NEW YORK TIMES
By Andrew Pollack
The Initiative for Medicines, Access and Knowledge, a legal group in New York, is expected to announce Wednesday that it has filed challenges in Argentina, Brazil, China, Russia and Ukraine. In all those countries except China, the organization is being joined by local patient advocacy groups.
The actions are a sign that the controversy over Sovaldi is spreading beyond the United States, where the $84,000 charge for a course of treatment has strained Medicaid budgets, to middle-income countries.
Sovaldi, when used with another drug, can cure most cases of hepatitis C in 12 weeks with few side effects. That has stoked huge demand for the medicine around the world. Globally about 150 million people have hepatitis C, which gradually destroys the liver.
Gilead is allowing 11 generic drug manufacturers in India to make sofosbuvir, as Sovaldi is known generically, and sell it in 91 developing countries. But those do not include some middle-income countries like Argentina, Brazil, China and Ukraine, or Russia, which is considered a high-income country by World Bank standards.
I-MAK, as the New York organization is known for short, estimates it would cost $270 billion to treat the 40 million people with hepatitis C in those five countries, assuming Gilead charges most of the other countries the $7,500 a treatment it is proposing in Brazil.
“What that means in simple terms is that people who need the drug aren’t getting it or are not going to get it in the near term,” said Priti Radhakrishnan, a founder and director of I-MAK. If there were no patents, the generic versions selling for about $1,000 in India could be sold in those countries as well, she said.
Patent challenges are already underway elsewhere. In January, the patent office in India denied a patent on sofosbuvir, the active ingredient in Sovaldi, after challenges were filed by I-MAK and others. A patent challenge was filed in Europe in February by Doctors of the World, a humanitarian aid group.
I-MAK officials said it would be too expensive for them to try to nullify Gilead’s patents in the United States. But they say they have received inquiries from others, whom they would not identify, who might be interested.
Gregg H. Alton, executive vice president for corporate and medical affairs at Gilead, said the company was “working to facilitate broad patient access to its hepatitis C treatments as quickly as possible in as many places as possible.” He said at least 50,000 people in lower-income countries had already been treated with sofosbuvir.
“We recognize that challenges to our intellectual property are an inevitable consequence of implementing such a worldwide access effort with such breakthrough products,” he said in an emailed statement. Gilead has also faced challenges to its patents on H.I.V. drugs, some from the same groups now trying to block its hepatitis patents.
Mr. Alton said Gilead would soon sign an agreement with the government in Brazil that would allow for a significant increase in the number of patients treated.
Marcela Vieira, a Brazilian lawyer involved in the patent challenge there, said the government was proposing to treat only people whose livers already show signs of damage. If the price were lower than the $7,500 Gilead is proposing, the government might be able to treat less advanced cases, preventing liver damage, she said.
Ms. Vieira, coordinator of a coalition called the Working Group on Intellectual Property for the Brazilian Network for the Integration of Peoples, said that with more than $16 billion in global hepatitis C sales since Sovaldi reached the market in late 2013, Gilead had “already recouped much, much more than was spent” on research and development for the drug.
Patents have not been granted yet in Argentina, Brazil and Ukraine, so in those places the groups will seek to prevent them from being issued. The challengers say that sofosbuvir is not novel compared with compounds disclosed in other patent applications.
“Despite sofosbuvir’s medical benefits, it’s really based on old science,” Ms. Radhakrishnan said.
That may be a hard case to make. Even the deputy patent controller in India, a country in which it is notoriously difficult to patent drugs, wrote in his decision in January that he had “no hesitation to acknowledge the novelty and inventive step” of sofosbuvir.
Nevertheless, he denied that patent under a controversial clause in India’s patent law that requires a patented drug to be more effective in treating patients than an older, similar one. The clause was the reason the Supreme Court of India denied a patent to Novartis for its highly effective leukemia drug, Gleevec.
In the case of sofosbuvir, Gilead had failed to show that sofosbuvir was more effective than a compound disclosed in a patent filing by another company that Gilead says was never even developed as a drug. The case has now been sent back to the patent office to be re-examined.
The activists face other hurdles as well. Sofosbuvir can be protected by many patents, though I-MAK says there are two main ones. Also, sofosbuvir cannot be used alone, and some of the drugs it can be paired with have patents and high prices of their own.
Even if the challenges ultimately fail, however, the activists hope the pressure could move Gilead to make some concessions.
A version of this article appears in print on May 20, 2015, on page B3 of the New York edition with the headline: High Cost of Hepatitis C Drug Prompts a Call to Void Its Patents.