Biosimilars: Regulation and Litigation

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Presentation transcript:

Biosimilars: Regulation and Litigation

Agenda

Key Regulatory Exclusivities for Biologics

Additional Regulatory Exclusivities

Patent Strategy for Biologics

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

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

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

Limitations/Remedies

Later litigation...

Case Study: Amgen v. Sandoz Amgen v. Sandoz, 14-cv-04741 (N. D. Cal Case Study: Amgen v. Sandoz Amgen v. Sandoz, 14-cv-04741 (N.D. Cal., filed Oct. 24, 2014), on appeal, 15-1499 (Fed. Cir., filed Mar. 26, 2015).

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

Patent Dance: Mandatory or Optional? Overview

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

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

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

Notice of commercial marketing: When can it be given?

District Court: March 19, 2015 Order

Amgen v. Sandoz Appeal: Fed. Cir.

Other Litigation

Questions?