On Friday, June 26, 2015 Amgen Inc. filed IPR petitions (IPR2015-01514 and IPR2015-01517) against two Humira (adalimumab) patents owned by AbbVie Inc., in an effort to clear the way for its Humira biosimilar, ABP 501. The patents, 8,916,157 and 8,916,158, are directed to improved formulations of Humira, which Amgen argues are obvious because they merely combine adalimumab, a known antibody, with known antibody-containing liquid formulations. The ’157 and ’158 patents were filed in August of 2014 and issued in December of the same year, and both have a priority date of August 16, 2002.
Amgen’s Humira biosimilar, ABP 501, met the primary end-point of equivalence in treating moderate to severe rheumatoid arthritis in a Phase III clinical trial in February of this year. Amgen has stated that it could to launch ABP 501 in 2017, after patents covering the adalimumab molecule expire.
We expect that AbbVie will respond to Amgen’s petitions in three months, and that the Patent Trials and Appeals Board will issue a decision as to whether or not it will institute the IPRs by end of December. We will provide updates as the IPRs progress.