- The India Patent Office this week began hearings on the validity of Gilead's patent for Sovaldi (sofosbuvir), which was challenged by U.S. based legal group Initiative for Medicines, Access & Knowledge (I-MAK) in November 2013.
- The group is attempting to have Gilead's patent thrown out, arguing the science behind the drug does not meet India's patent standards. I-MAK partnered with the Delhi Network of Positive People to file a patent opposition over two years ago.
- Similar attempts have been filed by I-MAK in Argentina, Russia, and Brazil.
Sovaldi, which has a list price of roughly $84,000 for a 12-week regimen, has been a lightning rod for criticism. Late last year, the U.S. Senate Finance Committee released a report which heavily criticized Gilead for putting profits before patients by pricing the hepatitis C drug so high. In 2014, Medicaid programs spent $1.3 billion before rebates on Gilead drugs to treat just 2.4% of enrollees with hep C.
For its part, Gilead has contended the list price does not factor into the discounts and rebates which frequently lower the net price. Sovaldi is also highly effective, curing more than 90% percent of patients. Its successor, Harvoni, has even higher levels of efficacy with fewer side effects.
In the case before the India Patent Office, I-MAK contends the base compound for Sovaldi is "old science," and had been disclosed in earlier patents. India patent law requires a new product to demonstrate enhanced therapeutic efficacy in order to merit a patent.
The humanitarian group Doctors Without Borders supports I-MAK's case and is pushing for greater availability of generic Sovaldi.
"Gilead says this drug is priced based on the value it provides, but a cure hardly anybody can afford is worthless," said Isabelle Andrieux-Meyer, an advisor to Doctors Without Borders. "Patents and restrictive licensing agreements should not stand in the way of middle-income countries’ efforts to provide people the treatment they need to stay alive."
Gilead has licensed generic versions of the drug to 11 Indian manufacturers and a generic pill can go for as little as $4.29, according to Bloomberg. The company negotiates lower prices with countries it deems "low-income," a category which includes 101 countries. So far, however, Gilead has either completed or is in the process of completing licensing negotiations with just 16 of those 101 countries.
For Doctors Without Borders, the slow process of licensing generic versions or negotiating lower prices for need countries has left 49 million people without access to the drug.
"Gilead wants the world to think their licensing deals have solved the global problem of access to this medicine, but today countries like Thailand, Malaysia, and Brazil are being asked to pay thousands of dollars for sofosbuvir from Gilead," said Tahir Amin, the co-founder of I-MAK.
Like most for-profit companies, Gilead seeks to avoid losing money on sales of the drug. But that is not always the case. In an interview with Bloomberg, Gilead EVP Gregg Alton highlighted the case of Georgia, where Gilead provides Sovaldi for free in an attempt to eradicate hep C in the country.