Medicines Patent Pool Reaches Licensing Deal With BMS to Expand Access to AIDS Drug

Dec. 12, 2013

Medicines Patent Pool Reaches Licensing Deal With BMS to Expand Access to AIDS Drug

140-Country Deal Is a Step on the Path to End AIDS – Meanwhile, Global Fund Turns in Wrong Direction

CAPE TOWN – An agreement announced today between the Medicines Patent Pool (MPP), a Swiss foundation funded by UNITAID, and Bristol-Myers Squibb (BMS) will improve access to HIV/AIDS treatment in developing countries if the complete terms are as reported, Public Citizen said today. The agreement licenses BMS patents and technology (or “know-how”) for atazanavir (marketed by BMS as Reyataz), a key second-line HIV/AIDS medicine. It would help facilitate the widespread generic competition needed to reduce costs, expand access to treatment – and eventually help end AIDS.

The example set by the MPP is all the more important at a moment when the Global Fund to Fight AIDS, Tuberculosis and Malaria appears to be turning its back on increased competition in favor of a tiered pricing arrangement preferred by Big Pharma, said Peter Maybarduk, director of Public Citizen’s Global Access to Medicines Program.

The MPP agreement authorizes competing pharmaceutical firms to manufacture and market atazanavir in 110 named countries. Another provision provides for sales where no patent is held – an additional 30 countries, according to an MPP database. Until now, use of atazanavir in HIV treatment response has been limited in many of these countries due, in part, to firms’ concerns about litigation related to a prior BMS license, even though atazanavir is not widely patented.

The MPP license provides legal certainty that should help HIV treatment programs provide atazanavir. It represents a significant improvement to the status quo and a remedy to the defects of the prior BMS license. Atazanavir can be manufactured for lower costs compared to the alternative second-line treatment. It also can be formulated for once-a-day treatment, which improves patient adherence.  

In contrast, Global Fund Executive Director Mark Dybul announced a Blue Ribbon Task Force on tiered pricing of pharmaceuticals for middle-income countries, to the great disappointment of many treatment advocates.

“Generic competition has consistently proven the most effective means to reduce medicine prices and ensure prices continue to fall over time,” Maybarduk said. “Since 2000, approximately 10 million lives have been saved in developing countries due in large part to the advent of robust generic competition. But the newer drugs needed to treat resistance, reduce harmful side effects and prevent transmission are broadly patented, too expensive, and still out of the reach of many who need them.”

At the International Conference on AIDS and Sexually Transmitted Infections in Africa (ICASA), hosted this week in Cape Town, global leaders touted the prospect of an “AIDS-free generation.” Studies showing that HIV treatment can also be effective as prevention now allow health authorities to map out an effective end to the pandemic.

But we can end AIDS in our time only if political leaders significantly increase funding or reduce costs — and preferably both, Maybarduk said.

“AIDS treatment need not be nearly as expensive as it is today,” he said. “An AIDS-free generation requires widespread generic competition and solutions to the problem of pharmaceutical monopolies. A careful study of the just-released license is warranted, but the Medicines Patent Pool appears to have made a significant contribution today.”

Not all licenses are created equal. A prior BMS license with three generics firms covering 49 countries left those firms unwilling or unable to market in most other countries, even in countries where no patent had been granted, lest they risk litigation or their commercial relationship with BMS. (BMS also did not register atazanavir in all developing countries.) The MPP seems to have negotiated a license that can resolve this conflict, to the significant benefit of people living with HIV. The MPP deal effectively covers more than 90 percent of people living with HIV in low- and middle-income countries.

At first blush, the agreement seems to provide an improved framework for future industry licensing. For example, licensees will pay no royalties where no patent has been granted (there will be no royalty payments for mere patent applications). Licensees are free to challenge patents and take advantage of compulsory licenses issued by governments to protect health. 

“If the license contains no unfortunate surprises, BMS may be commended for concluding an essentially pro-competitive license with the pool,” Maybarduk said. “Nevertheless, it is regrettable that BMS chose not to include a number of middle-income countries. We hope BMS will reconsider. Pharmaceutical companies should license to all low- and middle-income countries, to improve treatment access and help create the economies of scale needed to further reduce costs. We congratulate the MPP and encourage all of Big Pharma to jump in the Patent Pool.”

In a closely related positive development, the MPP has initiated negotiations with AbbVie (formerly Abbott Laboratories), for lopinavir and the booster drug ritonavir. AbbVie’s ritonavir patents are an obstacle to achieving the maximum possible benefits of the MPP license with BMS (and indeed, an obstacle to scaling up HIV/AIDS treatment generally). Ritonavir can be used to boost the BMS treatment, including in a single co-formulated pill. Atazanavir+ritonavir has emerged as a preferred second-line therapy, but it can be made available only at the lowest possible cost and in a single pill where AbbVie’s patent barriers can be overcome. AbbVie should follow the MPP’s lead and license ritonavir on the broadest possible terms.

“Johnson & Johnson (J&J) and Merck are the stragglers; the only patent-holding pharmaceutical giants that have not entered negotiations with the Medicines Patent Pool,” Maybarduk said. “J&J and Merck should pick up their pace, join their peers and begin negotiations. Where companies fail to negotiate, health advocates will pursue compulsory measures. With partners worldwide, we will challenge any patent barrier that impedes the goal of an AIDS-free generation.”

Learn more about Public Citizen’s Global Access to Medicines Program.