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A US judge has authorised a class action lawsuit against the drug company Abbott for its 400% hike in price, begun in late 2003, of the anti-HIV drug ritonavir (Norvir).
The lawsuit charges that the increase was a violation of US antitrust laws. It aims to roll back the increase and seeks compensation for everyone who has overpaid for the drug since the price increase.
Ritonavir had been developed as a protease inhibitor but did not work particularly well on its own. Over the course of using it with various combination treatments, clinicians observed a synergistic effect with other protease inhibitors. Ritonavir impeded the clearance of those drugs by the liver. Second generation protease inhibitors were developed that used ritonavir in subclinical doses as a “booster.” Some compounds under development in the new integrase inhibitor class of drugs also use a ritonavir booster.
When this role for ritonavir became apparent, Abbott increased the price of ritonavir by 400%, from $1.71 (£0.90; €1.30) to $8.57 per daily dose. The company said the rise reflected the increased “value” of the drug. It did not increase the price of Kaletra, its co-formulation of the protease inhibitor lopinavir with a booster of ritonavir.
The price increase sparked protests by numerous AIDS specialists and activists in the United States and abroad, but doctors often had little option but to continue to prescribe ritonavir as part of their patients' regimen.
The very early development of ritonavir had been undertaken with funding from the US National Institutes of Health (NIH), which granted patent use to Abbott. The outcry over the price increase prompted the NIH to launch a highly unusual investigation of whether Abbott's price increase violated that patent.
At a public meeting held by the NIH in 2004 Bob Huff of the New York AIDS charity the Gay Men's Health Crisis charged that “the practical and intended effect [of the price increase] was to position Kaletra in advantage to its competitors.”
The NIH ultimately found that it did not have the authority to revoke Abbott's patent for ritonavir on the grounds of the price increase.
Also in 2004 a class action lawsuit was launched on behalf of patients and healthcare payers who have suffered under Abbott's alleged anti-competitive price increase. Several rounds of pre-trial motions and appeals ensued.
On 11 June a ruling by the federal judge Claudia Wilken allowed the class action lawsuit to move forward to trial.
Joseph Tabacco Jr, the lead attorney for the plaintiffs, said, “We believe the damages here are in the several hundreds of millions of dollars range.”
The Abbott spokesman Scott Stoffel called the judge's decision “a procedural ruling that has no bearing on the merits of the case.” Abbott believes the charges to be without merit and is likely to appeal the decision.
In May the company initiated a lawsuit against the Paris activist group ACT UP (AIDS Coalition to Unleash Power) over that group's efforts to shut down an Abbott website in protest at the company's policy towards Thailand with regard to patents. If found guilty the group could be fined up to €75000 and disbanded.