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India grants first Compulsory licence of a patended drug under TRIPS
Indian patient office granted its first compulsory license for Sorafenib owned by Bayer. Bayer sells the drug in India for a price of aprox USD 70,000 a year which beyond the means of most Indians rich and poor. The generic version will be available for USD 2200 per year which will still be a big sum for most Indians but affordable to middle class. Most Indians do not have health insurance and pay as and when required. Under the terms of the license, the licensee NATCO Pharma will have to supply the drug free to 600 patients and pay 6% of the topline revenue as license fee to Bayer.
Companies like Bayer have been making a mockery of sales by pricing their products totally out of reach the population showing callous disregard for Indian people.
While India has a very healthy domestic generic pharmaceutical industry with chemistry skills for reverse engineering patented drugs, this is the first time a compulsory license has been granted. To receive such a license, applying companies have to prove three terms
i) The drug is essential and required
ii) The can manufacture it at significantly competitive rates
iii) The patent holder has outpriced their product out of the market
All of these have been easily fulfilled and the question that begs answering is why Bayer has been selling it for such obscene prices inviting compulsory license.
This judgement can set a precedent and many more companies are expected to apply for more products
+Regulatory Affairs Professionals Society +Regulatory Affairs
Indian Rheumatology Association's profile photoLupus's profile photoCochrane Collaboration's profile photoJeffrey J Davis's profile photo
+Doctors Without Borders/Médecins Sans Frontières “When drug companies are price gouging and limiting availability, there is a consequence: the Patent Office can and will end monopoly powers to ensure access to important medicines. If this precedent is applied to other drugs and expanded to include exports, it would have a direct impact on affordability of medicines used by MSF and give a real boost to accessing the drugs that are critically needed in countries where we work,”

Comment by Medecens sans Frontiers
+New York Times says this
"Monday’s decision is likely to have little immediate financial impact on Bayer and Onyx, because so little Nexavar is being sold in India"
"Monday’s decision is likely to have little immediate financial impact on Bayer and Onyx, because so little Nexavar is being sold in India"
Are they dreaming? Not even 0.1% of Indians can even dream of the drug at Bayers prices
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