Last week, the Federal Circuit affirmed a lower court’s dismissal of AbbVie’s complaint seeking declaratory judgment of invalidity of U.S. Patent No. 6,248,516 (“the ’516 patent”) owned by Astra Zeneca subsidiary MedImmune. AbbVie brought this declaratory judgment action in June 2016 in the hopes of ending its royalty obligations to MedImmune.
The Fed. Circuit’s decision
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years. Global sales
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the coming years. Global sales for the top nine branded biologic
Samsung Bioepis (“Bioepis”) has joined a growing list of challengers to Genentech’s U.S. Patent No. 6,407,213 (“the ʼ213 patent”) issued to Carter, et al. by filing two new petitions for inter partes review (“IPR”). The ʼ213 patent, entitled “Method for Making Humanized Antibodies,” is generally directed to antibodies with humanized variable domains comprising non-human complementarity
As pharmaceutical drug costs attract increasing media attention and political scrutiny, a growing number of biosimilar drugs are set to enter the U.S. and European markets in the
Biologic drugs are quickly reshaping the pharmaceutical landscape as they dominate the drug market in annual sales revenue. Abbvie’s Humira® (adalimumab) rocketed to the best-selling drug in the world with sales generating over $16 billion USD in 2016. The top biologic drugs are all driving revenues well beyond the $1 billion sales revenue demarcation that
H.R.2430 – FDA Reauthorization Act of 2017, a bill reauthorizing all of the U.S. Food and Drug Administration (“FDA”) user fee programs, including reauthorization of the Biosimilar User Fee Act (“BsUFA II”), was passed in the House of Representatives on July 12, 2017, with bipartisan support by voice vote. The House bill comes as
On June 19, 2017, the European Commission (EC) approved Sandoz’s Rixathon® (rituximab), a biosimilar to Roche/Genentech’s Rituxan®/Mabthera®. The approval follows the positive recommendation by the Committee for Medicinal Products for Human Use (“CHMP”) issued two months ago.
Rituximab is an anti-CD20 monoclonal antibody approved for the treatment of non-Hodgkin’s lymphoma (follicular lymphoma and diffuse large