I-MAK Challenges Validity of Remaining Hepatitis C Drug Patent
NEW YORK – In a move that could strike down barriers to treatment for the exploding hepatitis C epidemic that kills 700,000 people every year, attorneys and scientists from the Initiative for Medicines, Access & Knowledge (I-MAK) filed a legal challenge against Gilead’s (NASDAQ:GILD) remaining patent for the hepatitis C medicine sofosbuvir in China. Branded as Sovaldi®, this patent covers the sofosbuvir base compound and is founded on previously published techniques, and does not meet the legal criteria for a patent. This new filing follows another legal challenge filed by I-MAK in 2015, which helped result in a rejection in June 2015 by China’s State Intellectual Property Office (SIPO) on the other critical patent application on sofosbuvir. SIPO found that this patent, covering the prodrug that activates the otherwise inactive base compound in the body, did not deserve a patent under the law.
The hepatitis C virus, which the World Health Organization has called a “viral time bomb,” affects about 80 million people globally. When left untreated, the virus can lead to liver disease or liver cancer. The World Health Organization has added hepatitis C treatments, including sofosbuvir, to its list of essential medicines and called for lower prices to help ensure every person who needs the medicine can get it.
While the rejection on the prodrug patent application in 2015 in China significantly weakens Gilead’s reliance on unjustified patents, removing the unmerited base compound patent will open the market to lower-cost generic versions that could help as many as 8.9 million people in China receive the treatment they need to survive and lead healthy lives.
“When presented with the facts, patent offices around the globe are increasingly recognizing that patents must be reserved for drugs that are proven to be novel, non-obvious and useful,” said Tahir Amin, I-MAK co-founder and director of intellectual property. “We hope that the Chinese patent office does the right thing and ends Gilead’s manipulation of the law, so that millions of people can have affordable access to the medicine they need.”
I-MAK’s legal challenges could have a far-reaching impact on the market for affordable medicines in China and around the world. In China, freeing sofosbuvir of its unmerited patents would open the door to affordable generic treatment, saving government health programs and consumers billions of dollars. Affordable treatment for just four million people – or just 46% of those living with hepatitis C in the country – would save at least $26.8 billion USD. If every person in China with hepatitis C was treated, the total potential savings of using generic sofosbuvir is at minimum US$59.0 billion, over half of China’s annual spending on prescription drugs.
“The lives of 80 million people around the globe are affected by a public health crisis that will not be solved until companies like Gilead can no longer claim existing public knowledge as their own,” said Priti Radha Krishtel, I-MAK co-founder and director of treatment access. “Gilead’s pursuit of illegitimate patents only serves to increase its record-breaking profits, at the expense of patient health and access to needed hepatitis C drugs.”
China serves an essential role in the global pharmaceutical drug supply chain, manufacturing more than 800,000 tons of pharmaceutical ingredients each year – more than any other country. More than 70% of all active drug materials consumed in the U.S. and Europe are imported from China and India. China provides roughly 43% of the raw materials used to produce anti-infective medicine for the world, according to the World Bank’s Human Development Network. Removing all unjustified patents for sofosbuvir in China will help open the supply of raw materials to manufacturers around the country and get the drug to millions of people with hepatitis C worldwide who currently cannot get the medicine they need to get well.
To date, I-MAK has worked with partner organizations to remove patent barriers against sofosbuvir in 46 countries, including Argentina, Brazil, China, Egypt, India, Russia, Thailand, and Ukraine, and in Europe (covering 38 countries). On the heels of China’s prodrug rejection, Ukraine’s patent office followed suit and rejected a patent application for sofosbuvir by Gilead; other countries such as Egypt have also rejected key patents on sofosbuvir.
The current lowest market price for a 12-week regimen of generic sofosbuvir produced by leading generic suppliers in India is around $250, and a University of Liverpool study found that generic manufacturers could produce a 12-week treatment course for as little as $62. However, in middle income countries like Brazil, the current price of sofosbuvir is $6900 per course. If the price of sofosbuvir in middle-income countries like China is ultimately comparable to Brazil’s, it will put the drug out of reach for most people.
In the United States, where Gilead was demanding a launch price out of reach for most people – up to $1,000 per pill– the pharmaceutical giant faces growing outrage and scrutiny, including state governments calling for greater transparency into the company’s high drug prices. Since the launch of sofosbuvir, U.S. Senators Ron Wyden (D-Ore.) and Charles Grassley (R-Iowa) led an investigation on Gilead’s pricing decisions, and an investigative report was released by Americans for Tax Fairness, which found that Gilead has avoided paying $10 billion in U.S. taxes on profits from hepatitis C medicines.
Since 2006, I-MAK has been working to increase access to medicines around the world. I-MAK’s legal work and research spans 49 countries, eight diseases and 20 therapies. I-MAK’s wins on high-impact cases on HIV drugs has saved health programs worldwide over $1 billion. In order to stay independent and exclusively represent the interests of patients and consumers, I-MAK does not accept funding from branded or generic pharmaceutical companies. Click here for more on I-MAK’s impact around the world.