China, the world’s second largest drug market, has rejected Gilead Sciences Inc.’s (Gilead; CA, USA) patent application for an inactive ‘prodrug’ form of their blockbuster hepatitis C therapy sofosbuvir (SOVALDI®). Gilead holds the Chinese patent for the base compound, and as such the verdict does not allow for copycat drugs to be produced in China, but it may lead to other countries considering rejection of patents related to sofosbuvir.
The World Health Organization (Geneva, Switzerland) has said that up to 150 million people worldwide are living with chronic hepatitis C infection, many in low- and middle-income countries. It has recently added Gilead’s blockbuster drug sofosbuvir to its essential medicines list, a treatment option that has been controversial due to its cost.
The cost of the top-selling drug has been set at $1000 per pill and $84,000 for a typical 12-week course in the USA, with Gilead’s combination therapy of sofobuvir and ledipasvir (HARVONI®) selling for $94,500 for a 12-week treatment course. These treatment options can offer a 95% cure rate and significantly fewer side effects than older drugs.
Gilead’s patents have been challenged in the USA, India and Europe. In January 2015 India’s patent office rejected Gilead’s patent application for sofosbuvir, on the basis that it was not sufficiently inventive, a ruling that is currently being appealed by the company.
After international pressure, Gilead last year agreed to make the drug available for a lower price in 91 developing countries, by signing an agreement in September 2014 with seven Indian pharmaceutical manufacturers who are permitted to sell generic versions of sofobuvir and ledipasvir. The intention was that by splitting the generic market between Indian manufacturers, market competition would put downward pressure on price.
However, Gilead has faced legal challenges from the Initiative for Medicines, Access & Knowledge (DE, USA) against patents held in five countries not covered by the agreement: China, Argentina, Brazil, Ukraine and Russia. Decisions in these cases are pending and we eagerly await new precedent-setting verdicts.