OPINION
KATHARINE S. HAYDEN, District Judge.
I. Background
A. The Present Dispute
This patent infringement suit arises under the Federal Food, Drug, and Cosmetic Act ("FD & C Act"), and, more specifically, the Hatch-Waxman Amendments to that body of law. Plaintiff PDL Biopharma, Inc. ("PDL"), now substituted by EKR Therapeutics, Inc. ("EKR"),
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