- Diseases, Disorders & Conditions
New hepatitis C treatment costs only $1000
India rejects sofosbuvir patent
On January 13, 2015, Indian Patent Office rejected Gilead's application for sofosbuvir patent, explaining that this compound is not innovative enough to qualify for the patent. Gilead tried reversing this decision and began putting pressure on India, including the Indian Department of Industrial Policy, a governmental body that overlooks the Patent's Office. Regardless of the decision on the patent, affordable sofosbuvir will still be available in India and in the countries of the third world, claims Gilead, making it their main argument.
Same drug, but at 1/100 of its price
License agreements in India
At $84,000 for 12 weeks of treatment, sofosbuvir remains the drug that the majority of the developed world simply can’t afford. Gilead, the company that owns sofosbuvir patent in the US, has been openly criticized for its outrageous pricing strategy. In India, however, their approach is very different. In September 2014, Big Pharma signed voluntarily licensing agreements with seven Indian generic drug manufacturers (Zydus Cadila, Cipla, Hetero Labs, Mylan Laboratories, Ranbaxy, Sequent Scientific and Strides Arcolab). These goal of these agreements, according to Gilead, is to broaden access to innovative hepatitis C drugs, sofosbuvir (known in the US under the trademark Sovaldi™) and ledipasvir (which later became one of the active components of Harvoni™), by enabling the production of their generic versions.
Generic sofosbuvir, is it worse than Sovaldi?
People Before Profit or just a marketing strategy?
A number of HCV advocates and experts openly criticize this license agreement, asking if it is actually aimed at democratizing access to the drug, or it is just a trick to avoid open generic competition. The latter, they claim, could have disturbed the market and lower down the prices of new hepatitis C treatment even more than today’s generics do.
What do you think?
Why did Gilead allow Indian companies to produce the generics?
What the experts say...
“…Gilead’s licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 % of people with hepatitis C live today.” Médecins Sans Frontières
“… sofosbuvir is not yet registered or available in South Africa, and existing patent barriers could hinder the country from looking for multiple generic sources of the drug in order to get the most affordable prices” Médecins Sans Frontières
India has made it to the list of the countries that “present the most significant concerns regarding insufficient [intellectual property rights] protection or enforcement”, according to United States Trade Representative.
86 000 000
1 200 000 000
People with hepatitis C
12 000 000
12 000 000
Hepatitis C-affected population, %
Generics in India means it's over somewhere else
Experts say that the this voluntary license agreement will restrict the export of raw materials used for generics production. Only Gilead-approved producers will be able to benefit from raw compounds produced in India. So, in the countries where the patent wasn't accepted, but there's no license agreement either (such as Egypt or China, for example), the generic manufacturers will run out of supplies and will have to stop producing cheap sofosbuvir generics - or increase the price.
People before Profit
Affordable hepatitis C treatment is not for everyone
Generic treatment for hepatitis C produced in India is a highly effective, quality drug, but
- it cannot be sold in the developed world,
- it is too expensive for the majority of the developing countries,
- it is restricting other the countries that did not accept the patent from producing their own generics.
Would you benefit from Indian generics if you had a chance?
If you or somebody in your family was affected by hepatitis C, do you think you would have been able to benefit from this generic treatment in India?
Let's forget for a moment that India is a difficult country for an inexperienced tourist, that you need a prescription from the local doctor - and soon, with the new rules in place, you would have to be a resident, too, in order to buy the drug.
Let's say, you still have a chance to personally travel to India and buy the generics. Would you do it?