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The Malaysian government has approved a government-use compulsory license which would allow the import of generic versions of Gilead’s patented hepatitis C drug, Sovaldi. The decision was made in August but has become public this week. On September 14, the Malaysian cabinet approved for this license. The move will make generic and cheaper versions of the same drug, which has been sold globally at $1000 per pill. The low-cost versions will now be available in Malaysian public hospitals and will benefit around 4,00,000 people in Malaysia. Sofosbuvir, which goes by the brand name Sovaldi, is on the World Health Organization’s list of essential medicines.
In 2015, India’s patent office had rejected Gilead’s application for a patent on the same drug, which meant India would be able to make and sell generic versions domestically and globally. However, in 2016, India’s patent office reversed its own decision. This happened after Gilead appealed to the Delhi high court, which directed India’s patent office to reconsider its refusal of patent. India said it rejected Gilead’s patent application because the drug represented only minor changes to a previous formulation and that minor changes in the molecule did not improve the drug’s efficacy. After Gilead appealed it, the same patent office granted Gilead a patent, saying it had now found its compounds to be novel and inventive. Last month, India also issued a patent for Pfizer’s pneumococcal vaccine. This vaccine had it’s patent revoked by the European Patent Office in 2014.
The hepatitis C virus destroys the liver and is estimated to have infected 150 million people globally, according to the World Health Organization. In Malaysia, hepatitis C affects 2.5% of the population, which is about 5,00,000 people. In India, it has affected an estimated 12 million people.
The Malaysian government’s decision was apparently taken on August 4, 2017, but was made public only this week. Towards the end of August, Gilead reportedly offered Malaysia a voluntary license for this drug along with Thailand, Ukraine and Belarus, but the government appears to have rejected that offer in favour of a compulsory license.
Read more…https://thewire.in/179123/malaysia-allows-generics-gileads-hepatitis-c-drug-india-issued-patent/