A legal challenge against Gilead Sciences’ (Nasdaq: GILD) patent application for the combination of sofosbuvir and velpatasvir has been launched by Médecins Sans Frontières (MSF).
The therapy, which was approved last year in the USA and in Europe, is marketed as Epclusa.
The company has faced numerous similar patent challenges this year, including multiple aggressive actions from USA-based non-profit Initiative for Medicines, Access & Knowledge (I-MAK) and, in Europe, from MSF.
The latest challenge from the Geneva-based aid group has been launched in China and seeks to show that the drug combination does not merit patenting under China’s Patents Law.
MSF said that: “If granted, the unjustified patent on the combination of these two medicines would give Gilead the monopoly over production and sales of the treatment in China.”
“It would block Chinese generic companies from producing affordable versions, for use in China and globally.”
Epclusa is the first direct-acting antiviral (DAA) treatment to be registered for use against all genotypes of the disease.
Gilead recently launched sofosbuvir at a price of $8,937 per treatment course, or around $100 per pill, and MSF estimates that the combination could be priced at around $12,000 for the 12-week treatment.
Generic competition has driven the price of the combination to around $120 per 12-week treatment in countries where patents have expired.