News & Analysis as of

Food and Drug Administration (FDA) Doctrine of Equivalents

Robins Kaplan LLP

Horizon Medicines LLC v. Alkem Labs. Ltd.

Robins Kaplan LLP on

Duexis® (ibuprofen / famotidine) - Case Name: Horizon Medicines LLC v. Alkem Labs. Ltd., No. 18-1014-RGA, 2020 WL 7022591 (D. Del. Nov. 30, 2020) (Andrews, J.) ...more

Akin Gump Strauss Hauer & Feld LLP

Delaware Court Recommends Dismissal with Prejudice of Biosimilar Neulasta Suit

In a Report and Recommendation issued December 7, 2017, Magistrate Judge Burke in the District of Delaware recommended that Amgen’s BPCIA complaint for infringement against Coherus Biosciences Inc. be dismissed with prejudice...more

McDermott Will & Emery

No Approval for Generic Product for Treatment of Rosacea **WEB ONLY**

Addressing infringement under the doctrine of equivalents and obviousness issues, the US Court of Appeals for the Federal Circuit affirmed the district court’s ruling barring approval of a generic version of Finacea® gel...more

McDonnell Boehnen Hulbert & Berghoff LLP

An Inflectra Update: Janssen Requests an Expedited Trial

As we reported last week, the U.S. Food and Drug Administration approved Celltrion's application to market Inflectra, a biosimilar to Janssen Biotech Inc.'s REMICADE (infliximab) anti-TNF-a antibody. On Tuesday, April 12,...more

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