The Skinny Label Crisis in Pharma Licensing: Innovation vs. Affordability

The Skinny Label Crisis in Pharma Licensing: Innovation vs. Affordability The “skinny label” strategy has emerged as a contentious battleground in pharmaceutical patent law, allowing generic manufacturers to launch products early by carving out patented uses from their FDA-approved labels under Section VIII of the Hatch-Waxman Act. This regulatory carve-out enables market entry for unpatented […]

The Effect of the New Patent Amendment on Pharmaceutical Companies

INTRODUCTION Whether the Indian pharmaceutical firms are indeed innovating in developing new drugs or just incrementally improving the existing drugs to gain patents and arrive on the drug market. Indian Pharmaceutical Industry: regained focus on research and development, having turned out as the fourth largest in the world in volume terms (8% of global production) […]

Roche’s Struggle Over its Patents in India – Two suits, Two oppositions

The struggle between innovator pharmaceutical companies (mostly in the Western world) and developing world Generic companies have been lately played out in India and especially for the last 2-3 years in the form of litigations and oppositions. Here I would be discussing the specific case of Roche (a Swiss Pharma Company) showcasing its journey of […]