Posted in:News PTAB Final Written Decision Finds All Claims (1-5) of U.S. Patent No. 8,821,873 Obvious Over the Combination of Five Prior Art References By Rachel M. Echols December 3, 2018 As we previously reported, one of three Pfizer IPR petitions filed in April 2017 against Biogen-owned patents claiming methods of treatment... Read more Tagged with: Biogen, IPR, News, Pfizer, PTAB, Rituxan®, Rituximab
Posted in:Legal Litigation Spotlight: The Adello Filgrastim (Neupogen®) Litigation By Rachel M. Echols May 29, 2018 On March 8, 2018, Amgen Inc. (“Amgen”) filed suit against Adello Biologics, LLC (“Adello”) in the District of New Jersey, alleging... Read more Tagged with: Adello Biologics, Amgen, Featured, filgrastim, Legal, Neupogen®, Patent Dance, Sandoz v. Amgen
Posted in:Legal Litigation Spotlight: The Apotex Filgrastim (Neupogen®) and Pegfilgrastim (Neulasta®) Litigation By Rachel M. Echols May 10, 2017 Introduction and Background The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the... Read more Tagged with: Amgen, Amgen v. Apotex, Apotex, BPCIA, District Court, Featured, Federal Circuit, filgrastim, Legal, Litigation, Litigation Spotlight, Neulasta®, Neupogen®, Notice, Notice Requirement, Patent Dance, pegfilgrastim
Posted in:Regulatory FDA Issues Final Guidance on Non-Proprietary Naming of Biological Products By Rachel M. Echols January 15, 2017 On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming... Read more Tagged with: FDA, Featured, Guidance, Labeling, Naming, Regulatory