Narrative Opinion Summary
In two related patent-infringement cases, Genentech, Inc. and City of Hope sued Amgen Inc. over its intent to market Mvasi, a biosimilar of Avastin, earlier than initially stated. Genentech sought a declaratory judgment to prevent Amgen from marketing Mvasi before December 18, 2018, as per the Biologics Price Competition and Innovation Act (BPCIA). Amgen filed motions to dismiss the claim for lack of subject matter jurisdiction and for failure to state a claim. The court ruled that it lacked jurisdiction because there was no immediate controversy as required under the Declaratory Judgment Act. The court found that Genentech had not provided sufficient evidence of an actual controversy, given that the notice of commercial marketing expired on April 4, 2018. Consequently, Amgen's motions to dismiss were granted, resulting in the dismissal of the relevant counts from Genentech's complaints without prejudice. The court noted that Genentech could pursue further legal remedies if Amgen launched Mvasi before the disputed date.
Legal Issues Addressed
Burden of Proving Subject Matter Jurisdictionsubscribe to see similar legal issues
Application: The party asserting jurisdiction bears the burden of establishing it, and jurisdictional challenges can be either facial or factual.
Reasoning: The burden of proving subject matter jurisdiction lies with the asserting party. Challenges to jurisdiction can be either facial, questioning the sufficiency of pleadings, or factual, questioning the sufficiency of jurisdictional facts.
Commercial Marketing Claims under BPCIAsubscribe to see similar legal issues
Application: Genentech's claim related to Amgen's marketing of a biosimilar is dismissed due to lack of jurisdiction and insufficient immediacy of controversy.
Reasoning: The court perceives the commercial marketing claim as lacking the necessary immediacy for a declaratory judgment.
Facial vs. Factual Attack on Jurisdictionsubscribe to see similar legal issues
Application: A facial attack considers only the complaint's allegations, whereas a factual attack allows the court to weigh additional evidence.
Reasoning: In a facial attack, only the allegations in the complaint and attached documents are considered favorably to the plaintiff. Conversely, a factual attack allows the court to weigh evidence outside the pleadings, where plaintiffs' allegations do not receive a presumption of truthfulness.
Procedural Limitations in Jurisdictional Challengessubscribe to see similar legal issues
Application: The court dismisses claims not supported by evidence attached to or referenced in the complaint, excluding additional documents.
Reasoning: The dismissal is based on procedural limitations, as the court can only consider the allegations in the complaint and related documents, excluding letters provided by Genentech that were not referenced or attached to the complaint.
Subject Matter Jurisdiction under Declaratory Judgment Actsubscribe to see similar legal issues
Application: The court examines whether there is an actual controversy of sufficient immediacy to warrant jurisdiction under the Declaratory Judgment Act.
Reasoning: The court emphasizes that, to exercise jurisdiction under the Declaratory Judgment Act, there must be an actual controversy of sufficient immediacy.