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BPCIA
102 published works
Big Molecule Watch
Litigation Update: Genentech’s Motion to Dismiss Amgen’s Counterclaims Denied in Avastin Biosimilar Litigation
On February 11, 2020, in the Biogen v. Amgen BPCIA litigation regarding MVASI (bevacizumab-awwb), Amgen’s biosimilar of AVASTIN, Judge Colm Connolly of the Delaware District Court denied most of Genentech’s…
Big Molecule Watch
Congress Adopts Biosimilar Related Provisions in the 2020 Appropriations Act
In passing H.R. 1865, the Further Consolidated Appropriations Act, 2020 (“FCAA”), on December 20, 2019, Congress adopted a number of changes to the BPCIA that impact biosimilars. Under the BPCIA,…
Big Molecule Watch
Legal Developments to Keep an Eye Out for in 2020
Here are our picks of some legal developments to keep an eye out for in the new year: Federal Circuit Decisions on Bevacizumab and Trastuzumab Preliminary Injunctions: Appeals are pending…
Big Molecule Watch
Year in Review: The Top-Five U.S. Biosimilar Market Developments of 2019
As we start the new year, we look back at the top U.S. biosimilar market developments of 2019. Here are some of our highlights, in no particular order: 1) Launch…
Biosimilars Law Bulletin
FDA Approves Four Biosimilars During Summer 2019 While Europe is on Vacation
FDA approves fourth Humira® (adalimumab) biosimilar with launch delayed to 2023. FDA approves second Rituxan® (rituximab) biosimilar, neither of which has launched. FDA approves second Avastin® (bevacizumab) biosimilar, which is…
Patents Post-Grant
BPCIA & FDA Steps as Article III Standing from the PTAB?
By Scott McKeown, Scott McKeown Wolf Greenfield
Are Biosimilar Development Efforts Enough? In Momenta Pharmaceuticals, Inc. v. Bristol-Myers Squibb Co. (here), the Federal Circuit was poised to explore the level of biosimilar legwork that could satisfy Article III…
Biosimilars Law Bulletin
FDA Issues New Guidance on Biosimilar Development under the BPCIA
Last month, the FDA released four new guidance documents providing insight on the FDA’s interpretation of provisions of the Biologics Price Competition and Innovation Act (“BPCIA”), as it amends the…
Biosimilars Law Bulletin
Third Time’s a Charm? Amgen Files Another BPCIA Lawsuit Against Apotex
Earlier this month, Amgen initiated suit against Apotex in the Middle District of Florida, alleging infringement of U.S. Patent No. 9,856,287 (“the ’287 patent”). This is the third complaint that…
PTABWatch
Proposed Hatch-Waxman Amendment Would Effectively Eliminate IPR Challenges by Generics
On June 13, 2018, Senator Orrin Hatch (R-UT) introduced to the Senate Judiciary Committee an amendment to restore the careful balance sought in the Hatch-Waxman Act, which provided incentives for…
Biosimilars Law Bulletin
Final Judgment Entered in <i>Amgen v. Coherus</i> Neulasta Litigation
Last week, on April 18, 2018, Judge Stark in the District of Delaware entered the Final Judgment and Order dismissing the patent infringement case brought by Amgen Inc. and Amgen…