Editor’s Note: Priti Radhakrishnan is co-founder and director of the Initiative for Medicines, Access & Knowledge (I-MAK), which is a U.S.-based nonprofit group of scientists and lawyers working globally to get people lifesaving medicine. Prior to founding I-MAK, Radhakrishnan worked as a health attorney in the U.S., Switzerland and India. The opinions expressed in this commentary are hers.
Priti Radhakrishnan: Prescription drug prices are soaring; for example, a $1,000-per-pill hepatitis C drug
She argues that opposing drug company patent applications is one route to lower prices
Prescription drug prices are soaring, as exemplified by pharmaceutical giant Gilead’s $1,000-per-pill hepatitis C drug, Sovaldi. High prices for drugs that treat deadly diseases are creating barriers for patients, burdening governments and leading to rationing and denial of lifesaving treatments around the world.
One possible route to ensuring people get the care they need is passing new laws. Indeed, in response to the growing backlash against skyrocketing drug prices, U.S. states have introduced bills that would require price transparency from pharmaceutical companies. But while these efforts are welcome, their success is not assured, and they address only part of the problem.
Fortunately, there is another path that history shows is effective at reining in the pharmaceutical industry’s excesses. And globally, there is a growing movement to remove artificial barriers to health that drug companies create when they seek illegitimate patents.
Patents are rights that governments confer to products proven to be novel, nonobvious and useful. But too often, pharmaceutical companies increase profits through exclusive claims on science that is already in the public domain. Lawyers, scientists and health advocates are pushing to end drug companies’ abuse of patents and remove obstacles to vital hepatitis C treatment.
Today’s struggle for hepatitis C treatment is the continuation of a global movement that began over a decade ago in the successful effort to remove patent barriers to HIV/AIDS medicines in India.
When India amended patent law in 2005 to comply with the World Trade Organization, it opened the door for pharmaceutical companies to make exclusive claims for drugs. At the time, the country’s HIV/AIDS epidemic was exploding, second only to South Africa’s. Almost overnight, pharmaceutical companies swept in to apply for thousands of drug patents, and medicines suddenly cost ten times as much.
India decided to address the root problem of companies seeking illegitimate patents: It created strict patent standards and a citizen review process under which the public could challenge a patent’s claim to being “novel, nonobvious and useful,” as the law required.
After patent attorneys and patient advocates filed patent challenges, the Indian patent office dismissed many patent applications for failing to meet the “nonobvious” requirement; some companies also withdrew applications and dropped their prices. By taking the legal requirements seriously, the law prohibited patents that only sought to extend the duration of a company’s market hold, a strategy known in the industry as “life-cycle management.” Over the next five years, as a result, the continued availability of generic drugs saved governments half a billion dollars globally and medicines reached 13 million people living with HIV/AIDS worldwide.
Today’s hepatitis C epidemic affects 150 million people around the world, killing 700,000 people annually, according to the World Health Organization. And once again, drug companies are claiming patents for routine science and existing compounds, standing in the way of affordable treatments.
Here in the U.S., Gilead has set a price tag of up to $84,000 per course of treatment with its patented drug, Sovaldi, also known as sofosbuvir. Prices are expected to be out of reach for developing countries as well, particularly in middle-income countries like Brazil and Argentina, where 73% of all people with hepatitis C live.
But here’s the catch: Despite Gilead’s claims, sofosbuvir isn’t new. It was developed using previously published information and an existing compound. A drug based on old science doesn’t meet the legal requirements for a patent.
In India, our organization partnered with an HIV advocacy group called the Delhi Network of Positive People to file challenges to Gilead’s patent application for Sovaldi, where the patents for sofosbuvir are still pending. The Indian patent office ruled last July that the main compound in sofosbuvir was a “molecule with minor changes” and had the “same use in the treatment of HCV infection and flavivirus infection,” compared with an earlier compound. Following the challenges in India, Egypt rejected the sofosbuvir patent.
If low-cost generics were available, it is estimated they could cost as little as $101 for a three-month course.
And just last month, we announced additional Sovaldi patent challenges with partners in Brazil, China, Argentina, Ukraine and Russia. If these combined efforts succeed, these health programs could save $270 billion. We based our analysis on the difference in cost between the price Gilead is expected to charge these five governments, and an estimated generic price for these same countries.
To be sure, true innovation must be rewarded. And there is no question that legitimate patents can be awarded to drugs if they meet the law’s requirements. But when a drug company claims a patent without justification, price gouging often follows and the public suffers. If an essential medicine isn’t reaching the people who need it, the social contract of a patent is clearly broken.
People who need sofosbuvir are dying preventable deaths. The global movement of patient advocates, attorneys, doctors and scientists is growing to stop pharmaceutical companies from padding profits by claiming existing, public knowledge as their own.