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Intellectual Property Protection › FDA Approval › Patent Trial and Appeal Board

Venable LLP

FDA Approves Third Actemra® Biosimilar, Celltrion’s Avtozma® (tocilizumab-anoh)

Venable LLP on

On January 24, 2025, the FDA approved Celltrion’s Avtozma® (tocilizumab-anoh), in intravenous and subcutaneous formulations, as the third biosimilar of Genentech’s Actemra® (tocilizumab)...more

Robins Kaplan LLP

Sanofi-Aventis U.S. LLC v. Apotex Corp. Jevtana® (Cabazitaxel)

Robins Kaplan LLP on

Case Name: Sanofi-Aventis U.S. LLC v. Apotex Corp., C.A. No. 20-cv-804-RGA, 2022 WL 2643532 (D. Del. July 8, 2022) (Hall, J.)  Drug Product and Patent(s)-in-Suit: Jevtana® (cabazitaxel); U.S. Patents Nos. 8,927,592 (“the ’592...more

Herbert Smith Freehills Kramer

Biosimilar Litigation Trends and Lessons Learned in 2019

Herbert Smith Freehills Kramer on

It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more

Jones Day

Tribal Sovereign Immunity Doctrine Does Not Insulate Tribes From Board Actions

Jones Day on

In a case of first impression, the PTAB recently decided that the doctrine of tribal sovereign immunity does not apply to inter partes review proceedings. See Mylan Pharmaceuticals Inc. v. Saint Regis Mohawk Tribe,...more

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