Recent Trends in Litigation between Originators and Generics

• Jurisdiction: European Union
• Year: 2021
• Author: Marleen van den Horst

Speaker

Marleen is a partner in the IP & Technology department of BarentsKrans. She is head of the firm’s Healthcare & Life Sciences Industry Group. Marleen has over 25 years of experience in litigating and coordinating multi-jurisdictional patent cases. She is internationally renowned for having successfully represented clients in many patent disputes in all fields of technology: mechanical engineering, life sciences, chemistry and high tech/telecoms.

Marleen has acted as lead counsel in patent/SPC and regulatory proceedings and/or has advised clients in respect of many blockbuster molecules. In regulatory matters, Marleen has advised clients regarding clinical trials, orphan drug issues, disputes with the Medicines Evaluation Board (CBG) on marketing authorizations and the naming of products, questions concerning new active substances, line extensions and data & market exclusivity.

Topic

This e-presentation delves into two critical aspects that significantly influence the healthcare landscape and pharmaceutical industry. The first part of this presentation sheds light on the multifaceted topic of barriers to biosimilars, highlighting the profound impact they can have on both access to affordable medicines and the overall burden on public health expenditure.

Biosimilars, as similar but more affordable versions of biologic medicines, present a promising solution to the challenge of escalating healthcare costs. However, numerous obstacles hinder their widespread adoption. Throughout this segment, the speaker explores various barriers such as stringent regulatory requirements, intellectual property complexities, and market dynamics that impede the smooth integration of biosimilars into the healthcare system. By examining these hindrances, the speaker aims to highlight the potential loss of cost-saving opportunities and reduced accessibility to essential treatments for patients.

Moving on to the second part, the speaker delves into the ramifications of unjustly granted preliminary injunctions in patent litigation cases, a matter of paramount importance in the pharmaceutical realm. To illustrate this, the speaker refers to a recent landmark ruling...