As we reported last week, on Thursday, August 4, AbbVie sued Amgen seeking an injunction to prevent Amgen from launching its biosimilar version of AbbVie’s Humira. The complaint alleges that Amgen’s biosimilar infringes 61 U.S. patents (and five pending U.S. patent applications that have since been allowed), but that AbbVie has asserted only 10 of those patents now due to Amgen’s choice under the BPCIA to limit the number of patents that will be litigated in the “first wave” of the action.*
In the complaint, AbbVie alleges that Amgen will need to overcome three “hurdles” in its attempt to launch a HUMIRA biosimilar: (1) its allegedly-infringed U.S. patents, including two that were the subject of Amgen IPR petitions that the PTAB declined to institute (see our IPR page with copies of those petitions and decisions denying institution); (2) Amgen’s choice under the BPCIA to litigate only some of the 61 allegedly infringed patents in the first wave of litigation; AbbVie promises a second wave of litigation regarding the remaining 51 allegedly infringed patents following Amgen’s 180 Day Notice of Commercial Marketing; and (3) Amgen’s previous arguments in defending its own patents against biosimilar challenges, which AbbVie contends are “at odds with those it is advancing in this case.”
The case arose following Amgen’s November 25, 2015 submission of its aBLA to the FDA requesting that its biosimilar adalimumab product be licensed for commercial sale as a biosimilar to Humira. According to AbbVie’s complaint, the FDA accepted the aBLA for filing “on or about” January 22, 2016.
The patents at issue are U.S. Patent Nos.: 8,663,945; 8,911,964; 8,916,157; 8,961,973; 8,986,693; 9,096,666; 9,220,781, 9,272,041; 9,359,434; and 9,365,645.
*(For more information on the exchange of patent lists and the negotiations that lead to the first wave litigation under the BPCIA, please contact us to request your free copy of Goodwin Procter’s 2016 edition of Biosimilars: A Guide to Regulatory and Intellectual Property Issues.)