New BPCIA Litigaton: AbbVie Sues Boehringer Ingelheim Regarding Proposed Biosimilar to Humira (adalimumab)

Today, AbbVie filed a complaint against Boehringer Ingelheim (BI) in the U.S. District Court for the District of Delaware regarding BI’s aBLA for a biosimilar version of AbbVie’s Humira (adalimumab) product.

The complaint alleges infringement of 8 patents: U.S. Patent Nos. 8,926,975; 9,018,361; 9,090,867; 9,096,666; 9,255,143; 9,266,949; 9,272,041; and 9,546,212.  According to the complaint, AbbVie identified to BI 74 patents as potentially infringed, pursuant to § 262(l)(3)(C) and § 262(l)(7), and proposed during the subsequent negotiations to litigate all of these patents in the litigation.  However, the complaint alleges, pursuant to § 262(l)(5), BI indicated that it would only agree to be sued on five patents and the parties then exchanged lists of five patents each; two patents on each list overlapped, resulting in eight patents-in-suit in this litigation.

As we have covered previously, AbbVie also sued Amgen regarding Amgen’s proposed biosimilar to Humira.  In the case against Amgen, AbbVie asserted the following ten patents:  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 — only two of which (U.S. Patent Nos. 9,096,666 and 9,272,041) are also asserted in AbbVie’s complaint against BI.

Stay tuned to the Big Molecule Watch for further updates.