News & Analysis as of

Abbreviated New Drug Application (ANDA) Enablement Inquiries Obviousness

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

McDermott Will & Emery

Claimed Formulation Not Obvious Despite Recitations Falling Within Prior Art Ranges - Allergan, Inc. v. Sandoz Inc.

McDermott Will & Emery on

Addressing obviousness issues, the U.S. Court of Appeals for the Federal Circuit affirmed a lower court’s finding that patents were valid and infringed, despite undeniably including recitations falling within a prior art...more

McDonnell Boehnen Hulbert & Berghoff LLP

Teva Pharmaceuticals USA, Inc. v. Sandoz, Inc. (Fed. Cir. 2013)

A claim term that can have different meanings or values depending on the method used to measure it renders the claim indefinite because it is impossible for a potential infringer to discern the boundaries of the claim. This...more

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