This marks the first issue of WilmerHale’s The Interplay: Key Decisions at the Intersection of Antitrust & Life Sciences, a monthly bulletin that will highlight developments in the antitrust and life sciences space. We will cover important decisions in the appellate courts, dispositive decisions from district courts and relevant updates and developments from the FTC. This will serve as a reliable and informative resource for readers who wish to stay current on this dynamic area of litigation. Beginning this month, you will receive digestible summaries of these decisions and other recent developments.
Federal Trade Commission v. Amgen, Inc. (N.D. Ill.) – FTC and State AGs End Challenge to Amgen/Horizon Deal. On September 1, the FTC announced it has agreed to a proposed consent order with Amgen, settling its suit to block Amgen’s proposed acquisition of Horizon Therapeutics. In May 2023, the FTC and six state attorneys general alleged that the deal would enable Amgen to use its extensive drug portfolio to offer bundled discounts that would make it difficult or impossible for future competitors to challenge Horizon’s monopoly in two drug markets. This was the first time in over 40 years that a US antitrust agency has challenged a transaction based on a “conglomerate” theory of competitive harm. The proposed order will, among other things, prohibit Amgen from bundling Tepezza and Krystexxa with an Amgen product. This is the first time in more than 5 years that the FTC had agreed to accept a behavioral remedy to address competitive concerns. The proposed consent order is subject to a notice and comment period. For more information on the FTC’s challenge, see WilmerHale’s alert here.
Federal Trade Commission v. Endo Pharms. Inc. (D.C. Cir.) – D.C. Circuit Affirms Denial of FTC Challenge to “Standard Exclusive Licensing Agreement.” On August 25, the D.C. Circuit affirmed dismissal of the FTC’s suit against Endo Pharmaceuticals and Impax Labs. Endo and Impax originally reached an agreement in 2010 that granted Impax a license to launch a generic version of Endo’s pain medication Opana ER (extended release oxymorphone) in January 2013, under a license covering Endo’s patents for oxymorphone ER, and including (in Impax’s view) patents acquired after the agreement became effective. In 2012, Endo launched a Reformulated Opana ER designed to prevent abuse and acquired additional patents related to Opana ER. In 2015, Endo asked Impax to pay an 85 percent royalty for a license to these additional patents and sued when Impax refused. During that litigation, Endo withdrew Reformulated Opana ER, leaving Impax’s generic version of Opana ER as the only oxymorphone ER on the market. In a 2017 settlement agreement, the Endo and Impax agreed that Impax would pay royalties for the additional patents but that the royalty obligation would end if Endo re-entered the oxymorphone ER market. In 2021, the FTC challenged the 2017 agreement as an allegedly anticompetitive exclusive licensing arrangement. The district court and D.C. Circuit, however, found that the 2017 agreement was a “standard exclusive license” that is lawful under the Patent Act. While the FTC argued that the 2017 agreement was an illegal non-compete agreement because the 2010 agreement allegedly gave Impax a license to Endo’s patents, the D.C. Circuit—applying circuit precedent recognizing the legality of “standard exclusive licensing agreements” when they “restrain trade only to the extent traditionally recognized by patent law”—affirmed the district court’s finding that the FTC failed to explain why the 2017 agreement, on its own, was not a Congressionally-sanctioned “standard exclusive license.”
Jacksonville Police Officers and Fire Fighters Health Insurance Trust v. Gilead Sciences, Inc., et al. (N.D. Cal.) – Court Dismisses Allegations of Antitrust Injury That Are “Speculation and Conjecture.” On August 28, a court in the Northern District of California granted Gilead’s motion to dismiss the second amended complaint, holding that plaintiffs failed to allege an antitrust injury. Plaintiffs alleged that Gilead entered anticompetitive reverse-payment settlement agreements involving Gilead’s HIV medications. The court found that the plaintiffs’ “allegations about whether Cipla, or any other generic manufacturer, intended to seek approval for a [generic] version of Truvada are based on speculation and conjecture and are insufficient to plausibly allege their theory of injury.” That is, the court found plaintiffs had failed to adequately allege that but for the alleged reverse payment settlement, one or more generics would have entered the market, thereby creating competition for Truvada. The district court gave the plaintiffs one final opportunity to amend their complaint.
In re Suboxone Antitrust Litigation (E.D. Pa.) – Court Denies Motion For Legal Determination of Relevant Market. On August 30, a court in the Eastern District of Pennsylvania denied plaintiffs’ motion for partial summary judgment in a monopolization case that the “relevant market” should be defined as the market for Suboxone (an opioid dependence drug) and its AB-rated generic equivalents. Defendants contended that the relevant market should include a broader array of opioid dependence therapies. The district court found that the defendants had introduced evidence of the functional interchangeability of, real-world switching between, and cross-price elasticity of demand between Suboxone and other opioid dependence drugs. The court therefore held that the relevant antitrust market, “particularly in this convoluted pharmaceutical market, is more properly decided by a jury” and denied plaintiffs’ motion.