Appeals Court Reverses Dismissal of Tracleer Class Action
On April 13, 2021, the United States Court of Appeals for the Fourth Circuit reversed the United States District Court for the District of Maryland’s dismissal of an antitrust class action in which plaintiffs allege that Actelion unlawfully monopolized the Tracleer market. Tracleer was the first oral treatment for pulmonary arterial hypertension.
The plaintiffs allege that Actelion blocked generic manufacturers from entering the market by refusing to provide samples of Tracleer that the generic manufacturers needed to obtain FDA approval. Actelion and the generic manufacturers litigated a series of antitrust lawsuits flowing from Actelion’s refusal and all settled on confidential terms in February 2014. The plaintiffs assert that Actelion’s tactics allowed it to delay generic competition and to keep 100 percent of the market for three years after the November 2015 expiration of the patent protecting Tracleer.
The district court had concluded that plaintiffs’ claims, filed in November 2018, were barred by the statute of limitations because the last overt acts in Actelion’s anticompetitive scheme were the February 2014 settlements. The Fourth Circuit reversed, holding that the plaintiffs’ claims did not accrue until the Tracleer patent expired in November 2015, because the plaintiffs’ claims were not ripe until then. The Clayton Act, Section 4, provides a private right of action for antitrust violations, with a statute of limitations that expires based on being “barred unless commented within four years after the cause of action accrued”. The Fourth Circuit noted that the Supreme Court has held that a cause accrues when “a defendant commits an act that injures a plaintiff’s business”. In this case, the court concluded the first injury occurred after the expiration of the patent in 2015.
Actelion’s was acquired for $30 billion by Johnson and Johnson, a purchase completed in 2017. Actelion became a part of Johnson and Johnson’s Janssen Pharmaceutical Companies. On behalf of Actelion, Janssen spokeswoman Natalia Salomao said. “At Janssen, we cooperate with generic manufacturers so they have access to our medicines at reasonable, market-based prices … Following today’s decision, we intend to defend our position in court.”
The proposed class includes persons and entities that indirectly purchased, paid, and/or provided reimbursement for some or all of the purchase price of Tracleer or its generic version from November 20, 2015 until the alleged anticompetitive effects of Actelion’s conduct cease. A number of generic manufacturers gained FDA approval of generic versions of Tracleer in April 2019, with the first version marketed in June 2019.
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