September 06, 2016
A Florida federal judge on Tuesday cleared Canadian generics maker Apotex Inc. of patent infringement claims brought by pharmaceutical firm Amgen Inc. related to its blockbuster biologic Neulasta, saying that Amgen didn't prove how Apotex's biosimilars infringed but stopping short of awarding attorneys' fees.
July 11, 2016
Amgen Inc. began its pitch Monday to a Florida federal judge to block Canadian generics maker Apotex Inc. from making a copy of Amgen's blockbuster biologic Neulasta by arguing that the proposed biosimilar infringes a patent designed for industrial-scale protein production.
December 09, 2015
A Florida federal judge on Wednesday found that biosimilar makers must always provide 180-day notice of sales to brand-name rivals when using a streamlined approval pathway, a milestone ruling that would delay Apotex's copy of Amgen's blockbuster Neulasta and potentially reverberate industrywide.
October 19, 2015
Amgen Inc. asked a Florida federal court Friday to stop Canadian generics maker Apotex Inc. from marketing its biosimilar copy of the blockbuster biologic Neulasta until it complies with a federal law requiring it to give Amgen proper notice.
October 06, 2015
Canadian generics maker Apotex Inc. fired back in Florida federal court Monday with counterclaims accusing Amgen Inc. of filing sham litigation alleging Apotex infringed two patents for blockbuster biologic Neulasta.
August 26, 2015
Janssen Biotech Inc. and Celltrion Inc. are squaring off in Massachusetts federal court with competing views of a recent Federal Circuit interpretation of the Biologics Price Competition and Innovation Act, debating whether it made advance-notice of biosimilar marketing mandatory in all circumstances.