1. Scrip
  2. >>Focus On Asia
  3. >>India

Data Exclusivity Demand In EFTA-India Deal: Access, Licensing, Other Implications

 
• By Vibha Ravi

The contentious issue of data exclusivity came to the fore during the European Free Trade Association's negotiations with India for a Free Trade Agreement. What are the arguments in support and against, including impact on compulsory and voluntary licensing?

Intellectual Property Rights A Representative Image
Intellectual Property, Including Data, Has Been At The Heart of EFTA-India Trade Negotiations • Source: Shutterstock

The contentious issue of data exclusivity has came to the fore once again after recent speculation that India could succumb to a demand made by the European Free Trade Association (EFTA), comprising Switzerland, Norway, Iceland and Liechtenstein, to accept data exclusivity norms in a Free Trade Agreement (FTA) under negotiation.

Given that only the owner or generator of non-clinical and clinical trial data can use such data to seek marketing authorization while other applicants are barred from relying on these...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from India

Loss Of Exclusivity Product Launches To Fuel Aurobindo’s FY26 Europe Growth

 
• By Vibha Ravi

Aurobindo is banking on launches of loss of exclusivity products and biosimilars to fuel sales in Europe as it awaits a US announcement on tariffs and predicts high single-digit growth overall during FY26 for now

Sun On Leqselvi US Launch Ahead, MFN Pricing And Pipeline Changes

 
• By Anju Ghangurde

Sun readies US debut of Leqselvi for alopecia areata, while PD-L1 inhibitor Unloxcyt is in the line up once the Checkpoint Therapeutics deal is completed. Management also discusses limited clarity on President Trump’s most favored nation pricing push, pipeline tweaks and M&A outlook.

Pharma Women’s Workforce In India: Weak Start, Promotions, C-Suite Drop Off

 
• By Anju Ghangurde

McKinsey senior partner Vivek Pandit talks to Scrip about some of the intricacies underlying the key findings of a study on pharma’s workforce gender gap in India. Women’s representation starts low at entry level, peaks at senior manager positions and falls off again for C-suite roles, this found.

Zydus To Continue Mirabegron Sales, Looks To World-First Dual Shigella-Typhoid Vaccine

 
• By Vibha Ravi

Zydus expects strong mirabegron sales in FY26 amid US litigation even as it builds a growth pillar in vaccines with a world-first, Gates Foundation-aided dual shigella-typhoid vaccine under development and others on the WHO prequalified list

More from Focus On Asia

Ascentage Broadens Horizons As Pipeline Shows Renewed Promise

 
• By Xu Hu

Ascentage will share at ASCO new clinical data on its Bcl-2 inhibitor lisaftoclax, part of the Chinese firm's novel pipeline, on which its CEO shared with Scrip plans and strategy, along with some views on the use of RWD in China.

Tech Convergence, Quality Data Needed To Accelerate Korea’s AI-Powered R&D

 
• By Jung Won Shin

AI-powered drug development was a major topic at the recent Bio Korea meeting, where experts discussed how the technology is changing R&D activities and the challenges being faced by Korean firms as they look to catch up with their global competitors.

Strong Data For CARsgen’s CAR-T In Late-Line Gastric Cancer

 
• By Dexter Jie Yan

In first confirmatory randomized controlled trial of any CAR-T therapy in solid tumors, CARsgen’s Claudin 18.2-targeting satri-cel reduced risk of death or disease progression by 63% in Chinese patients with gastric/gastroesophageal junction cancer.