Patent Fighters: Taking on Big Pharma

Fran Quigley

It was at a street protest for access to medicines when Priti Krishtel and Tahir Amin realized that they needed to go beyond street protests. Krishtel and Amin were both young lawyers who had walked away from lucrative law firm jobs, Krishtel in Los Angeles and Amin in London, to travel to India, seeking to make a difference in the lives of the sick and the poor. When they met at a demonstration in Bangalore against high prices for HIV/AIDS medicines, they debated about the best way to help the millions of people who cannot afford the medicines to treat them. They decided to take on Big Pharma at the very source of its power, the process where companies obtain patent monopolies of 20 years and longer. “It was time to move from protests in the streets to technocratic fights at the patent office,” explained Krishtel.

Patents keep generic alternatives off the market. Monopoly prices of essential medicines usually stay high as long as the patents last. For example, the groundbreaking hepatitis C treatment, sofosbuvir, is manufactured at a cost of about $1 per pill, but that single pill is sold by its patent-holder Gilead Sciences at prices as high as $1,000. When generic medicines enter the market, medicine prices can drop dramatically.

Krishtel and Amin found their opportunity to challenge this dynamic in 2006, when the Indian government decided to give citizens broad rights to oppose patent applications. Patent laws can vary for each country, but all are built on the expectation that a patent should only be granted after a company demonstrates that a drug is new, inventive, and useful. The patent application and review procedure for medicines has long been the near-exclusive domain of pharmaceutical companies who could arm themselves with attorneys and scientists. But Krishtel and Amin realized that India’s new patent process set the stage for public health advocates to engage with those companies on the battleground they had dominated for decades.

With a loan from some friends, Krishtel and Amin founded the Institute for Medicines, Access, and Knowledge (I-MAK). In the early days, I-MAK’s headquarters was Krishtel’s dinner table in Bangalore. Lawyers and scientists huddled over laptops, scrutinizing the patents on medicines priced outside the reach of the poor. Then the I-MAK team, many of whom had left behind lucrative jobs in the private sector, would hop on planes and head to patent offices, filing detailed objections and making their cases to patent examiners.

Krishtel and her colleagues soon realized the challenge they faced. Billion-dollar decisions are made in anonymous patent offices, usually staffed by under-budgeted bureaucrats reviewing obscure aspects of law and science. The pharmaceutical industry spares no expense in deploying its legendary “floors full of lawyers” to dominate those venues, building monopoly patent protections around their money-makers.

For example, AbbVie has obtained more than 100 patents on its best-selling drug Humira, a treatment for rheumatoid arthritis and other inflammatory diseases. The patent on Humira’s main ingredient expired last year, but no generic manufacturer has yet been willing to introduce a competitor and tackle all the remaining patent barriers.

Many of the most exciting treatments in medicines, including cancer drugs and vaccines, are biologics, derived from a biological source rather than traditional small-molecule drugs. The FDA has approved seven generic versions of biologics, known as biosimilars, which should lead to lower-priced medicines. But four of the seven approved biosimilar are not yet available for sale and may not be for years, due to so-called “patent thickets” created by pharmaceutical industry lawyers. “Basically, there’s a gazillion patents,” an industry consultant told Bloomberg News.

For drug companies, every day their monopoly pricing power survives is a good day. When the corporation Celaphon achieved an extension of its monopoly on the sleep-disorder drug Provigil in 2006, the company CEO did not hide his excitement. “We were able to get six more years of patent protection. That’s $4 billion in sales that no one expected,” he said.

I-MAK versus Big Pharma is David versus Goliath. But David sometimes wins in this story too. After eight years of a struggle that went all the way to the Supreme Court of India, Krishtel, Amin, and their fellow advocates prevailed in the effort to block the Novartis application for a patent on the leukemia drug Gleevec, which the company aimed to price at $2,000 a month in a country where most people live on less than $2 a day. I-MAK also won an Indian patent challenge against Abbott Laboratories for the HIV drug Kaletra. I-MAK has participated in patent contests in 47 countries.

“There are many ways the patent system is gamed to the detriment of public health, but patent reviews are such highly technical and arcane processes that individual patients and physicians don’t have the skills to engage at that level,” explained Dr. Aaron Kesselheim, an associate professor at Harvard Medical School who studies the impact of intellectual property rules on access to medicines. “So we desperately need organizations like I-MAK to get involved there. Their work has already helped significantly improve access to lower-cost medicines in multiple countries.”

I-MAK’s current docket is filled with challenges to patents for the hepatitis C drug sofosbuvir. The World Health Organization estimates that over 70 million people worldwide are chronically infected with the hepatitis C virus. Hepatitis C complications, including liver cancer, kill hundreds of thousands of people each year. The good news is that sofosbuvir is a remarkably effective treatment for the virus, curing over 95% of those who receive the medicine. The bad news is that sofosbuvir patent-holder Gilead Sciences sets the price as high as $84,000 for a 12-week course, compared to an estimated generic cost of $250.

The company has reached agreements with some generic manufacturers to sell lower-cost versions in poor countries, but middle and high-income countries are not included in the deal. That means that the vast majority of persons infected with hepatitis C, including most of those in the United States, are blocked from access to the drug that would cure them.

The moral argument against this state of affairs is clear enough. The legal argument poses more of a challenge. I-MAK steps has contested Gilead’s patents in multiple countries, including India, Brazil, and Russia. There are two main patents protecting sofosbuvir, and I-MAK contends that neither deserves monopoly protection. “The science surrounding the drug was already in the public domain,” argued Krishtel. “Gilead is trying to claim public knowledge as its own.”

Gilead strongly disagrees with that assertion. But Rohit Malpani of the Doctors Without Borders Access Campaign says that I-MAK has effectively used arguments like these to create an entirely new front in the battle for access to medicines. “The idea of challenging patents at their origins or fighting against patent extensions has gone from being a small corner of the advocacy in this field to a mainstay, and that is because I-MAK has led the way,” said Malpani.

Krishtel and Amin insist that I-MAK’s challenges are not anti-patent. Instead, they say, its advocacy upholds the pro-innovation spirit that should be the foundation of patent law and policy, but is too often exploited for the sake of maximum profit. “When the patent system allows over-patenting and extensions of old patents, it just means that companies are investing more on lawyers and marketing and less on research for something new, and that hurts patients.”

They believe that the best chance to permanently reverse this trend is by supplementing I-MAK’s handful of lawyers and scientists on staff with what they call an “army of patent detectives.” I-MAK is partnering with advocates to file challenges to unjustified patents in their home countries. It worked alongside HIV-positive Argentinian lawyer Lorena Di Giano when she filed challenges to patents for HIV and hepatitis medicines in her home country. These challenges led to Argentina’s health ministry importing generic versions of the drugs and Gilead withdrawing some of its patent applications.

I-MAK has its sights set on two potentially enormous global health wins. In October 2017, it filed a challenge to Gilead’s patent rights to sofosbuvir in the United States where as many as 85% of hepatitis C patients cannot access the drug due to its price. It has already successfully challenged one of Gilead’s patent applications for sofosbuvir in China, becoming the first organization to win a patent contest there. Now, it is trying to overturn the Chinese patent on the drug’s base compound. China is the world’s leading manufacturer of active pharmaceutical ingredients, so overturning the sofosbuvir patent there could lead to millions of hepatitis C patients getting access to the medicine.

There is no guarantee either of these big challenges will succeed, but Krishtel and Amin have no regrets about leaving their well-paying law firm jobs to wage these fights. “This is an exciting time, because I feel like we are part of a growing movement around access to medicines,” says Krishtel. “More and more people are waking up to the impact that unwarranted patents have, and are determined to make sure that everyone receives the treatment they deserve.”

Fran Quigley is a clinical professor and director of the Health and Human Rights Clinic at Indiana University McKinney School of Law and is coordinator of People of Faith for Access to Medicines.