Gilead's India Patent Roadblock May Spur More Sovaldi Copies

January 15, 2015
By Jessica Wilson, BioSpace.com Breaking News Staff

The Indian Patent Controller has rejected a key patent application for Gilead Sciences Inc. ’s Hepatitis C drug Sovaldi, also known as sofosbuvir, this week. This decision opens the playing field for generic companies not already licensed by Gilead to create their own version of the blockbuster drug.

The Hyderabad, India-based pharmaceutical company Natco is one possible beneficiary of this decision. The company has filed a claim opposing another patent on the formulation of Sovaldi in India, according to Bloomberg.

Several other groups, including the New York-based Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+), also filed patent oppositions against Gilead’s Sovaldi in India in November 2013 and March 2014.

“The move to reject Gilead’s patent application really opens up the playing field, so we hope to now see many other generic companies starting to produce more affordable versions of this drug,” said Director of I-MAK Tahir Amin in a statement. “The bottom line here is that India’s patent law doesn’t give monopolies for old science, for compounds that are already in the public domain."

In order for a patent to be granted, the Indian patent office states that, “a molecule with minor changes, in addition to the novelty, must show significantly enhanced therapeutic efficacy” compared with the reference drug, according to the Wall Street Journal. The decision to reject the application means that Gilead did not sufficiently prove the new compound improved efficacy as compared to the currently approved compound.

The U.S. Food and Drug Administration approved the oral drug in November 2013 and Solvadi currently costs $84,000 for a twelve-week treatment course, which breaks down to $1,000 per pill. This price tag has drawn severe criticism worldwide, especially considering doctors at Liverpool University have calculated that Gilead could produce this drug, “for as little as $101 for the full three month treatment course. That’s roughly $1 per pill,” said Andrew Hill, senior research fellow of the Department of Pharmacology and Therapeutics at Liverpool University. “At the current prices, sofosbuvir is unaffordable for widespread use in most countries of the world,” he pointed out.

“Sofosbuvir has proved to be a billion-dollar blockbuster drug and we hope today’s decision opens the floodgates for more open competition that could rapidly lower the price,” said Manica Balasegaram, executive director of Médecins Sans Frontières (MSF, also known as Doctors Without Borders) Access Campaign. “This drug makes hepatitis C treatment more effective and easier for patients and doctors, so broad access to affordable versions will allow treatment to be scaled up dramatically,” she continued. “This is a good opportunity for generic producers in India to swiftly ramp up production to levels needed to treat the 185 million people infected with hepatitis C worldwide."