11/25/2023 0 Comments Ftc suit against endo pharmaThe Court's opinion in Actavis, however, did not specify whether this rule applies to noncash payments. 2 Conduct subject to the rule of reason is not automatically illegal rather, a court must consider the surrounding facts and circumstances to weigh the potential benefits to consumers against its harms. Actavis that patent settlements involving unjustified or unexplained large reverse payments are subject to antitrust scrutiny under the antitrust rule of reason. For instance, when the brand manufacturer agrees not to license an authorized generic during the first filer's 180-day exclusivity period, this is known as a no-AG agreement. Although such payments were typically in cash, parties have grown more creative in crafting settlements so that cash payments are not included. While patent infringement suits are usually settled by payments from the infringer to the patent holder, in branded/generic patent litigation, suits are often settled by the branded drug manufacturer paying the generic manufacturer company-a "reverse payment." In return for the payment, the generic manufacturer will delay its immediate entry into the market for some period of time. Alternatively, the generic may also sue the branded manufacturer alleging that its patent is invalid. This suit automatically prevents the generic manufacturer from entering the market for 30 months. When a generic manufacturer tries to launch its product before the brand manufacturer's patent has expired, the brand manufacturer may sue the generic for patent infringement. The Act also includes procedures that govern patent disputes between generic and branded drug manufacturers. During the first filer's exclusivity period, no other generic manufacturer can sell the drug however, the branded manufacturer can continue to sell the original branded drug, as well as license its own generic version, known as an "authorized generic." The existence of a second generic on the market decreases the first generic's profits, as sales of generics (promoted by various state mandatory substitution laws) will be split between both generic versions. The Hatch-Waxman Act (Act) encourages the introduction of generic versions of popular drugs by 1) permitting generic manufacturers to gain approval through filing a less cumbersome application, known as an Abbreviated New Drug Application (ANDA), and 2) providing a 180-day statutory exclusivity period to the first generic drugmaker to file an ANDA (known as the first filer) when its drug goes to market. While this process is very expensive and time-consuming, the drugs are typically protected by patents, giving the manufacturers a period of exclusivity to reap the rewards of their investment in the drug development and approval process. When a pharmaceutical manufacturer wants to launch a new drug, it must file a New Drug Application (NDA) with the Food and Drug Administration (FDA) before it can market and sell that drug. Second, the FTC is likely to pursue the remedy of disgorgement in pay-for-delay cases. First, the FTC is taking an increasingly broad view of what constitutes an unlawful pay-for-delay settlement, in this case by attacking a noncash settlement for the first time. The Endo case reveals two key elements of the FTC's ongoing, aggressive strategy against pay-for-delay agreements. (Endo) and other pharmaceutical manufacturers entered into "pay-for-delay" settlements that raised costs for consumers, in violation of the antitrust laws. Endo Pharmaceuticals Inc., the FTC alleges that Endo Pharmaceuticals Inc. Subscribe FTC Maintains Aggressive Stance Against Pay-for-Delay Dealsīy Lisl Dunlop, Partner, Litigation | Ashley Antler, Associate, Health | Shoshana Speiser, Associate, LitigationĪ recent complaint filed by the Federal Trade Commission (FTC) indicates that the agency is continuing its aggressive pursuit of agreements between drug manufacturers that delay the entry of generic pharmaceuticals into the market. Long-Term Care/Long-Term Services and Supports. ![]() Technology and Intellectual Property Litigation.TCPA Compliance and Class Action Defense.Investigations, Compliance and White Collar Defense.Intellectual Property Protection and Enforcement.Government Litigation and Administrative Law.Financial Services Litigation and Enforcement.
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