Overview
On September 6, 2024, the Court granted Plaintiff’s motion for class certification and denied Defendant Actelion’s motion for summary judgment. The Court’s order also appointed Cohen Milstein as Co-Lead Counsel for the Class.
This certified antitrust class action concerns branded and generic Tracleer, which is used to treat pulmonary artery hypertension. Plaintiff claims Actelion engaged in a monopolistic scheme to prevent generic manufacturers from developing a competing generic version of its blockbuster drug Tracleer. Specifically, Plaintiff alleges that Actelion blocked would-be generic manufacturers from obtaining samples of Tracleer, which is a prerequisite imposed by the FDA for developing a generic version, including by contractually forbidding its distributors from selling Tracleer to those generic manufacturers. By doing both, Actelion effectively blocked every path generic manufacturers had to obtain samples of Tracleer. As a result, Actelion delayed market entry of less expensive generic versions of its blockbuster drug after its patent exclusivity had run its course. Actelion’s alleged scheme was so successful that no generic product came to market until over three years after the Tracleer patent expired, during which time End-Payors allege that they overpaid for these products to the tune of hundreds of millions of dollars.
Other Important Decisions
- On April 13, 2021, the United States Court of Appeals for the Fourth Circuit found that the End-Payor Plaintiffs’ claims were not time-barred as the U.S. District Court of Maryland had ruled, but that it was filed within the statute of limitations. The Court also held that whether or not named plaintiffs could represent absent class members in states where they themselves had not made purchases was a question that should be addressed under Rule 23 at the class certification stage. The Fourth Circuit’s decision revived all of the End-Payor Plaintiffs’ claims against Actelion.
- On January 18, 2019, Cohen Milstein was appointed Interim Co-Lead Counsel.
Case Background
On January 25, 2019, Cohen Milstein and co-counsel filed a consolidated antitrust class action on behalf of purchasers against Actelion Pharmaceuticals LTD, manufacturer of the brand prescription drug bosentan, marketed as Tracleer. The complaint alleges a monopolistic scheme to prevent generic manufacturers from developing a generic version of the drug in order for Actelion to prolong its monopoly over the drug well past the time period it was lawfully entitled to.
Bosentan is a dual endothelin receptor antagonist that Actelion sells as a treatment for pulmonary artery hypertension (“PAH”) under the brand name “Tracleer.” PAH is a relatively rare, but chronic, and potentially fatal disorder in which elevated blood pressure in the arteries of the lungs causes the heart to work harder than normal. It affects between 10,000 and 20,000 people in the U.S. — most of them women. It is estimated that on average PAH patients pay $103,464 and $196,560 per year for Tracleer. As a result, Tracleer is a highly profitable drug (billions in sales) for Actelion.
Plaintiff alleges that despite the expiration of Actelion’s regulatory and patent exclusivity over the use of bosentan to treat PAH, which expired on November 20, 2008 and November 20, 2015, respectively, no generic manufacturer was able to bring a generic bosentan to market for years.
Specifically, Plaintiff alleges, Actelion blocked would-be generic bosentan manufacturers from obtaining samples of Tracleer, which is a required part of testing in order to obtain FDA approval of a generic drug application, including, admittedly, forbidding its distributors from selling Tracleer to those generic manufacturers and refusing to sell Tracleer directly to the manufacturers as well. By doing both, Actelion effectively blocked every path generic manufacturers had to obtain samples of Tracleer.
Furthermore, when generic manufacturers attempted to get samples of Tracleer directly from Actelion, Actelion cited consumer safety protocols imposed by FDA as the reason it refused to sell Tracleer samples to generic manufacturers (and the reason it prevented its distributors from selling them as well), despite the FDA and Congress specifically dictating that such safety protocols could not be used to delay generic competition.
Plaintiff alleges that Actelion’s anticompetitive scheme has been 100% effective.
As a result of Actelion’s monopolistic scheme, Plaintiff and other purchasers have been forced to pay higher prices for bosentan for far longer than they otherwise would have. Plaintiff alleges that absent Actelion’s years-long blockade, one or more generics would have been available at or around the expiration of Tracleer’s patent protection in November 2015.
Case name: Baltimore v. Actelion Pharmaceuticals LTD, Case No. 1:18-cv-03560-GLR, U.S. District Court, District of Maryland