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[e-drug] Sharing US Drug Patents with Neglected Patients: A Scientist¹s View

E-DRUG: Sharing US Drug Patents with Neglected Patients: A Scientist?s View
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Intellectual Property Watch
5 November 2010

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

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  

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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