Patent Rights and Competition: FTC Challenges J&J Case as Turkish Court Clarifies Pharma Patent Boundaries

The US Federal Trade Commission has urged a federal appeals court to reconsider a lower court's handling of antitrust claims involving Johnson & Johnson's acquisition of patent rights tied to its blockbuster drug Stelara, arguing that the decision could weaken enforcement against conduct that allegedly preserves pharmaceutical monopolies. Meanwhile, in Turkey, the Court of Cassation has issued a ruling clarifying the boundary between the lawful exercise of patent rights and unfair competition in disputes between originator and generic pharmaceutical companies.

The FTC's challenge centers on J&J's acquisition of patent rights related to Stelara and whether the lower court's approach adequately addresses anticompetitive conduct in pharmaceutical patent dealings. The Commission has argued that the decision under review could undermine enforcement efforts targeting practices that preserve monopolies in the drug market.

In a separate but thematically related matter, the Turkish Court of Cassation, in a May 2025 decision, addressed whether a patent holder's actions — specifically filing a patent infringement lawsuit and sending a warning letter to a third-party contract manufacturer — could constitute unfair competition. The case involved an originator pharmaceutical company that had sued a generic company over patent infringement, while the generic product's manufacturing was handled by a separate contract manufacturer not party to the litigation.

During the proceedings, the patent holder sent a warning letter to the contract manufacturer detailing the patent's scope and the existence of the pending litigation, requesting that patent rights be respected. The letter contained no false or misleading statements regarding the case's potential outcome. After reviewing evidence including the generic marketing authorization dossiers and an expert report, the patent holder concluded that the generic product did not fall within the patent's scope and requested the proceedings be terminated. The patent infringement action was ultimately dismissed without a preliminary injunction, and that decision became final.

The generic company then brought a separate unfair competition action, claiming that the patent infringement lawsuit and the warning letter had prevented it from placing its product on the market and cost it the opportunity to become the first generic entrant. A lower court initially found in the generic company's favor, ruling that while the warning letter contained factually accurate information, it created the impression that a preliminary injunction might be granted, leading the contract manufacturer to suspend production. The court found this violated the good-faith principle under article 54(2) of the Turkish Commercial Code and awarded non-pecuniary damages for reputational harm.

The Court of Cassation reversed that decision, holding that the filing of a patent infringement action and the notification of third parties about it fall within the scope of patent rights and cannot in themselves be characterized as unfair competition. The court determined that the warning letter did not state that patent infringement had been definitively established, did not create a false or misleading impression as if a preliminary injunction had already been granted, and provided accurate and objective information regarding the ongoing proceedings. The letter could not be regarded as false, misleading, or disparaging in nature.

Following the Court of Cassation's ruling, the case was returned to the first-instance court, which in November 2025 dismissed the unfair competition action. The decision cemented the scope of the good-faith principle as it applies to patent rights enforcement, establishing that exercising patent rights — including notifying third parties about infringement proceedings — is lawful provided the communications are truthful and accurate.