As we previously reported, one of three Pfizer IPR petitions filed in April 2017 against Biogen-owned patents claiming methods of treatment with rituximab was instituted. The instituted IPR is IPR2017-01168 regarding U.S. Patent No. 8,821,873 (the “’873 patent”), and the PTAB recently issued its Final Written Decision.
Adhering to its institution decision where it
On March 8, 2018, Amgen Inc. (“Amgen”) filed suit against Adello Biologics, LLC (“Adello”) in the District of New Jersey, alleging infringement of seventeen patents: U.S. Patent Nos. 6,180,391; 7,083,948; 7,118,884; 7,384,765; 7,427,659; 7,662,930; 7,735,525; 7,781,395; 8,191,566; 8,273,707; 8,940,878; 8,952,138; 9,418,416; 9,632,095; 9,643,997; 9,704,239; and 9,856,287. The case is assigned to Judge Claire C. Cecchi
Introduction and Background
The Apotex filgrastim/pegfilgrastim biosimilar litigation was the first biosimilar litigation where the parties participated in the patent dance. As a result, important issues regarding the interpretation of the Biologics Price Competition and Innovation Act (the “BPCIA”) were raised, including whether a biosimilar applicant (“(k) applicant”) must give 180-days’ notice to the reference
On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming of Biological Products.” According to FDA, the nonproprietary naming convention provided in the final guidance is intended to aid pharmacovigilance and to help prevent confusion and inadvertent substitution.
FDA’s newly-issued guidance covers the nonproprietary naming convention