On April 13, 2021, the Court of Appeals for the Fifth Circuit issued its long-anticipated decision in Impax v. FTC, marking the first time an appellate court has weighed in on the merits of a so-called reverse payment case prosecuted by the Federal Trade Commission (“FTC”) since the Supreme Court’s Actavis decision in 2013. The case resulted in a validation of the FTC’s approach to policing reverse payment agreements. Specifically, the Court affirmed the Commission’s conclusions that (1) large, unjustified reverse payments are anticompetitive regardless of the strength of the underlying patent litigation, and (2) reverse payment settlements are more anticompetitive than procompetitive if a less-restrictive alternative exists, and that a less-restrictive alternative can be an agreement without a payment that results in an earlier generic entry.
Stop me if you’ve heard this one before: the FTC is suing pharmaceutical manufacturers Endo and Impax over an alleged “reverse payment” agreement to reduce competition in the market for Opana ER, an oxymorphone extended release product. In fact, the FTC’s complaint follows quickly on the heels of the Commission’s decision that a 2010 agreement between the same manufacturers to settle Impax’s patent litigation against Endo for a $112 million payment constituted an illicit “reverse payment” that delayed the entry of Impax’s generic version of Opana ER. (Click here for background on that decision.) Oral argument on Impax’s appeal of the FTC’s decision happened six months ago; the Fifth Circuit’s decision will mark the first time a Circuit Court weighs in on the FTC’s interpretation of the Supreme Court’s 2013 decision in FTC v. Actavis. (Click here for analysis of the oral argument)
Antitrust litigation has been ongoing for several years in the U.S. District Court for the Northern District of Alabama against one of the biggest business associations in America, the Blue Cross Blue Shield Association (“BCBSA”) and its members. We previously wrote about this litigation here and here. BCBSA is comprised of independent health insurers that license the “Blue Cross” and “Blue Shield” trademarks from BCBSA. As a condition of their licenses, BCBSA members grant each member exclusive geographic territories where each is allowed to use the Blue trademarks; some BCBSA members also happen to enjoy very high market shares in a number of their respective jurisdictions. There are also licensing rules that limit how much revenue each member can derive from lines of business that do not use the Blue trademarks. One of these rules was the “National Best Efforts Rule.” This rule required that two-thirds of each member’s national revenue be derived from Blue-branded plans. In other words, while each member could theoretically compete in others’ territories using brands that did not include the “Blue Cross” and “Blue Shield” trademarks, there was a cap on how much business a member could generate this way. These restrictions allegedly reduced competition between BCBSA members
On June 9, the United States Court of Appeals for the Fifth Circuit heard oral argument in Impax Laboratories, Inc., Etc. v. Federal Trade Commission. The appeal by pharmaceutical manufacturer Impax marks the first time a court will review the Federal Trade Commission’s (“FTC”) interpretation of the Supreme Court’s watershed decision on reverse payment settlements, FTC v. Actavis, 570 U.S. 136 (2013).
Yesterday we discussed 2019’s most significant developments in challenges to reverse-payment settlements. Today we continue our analysis of recent trends in pharmaceutical antitrust actions with a discussion of cases addressing class certification requirements in the reverse-payment context.
2019 witnessed a number of developments in challenges to reverse-payment settlements. In its first decision on a pay-for-delay settlement since the Supreme Court’s seminal 2013 decision in FTC v. Actavis, the FTC took an aggressive approach to evaluating a plausible restraint on trade and analyzing proffered procompetitive benefits, reversing the ALJ who heard the case. In the Southern District of New York, an attempt by direct purchasers to plead a conspiracy arising out patent-infringement settlements without an alleged reverse payment failed. And, in the class certification context, district courts grappled with Rule 23(b)(3)’s predominance requirement. These notable cases in antitrust actions concerning the pharmaceutical industry are discussed below.
Last month, we reported on a partial settlement in an antitrust case alleging that entities within the Duke and the University of North Carolina systems agreed not to hire each other’s medical personnel unless the lateral hire involved a promotion. The Court has now granted in part the plaintiff’s motion to certify a class.
The Third Circuit recently denied a petition for rehearing en banc a panel’s earlier decision in the In re Flonase Antitrust Litigation. In that case, the panel decision addressed the degree to which class settlements can bind non-participating U.S. state class members. After vigorous briefing on the issue, the panel found that the state of Louisiana had not waived its sovereign immunity, and therefore could not be bound by a class settlement that enjoined class members from subsequently bringing separate suits. This is a case with potentially wide reaching implications, as it could impact the negotiation of settlements in class actions that include states as class members.
As the college basketball season heats up, bitter rivals Duke and the University of North Carolina stand accused of maintaining a cozier (and illegal) relationship off the court. UNC, the UNC School of Medicine, and the UNC Health Care System (together the “UNC Defendants”) recently entered into a settlement agreement with a class of individuals employed by the UNC Defendants or of Duke-affiliated defendants (“the Duke Defendants”) between 2012 and 2017 to resolve an action alleging that the Duke Defendants and UNC Defendants agreed not to hire each other’s medical personnel unless the lateral hire involved a promotion. The settlement enjoins the UNC Defendants from agreeing to refrain from soliciting, hiring, or otherwise “poaching” employees of any other company or organization.
The Third Circuit recently affirmed the grant of summary judgment to GlaxoSmithKline (“GSK”) in the nearly 10-year-old Wellbutrin XL Antitrust Litigation, which challenged the lawfulness of settlement agreements resolving patent disputes over Wellbutrin XL. In determining that GSK had not violated the Sherman Act, the court determined that GSK’s settlement of patent infringement lawsuits did not reflect that GSK had engaged in sham litigation, or that GSK made unlawful “reverse payments” to settle that litigation. To reach these conclusions, the court carefully picked apart years of evidence
Outlet malls are popular destinations for consumers seeking a bargain, even if not everyone agrees that the deals are as good as advertised. But although the prices may seem low, a common provision in lease agreements between the operators of outlet malls and retailers may have reduced competition and raised the prices consumers paid. This week, the operator of the most popular outlet mall in the New York City metropolitan area reached a settlement with the New York Attorney General that may lead to increased competition in the outlet mall space in New York and beyond.
This week, the Second Circuit affirmed the approval of a $50 million agreement settling price-fixing claims brought by a class of farmers against a dairy cooperative and a dairy marketing company. The settlement in Allen et al. v. Dairy Farmers of America et al. was notable for at least two reasons that were seemingly at odds: First, the unusually high number of claims filed; and second, the vociferous advocacy of two named plaintiffs who objected to the settlement. The objectors argued that class counsel colluded with defendants’ to reach a settlement agreement, and coerced class members to support the settlement.
On August 8, the District of Connecticut issued a noteworthy ruling on how to approach defining the relevant market definition in a pay-for-delay suit.
The European Commission on Tuesday announced its decision finding truck makers MAN, Volvo/Renault, Daimler, Iveco, and DAF liable for violating EU antitrust rules. The companies acknowledged that for 14 years they colluded in setting truck prices, settling the case for a record total of €2.93 billion. Competition commissioner Margrethe Vestager reported that the five-company cartel “account[s] for around 9 out of every 10 medium and heavy trucks produced in Europe.” Vestager also said that the unprecedented fines send a “clear message to companies that cartels are not accepted.”
Today the FTC filed a complaint in the U.S. District Court for the Eastern District of Pennsylvania against Endo Pharmaceuticals for entering into “pay-for-delay” agreements with two different generic manufacturers that restricted generic competition for two of its patented drugs, Opana ER and Lidoderm. The FTC alleges that Endo paid Impax, a generic drug manufacturer, $40 million to keep a generic version of Opana ER off the market for over 2 years, and that Endo and its partner Teikoku gave Watson (now Allergan) Lidoderm patches worth hundreds of millions of dollars “at no cost” for Watson to sell through its distribution subsidiary in exchange for abandoning its patent challenge.
MLB Settles, Leaving Unanswered Questions: Do Sports Leagues’ Regional Blackout Agreements Violate Antitrust Laws?
In the wake of Major League Baseball’s settlement of antitrust claims on the eve of trial, the central question from the lawsuit remains: are sports leagues’ exclusive broadcasting territories for live games an antitrust violation? Although suits against the MLB and National Hockey League have both settled, analogous antitrust claims are pending against the National Football League, leaving open the possibility that these issues may be finally resolved in the court room.
A settlement agreement last week in the long-running U.S. Cargo Antitrust Class Action brought the settlement fund in that case to over $1.1. billion. Polar Air Cargo, Polar Air Cargo Worldwide, and Atlas Air Worldwide Holdings agreed to pay $100 million in three installments. The settlement is the second-largest so far in this case, after Korean Air Lines's agreement in December 2013 to pay $115 million. It is subject to approval by the U.S. District Court for the Eastern District of New York, where the case is pending.
FTC Asserts That Its Failure to Object to a “Reverse Payment” Settlement Should Not Be Interpreted as Approval
On November 17, 2015, the FTC submitted an amicus brief to the Third Circuit Court of Appeals in In re Effexor XR Antitrust Litigation, where the district court had dismissed the plaintiffs’ claims of antitrust violations based on an alleged reverse payment under FTC v. Actavis, Inc., 133 S. Ct. 2223 (2013). In its brief, the FTC argues that its failure to object to a pharmaceutical patent settlement should play no role whatsoever in evaluating the legality of alleged reverse payments, and urged the Third Circuit to reverse the district court’s decision to the extent it relied on such considerations.
Better Early than Never: SDNY Dismisses Lawsuit over Patent Settlement where Generics were Granted Early-Entry Licenses with Acceleration Clauses
On September 22, Judge Ronnie Abrams of the Southern District of New York dismissed an antitrust lawsuit against Takeda Pharmaceuticals and three generic drug manufacturers based on settlements they had reached regarding a patent dispute over the drug ACTOS. The court held that the settlements were not illicit “reverse payments” warranting scrutiny under the Sherman Act because there was no plausible basis for holding that the settlements reduced competition for the drug. In the settlements, the generics did not receive any cash payments and primarily gained early entry licenses with acceleration clauses.
Portions of a reverse payment suit against Endo Pharmaceuticals and others were recently dismissed by Judge William H. Orrick of the Northern District of California. The case was brought by plaintiffs who allege that a settlement agreement resolving a patent dispute over the drug Lidoderm illegally delayed the release of a generic version.
On June 26, 2015, the Third Circuit extended Actavis to non-cash settlements and held that Actavis can cover a no-AG agreement – “a settlement in which the patentee drug manufacturer agrees to relinquish its right to produce an ‘authorized generic’ of the drug” during the statutorily guaranteed 180 days of market exclusivity for the first-filing generic drug manufacturer.
AlarMax Distributors Inc. may pursue price discrimination claims under the Robinson-Patman Act (RPA) against Honeywell International Inc., a federal judge in Pennsylvania ruled last week. Fire and security product distributor AlarMax alleges that Honeywell violated a decade-old settlement and supply agreement by engaging in unlawful pricing activity.
Nippon Cargo Airlines Co. Ltd last week agreed to pay $36.55 million to settle claims that it conspired with other airlines to fix rates for air cargo services in the early 2000s. Two dozen airlines have settled in the long-running multi-district litigation (MDL), bringing the settlement fund to more than $900 million.
On Monday, the United States Court of Appeals for the Second Circuit heard oral argument in Apple’s appeal in the e-book price-fixing lawsuit brought by the Department of Justice. This appeal follows an adverse decision from June 2013, in which the district court determined that Apple had conspired with five book publishers to raise prices on e-books in violation of the antitrust laws.
Much has happened since our last post on the Nexium “pay for delay” class action lawsuit. Jury selection began in the District of Massachusetts on Monday, October 20, 2014. The day prior, one of the generic drug makers, Dr. Reddy’s Laboratories (“DRL”), settled with the plaintiffs and agreed to cooperate in plaintiffs’ case against AstraZeneca, Teva Pharmaceutical Industries, and Ranbaxy Inc.
The Canadian Competition Bureau intends to take a tough approach to so-called “pay-to-delay” settlements, potentially anti-competitive agreements in which generic drug manufacturers agree to delay the launch of a low-cost generic medicine in exchange for settlement of patent litigation with their brand-name drug competitor. Canadian Competition Bureau commissioner John Pecman delivered this message in his white paper, “Patent Litigation Settlement Agreements: A Canadian Perspective,” which he presented at a George Mason University pharmaceutical industry conference on September 23rd.
On June 30, 2014, the FTC announced in a series of orders that it would consent to Actavis PLC’s acquisition of Forest Laboratories only under certain conditions. Under a February 2014 Merger Agreement, Actavis plans to acquire Forest for approximately $25 billion. The FTC filed a complaint alleging that the proposed merger would negatively impact the market for four drugs, resulting in violations of Section 7 of the Clayton Act and Section 5 of the FTC Act.
As we noted last month, the DOJ invited public comment last June on whether to modify its consent decrees with the music licensing firms ASCAP and BMI to respond to changes in the digital music business. The DOJ review comes on the heels of decisions issued last year in the Southern District of New York, by Judges Cote and Stanton, holding that the consent decrees did not permit music publishers to partially withhold digital performance rights – which the publishers sold separately, at a premium, to the streaming music service Pandora. The challenge now will likely be convincing the DOJ (and, if necessary, the district court) – that the decrees have already achieved their purposes – or are no longer suited to do so – despite recent finding of coordinated, anticompetitive conduct by some of the key players in the dispute.
The Federal Trade Commission has reached a proposed consent agreement with two major propane distributors, Ferrellgas, L.P. (d/b/a Blue Rhino) and AmeriGas Partners, L.P., that would settle an FTC price-fixing investigation into the two companies. The proposed deal was announced by the FTC in an order withdrawing the matter from adjudication so that the proposed agreement could be reviewed.
On August 8, 2014, Judge Koh denied a motion for preliminary approval of a proposed $324.5 million class action settlement with Adobe, Apple, Google, and Intel in the No-Poach litigation pending in the Northern District of California, finding that "the total settlement amount falls below the range of reasonableness" because "there is ample evidence of an overarching conspiracy" and "[c]lass members would receive an average of approximately $3,750 from the instant settlement if the Court were to grant all requested deductions and there were no further opt-outs."
In June 2014, the DOJ announced that it planned to review the consent decrees with music licensing firms ASCAP and BMI. These consent decrees were initially entered in 1941; the ASCAP consent decree was last amended in 2001 and the BMI consent decree was last amended in 1994. The DOJ asked for comments concerning whether the consent decrees "need to be modified to account for changes in how music is delivered to and experienced by listeners." On August 6, ASCAP and BMI filed public comments regarding the consent decree review.
On August 1, 2014, Judge Cote preliminarily approved a $450 million settlement in the Apple e-books litigation. As many of you will recall, a June 2013 trial resulted in a finding that the various plaintiffs (including numerous states, the United States, and a class action) succeeded in proving that Apple had conspired with five book publishers to raise e-book prices.
A panel of the U.S. Court of Appeals for the First Circuit heard oral argument this week in In Re: Nexium (Esomeprazole) Antitrust Litigation in an appeal of a lower court’s decision certifying a class of drug consumers and third-party payors challenging AstraZeneca’s “pay-for-delay” patent suit settlements, as reported by the National Law Journal.
We are pleased to announce the launch of Antitrust Update, Patterson Belknap’s new resource for the latest news and happenings in the antitrust and competition law arena.