Sandoz, Inc. (“Sandoz”) entered into the battlefield over patents related to AbbVie’s Humira® (adalimumab). On July 20, 2017, Sandoz filed petitions with the Patent Trial and Appeal Board (“PTAB”) for inter partes review (“IPR”) of two patents assigned to AbbVie, U.S. Patent No. 8,802,100 (“the ’100 patent”) entitled “Formulation of Human Antibodies for Treating TNF-Alpha Associated Disorders,” and U.S. Patent No. 9,512,216 (“the ’216 patent”) entitled “Use of TNF- α Inhibitor.”
Adalimumab is a TNF (tumor necrosis factor) inhibitor that binds to TNF-alpha (TNF-α), preventing it from activating TNF receptors, which cause the inflammatory reactions associated with autoimmune diseases. Humira® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, psoriasis, and ulcerative colitis.
The proceedings are IPR2017-01823 (involving the ‘100 patent) and IPR2017-01824 (involving the ’216 patent). The only real party-in-interest identified for Petitioner is Sandoz.
Several other companies including Coherus, Boehringer Ingelheim, and Amgen have previously filed IPR petitions on other patents related to Humira®. A complete list of IPRs can be found in RFEM’s IPR Dashboard. We will continue to provide updates as these cases progress.