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

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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.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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