Shall we Dance: Mastering the “Steps” of the BPCIA While Avoiding Common Pitfalls
What is it about?
This interactive session will delve into the decision-making process for each step along the way from decision to go through the BPCIA, to litigation strategies, to product launch and marketing. The audience will divide into small “working groups,” each with a moderator. Topics to be discussed include:
- Possible impact of Amgen v. Sandoz on the patent dance
- Pros and cons of taking part in the patent dance
- Interplay between IPRs and the Patent Dance
- Strategically timing the filing of a biosimilar application in light of 180-day notice provision
- Tips for minimizing litigation risks for biosimilars applicants