Sign Of The Times: Merck Ought To Take Heed -- Low Cost Producer Licensing In India

With the extremely high burden of Hep C as a disease in India, it seemed only a matter of time before -- either through the mechanism of the DOHA Declaration (in international proceedings), the Indian patent courts, the Ministries of Health in country or otherwise, a life saving drug like Sovaldi^® would be made more affordably in India. It will now appear in low cost authorized generic form, in over 90 countries around the globe. It is already there, in Egypt (March 2014). [This development will dampen only marginally the patent fights' income potential, however. That vast trove of money is generated in the post industrial Western world primarily.]

This has as much to do with the high price of it -- as it does to do with the fact that it is effectively a cure for Hep C. And more people in India suffer from Hep C than in any single country on the planet. Even so, the price is unlikely to fall to the under $90 per regiment price that WHO experts estimate would put it in the hands of most of the world's poorest Hep C patients. From the Irish Times then:

. . . .Gilead Sciences will allow seven large Indian generic drug producers to make and sell its blockbuster hepatitis C drug Sovaldi in more than 90 developing countries, in a move it says will ensure affordable access to the potentially life-saving treatment.

The deal with companies including Cipla and Ranbaxy Laboratories follows months of fierce debate over the price of Sovaldi, which has been hailed as the biggest breakthrough in treatment for hepatitis C since the virus was discovered in 1989. . . .

The object lesson here is glaringly obvious: Merck should be prepared for similar pressures in India, as Keytruda^® becomes available for more strains of cancers. India's cancer burden is unimaginably vast. So, India ministers will feel strong pressure to license, even on a compulsory basis, a bio-similar at some point. Stay tuned. The same applies to BMS -- and nivolumab. Just my $0.02. [Should be yours, too -- heh.]