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Federal Circuit Axes Amgen Antibody Patents, Finding Lack of Enablement

USA - February 18 2021 The Federal Circuit considered its 35 U.S.C. § 112 enablement case law and found that “the enablement inquiry for claims that include functional…

Andrew D. Cohen.

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…

Jordan Engelhardt.

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…

Jordan Engelhardt.

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, Jordan Engelhardt.

Judge Ramos Finds Forum Selection Clause of NDA Implicates Confidentiality and Not IP Rights and Allows IPRs to Proceed

USA - January 26 2021 On January 19, 2021, United States District Judge Edgardo Ramos (S.D.N.Y.) denied Kannuu Pty Ltd. (“Kannuu”)’s motion for preliminary injunction and…

Lewis V. Popovski.