Takeda has already faced claims it used an illegal “pay-for-delay” deal to push back competition to constipation drug Amitiza. Now, a group of drug purchasers is going after the company, alleging illegal conduct on the gout medicine Colcrys.
In a lawsuit filed this week in Pennsylvania federal court, a group of drug purchasers and distributors argues Takeda’s patent settlements with Par Pharmaceutical—now part of Endo—and other generics companies constituted a “single conspiracy” or “multiple bilateral conspiracies” to protect against price declines on the medicine. The plaintiffs include AmerisourceBergen, Cardinal Health, McKesson and several regional drug buyers.
As the plaintiffs point out, Colcrys’ active ingredient, colchicine, is a “very old drug that has been used in the treatment of gout for a very long time.” In fact, ancient Greeks used the substance—found naturally in a plant—about two thousand years ago to treat and prevent gout, according to the lawsuit.
In the early 2000s, the drug was available in the U.S. for pennies per pill, according to the lawsuit. But when the FDA in 2006 kicked off its “Unapproved Drugs Initiative” to pull all medicines through its approval process, that would soon change.
Two years later, a company called Mutual Pharmaceutical Co. filed three approval applications for colchicine tablets to treat familial Mediterranean fever and also to treat and prevent gout flares. The FDA approved these applications in 2009 under the brand name Colcrys. In 2012, Colcrys ownership changed to Takeda, when it obtained Mutual Pharma through its purchase of URL Pharma.
Colcrys secured three years of regulatory exclusivity for treating gout flares and seven years for treating FMF. Takeda’s “final exclusivity” expired on July 29, 2016, according to the suit.
Also after the FDA’s approval, more than 20 generic versions of colchicine were pulled from the market, according to the plaintiffs. By May 2014, Takeda had raised the price by 5,733.33% compared with the med’s cost in 2006, the plaintiffs say.
In addition to the regulatory exclusivity, Takeda sought U.S. patents for its drug. But the plaintiffs argue those patents were “fatally weak” and were doomed to fail in court.
By taking the patent arguments through the court, Par would’ve been able to launch its generic as early as July 2016, according to the lawsuit. Then, other generics makers could’ve entered the fray six months later, after Par’s 180-day first-filer advantage lapsed.
Instead of going down that road, Takeda “entered into a single conspiracy,” or “multiple bilateral conspiracies,” to protect against price declines, the plaintiffs say. With Par, the company entered a license agreement “which was in fact a sham joint venture,” according to the lawsuit. In doing so, Par agreed to not launch an authorized generic of Colcrys until July 2018.
With other generics makers Watson and Amneal, Takeda entered deals to delay generic launches until October 2020, according to the lawsuit. Those deals gave the rivals a head-start on a “third wave” of generic filers, the plaintiffs say.
In all, the deals restricted competition and forced the plaintiffs to pay “supracompetitive prices” for the drug, according to the lawsuit.
The plaintiffs are seeking “threefold damages, costs of suit and reasonable attorneys’ fees” for the alleged conspiracy. They expect the damages to be calculated after discovery and upon proof at trial.
It’s not the first time Takeda has faced antitrust claims in recent years. In fact, the company and Par faced similar allegations in 2021 on the constipation drug Amitiza. Late last year, the company lost a bid to dismiss the case.