Echoing Green fellows participate in a Why Do You Do What You Do presentation at Duke University on July 24, 2008.

Echoing Green fellows participate in a Why Do You Do What You Do presentation at Duke University on July 24, 2008.

Somewhere on the outskirts of Chennai, India, Imran*, a young man of 17 going on 7, was asking to live. Imran’s frame had wasted away due to HIV (human immunodeficiency virus) contracted from a negligent blood transfusion at a government hospital in Tamil Nadu.

“He was sweet, articulate, and desperately fighting to continue his education despite his withered condition. As my team prepared to file his petition in court to seek damages and demand free medication, I realized I was profoundly altered,” says Priti Radhakrishnan, co-founder—along with husband Tahir Amin—of the non-profit organization, I-MAK. One of the goals of the organization, founded in 2006, was to give voice to the poor.

I-MAK (Initiative for Medicines, Access and Knowledge) defends public interest by ensuring that pharmaceutical monopolies and weak patent systems do not cause people to suffer and die preventable deaths just because they cannot afford the health care treatments and medicines that exist to help them.

An Elusive Order: “Health For All”

“No one should be denied medication,” says Yusuf Hamied, Chairman and Managing Director of Cipla Limited, a leading pharmaceutical company in Mumbai, India. In September 2000, at a European Commission meeting in Brussels on “HIV/AIDS, Malaria, Tuberculosis and Poverty Reduction,” Hamied raised eyebrows when he declared that he would gladly provide the poor people of the world with AIDS medications at less than one-tenth the price of what big pharmaceutical companies charged; Hamied offered to charge $800 per patient per year, versus the $10,000 per patient per year charged by the big firms. Hamied’s principled stand went on to save many a million lives around the world. But it grazed just the surface of the problem.

According to the 2008 World Health Report published by the World Health Organization (WHO), too many populations in the world have been left behind by mismanaged healthcare systems. The WHO calls for a revisit of the Alma-Ata declaration of 1978, which was a major milestone in the field of public health. The Declaration identified primary health care as the key to the attainment of the goal of “Health for All”: social justice and the right to better health for all, participation, and solidarity. However, 30 years after the “Health for All” initiative, even developed nations like the United States don’t provide consistent, equal-access health care. Today, one in seven people in the United States cannot afford health insurance, according to 2007 data from the Center for Disease Control (CDC).

Differences: Developed vs. Developing Nations

Developed nations grappling with the health care crisis struggle to get all citizens covered by insurance and make insurance premiums affordable across all income groups. In countries like the United Kingdom, which has adopted a model of universal health care, the system simply cannot offer specialized care fast enough. So an entirely new industry called “medical tourism” has mushroomed around the idea of timely, specialized health services, with countries like India and Thailand offering cheaper and safe alternatives to medical care at home.

Developing nations struggle with a host of other issues: They have to address health care concerns stemming from poverty, low standards of hygiene, and lack of education. The WHO states that 10 million lives could be saved each year if access to medicines and medical care were improved in the developed world.

“Third world” nations also have to deal with outbreaks of diseases that were thought to have been eradicated—polio being one such example in remote pockets of Northern India and parts of Africa.

According to the WHO, chronic diseases are the major cause of death and disability worldwide: In India alone, over five million died due to chronic disease in 2005, accounting for over 50 percent of all deaths in the country. In Africa, one million children die from malaria every year, according to the Clinton Foundation. But of all the health wars the world has fought in the last several hundred years, the battle against HIV/AIDS is one of epic proportions.

Echoing Green fellows participate in a Why Do You Do What You Do presentation at Duke University on July 24, 2008.

Echoing Green fellows participate in a Why Do You Do What You Do presentation at Duke University on July 24, 2008.

An Epic Battle: The HIV/AIDS Epidemic

Sub-Saharan Africa is home to over 70 percent of the total world HIV-positive population. HIV/AIDS, a disease that popped up first in 1981, decimated millions around the world during the decade. Almost two decades later, however, the epidemic has grown, and 33 million people across the globe live with HIV today. Increasingly, HIV/AIDS is skewing younger; half of the 5 million people worldwide who are newly infected each year are between the ages of 15 and 24.

In 1996, doctors discovered they could put three different medications together to slow the progress of this disease. The expensive mode of treatment, called antiretroviral therapy, revolutionized the treatment of HIV in North America.

“People were getting up from their deathbeds and having a new lease on life. I’d probably be dead today if any of these drugs weren’t around,” says Greg Gonsalves, an AIDS activist for over 17 years. Gonsalves has played a major role in international efforts to accelerate AIDS research and improve access to lifesaving drugs. “The tragic thing is if I were born in India or in Zambia, would I have access to these drugs today? No.”

Gonsalves says that the drugs prescribed to an AIDS patient—generally a combination of three drugs—can cost anywhere from $10,000 to $15,000 per year in the United States if one pays out of pocket. When patients covered by insurance balk at such exorbitant prices, how can under-privileged patients with no health coverage cope?

This is where Gonsalves believes I-MAK’s humanitarian goals are right on. I-MAK’s team of attorneys and scientists work with governments, researchers, procurers, and suppliers to strengthen patent systems and encourage innovation in new medicines, while challenging the non-meritorious pharmaceutical patents that drive up costs and put affordable medicines out of reach for many people around the world. “The important thing that Priti and Tahir and I-MAK are doing is that they are part of a global movement to ensure that people get access to these drugs. It’s really a life or death situation,” he says.

Cipla’s Hamied believes one way to improve access for the poor is to stop the monopoly in the supply of drugs to all of the developing world. He credits I-MAK’s founders with trying to make a big difference in questioning the fairness behind monopoly, especially when many million lives are at stake.

Dollars, or Lives?

It’s quite simple, really. When I-MAK finds that a high-priced drug could be made accessible by coming into the generic market, it examines the patents that the company has on it.

I-MAK chases frivolous patents filed by big name pharmaceuticals. The classic example of this is a “patent cluster,” which occurs when a company uses a deliberate tactic to ward off legitimate competition by filing more patents on one invention than necessary. “Sometimes big pharmaceutical companies take out one patent after another with an idea of monopoly—what is called ‘evergreening’—through extending a patent’s life,” explains Hamied. The patent system, more often than not, is one way that corporations circumvent the law for unlawful gain by misleading consumers and government authorities.

I-MAK’s founders don’t deny that patents are critical to innovation. True, the patent system was aptly intended to reward the creative and intellectual process and to disseminate inventions to society. “But unfortunately,” Radhakrishnan says, “companies are being rewarded, while the inventions are not reaching the majority of society.”

The term of a pharmaceutical patent—as defined by the United States Patent and Trademark Office—is generally 20 years from the date on which the patent application was filed. When companies game the system to hold on to their monopoly long beyond the 20 years permitted under law, and hold these drugs out of reach of poor patients, I-MAK intervenes.

Patents give companies the legal right to be the only seller of some of their drugs, and patents protect companies against competitors who might produce less costly versions of their drugs. These copies are called “generic” drugs. Countries like Brazil, India, and China are in the business of making generic drugs and supplying them at low cost for domestic use and for poor communities in other countries.

Protection against generics is not permanent. Companies know that when the time limit for a patent ends, a competing company can sell its generic version of the drug. At that point, the more costly drug often loses about half its business within months after the generic drug is first sold. Almost as a buffer against an uncertain future, drug companies charge indiscriminate amounts for a drug while a patent is in effect. Consequently, life-saving drugs—such as antiretroviral drugs to combat AIDS and chemotherapy drugs—are often prohibitively priced.

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Adding an ‘I’ to “Patent”: Putting the Patient First

It’s clear then, why, to continue to plump up profits, companies might find creative loopholes with which to stretch a patent’s life. One of I-MAK’s jobs is to pinpoint holes in questionable patents. Over the last three years, it has found that filing a patent challenge can rattle a company and help bring it to the table. If a patent is rejected, more generic companies can produce a drug at lower cost, and competition drives prices lower still.

In 2006, I-MAK prepared a patent challenge on behalf of the Indian Network of People Living with HIV/AIDS (INP+) and the Positive Women’s Network, both based in Chennai. The drug in question, Nevirapine, had been found to be effective in blocking the mother-to-infant transmission of HIV. Soon after the challenge was filed, Boehringer Ingelheim (BI) permitted generic manufacture of the drug for developing countries.

Following I-MAK’s challenge of BI’s patent, the patent office also rejected the patent in July 2008. “This decision is serving as a groundbreaking precedent for future drug patent cases, as it held that follow-on patents must demonstrate ‘th

erapeutic benefits for patients’ in order to receive patent protection,” Radhakrishnan says.

In another endeavor, I-MAK filed a patent challenge in May 2006 against Gilead Sciences on behalf of INP+ and the Delhi Network of Positive People (DNP+) based in New Delhi, India. The same month, representatives of Gilead Sciences flew to India and offered licenses to Indian generic companies to manufacture and supply the drug to developing countries across the world. I-MAK says countries are now purchasing this drug for less than $200 per patient per year.

Other such patent challenges have resulted in wins. In July 2006, I-MAK prepared a patent challenge on Abacavir (also an HIV drug) on behalf of INP+. In 2007, just a year after the Abacavir challenge, Glaxo SmithKline (GSK) announced the withdrawal of its patent application. Soon GSK also announced a 31 percent price reduction for low-income countries, in anticipation of increased generic competition as a result of the patent withdrawal.

I-MAK’s efforts are not merely driving down the prices of life-saving drugs. “An important consequence of patent withdrawals in India is the effect on related patents around the world,” says Radhakrishnan. I-MAK’s founders are seeing a ripple effect in countries like Thailand and Brazil. “Thailand also issued compulsory licenses on Efivarenz and Lopinavir/Ritonavir in 2007, bringing down the price on Efivarenz from $468 to $216, and on Lopinavir/Ritonavir from $2967 per person per year to $676 per person per year.”

Humanitarian organizations like the Clinton Foundation have found I-MAK’s contribution invaluable as they try to assess how best to solve health issues like malaria and HIV/AIDS around the world. In the words of Dai Ellis, Executive Vice President for Access Programs at the Clinton Foundation, I-MAK is able to provide the Foundation with rich, nuanced analyses in a way that no one has been able to do thus far: “What I-MAK does that almost no one else does is to combine two expertise areas: they have a deep understanding of the country contacts and the country’s patent regime (set of laws and regulations around patents), and they also have, generally, deep knowledge on the content side with intellectual property regimes as they apply to health technologies, particularly drugs.”

Prescriptions for the Future

Hamied prescribes a surefire method to take medicines to the poorest sections of world: adopt what Canada had in effect from 1969 until 1992 when it joined the North American Free Trade Agreement (NAFTA). He says that everyone in the third world should be allowed to copy a drug, provided they pay the inventor a royalty fee.

“What the world requires, then, is a pragmatic, compulsory licensing system very similar to what Canada had,” he says. Compulsory licensing, a mechanism to curb the monopoly power of a patent, forces the patent owner to license the invention to which the patent applies to others, in return for a royalty fixed by the government.

For now, I-MAK has many things on its agenda. It’s confronted with a convoluted Intellectual Property (IP) process divided by geographic boundaries. As Ellis of the Clinton Foundation says, “There’s no such thing as a world patent. Every individual country has its own system. [And] it’s a very complicated system.” I-MAK says that most patent offices don’t have enough time to find all the relevant patents and literature that could potentially nullify a patent outright.

Amin started thinking about a “wish list”—the things that I-MAK and other groups interested in this work would need in order to simplify and streamline the patent challenge process. The result is that I-MAK has also undertaken building a database that will assess the quality of pharmaceutical patents and map innovation in the industry. “Not only would it release information and knowledge that is often not transparent,” Amin says, “it would also mean that our work could travel virtually without us having to be on the ground in all these countries we are involved in.”

I-MAK is hoping that by using this tool, patent examiners will be able to review pharmaceutical patents and reject patents that do not comply with the law. I-MAK’s open source knowledge database will be an objective way for people to glean the finer truths for themselves and also compel them to challenge existing policies.

In Search of the Finer Truth

When you are trying to change the world, you invariably butt heads with people at the helm of governments, industries, and universities. I-MAK is often walking that tightrope. Amin says health ministers sometimes prefer to meet them discreetly to hear their evidence: “This is to avoid any confrontation with commerce department ministers who are usually pro-Intellectual Property.”

On occasion, I-MAK may find itself in a tacit corner with members of the scientific community. “Academic institutions that would like to support our work often cannot because some pharmaceutical companies support their research, and they do not want to be controversial.”

Spearheading a tricky, humanitarian project of Herculean proportions takes tact and smarts. Or as billionaire Hamied puts it, referring to the I-MAK founders: “You have to be bright. You have to be dedicated. You have to be a jack of all trades. And, master of all trades!”

A meeting at a non-governmental organization (NGO) in India first brought Radhakrishnan and Amin together—she a Hindu and he a Muslim—as life partners to drive meaningful change for a cause that transcends caste and creed, religion and race, and border and country. Amin says that an experience sitting with PLHA (People Living with HIV/AIDS) activists from around the globe in a meeting in London—fiercely debating the situation with pharmaceutical company executives about the inaccessibility of medicines—made him realize that his decision to ditch the corporate world, a handsome salary, and partnership opportunities was justified.

Amin, who specialized in Intellectual Property law in the U.K. and is currently a Fellow at the Harvard Medical School in the Department of Global Health and Social Medicine, says his parents could never understand why he went to India and gave up his lucrative career in England. They helped him become educated so he “didn’t have to struggle, like them.” He recalls telling his parents that it was because of that education that he did it at all: “What good is it to be educated when you continue to be ignorant of systemic abuses that cause those whose voices are not represented to die unnecessary deaths?”

In October 2008, Radhakrishnan received the Pop!Tech 2008 Social Innovation Fellowship for her work “as a world-changing innovator.” Pop!Tech Fellows are selected on the basis of their work on a transformative solution to a critical global challenge. Last year, both Radhakrishnan and Amin were also awarded the Echoing Green fellowship in support of “outstanding emerging social entrepreneurs to launch new organizations that deliver bold, high-impact solutions” to effect social change.

What expresses best the passion behind I-MAK is buried in the thoughts expressed by Gonsalves. “It [would be] very easy to turn the law degree that Priti has from [New York University] into a nice gig at a corporate law firm, and [for them to] have a comfortable life somewhere. But both Priti and Tahir decided, ‘You know what? We have skills. We have talent. And we are going to turn it towards the greater public good.’”

 

Kalpana Mohan is a freelance writer in Saratoga, Calif. 
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