[Ip-health] Public Citizen statement on MPP-BMS License

Peter Maybarduk pmaybarduk at citizen.org
Thu Dec 12 04:01:24 PST 2013

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

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

Dec. 12, 2013                                                              

Contact: Peter Maybarduk +1 (202) 390-5375; +27 (0) 21 406 1911; pmaybarduk at citizen.org  
Statement of Peter Maybarduk, Public Citizen Global Access to Medicines Program Director

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. 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 facilitate a part of the widespread generic competition needed to reduce costs, expand access to treatment - and eventually help end AIDS. 

The example set by the Medicines Patent Pool 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. 

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 can also 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. Since 2000, approximately ten 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 only end AIDS in our time if political leaders significantly increase funding or reduce costs -- and preferably both. AIDS treatment need not be nearly as expensive as it is today. 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 Medicines Patent Pool seems to have negotiated a license which 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. 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 only be made available at the lowest possible cost and in a single pill where AbbVie's patent barriers can be overcome. AbbVie should follow the Medicines Patent Pool'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 which have not entered negotiations with the Medicines Patent Pool. 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. 

More information about Public Citizen's Global Access to Medicines Program is available at: http://www.citizen.org/access. 

Public Citizen . 1600 20th Street, NW / Washington, D.C. 20009

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