Sharing US Drug Patents with Neglected Patients: A Scientist’s View

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By John Erickson, PhD

In 1998, while working at the National Cancer Institute of the US National Institutes of Health (NIH), my colleagues and I discovered and patented a class of compounds for the treatment of drug-resistant HIV-infections. It took another eight years of research and development to bring one of these compounds, darunavir, through the lengthy drug approval process. Since 2006, darunavir has been used to improve the lives of HIV-infected patients, mainly in the US and Europe, where people can afford the high prices of patented medicines. I was pleased to learn that, recently, a significant step has been taken to make darunavir accessible to the rest of the world through a licence of NIH’s darunavir patent to the Medicines Patent Pool. The Pool was established with the support of UNITAID, a global health initiative dedicated to improving access to medicines for AIDS, tuberculosis and malaria.

Why is this important, and why not just ask the drug-maker, Johnson & Johnson, to provide darunavir at low cost to poor markets? For one thing, the global numbers of HIV-infected people in these markets dwarfs those in the US and Europe – supplying the drug to all who need it would require increasing the scale of drug production by a factor of 10 or even more. For a drug like darunavir, whose manufacturing costs are relatively high, it is not currently realistic to put the burden of global production on the drug developer or on any one particular manufacturer. Another reason is that the commercial infrastructure of the pharmaceutical industry was not designed to register, distribute and sell drugs in lower-income markets, although the global marketplace for drugs is evolving rapidly. Finally, allowing multiple generic companies to make the drugs increases security of supply and lets competition drive prices to their lowest sustainable levels, both of which are critical when providing lifelong treatment in countries where people live on as little as a dollar a day.

Enter the Medicines Patent Pool, which is designed to licence drug patents to quality-
assured, generic drug makers who are equipped to produce large-scale quantities of low-cost medicines for low- and middle-income countries. With this first licence in hand, the Pool is a critical step closer to achieving its goal of making lifesaving medicines more affordable and accessible to people in developing countries.

I have witnessed the heated debates over the last decade on how to ensure that patents do not stand in the way of access to medicines, especially for the world’s poorest. HIV/AIDS has been a lightning rod for much of this debate, partly because over 95 percent of the multi-billion dollar HIV drug market was reaped from less than 5 percent of the (richest) global patient population. But thanks to robust competition among drug manufacturers, particularly those in India, and funding from initiatives like the US President’s Emergency Plan for HIV/AIDS Relief, the Global Fund to Fight AIDS, Tuberculosis and Malaria, and UNITAID, the price of a year’s worth of AIDS drugs in developing countries has fallen from about $10,000 in 1999 to $67 for a first-line regimen today. These dramatic price decreases helped make it possible to expand access to AIDS treatment to reach more than five million people in developing countries by 2009 – a twelve-fold increase in just six years.

But a harsh reality is that HIV rapidly mutates to become drug-resistant, and many patients on first-line regimens will soon need to switch to second-line therapies that are more effective against drug resistant HIV.

In addition, of the estimated two million children living with HIV, many were born with or have developed drug resistant HIV. They will need access to newer drugs like darunavir, often right from the start. At the same time, an estimated nine million people are still waiting for first-line treatment, and funds are falling short. Just as we need to continually develop new drugs, we need to develop new approaches for improving drug access globally. So it is refreshing to see that patent-holders such as the NIH are willing to collaborate with the Medicines Patent Pool.

That the NIH is leading the way with the Patent Pool initiative is no surprise to me. In the 1980s, the NIH developed an innovative funding mechanism, the National Cooperative Drug Discovery Program, to spur public-private industry partnerships to develop HIV drugs in an era when antiviral drugs were not only unheard of, but were deemed by many experts to be impossible to develop. In 1988, while working at Abbott Laboratories, my team was awarded an NIH grant from this program that led to the development of ritonavir, a component of many life-prolonging HIV drug cocktails prescribed today. In the 1990s, the NIH supported my research team’s efforts to identify drugs like darunavir to treat drug-resistant HIV infections at a time when the industry believed this to be a fruitless endeavour.

That public funding is a key ingredient for successful innovation of drugs and technologies developed by the private sector is inarguable. The Medicines Patent Pool provides a valuable model for attacking a long-standing problem: how to get patented products, developed through public and private investment, to developing country markets today, without having to wait many years for patents to expire in high income markets. The NIH’s darunavir patent is a start, but it is not enough. Most new drugs are protected by ‘patent fences’ that cover not only the structure and composition of the drug, but also how it is made, and how it is converted into the capsules we buy at the drug store – a process called formulation.

Thus, the Medicines Patent Pool needs the pharmaceutical industry to step up with appropriate patent licences.

Instead of re-hashing old debates about patents, patients and profits, forward-looking pharmaceutical executives should consider new ways of ensuring that medicines reach all patients who need them. We also need to consider creative approaches to conducting research & development that meet global health needs. One of the most gratifying outcomes for a scientist is to see that our work has made a real difference in people’s lives. I applaud the NIH, and hope that other pharmaceutical companies and public research institutions will follow its lead.

John Erickson is the President and CEO of Sequoia Pharmaceuticals, Inc., and President of the Institute for Global Therapeutics, a non-profit foundation.

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Comments

  1. 1971Thistle says

    This article seems to ignore that fact that the section of J&J who own the darunavir patent have already taken steps to make it available. They have also addressed the potential production bottlenecks Dr. Erickson seems to worry about.

    From the Tibotec website: “In 2007, the company signed a royalty-free voluntary licensing agreement with the generic manufacturer Aspen Pharmacare of South Africa to register, package and distribute darunavir at a special access price in sub-Saharan Africa.”

    Also:

    “in 2008, Tibotec signed a royalty-free, non-exclusive license agreement with Emcure Pharmaceuticals Ltd of India to distribute the protease inhibitor darunavir in India under its own trade name.”

    The patent pool may be a good concept, but it is not the only solution, and should not obscure the fact that manufacturers are aware of the issue and have taken action. Better a good plan is executed now than delayed for a perfect plan tomorrow.

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