2024 Open Forum // Patents - Patent Linkage

Patent Linkage

“Patent linking” in the classic sense is thought of as linking the approval of a generic pharmaceutical to the patent status of the name brand drug.

The Hatch-Waxman Act in the United States uses this classic approach in attempting to balance the rights of patentees with generic medicines and patients to provide a statutory framework intended to bring generic pharmaceuticals to market in a timely manner.  

But, this is not the only approach. Europe, for example, focuses its efforts on data and marketing exclusivities to promote R&D as well as facilitate generic market entry, while India uses a hybrid approach without formal linking.  Rather, India combines a developmental safety harbour with patent opposition practices to reduce evergreening.  

The Panel comprising Alessandro Pontiroli, Head Patent Attorney for Zentiva, and practitioners from India, Poland and China, will provide an overview of each system and will discuss practice tips from each perspective as well as how to coordinate efforts between the jurisdictions when seeking to bring a generic to market.

Moderator: Branko Pejic
Speakers: Juhua Luo, Alessandro Pontiroli, Deepa Tiku, Rafal Witek