So-called “Pay-for-Delay” settlements, also called Reverse Payment, settlements—in which an innovator sponsor pays a generic sponsor to settle ongoing patent infringement litigation in exchange for a delay in generic market entry—have been fodder for antitrust concerns for decades (see, for example, our coverage from 2013). Effectively, the first generic filer gets paid not to market—and, as a result of its 180-day exclusivity, block subsequent filers from coming to market—while an innovator gets an extension of its monopoly. Critics of these agreements believe that these agreements belie the intent of the ANDA pathway: facilitation of access to affordable medicines. Supporters, on the other hand, point out that the public ultimately benefits from these arrangements: sponsors can lower the costs of their medicines as a result of the money saved from lengthy litigation, and, should the relevant patent be valid and enforceable, generic sponsors can market their products earlier than if they had to await patent expiration. To balance these concerns, Congress delegated to FTC the authority to review and sign off on all generic drug and biosimilar patent settlement agreements based on a “rule of reason” standard established in the 2013 case, FTC v. Actavis.
In February 2017, FTC had the opportunity to test out the Actavis framework. After reviewing a settlement between Impax Laboratories and Endo Pharmaceuticals with respect to Paragraph IV patent litigation arising from Impax’s ANDA—eligible for 180-day exclusivity—seeking approval of a generic version of Endo’s Opana ER (oxymorphone), FTC brought separate enforcement actions against the parties alleging that the settlement was an unfair method of competition under and an unreasonable restraint of trade in violation of the FTC Act. At that time, Endo had decided to launch a crush-resistant Opana ER and remove the original Opana ER from the market, which would ultimately render any generic to original Opana ER not substitutable, but Endo needed some time to shift the market to its crush-resistant product. To buy some time, Endo sued Impax for patent infringement and triggered a 30-month stay in Impax’s ANDA approval. One month before the expiration of the 30-month stay, FDA tentatively approved Impax’s ANDA, and, on the cusp of trial, Endo and Impax settled the litigation.
Under the terms of that settlement, Impax would delay first commercial marketing of its generic until January 2013—which, as the first applicant with 180-day exclusivity, would delay all subsequent generic launches—and Endo agreed not to launch an authorized generic until after expiration of Impax’s 180-day exclusivity; to provide credit for any lost revenues upon Endo’s launch of crush-resistant Opana ER; to provide Impax a license for all existing and future Opana ER patents; and to collaborate with Impax on a new drug product with payments up to $40 million. In total, Impax received approximately $100 million not to delay market entry for 2.5 years. And, when Impax finally could come to market, Endo product-hopped to its crush-resistant Opana ER so that Impax’s generic did not even compete with Endo’s product. Unfortunately for End, FDA the new crush-resistant Opana was withdrawn for safety reasons, leaving Impax’s the only version of Opana ER on the market.
Endo settled with FTC while Impax fought the allegation allegations. An Administrative Law Judge reviewed the agreement and determined that it restricted competition, but its procompetitive benefits outweighed the anticompetitive effects. FTC, however, rejected the ALJ’s determination and determined that the cited procompetitive benefits could have been achieved through a less restrictive agreement. Consequently, FTC issued a cease-and-desist order enjoining Impax from entering into any similar reverse payment agreements in the future. Though Impax did not challenge the classification of the agreement as a “Reverse Payment” agreement, it appealed the FTC Order to the Fifth Circuit arguing that the payments and settlement size were justified.
On April 13, 2021, the Fifth Circuit upheld the FTC’s Order looking to whether the agreement caused anticompetitive effects that outweigh the procompetitive benefits. Under Actavis, the Court explained that the “likelihood of a reverse payment bringing about anticompetitive effects depends upon its size, its scale in relation to the payor’s anticipated future litigation costs, its independence from other services for which it might represent payment, and the lack of any other convincing justification.” When that payment is large an unjustified, it creates a likelihood of significant anticompetitive effects. Using the Actavis “rule of reason” standard, the Court agreed that the FTC met its burden to show that the settlement was anticompetitive based on size and lack of justification. Indeed, the size of the payment from Endo to Impax was comparable to other instances in which courts inferred anticompetitive effect, and that Endo’s savings in litigation expenses from settling—totaling approximately $3 million—was not enough to justify the $100 million that Endo would end up paying Impax under this agreement. With the threat of competition “snuffed out” by the reverse payment agreement—combined with Endo’s known product-hop plans—the Court agreed that the FTC had “substantial evidence to conclude that the reverse payments replaced the ‘possibility of competition with the certainty of none.’”
The Court rejected Impax’s argument that the FTC should have considered the strength of patent as irrelevant. While Impax explained that the settlement would not have been anticompetitive if the patents were strong, as it would have permitted generic entry prior to patent expiration, the Court inferred anticompetitive effect merely from the large amount Endo was willing to pay to prevent further competition. The Court further declined to look at the agreement in hindsight.
While the next rule-of-reason question concerned whether the agreement has any procompetitive benefits—and FTC argued that it did not—the Court did not address this element because the FTC assumed arguendo that it have procompetitive benefits. Instead of requiring Impax to meet its burden of demonstrating procompetitive benefits, the Court turned directly to the question of whether FTC reasonably found that the presumptive procompetitive benefits “could be reasonably achieved through less anticompetitive means.” For such an assessment, FTC relied on industry practice, economic analysis, expert testimony, and credibility of Impax’s lead settlement negotiator.
Based on the fact that most Paragraph IV patent challenge settlements do not include reverse payments and the economics showing that Endo likely would have entered the settlement agreement without the $100 million payout, the Court found that substantial evidence supported the FTC’s finding that the settlement could be achieved through less anticompetitive means. Despite the testimony of the Impax negotiator, whose credibility was questioned, insisting that Impax would not have agreed to such a settlement, the Court explained that “any reluctance Impax had to agree to a no-payment settlement . . . cannot undermine the Commission’s finding that a less restrictive settlement was viable.” Because evidence supported a reasonable factfinder to make such a conclusion, the Court upheld the FTC Order.
This case is important. Not only does it reaffirm the utility of the FTC’s review of patent settlement agreements, but it for the first time clearly applies the rule-of-reason framework, including the necessary shifting of burdens, for evaluating the pay-for-delay cases. While much deference is afforded to the FTC’s opinion, it’s clear that the framework leaves room for justification as to the procompetitive benefits of such a settlement, suggesting that each settlement truly will be evaluated on a case-by-case basis. Unlike the recent California pay-for-delay law, in which these types of settlements are presumptively anticompetitive, the Court’s analysis here leaves room for sponsors to continue negotiating these types of settlements, as long as the terms are justifiable and ultimately beneficial to the public. Nevertheless, the decision’s deference to FTC’s determination that a no-payment settlement, which theoretically should be available in any patent settlement, is a feasible less restrictive alternative to a reverse-payment settlement suggests that the FTC’s unspoken anticompetitive presumption may be difficult to overcome.
The FTC brought additional action against both Impax and Endo in January 2021 for conspiring to share monopoly profits from Impax’s extended release oxymorphone product—the only extended release oxymorphone remaining on the market—after FDA withdrew approval of crush-resistant Opana ER. On the condition that Endo would refrain from reentering the market, FTC alleges, Impax agreed to pay Endo a percentage of its oxymorphone ER profits. This case remains ongoing.