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 […]

Patent Rights and Their Impact on Pharmaceutical Markets

Introduction The recent decision of the National Company Law Appellate Tribunal (NCLAT) in “Swapan Dey v Competition Commission of India & Anr.[1]” brings back the focus on the interplay between patent rights, competition law, and public health in the pharmaceutical sector. While the case has largely been viewed as a jurisdictional determination concerning the respective […]

Regulatory And Legislative Realm Of Generic Drugs In India And Abroad

The importance of Intellectual Property Rights in the 21st century cannot be more emphasised.  The concept of asset fencing, to secure the Intellectual Property is echoing every corner of the world. Pharmaceutical industry is no exception to it, and hence there is a whispered use of IPR in this area, with wide range of controversial […]