According to the 2021 Centre for Medicines Research (CMR) factbook, cancer and immunomodulating treatments represent the therapeutic areas with the greatest R&D spending, accounting for 47.6% of all R&D expenditures in this field and totalling more than $18 billion (USD). They also represent a highly competitive space, as illustrated by recent market trends.
This report will examine the most strategic choices for litigating patents relating to antineoplastic (chemotherapy) and immunomodulating therapies in order to bring a generic drug to the market.
We will review post-grant litigation trends, including win rate and duration of first instance proceedings. Key takeaways revealed by our analysis include:
- Where does patent litigation take place
- Where are infringement litigation actions most likely to be successful
- What jurisdictions should patent owners focus on to protect their IP
- Where can patent owners pursue the most successful invalidity actions
The report also provides an analysis of paragraph IV certification, including where the largest paragraph IV filers are based, the number of paragraph IV filers per product and the products for which paragraph IV certification is most frequently filed.