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Federal Circuit Clarifies Limits of Safe Harbor Defense in Amgen v. Hospira

USA - January 3 2020 Recently, in Amgen Inc. v. Hospira, Inc.,the Federal Circuit clarified the limits of the Safe Harbor defense in cases involving patented…

Benjamin F. Jackson.

The 2019 U.S. Federal Government Shutdown and its Potential Impact on Biologics

USA - January 9 2019 On December 22, 2018, the United States federal government entered a partial shutdown, which now enters its 19th day. If the shutdown continues…

Andrew D. Cohen.

2019 Year-End Biosimilar Litigation Roundup

USA - December 6 2019 As 2019 draws to a close, a handful of actions regarding biologics are pending in the federal courts. The current cases are listed below, in order…

Nathan Monroe-Yavneh.

Amgen Files New Patent Infringement Suit Over Neupogen Biosimilar

USA - August 5 2019 On July 23, 2019, Amgen, maker of the cancer treatment drug Neupogen (filgrastim), filed patent infringement claims in the Southern District of…

Michael Fresco.

FDA Approves Pfizer’s Biosimilar of Neupogen® as Amgen and Pfizer Litigate Patent Infringement

USA - August 9 2018 On July 20, 2018, FDA approved Pfizer’s biosimilar of Amgen’s Neupogen® (filgrastim). Pfizer’s product, Nivestym™, is the second biosimilar of…

Nicole A. Conlon.