Justia U.S. 2nd Circuit Court of Appeals Opinion Summaries

Defendants in these tandem cases (collectively, "Takeda") are a brand pharmaceutical manufacturer and related entities that began producing and marketing the Type-2 diabetes drug ACTOS in 1999. Purchasers of ACTOS filed suit against Takeda for improperly describing its patents to the FDA, in effect extending the duration of its patent protection over ACTOS and delaying generic competition. The district court denied Takeda's motion to dismiss, concluding that the alleged patent descriptions were incorrect under the Hatch–Waxman Act and pertinent regulations.On this interlocutory appeal, the Second Circuit held that under the "Listing Requirement" of 21 U.S.C. 355(b)(1), a combination patent does not "claim" any of its component drug substances past their individual patent expiration dates. The court also held that the purchasers were not required to allege that Takeda's interpretation of the Listing Requirement was unreasonable in order to plead a monopolization claim under the Sherman Act. Accordingly, the court affirmed the district court's denial of Takeda's motion to dismiss and remanded for further proceedings. View "United Food & Commercial Workers Local 1776 v. Takeda Pharmaceutical Co." on Justia Law

Plaintiffs filed a class action alleging that Takeda prevented competitors from timely marketing a generic version of Takeda’s diabetes drug ACTOS by falsely describing two patents to the FDA. Plaintiffs claimed that these false patent descriptions channeled Takeda’s competitors into a generic drug approval process that granted the first-filing applicants a 180-day exclusivity period, which in turn acted as a 180-day "bottleneck" to all later-filing applicants. 9 out of 10 generic applicants took that route. Teva was prevented from seeking approval via another regulatory mechanism when the FDA announced that all generic manufacturers would be required to take the bottlenecked route. Plaintiffs alleged that they were wrongfully obligated to pay monopoly prices for ACTOS when Takeda's patent on the active ingredient in ACTOS expired when the mass of generic market entry occurred. The district court dismissed plaintiffs' antitrust claims. The court affirmed to the extent that plaintiffs' theory posits a delay in the marketing of generic alternatives to ACTOS by all the generic applicants other than Teva, because plaintiffs' theory presupposes that these applicants were aware of Takeda’s allegedly false patent descriptions when they filed their applications, which is not supported by well-pleaded allegations. However, the court concluded that plaintiffs' theory as to Teva does not require any knowledge of the false patent descriptions. Therefore, the court reached other issues as to Teva and found plaintiffs plausibly alleged that Takeda delayed Teva's market entry. Accordingly, the court affirmed in part, vacated in part, and remanded for further proceedings. View "In re ACTOS End-Payor Antitrust Litigation" on Justia Law

Plaintiffs filed suit alleging that defendant fraudulently obtained his federal trademark registration for the PUDGIE’S mark in connection with restaurants that principally serve pizza, pasta, and submarine sandwiches. The district court granted summary judgment to plaintiffs. In this case, the district court correctly concluded that no material issue of fact existed as to whether defendant knowingly made false, material representations in his application where the specimen he included with his application exhibited that the PUDGIE'S mark originally came from another source. The court concluded that no genuine issue of material fact exists as to whether defendant knew that other entities had rights to use the mark in the very manner in which he sought to use the mark, and whether he intended to mislead the PTO by attesting otherwise in his trademark application. Accordingly, the court affirmed the judgment. View "MPC Franchise, LLC v. Tarntino" on Justia Law

RTI owns patents relating to the automatic routing of telephone calls based upon cost. Aware of infringement by Speakeasy, a telecommunications company, RTI offered to release Speakeasy from liability in exchange for a one-time payment under RTI’s tiered pricing structure. In 2007, the companies entered a “Covenant Not to Sue” with a payment of $475,000 to RTI, and a provision barring Speakeasy from challenging, or assisting others in challenging, the validity of the patents. The agreement defined “Speakeasy” to include both Speakeasy and Best Buy, which had previously announced plans to acquire Speakeasy. Three years later, Best Buy announced a plan to sell Speakeasy and merge it into Covad. RTI again learned of an infringement and notified Covad. Covad sought a declaratory judgment that the patents were invalid. The action was later dismissed voluntarily. RTI initiated the present lawsuit. The district court dismissed, holding that the doctrine of licensee estoppel, under which a licensee of intellectual property “effectively recognizes the validity of that property and is estopped from contesting its validity,” is unenforceable in the context of challenges to patents, and that the no-challenge clause was contrary to the public interest in litigating the validity of patents. The Second Circuit affirmed. View "Rates Tech. Inc. v. Speakeasy, Inc." on Justia Law

Appellants appealed from an order of the district court denying its motion, made after a preliminary injunction was vacated by the court, to recover damages against an injunction bond posted by appellee. At issue was whether the district court correctly concluded that the damages sought were not proximately caused by the injunction, and that, in deciding this issue, the district court should have applied a presumption in favor of recovery against the bond. The court held that a wrongfully enjoined party was entitled to a presumption in favor of recovery against an injunction bond and that the district court's decision was insufficient to permit meaningful appellate review. Accordingly, the court vacated the order and remanded for reconsideration and clarification.