Patents for Gilead's hepatitis C therapy Sovaldi challenged in five countries

The Initiative for Medicines, Access & Knowledge (I-MAK) and its partners have challenged patents held by Gilead Sciences for the hepatitis C drug Sovaldi (sofosbuvir) in Argentina, Brazil, China, Russia and Ukraine, I-MAK reported Wednesday. The advocacy group stated that despite its efficacy, the active ingredient in Sovaldi was developed using existing knowledge and a previously existing compound. I-MAK co-founder Priti Radhakrishnan remarked "by freeing [Sovaldi] from unjustified patents, we can fight this deadly disease and get more people the medicine they need to live healthy, productive lives.

I-MAK asserted that Gilead's price of Sovaldi of as much as $1000 per tablet in the US and "similarly exorbitant pricing in developing countries" has made the drug unaffordable for most patients. The advocacy group also said that acccording to an analysis by Médecins Sans Frontières, Gilead plans to offer Sovaldi for between $2000 and $15 000 for a 12-week course of treatment in countries such as Brazil, Argentina and China.

Last year, Gilead entered into licencing agreement permitting a number of drugmakers to market generic versions of Sovaldi in 91 developing countries. However, I-MAK noted that the agreement does not apply to middle-income nations such as Argentina, Brazil, China, Ukraine or Russia.

Jennifer Cohn, Access Campaign medical director at Médecins Sans Frontières, commented "it's deeply unsettling to see that the high price of hepatitis C treatment has led to treatment rationing," adding "with millions of people in developing countries in need of treatment, there needs to be a concerted global effort to ensure effective medicines are available to as many people as possible, as soon as possible."

Meanwhile, Gregg H. Alton, executive vice president for corporate and medical affairs at Gilead, explained that the drugmaker was "working to facilitate broad patient access to its hepatitis C treatments as quickly as possible in as many places as possible," continuing "we recognise that challenges to our intellectual property are an inevitable consequence of implementing such a worldwide access effort with such breakthrough products."

In January, India's patent controller refused to award a patent to Gilead for Sovaldi following challenges by I-MAK as well as Natco Pharma. Gilead has pledged to appeal the decision.

Last year, lawmakers in the US have criticised Gilead for the prices of its hepatitis C treatments, with the drugmaker recently acknowledging that discounts for Sovaldi, as well as Harvoni (ledipasvir/sofosbuvir), will be larger than expected in the US in 2015. Earlier this month, the World Health Organization called on drugmakers including Gilead to reduce the prices of new hepatitis C treatments after adding a number of these treatments to its list of essential medicines.

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