystolic, a beta blocker used to treat high blood pressure. Despite a lack of clarity from the Second Circuit as to what a plaintiff must plead to allege sufficiently a ‘large and unjustified’ payment under Actavis, the SDNY granted the defendant’s motion to dismiss.

Forest sued and settled with generic competitors for Bystolic after they filed Paragraph IV certifications for generic versions of the drug with the FDA. The settlement agreements allowed the generics to enter the market three months prior to patent expiration and included cash payments from Forest of between $200,000 and $2 million for expended and avoided litigation fees.^[52] The plaintiffs alleged that Forest also entered into various side agreements with each of the settling generic manufacturers that constituted part of the ‘large and unjustified’ payment for settling the patent litigation.^[53]

The side agreements varied in their terms. All but one included direct cash payments to the generic manufacturers. Others included various drug supply agreements (under which Forest paid cash for patent assignments) and collaboration agreements to jointly develop and invest in products in exchange for cash payments from Forest.^[54]

The SDNY found that the plaintiffs sufficiently alleged that these agreements were linked to the patent settlement agreements. The various side agreements were executed close in time to the execution of each patent settlement.^[55] Further, during its merger with Actavis, Forest listed these agreements as material contracts in connection with the patent litigation.^[56]

The court held that although the plaintiffs had sufficiently alleged that the reverse payments were large, they failed to plead that they were unjustified. Citing the Supreme Court’s decision in Actavis, the court held that most of the allegations relating to lack of justification were conclusory and not enough to persuade the SDNY to nudge the claim from ‘neutral territory’ into plausibility under Twombly.^[57] The SDNY dismissed the complaint without prejudice, providing the plaintiffs with an opportunity to amend their complaint. On 22 February 2022, the plaintiffs filed their third amended complaint under seal.

FTC and state AGs win favorable settlement against pharma company

During 2021 and early 2022, the high-profile case brought by the FTC and several states against pharmaceutical company Vyera Pharmaceuticals and two of its executives, Martin Shkreli and Kevin Mulleady,^[58] was concluded. The case was notable in several respects: the FTC and states chose to prosecute the individual executives for civil antitrust violations in addition to the company; and the partnership between the FTC and the states enabled them to step around the limitations of AMG Capital,^[59] a Supreme Court decision that stripped the FTC of its ability to seek equitable monetary relief, and obtain monetary disgorgement based on state antitrust law claims.

A complaint filed in January 2020 had alleged that Vyera and the two former executives engaged in anticompetitive contracting practices to prevent generic competition to Vyera’s branded drug Daraprim in violation of Section 5 of the Federal Trade Commission Act (the FTC Act), Sections 1 and 2 of the Sherman Act, and various state antitrust laws.^[60] Vyera acquired Daraprim in 2015 and allegedly developed a scheme to block generic competition, which involved distribution agreements that prevented purchasers from reselling Daraprim to generic drug manufacturers and exclusive supply agreements that prevented generic manufacturers from obtaining Daraprim’s active ingredient.^[61] As a result, prices for Daraprim increased significantly.^[62] The executives were included as defendants based on their direct involvement in the alleged anticompetitive scheme.^[63]

The Supreme Court decided AMG Capital on 22 April 2021,^[64] holding that the FTC’s authority under Section 13(b) of the FTC Act does not grant the agency the right to seek equitable monetary relief such as disgorgement or restitution. This required the FTC to rely on the states’ claims under state antitrust laws to pursue monetary equitable relief.

Both the defendants and the plaintiffs moved for partial summary judgment. The defendants argued that the plaintiffs’ state law claims – the only claims for which monetary relief was available – were limited to sales to purchasers within the plaintiffs’ states.^[65] The plaintiffs cross-moved for partial summary judgment on the same issue, arguing that the defendants should be precluded from contesting the plaintiffs’ ability to seek nationwide relief regardless of the location of purchases of Daraprim.^[66]

The SDNY denied the defendants’ motion and granted the plaintiffs’ motion, allowing the plaintiffs to pursue nationwide relief at trial. In doing so, the SDNY reasoned that New York law grants the New York Attorney General the authority to pursue claims on behalf of non-state residents injured by wrongdoing that occurred within New York.^[67] Because the defendants made decisions from New York, including entering into the restrictive contracts, the New York Attorney General has the authority to enforce the Donnelly Act on behalf of non-New York residents.^[68]

After the court denied the defendants’ summary judgment motion, Vyera and Mulleady settled with the FTC and the states.^[69] The settlement required Vyera to pay up to $40 million and restricts Mulleady’s participation in the pharmaceutical industry.^[70]

The case against Shkreli proceeded to a bench trial, where the court found Shkreli personally liable for the antitrust claims.^[71] The court rejected Shkreli’s argument that he did not maintain control of Vyera after he stepped down as chief executive officer and he was imprisoned on separate fraud charges, the court finding that, as the company’s largest shareholder, he ‘conceived of, implemented, maintained, and controlled Vyera’s anticompetitive and monopolistic scheme’.^[72] The court’s order banned Shkreli from the pharmaceutical industry for life, and ordered $64.6 million in disgorgement based on the state claims, of which Shkreli owes $24.6 million after taking into account the earlier settlement with Vyera.^[73]

Notes