1. Biosimilars: Regulation and Litigation

2. Agenda

3. Key Regulatory Exclusivities for Biologics

4. Additional Regulatory Exclusivities

7. Patent Strategy for Biologics

8. Comparison Between the 262(k) Pathway and the ANDA Pathway

9. Comparison Between the 262(k) Pathway and the ANDA Pathway (continued)

10. The “Patent Dance”: § 262(l) Provisions

11. Limitations/Remedies

12. Later litigation...

13. Case Study: Amgen v. Sandoz Amgen v. Sandoz, 14-cv-04741 (N. D. Cal
Case Study: Amgen v. Sandoz Amgen v. Sandoz, 14-cv (N.D. Cal., filed Oct. 24, 2014), on appeal, (Fed. Cir., filed Mar. 26, 2015).

14. Pioneer Case: First product to enter, and obtain approval under, the § 262(k) pathway

15. Patent Dance: Mandatory or Optional? Overview

16. Amgen: Patent Dance is Mandatory Provisions must be considered mandatory to achieve BPCIA goals

17. Sandoz: Patent Dance is Optional Applicants can choose either to (a) disclose, or (b) face declaratory judgment action

18. What remedies are available when applicants do not comply with the Patent Dance provisions?

19. Notice of commercial marketing: When can it be given?

20. District Court: March 19, 2015 Order

21. Amgen v. Sandoz Appeal: Fed. Cir.

22. Other Litigation

23. Questions?