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Biosimilar Litigation Trends: Settlements, Declaratory Judgment Rejections, Congressional Intervention

 
• By Brenda Sandburg

Of the 27 suits brought so far, four have resulted in patent settlements; restarting patent dance is new trend for ongoing litigation.

Close up golden chess pieces with blurry judge gravel and law book background.

While biosimilar patent disputes in the US are still nascent, the developments of the past year show how they are evolving. There have been four settlements, one jury award for a brand company, and several wins for biosimilar makers. District courts have also been rejecting efforts by biosimilar sponsors to get preemptory judgements of noninfringement and patent invalidity.

To date, 27 biosimilar patent suits appear to have been filed. These include declaratory judgment actions by biosimilar makers and duplicate Rituxan and Herceptin suits by Genentech Inc. against Celltrion Inc

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