Article III Declaratory Judgments

News & Analysis as of

Nearly Two Years After Dismissal of its Declaratory Judgment Action, FDA Accepts for Review Sandoz’s Application for a Biosimilar...

Sandoz Inc. announced on October 2, 2015 that FDA accepted its regulatory application for a proposed biosimilar of Amgen Inc.’s biologic arthritis drug Enbrel for review. The acceptance comes years after Sandoz attempted to...more

Biosimilars Update

Novartis came one step closer to becoming the first company to offer a biosimilar drug for sale in the United States. Last month, an independent panel voted 14-0 to recommend FDA approval of Sandoz’s (Novartis’ generics...more

A Covenant Not to Sue May Avoid Invalidity Claims

Last week, in Already, LLC v. Nike, Inc. (opinion attached), the Supreme Court unanimously decided that the voluntary cessation doctrine, most often used when a defendant claims its voluntary compliance moots a case where it...more

Just Moot It: Supreme Court in Already v. Nike Clarifies When a Covenant Not to Sue Can Kill a Declaratory Judgment Case

In 2007, the Supreme Court in MedImmune v. Genentech broadened the scope of declaratory judgment jurisdiction, making it easier for parties fearing IP claims to bring defensive lawsuits. Last week, the Court made it easier...more

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