Bayer cancer drug faces new patent problems in India

Nexavar (sorafenib tosylate), a crucial drug for kidney and liver cancer for which German pharma major Bayer (BAYN: DE) was granted a patent on March 3, 2008, has come under fire in India, whereby a landmark court ruling is set to define the contours of Bolar exception provisions in the Indian Patents Act, reports The Pharma Letter’s India correspondent.

The Delhi High Court recently held that local generic drugmaker Natco Pharma (BSE: 524816) could export the generic version of Nexavar for experimental purposes to a Chinese company. Nexavar is the first and only drug which has received a compulsory licence from the Indian Patent Office.

In a double whammy for Bayer, another Indian company, Alembic Pharmaceuticals, has also been allowed to export select active pharmaceutical ingredients (APIs) of Xarelto (rivaroxaban), a blood thinner and a heparin based drug, to Brazil and the Middle East, for R&D purposes.