China Patent Challenge Compels Gilead to Withdraw Key Patent Claims on Sofosbuvir Base Compound, Opening Life-Saving Hepatitis C Treatment Access for Millions

Press Release 9 Aug 2018

I-MAK’s successful patent challenge against Gilead cracks open world’s largest untapped market, with potential to save billions in treating epidemic

China joins growing list of countries to partially or fully remove Gilead’s unmerited sofosbuvir patents for company’s failure to meet legal requirements

New York—In a groundbreaking case that will unlock the market for entry of affordable generic hepatitis C medications, a patent challenge brought byI-MAK (Initiative for Medicines, Access & Knowledge) before China’s State Intellectual Property Office (SIPO) resulted on Wednesday in drugmaker Gilead withdrawing its key patent claims on the base compound for sofosbuvir, the core component of its hepatitis C drugsSovaldi®, Harvoni®, and Epclusa®.

The removal of key claims from Gilead’s main patent for sofosbuvir—which until now blocked production of affordable generic versions in China—has far-reaching implications. In a country with the largest number of people in the world living with chronic hepatitis C—10 million, almost none of whom are receiving treatment—the rulingopens the door to affordable generic treatment as early as 2019. I-MAK estimates that treating just 15 percent of China’s hepatitis C patients with generic drugs would save $13 billion USD, and a massive $87 billion USD if all patients are treated.

“Confronted with fact-based evidence, Gilead’s decision to withdraw its key claims on the base compound for sofosbuvir demonstrates that its patent was weak and unmerited, and that they themselves did not feel the patent would be upheld,” saidTahir Amin, co-founder and co-executive director at I-MAK.“This defeat for Gilead comes in one of the largest untapped markets in the world and will dramatically increase access to lifesaving treatments for millions of people in need. A growing list of countries have found Gilead’s patents onsofosbuvir wanting and insufficient.”

This outcome is the latest in a slew of victories over the last four years for patient advocacy groups, as countries rejecting Gilead’s sofosbuvir patents now include Egypt, Ukraine, Argentina, Brazil, Russia (partial invalidation) and 38 European countries (partial invalidation). It follows a June 2015 decision by SIPO, supported by evidence from I-MAK, which rejected Gilead’s prodrug patent on sofosbuvir because it did not meet the lawful criteria in China to claim a patent. The latest result comes in a jurisdiction where a similar challenge from Idenix on the base patent was unsuccessful.

“The removal of these key claims on the sofosbuvir base patent is a breakthrough step toward ensuring Gilead can no longer hold the market and more importantly, patients, hostage,” said Priti Krishtel, co-founder and co-executive director at I-MAK. “There is growing global momentum to continue to challenge unmerited patents to ensure more people can access life-saving treatments.This outcome affirms the potential ofmeaningful public participation in the patent system.”

The hepatitis C virus, which the World Health Organization has called a “viral time bomb,” affects about 71 million people globally, over 66 million of whom are not being treated. Gilead’s Sovaldi® (sofosbuvir 400mg) was priced at $8,939 for a standard twelve-week treatment regimen upon launch in China in November 2017. By comparison, generic alternatives are available for $249 or significantly less, reflecting the potential for a 98 percent price reduction enabled by this decision.

Gilead’s base compound patent on sofosbuvir was granted in China in 2009 and is set to expire in 2024. I-MAK’s successful patent challenge opens up the market for competition as early as next year.

Four out of 16 of Gilead’s claims remain in the patent, covering the metabolites of the sofosbuvir compound. However, these remaining claims should not prevent competitors producing generic versions of sofosbuvir and entering the market, as Chinese Patent Law does not recognize metabolites that are naturally occurring in the human body as a basis for infringement.

China serves an essential role in the global pharmaceutical drug supply chain, manufacturing more than 800,000 tons of active pharmaceutical ingredients (APIs) each year – more than any other country. More than 70 percent of all active drug materials consumed in the U.S. and Europe are imported from China or India, while China provides roughly 43 percent of the raw materials used to produce anti-infective medicine for the world, according to the World Bank’s Human Development Network.

ABOUT I-MAK

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.

Join us to stay updated
and help make lifesaving medicines accessible to all