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Federal Circuit Upholds Jury Award, Weighs in on Willfulness Standard, in Adynovate® Dispute

USA - March 30 2021 According to the Federal Circuit, $173 million was the right damages award for almost three years of patent infringement resulting from Baxalta’s…

Aron Fischer, Matthew Weiss

Sandoz Petitions the Supreme Court for Review of Enbrel® Patent License

USA - March 8 2021 The fight over proposed Enbrel® (etanercept) biosimilar Erelzi® continues. Sandoz Inc., Sandoz International GmbH and Sandoz GmbH (“Sandoz”) recently…

Matthew Weiss

FDA Approves Breyanzi®—A New Biologic for Treating Large B-Cell Lymphoma

USA - February 9 2021 On February 5, 2021, the FDA approved Juno Therapeutics, Inc.’s Breyanzi® (lisocabtagene maraleucel) for “treatment of adult patients with relapsed…

Matthew Weiss

2021 Biosimilar Approval and Litigation Update

USA - February 1 2021 The last two years saw the launch of several biosimilars. Looking ahead to 2021, several others may be on the horizon. In 2019-2020, the FDA approved…

Matthew Weiss

Rehearing Denied in Federal Circuit Hatch-Waxman Venue Case

USA - January 28 2021 The Federal Circuit has spoken. In a per curiam opinion, it denied Valeant’s petition for rehearing by the panel and rehearing en banc. A case…

Andrew D. Cohen, Matthew Weiss