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George O'Brien

ID:LEX-AR-D86H4KF8

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Unclaimed

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Organization: Hogan Lovells

FDA revises forms for submission of patent information to the Orange Book: Federal Circuit decision in Novartis AG v. Lee alters patent term adjustment

Focus on Regulation · February 27, 2014

Europe approves its first mAb biosimilar & FDA is handling 17 biosimilar INDs

Biosimilars Law Blog · October 7, 2013

FDA Denies 5-Year Exclusivity to “Stable Esters” and Confirms Structure-Based Approach to Exclusivity

Focus on Regulation · October 1, 2012

Public Comment on FDA Draft Biosimilars Guidances

Biosimilars Law Blog · February 29, 2012