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
Shared publiclyView activity