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Hatch-Waxman Enablement Inquiries Patent Litigation

Robins Kaplan LLP

Astellas Pharma Inc. v. Zydus, Inc. II

Robins Kaplan LLP on

Nature of the Case and Issue(s) Presented: Astellas sued Lupin and Zydus based on the generics manufacturers’ ANDA filing and their efforts to make and sell generic mirabegron. In the leadup to the 2023 bench trial, the...more

McDonnell Boehnen Hulbert & Berghoff LLP

GlaxoSmithKline Files Amicus Brief in Amgen v. Sanofi

The Supreme Court's decision to grant certiorari in Amgen v. Sanofi is the first time in almost a hundred years that the Court has deigned to consider sufficiency of disclosure decisions, in this case enablement under 35...more

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