News & Analysis as of

Permanent Injunctions Abbreviated New Drug Application (ANDA)

McDermott Will & Emery

ANDA Update - March 2017 Volume 3, Number 1

McDermott Will & Emery on

Speculative Evidence of Irreparable Harm Sinks Bayer's Request for Permanent Injunction - Bayer Pharma AG, et al. v. Watson Laboratories, Inc. (D. Del. December 28, 2016) - Applying the eBay factors to Plaintiff...more

Locke Lord LLP

Speculation of ANDA Product Launch Before FDA Approval Does Not Warrant Permanent Injunction

Locke Lord LLP on

On December 28, 2016, Judge Stark of the District of Delaware, despite having previously found infringement, held that plaintiffs Bayer Pharma AG, Bayer Intellectual Property GmbH, and Bayer HealthCare Pharmaceuticals Inc....more

McDermott Will & Emery

ANDA Update - October 2015

McDermott Will & Emery on

Federal Circuit Interprets Statutory Requirements for Biosimilar Regulatory Pathway - Amgen Inc., v. Sandoz Inc., (Fed. Cir. July 21, 2015): In a case of first impression, the U.S. Court of Appeals for the Federal...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

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